Publications by authors named "Surakit Nathisuwan"

43 Publications

Comparison of the HAS-BLED versus ORBIT Scores in Predicting Major Bleeding Among Asians Receiving the Direct-Acting Oral Anticoagulants.

Br J Clin Pharmacol 2021 Nov 16. Epub 2021 Nov 16.

Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom.

Aims: This study aimed to evaluate the performance of HAS-BLED and ORBIT scores in predicting bleeding risk among Asian patients with non-valvular atrial fibrillation (NVAF) using the direct-acting oral anticoagulant (DOACs).

Methods: A retrospective chart review was conducted among adult patients receiving DOACs for > 6 months during January 2013 - December 2017 in 10 tertiary care hospitals in Thailand. The area under the receiver-operating curve (AUROC) method or C-statistic was used to test the diagnostic accuracy for bleeding risk classification of HAS-BLED and ORBIT scores. The predictive performances of the two scores were compared using DeLong's method.

Results: A total of 961 NVAF patients, 52.5% warfarin-naïve and 47.5% warfarin-experienced, with mean age of 74.25±10.08 years, were included in the analysis. Mean HAS-BLED and ORBIT scores of the cohort were 1.98±1.10 and 2.37±1.71, respectively. During the mean follow-up time of 1.55+1.13 years, 34 patients experienced major bleeding (2.28 events/100 patient-year). For the overall cohort, both the HAS-BLED and ORBIT scores showed similarly moderate predictive performance on bleeding with C-statistic (95%CI) of 0.65 (0.57-0.74) and 0.64 (0.56-0.71), respectively. There was no statistical significance between the two scores (p = 0.62). Analysis based on the status of previous warfarin use was consistent with the overall cohort. Based on the calibration analysis, both HAS-BLED and ORBIT scores possessed moderate ability to identify those who experienced major bleeding from those who did not.

Conclusion: Both HAS-BLED and ORBIT bleeding risk scores had moderate predictive performance in Asian NVAF patients receiving DOACs.
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http://dx.doi.org/10.1111/bcp.15145DOI Listing
November 2021

Prospective randomised trial examining the impact of an educational intervention versus usual care on anticoagulation therapy control based on an SAMe-TTR score-guided strategy in anticoagulant-naïve Thai patients with atrial fibrillation (TREATS-AF): a study protocol.

BMJ Open 2021 10 11;11(10):e051987. Epub 2021 Oct 11.

Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, UK

Introduction: The burden of atrial fibrillation (AF) in Thailand is high and associated with increased morbidity, mortality and healthcare costs. Vitamin K antagonists (eg, warfarin), commonly used for stroke prevention in patients with AF in Thailand, are effective but are often suboptimally controlled. We aim to evaluate the impact of an SAMe-TTR score-guided strategy and educational intervention compared to usual care on anticoagulation control expressed by the time in therapeutic range (TTR) at 12 months, in anticoagulant-naïve Thai patients with AF.

Methods And Analysis: Multicentre, open-label, parallel-group, randomised controlled trial conducted in Thailand among adult patients (age: 18 years) with AF who are anticoagulant naïve. Patients will be randomised to one of two groups; an SAMe-TTR score-guided strategy with educational intervention and usual care versus usual care alone. The planned follow-up period is 12 months. The primary outcome is TTR at 12 months. Secondary outcomes include: (1) TTR at 6 months; (2) thromboembolic and bleeding events at 12 months; (3) composite major adverse cardiovascular events at 12 months; (4) change in patients' knowledge of AF between baseline and 6 months and 12 months; (5) cost effectiveness; (6) quality of life at baseline, 6 months and 12 months using EQ-5D-5L (Thai version) and (7) patient satisfaction/perceptions of the TREAT intervention. An embedded qualitative study will assess patient perceptions of the TREAT intervention.

Ethics And Dissemination: The study has been approved by the Ethical Review Committee, Ministry of Public Health of Thailand, and registered in the Thai Clinical Trials Registry. The results of this trial will be submitted for publication in a peer-reviewed journal. Participants will be informed via a link to a preview of the publication. A lay summary will also be provided to all participants prior to publication.

Trial Registration Number: TCTR20180711003.
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http://dx.doi.org/10.1136/bmjopen-2021-051987DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8506852PMC
October 2021

Economic evaluation of direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs) for stroke prevention in patients with atrial fibrillation: a systematic review and meta-analysis.

BMJ Evid Based Med 2021 Oct 11. Epub 2021 Oct 11.

Mahidol University Health Technology Assessment (MUHTA) Graduate Program, Mahidol University, Bangkok, Thailand.

Objectives: To assess cost-effectiveness of direct oral anticoagulants (DOACs) compared with vitamin K antagonists (VKAs) for stroke prevention in atrial fibrillation (AF) by pooling incremental net benefits (INBs).

Design: Systematic review and meta-analysis.

Setting: We searched PubMed, Scopus and Centre for Evaluation of Value and Risks in Health Registry from inception to December 2019.

Participants: Patients with AF.

Main Outcome Measures: The INB was defined as a difference of incremental effectiveness multiplied by willing to pay threshold minus the incremental cost; a positive INB indicated favour treatment. These INBs were pooled (stratified by level of country income, perspective, time-horizon, model types) with a random-effects model if heterogeneity existed, otherwise a fixed effects model was applied. Heterogeneity was assessed using Q test and I statistic. Risk of bias was assessed using the economic evaluations bias (ECOBIAS) checklist.

Results: A total of 100 eligible economic evaluation studies (224 comparisons) were included. For high-income countries (HICs) from a third-party payer (TPP) perspective, the pooled INBs for DOAC versus VKA pairs were significantly cost-effective with INBs (95% CI) of $6632 ($2961.67 to $10 303.72; I=59.9%), $6353.24 ($4076.03 to $8630.45; I=0%), $7664.58 ($2979.79 to $12 349.37; I=0%) and $8573.07 ($1877.05 to $15 269.09; I=0%) for dabigatran, apixaban, rivaroxaban and edoxaban relative to VKA, respectively but only dabigatran was significantly cost-effective from societal perspective (SP) with an INB of $11 746.96 ($2429.34 to $21 064.59; I=52.4%). The pooled INBs of all comparisons for upper-middle income countries (UMICs) were not significantly cost-effective. The ECOBIAS checklist indicated that risk of bias was mostly low for most items with the exception of five items which should be less influenced on pooling INBs.

Conclusions: Our meta-analysis provides comprehensive economic evidence that allows policy makers to generalise cost-effectiveness data to their local context. All DOACs may be cost-effective compared with VKA in HICs with TPP perspective. The pooling results produced moderate to high heterogeneity particularly in UMICs. Further studies are required to inform UMICs with SP.

Prospero Registeration Number: CRD 42019146610.
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http://dx.doi.org/10.1136/bmjebm-2020-111634DOI Listing
October 2021

Real-world experience of angiotensin receptor/neprilysin inhibitor (ARNI) usage in Thailand: a single-center, retrospective analysis.

BMC Cardiovasc Disord 2021 07 2;21(1):324. Epub 2021 Jul 2.

Division of Cardiology, Department of Internal Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.

Background: Treatment of heart failure with reduced ejection fraction (HFrEF) has been revolutionized by angiotensin receptor/neprilysin inhibitor (ARNI). ARNI has been shown to significantly reduce morbidity and mortality in a large, randomized controlled trial. However, real-world evaluation of ARNI with a diverse population is still limited.

Methods: HFrEF patients receiving angiotensin receptor/neprilysin inhibitor (ARNI) or standard HF treatment at a university hospital in Thailand were prospectively followed-up from January 2015 to December 2019. The primary outcome was a composite of all-cause mortality and heart failure hospitalization. Survival analysis and the Cox proportional hazard model were used to compare clinical outcomes between the two groups.

Results: During a follow-up period of 12 months, the primary outcome occurred in 10 patients in the ARNI group (11.5%) and 28 in the standard treatment group (28.0%) (hazard ratio 0.34; 95% CI: 0.15-0.80; p = 0.013). After adjustment for confounding factors, ARNI was significantly associated with a significant reduction in the primary outcome (HR 0.32, 95% CI: 0.13-0.82, p = 0.017). In addition, ARNI was also significantly associated with a decrease in the clinical signs and symptoms of HF, including dyspnea, orthopnea, and fatigue. Orthostatic hypotension was more frequently reported among the ARNI group than among the standard treatment group. The rates of target dose achievement were comparable between the two groups.

Conclusion: In real-world practice, ARNI use was associated with a significant reduction in both clinical outcomes and symptom improvement, while orthostatic hypotension was more common in patients in the ARNI group than in patients in the standard treatment group.
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http://dx.doi.org/10.1186/s12872-021-02145-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8254265PMC
July 2021

A systematic review and meta-analysis of randomized controlled trials of cardiovascular toxicity of medical cannabinoids.

J Am Pharm Assoc (2003) 2021 Sep-Oct;61(5):e1-e13. Epub 2021 Mar 26.

Background: Several systematic reviews (SRs) have summarized the potential effectiveness of medical cannabinoids, but it is unclear to what extent safety-related outcomes were incorporated.

Objective: The objective of this study was to evaluate the cardiovascular toxicity associated with medical use of cannabinoids.

Methods: A 2-stage systematic review (SR) approach was undertaken to assess the current evidence on cannabinoid-associated cardiovascular events reported among randomized controlled trials (RCTs). First, we searched for SRs in multiple sources until June 2019. Second, RCTs identified from the SRs were included if they assessed medical cannabis and reported cardiovascular events. The outcomes of interest were all types of cardiovascular events. Data were extracted by 2 independent reviewers. Study quality was assessed using the Cochrane risk of bias. A statistical test of heterogeneity was performed. The summary risk ratios (RRs) and 95% CIs were calculated using a random-effects model.

Results: A total of 47 studies involving 2800 patients were included. The median duration of cannabinoid use was 15.8 days (range 1 to 322), and 45% of the studies excluded patients with underlying cardiovascular diseases. Cannabinoid use was significantly associated with increased risks of orthostatic hypotension (RR 3.16 [95% CI 2.27-4.40], I = 2.3%) and hypotension (3.55 [1.45-8.71], I = 31.8%), with a trend of increased risk of tachycardia (1.94 [0.81-4.64], I = 48.6%). No study reported serious cardiovascular events.

Conclusions: Cannabinoid use was associated with tachycardia, hypotension, and orthostatic hypotension. There is a paucity of data for other cardiovascular events among medical cannabis users. More data, especially regarding long-term effects among patients with existing cardiovascular diseases, are needed.
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http://dx.doi.org/10.1016/j.japh.2021.03.013DOI Listing
October 2021

Effect of tomato, lycopene and related products on blood pressure: A systematic review and network meta-analysis.

Phytomedicine 2021 Jul 16;88:153512. Epub 2021 Feb 16.

Faculty of Pharmacy, Mahidol University, Bangkok, Thailand; Sireeruckhachati Nature Learning Park, Mahidol University, Nakhon Pathom, Thailand. Electronic address:

Background: A number of randomized controlled trials (RCTs) have been conducted to evaluate the hypotensive effects of tomato, lycopene, and related products. However, the findings were conflicting, partly due to differences in the types of products investigated. Therefore, this study aimed to assess and compare the hypotensive effects of different tomato-related preparations through a network meta-analysis based on randomized controlled trials.

Study Design: A systematic review and network meta-analysis.

Methods: A network meta-analysis based on a systematic review of RCTs comparing the effect of various tomato, lycopene and related products versus placebo on blood pressure in adults was performed. PubMed, EMBASE, SCOPUS, and Clinicaltrial.gov databases were searched up to October 2020 without language restrictions. The primary outcomes were systolic and diastolic blood pressure. Mean differences (MDs) along with 95% confidence intervals (CIs) were estimated and pooled using a random-effects model. Heterogeneity was assessed using the global inconsistency test.

Results: A total of 11 studies including six forms of tomato, lycopene and related products met the inclusion criteria. Among these trials, eight (N = 617) and seven trials (N = 501) were included in the analysis of systolic (SBP) and diastolic blood pressure (DBP) outcomes, respectively. The standardized tomato extract (STE) significantly decreased SBP compared to placebo, with a pooled MD (95% CI) of -5.89 (-9.13 to -2.64) mmHg. The effect on DBP was not significant, with a pooled MD (95% CI) of -3.51 (-7.39 to 0.38) mmHg. Subgroup analysis in hypertensive patients showed that STE significantly reduced both SBP and DBP with pooled MDs (95% CIs) of -8.09 (-11.52 to -4.67) and -4.25 (-6.97 to -1.53) mmHg, respectively, compared to placebo. Other forms of tomato, including other dose ranges of standardized tomato extract, tomato-containing diet, lycopene-free preparation, and synthetic lycopene, did not show consistent and significant effects on either SBP or DBP in all analyses.

Conclusion: Standardized tomato extract (STE) significantly decreased SBP compared to placebo in a mixed population of healthy volunteers and hypertensive patients. The BP-lowering effect was more pronounced among hypertensive patients. No significant BP effects were seen with other forms of tomato, lycopene and related products in the overall population or any subgroup of the population.
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http://dx.doi.org/10.1016/j.phymed.2021.153512DOI Listing
July 2021

Knowledge of stroke and medication adherence among patients with recurrent stroke or transient ischemic attack in Indonesia: a multi-center, cross-sectional study.

Int J Clin Pharm 2021 Jun 29;43(3):666-672. Epub 2020 Oct 29.

Clinical Pharmacy Division, Department of Pharmacy, Faculty of Pharmacy, Mahidol University, 447 Sri-Ayutthaya Road, Ratchathewi, Bangkok, 10400, Thailand.

BackgroundThere is a limited data in Indonesia regarding the stroke knowledge and medication adherence among stroke survivors.ObjectiveTo assess the level of stroke knowledge and medication adherence along with their relationship among stroke survivors.SettingTwo tertiary-care hospitals in Surabaya, East Java, Indonesia.MethodsA prospective, cross-sectional study was conducted among 215 stroke survivors. Stroke Knowledge Test and the Morisky Green Levine Adherence Scale questionnaires were used to evaluate stroke knowledge and medication adherence, respectively. Binary logistic regression was performed to assess the rela tionship between stroke knowledge and medication adherence. Main outcome measuresRelationship between stroke knowledge and medication adherence.ResultsA total of 215 patients with mean age of 56.34 ± 8.69 years were recruited into this study. Mean Stroke Knowledge Test score was 7.89 ± 3.38 with 76.7% had low level of stroke knowledge. Mean Morisky Green Levine Adherence Scale was 3.05 ± 1.11 with 52.1% had low to medium medication adherence. Education and duration of stroke correlated with stroke knowledge level (Spearman's correlation coefficient: 0.307, p = 0.001 and 0.128, p = 0.041, respectively). Age and disability correlated with medication adherence (Spearman's correlation coefficient: 0.169; p = 0.013 and 0.171; p = 0.012), respectively. After adjustment for covariates, stroke knowledge level was independently associated with medication adherence (adjusted OR: 4.37, 95% CI 2.00-9.53; p < 0.001).ConclusionStroke knowledge was low among Indonesian stroke survivors and independently related to medication adherence. Attempts should be made to increase stroke knowledge which may improve medication adherence among stroke survivors.
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http://dx.doi.org/10.1007/s11096-020-01178-yDOI Listing
June 2021

Real-World Comparative Effectiveness and Safety of Non-Vitamin K Antagonist Oral Anticoagulants vs. Warfarin in a Developing Country.

Clin Pharmacol Ther 2021 05 22;109(5):1282-1292. Epub 2020 Nov 22.

Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, UK.

We aimed to compare effectiveness and safety of the non-vitamin K antagonist oral anticoagulants (NOACs) vs. warfarin for stroke prevention in nonvalvular atrial fibrillation (NVAF) in a developing country where anticoagulation control with warfarin is suboptimal. A real-world study was conducted among patients with NVAF in Thailand receiving NOACs and warfarin from 9 hospitals during January 2012 to April 2018. Propensity-score weighting was used to balance covariates across study groups. Cox regression models were used to compare the risk of thromboembolism, major bleeding, and net adverse clinical events across matched cohorts. A total of 2,055 patients; 605, 604, 441, and 405 patients receiving warfarin, rivaroxaban, dabigatran, and apixaban, respectively, were included. Median (interquartile range) time in therapeutic range (TTR) for warfarin users was 49.5% (26.6%-70.3%). Compared with warfarin, NOACs were associated with a significant reduction in major bleeding either when analyzed as a group (adjusted hazard ratio (HR) (95% confidence interval (CI)) of 0.46 (0.34-0.62) or by each agent. Compared with warfarin users with poor TTR, apixaban (adjusted HR 0.48, 95% CI 0.26-0.86, P = 0.013) and dabigatran (adjusted HR 0.44, 95% CI 0.21-0.90, P = 0.025) were associated with a lower risk of thromboembolism, in addition to markedly lower risk of major bleeding. In a healthcare system where anticoagulation control with warfarin is suboptimal, use of NOACs was associated with a profound reduction in major bleeding. The effectiveness and safety advantages of NOACs were more pronounced compared with warfarin users with low TTR.
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http://dx.doi.org/10.1002/cpt.2090DOI Listing
May 2021

Prescriber compliance to direct oral anticoagulant labels and impact on outcomes in Thailand.

Br J Clin Pharmacol 2021 03 9;87(3):1390-1400. Epub 2020 Sep 9.

Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, UK.

Aims: This study aimed to evaluate the prescriber compliance to the approved labels of direct oral anticoagulants (DOACs) and impact of appropriateness of dosing on clinical outcomes.

Methods: A retrospective study was conducted using simple-stratified random sampling of adult patients receiving ≥6 months of DOACs for various indications during 2013-2017 in 10 tertiary care hospitals. Patients were classified into 3 dosing groups including approved dose, underdosing and overdosing based on the Thai Food and Drug Administration-approved labels. Cox proportional hazard models were used to evaluate the impact of different dosings on thromboembolic and bleeding events.

Results: From 1200 patients included in the data analysis, prescribing of DOACs was consistent with the approved indications in 1130 cases (94.2%) while 70 patients (5.8%) received DOACs despite having contraindications or with off-label usage. Among 1026 cases of dosing evaluation cohort, 688 patients (67.1%) received approved doses. There were 227 (21.9%) and 110 (10.7%) cases of underdosing and overdosing, respectively. Multivariate analysis showed that underdosing was associated with an increased risk of thromboembolism 3.023 (95% confidence interval [CI]: 1.291-7.080; P = .011) while overdosing was associated with an increased risk of bleeding requiring hospitalization (adjusted hazard ratio, 3.045; 95% CI, 1.501-6.178; P = .002) and Bleeding Academic Research Consortium type 2 or more (adjusted hazard ratio, 2.196; 95% CI, 1.083-4.452; P = .029).

Conclusion: Prescribers' compliance to approved indications were high. However, 1/3 of DOAC prescriptions were inconsistent with approved dosing. Dosing deviation was associated with an increase in adverse clinical outcomes.
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http://dx.doi.org/10.1111/bcp.14535DOI Listing
March 2021

Relationship of anemia and clinical outcome in heart failure patients with preserved versus reduced ejection fraction in a rural area of Thailand.

Int J Cardiol Heart Vasc 2020 Oct 30;30:100597. Epub 2020 Jul 30.

Clinical Pharmacy Division, Department of Pharmacy, Faculty of Pharmacy, Mahidol University, 447 Sri-ayutthaya Road, Phyathai, Ratchathewi, Bangkok 10400, Thailand.

Background: Heart failure (HF) has become a significant health burden in developing countries where anemia is highly prevalent. Limited data exists on the effects of anemia on HF in these population.

Methods: A retrospective observational study was conducted in all adult patients hospitalized due to HF at Buriram Hospital in Thailand, during July 2010 to June 2015. Survival analysis was performed to evaluate the impact of anemia on 1- year all-cause mortality for the overall cohort, patients with HF with reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF).

Results: A total of 414 HF patients including 287 HFpEF patients (69.3%) and 127 HFrEF patients (30.7%) were included in our analysis. Mean age was 62.51 ± 14.89 years, with 55% female. Overall prevalence of anemia in HF was 62.6% (259 patients). One-year all-cause mortality was significantly higher in patients with anemia than in non-anemia groups (20.08% vs 12.26%, p = 0.041). When analyzed based on types of HF, anemia significantly increased mortality risk in HFpEF group [adjusted hazard ratio (HR) 2.667, 95%CI, 1.216-5.853, p = 0.014] but not with HFrEF group (adjusted HR 0.901, 95%CI, 0.376-2.155, p = 0.804). The mortality of anemic patients who were left untreated was significantly higher than those who were treated (adjusted HR 2.13, 95%CI, 1.13-3.99, p = 0.027).

Conclusion: Anemia significantly increased mortality in HF patients, especially among HFpEF. Attempts to identify, diagnose and manage anemia should be integrated in HF care plan in developing countries with high prevalence of anemia.
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http://dx.doi.org/10.1016/j.ijcha.2020.100597DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7399103PMC
October 2020

Quality assessment and cost saving of renal dosing recommendation by clinical pharmacists at medical wards in Thailand.

Int J Clin Pharm 2020 Apr 27;42(2):610-616. Epub 2020 Mar 27.

Department of Pharmacy, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wanglang Road, Bangkoknoi, Bangkok, 10700, Thailand.

Background Renal dosage adjustment for patients with reduced kidney function is a common function of clinical pharmacy service. Assessment of pharmacist's intervention in the aspect of quality and economic impact should be conducted to evaluate the benefit of this service. Objective This study aimed to assess the quality and cost saving of clinical pharmacists' recommendation on renal dosage adjustment among patients with reduced kidney function. Setting Eight medical wards of the Siriraj Hospital, a tertiary-care hospital in Bangkok, Thailand. Method A retrospective study was conducted using medical records and clinical pharmacist's intervention database. All patients admitted to the study wards whose estimated creatinine clearance were less than 60 mL/min or presented with acute kidney injury on admission during October 2016-December 2017 were included. The targeted medications were antimicrobial agents. Main outcome measure Percentage of the concordance between pharmacists' recommendation compared to standard dosing references and related cost saving. Results Among 158 patients, pharmacists provided 190 recommendations, including 151 (79.1%) dose reduction, 17 (8.9%) dose increase and 22 (11.5%) recommendations to provide supplemental dose after dialysis. These recommendations were 90.5% consistent with standard references. Physician accepted and complied with 89.5% of pharmacists' recommendations. Average direct cost saving was €5,114.11 while cost avoidance was €863.47. Conclusion Trained clinical pharmacists were able to provide high-quality recommendation on dosage adjustment in these patients in accordance to standard dosing guidelines. In addition, dosage adjustment also led to a significant direct cost saving and cost avoidance from prevention of adverse drug reactions.
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http://dx.doi.org/10.1007/s11096-020-01016-1DOI Listing
April 2020

Comparative efficacy and safety of warfarin care bundles and novel oral anticoagulants in patients with atrial fibrillation: a systematic review and network meta-analysis.

Sci Rep 2020 01 20;10(1):662. Epub 2020 Jan 20.

School of Pharmacy, Monash University Malaysia, Bandar Sunway, Malaysia.

Warfarin care bundles (e.g. genotype-guided warfarin dosing, patient's self-testing [PST] or patient's self-management [PSM] and left atrial appendage closure) are based on the concept of combining several interventions to improve anticoagulation care. NOACs are also introduced for stroke prevention in atrial fibrillation (SPAF). However, these interventions have not been compared in head-to-head trials yet. We did a network meta-analysis based on a systematic review of randomized controlled trials comparing anticoagulant interventions for SPAF. Studies comparing these interventions in adults, whether administered alone or as care bundles were included in the analyses. The primary efficacy outcome was stroke and the primary safety outcome was major bleeding. Thirty-seven studies, involving 100,142 patients were assessed. Compared to usual care, PSM significantly reduced the risk of stroke (risk ratio [RR] 0.24, 95% CI 0.08-0.68). For major bleeding, edoxaban 60 mg (0.80, 0.71-0.90), edoxaban 30 mg (0.48, 0.42-0.56), and dabigatran 110 mg (0.81, 0.71-0.94) significantly reduced the risk of major bleeding compared with usual warfarin care. Cluster rank plot incorporating stroke and major bleeding outcomes indicates that some warfarin care bundles perform as well as NOACs. Both interventions are therefore viable options to be considered for SPAF. Additional studies including head-to-head trials and cost-effectiveness evaluation are still warranted.
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http://dx.doi.org/10.1038/s41598-019-57370-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6971267PMC
January 2020

Cost-effectiveness of warfarin care bundles and novel oral anticoagulants for stroke prevention in patients with atrial fibrillation in Thailand.

Thromb Res 2020 01 15;185:63-71. Epub 2019 Nov 15.

School of Pharmacy, Monash University Malaysia, Bandar Sunway, Malaysia; College of Pharmacy, University of Utah, Salt Lake City, UT, USA; Asian Centre for Evidence Synthesis in Population, Implementation and Clinical Outcomes (PICO), Health and Well-being Cluster, Global Asia in the 21st Century (GA21) Platform, Monash University Malaysia, Bandar Sunway, Selangor, Malaysia. Electronic address:

Introduction: Novel oral anticoagulants (NOACs) and warfarin care bundles (e.g. genotyping, patient self-testing or self-management) are alternatives to usual warfarin care for stroke prevention in patients with atrial fibrillation (AF). We aim to evaluate the cost-effectiveness of NOACs and warfarin care bundles in patients with AF in a middle-income country, Thailand.

Materials And Methods: A Markov model was used to evaluate the economic and treatment outcomes of warfarin care bundles and NOACs compared with usual warfarin care. Cost-effectiveness was assessed from a societal perspective over a lifetime horizon with 3% discount rate in a hypothetical cohort of 65-year-old atrial fibrillation patients. Input parameters were derived from published literature, meta-analysis and local data when available. The outcome measure was incremental cost per quality-adjusted life years (QALY) gained (ICER).

Results: Using USD5104 as the threshold of willingness-to-pay per QALY, patient's self-management of warfarin was cost-effective when compared to usual warfarin care, with an ICER of USD1395/QALY from societal perspective. All NOACs were not cost-effective in Thailand, with ICER ranging from USD8678 to USD14,247/QALY. When compared to the next most effective intervention, patient's self-testing and genotype-guided warfarin dosing were dominated. In the cost-effectiveness acceptability curve, patient's self-management had the highest probability of being cost-effective in Thailand, approximately 78%. Results were robust over a range of inputs in sensitivity analyses.

Conclusions: In Thailand, NOACs were unlikely to be cost-effective at current prices. Conversely, patient's self-management is a highly cost-effective intervention and may be considered for adoption in developing regions with resource-limited healthcare systems.
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http://dx.doi.org/10.1016/j.thromres.2019.11.012DOI Listing
January 2020

Cost-Effectiveness Analysis of Non-Statin Lipid-Modifying Agents for Secondary Cardiovascular Disease Prevention Among Statin-Treated Patients in Thailand.

Pharmacoeconomics 2019 10;37(10):1277-1286

College of Pharmacy, University of Utah, Salt Lake City, UT, USA.

Background: Using non-statin lipid-modifying agents in combination with statin therapy provides additional benefits for cardiovascular disease (CVD) risk reduction, but their value for money has only been evaluated in high-income countries (HICs). Furthermore, studies mainly derive effectiveness data from a single trial or older meta-analyses.

Objectives: Our study used data from the most recent network meta-analysis (NMA) and local parameters to assess the cost effectiveness of non-statin agents in statin-treated patients with a history of CVD.

Methods: A published Markov model was adopted to investigate lifetime outcomes: (1) number of recurrent CVD events prevented, (2) quality-adjusted life-years (QALYs) gained, (3) costs and (4) incremental cost-effectiveness ratios (ICERs) of proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) and ezetimibe added to statin therapy. Event rates and effectiveness inputs were obtained from the NMA. Cost and utility data were gathered from published studies conducted in Thailand. A series of sensitivity analyses were performed.

Results: Patients receiving PCSK9i and ezetimibe experienced fewer recurrent CVD events (number needed to treat [NNT] 17 and 30) and more QALYs (0.168 and 0.096 QALYs gained per person). However, under the societal perspective and at current acquisition costs in 2018, ICERs of both agents were $US1,223,995 and 27,361 per QALY gained, respectively. Based on threshold analyses, the costs need to be reduced by 97 and 85%, respectively, for PCSK9i and ezetimibe to be cost-effective.

Conclusions: Despite the proven effectiveness of PCSK9i and ezetimibe, the costs of these agents need to reduce to a much greater extent than in HICs to be cost-effective in Thailand.
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http://dx.doi.org/10.1007/s40273-019-00820-6DOI Listing
October 2019

Effects of Non-statin Lipid-Modifying Agents on Cardiovascular Morbidity and Mortality Among Statin-Treated Patients: A Systematic Review and Network Meta-Analysis.

Front Pharmacol 2019 22;10:547. Epub 2019 May 22.

Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Center of Pharmaceutical Outcomes Research, Naresuan University, Phitsanulok, Thailand.

Currently, there is a lack of information on the comparative efficacy and safety of non-statin lipid-lowering agents (NST) in cardiovascular (CV) disease risk reduction when added to background statin therapy (ST). This study determine the relative treatment effects of NST on fatal and non-fatal CV events among statin-treated patients. A network meta-analysis based on a systematic review of randomized controlled trials (RCTs) comparing non-statin lipid-modifying agents among statin-treated patients was performed. PubMed, EMBASE, CENTRAL, and Clinicaltrial.gov were searched up to April 10, 2018. The primary outcomes were CV and all-cause mortalities. Secondary CV outcomes were coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), any stroke, and coronary revascularization. Risks of discontinuations were secondary safety outcomes. Sixty-seven RCTs including 259,429 participants with eight interventions were analyzed. No intervention had significant effects on the primary outcomes (CV mortality and all-cause mortality). For secondary endpoints, proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK) plus statin (PCSK/ST) significantly reduced the risk of non-fatal MI (RR 0.82, 95% CI 0.72-0.93, = 0.003), stroke (RR 0.74, 95% CI 0.65-0.85, < 0.001), coronary revascularization (RR 0.84, 95% CI 0.75-0.94, = 0.003) compared to ST. Combinations of ST and all NST except PCSK and ezetimibe showed higher rate of discontinuation due to adverse events compared to ST. None of NST significantly reduced CV or all-cause death when added to ST. PCSKs and to a lesser extent, ezetimibe may help reduce cardiovascular events with acceptable tolerability profile among broad range of patients.
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http://dx.doi.org/10.3389/fphar.2019.00547DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6540916PMC
May 2019

Incidence, risk factors, and outcomes of warfarin-associated major bleeding in Thai population.

Pharmacoepidemiol Drug Saf 2019 07 8;28(7):942-950. Epub 2019 May 8.

Clinical Pharmacy Division, Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand.

Purpose: This study aimed to describe incidence, risk factors, and outcomes of warfarin-associated major bleeding (WAMB) in Thai patients.

Method: A nested case-control study was conducted in a cohort of adult patients receiving ≥6 months of warfarin therapy who were prospectively followed up at a tertiary care hospital in Thailand during January 2011 to December 2014. Logistic regression was used to identify risk factors associated with WAMB. The area under the receiver operating characteristic (AUROC) curve was used to assess the performance of the HAS-BLED score to predict WAMB in patients with non-valvular atrial fibrillation (NVAF).

Results: Among 1604 patients (2972 patient-year of follow-up), there were 93 major bleeding that occurred in 76 patients. The incidence of WAMB was 3.13 events per 100 patient-year. Time in therapeutic range (TTR) of <60% (RR: 3.62, 95% CI: 1.94-6.73, P < 0.001), mechanical valve replacement at mitral position (RR 3.43, 95% CI: 1.92-6.16, P < 0.001) cancer (RR: 2.84, 95% CI: 1.11-7.29, P = 0.029), and age ≥ 65 years (RR: 2.37, 95% CI: 1.20-4.67, P = 0.012) were independent risk factors for WAMB. There were 17 fatalities and 12 cases of disabilities from WAMB. Mean cost of WAMB was 45 341.54 THB/event. An exploratory analysis suggested that HASBLED score demonstrated an excellent discriminatory capacity to predict WAMB among NVAF patients (AUROC of 0.91, 95% CI: 0.85-0.97, P < 0.001).

Conclusion: WAMB in Thai population is common and associated with high rate of morbidity and mortality. Improvement in anticoagulation control is clearly needed.
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http://dx.doi.org/10.1002/pds.4781DOI Listing
July 2019

Characteristic of drug-related problems and pharmacists' interventions in a stroke unit in Thailand.

Int J Clin Pharm 2019 Aug 3;41(4):880-887. Epub 2019 May 3.

Department of Pharmacy, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wanglang Road, Bangkoknoi, Bangkok, 10700, Thailand.

Background Little information is available regarding pharmacist's intervention to solve drug-related problems (DRPs) in a stroke unit. Objective To investigate the nature and frequency of DRPs along with the role of pharmacists in a stroke unit. Setting The study was conducted at the stroke unit of Siriraj hospital, a university affiliated tertiary care hospital in Thailand. Method A retrospective descriptive study of DRPs and pharmacists' interventions for stroke patients was performed during July 2015 to December 2016. Data were collected from patient's medical records and pharmacist's intervention record forms. DRPs were categorized using the Hepler-Strand classification. The stroke pharmacist team, consisting of a board-certified pharmacotherapy specialist, neurology pharmacy residents and stroke unit pharmacists, participated in the multidisciplinary ward round in the stroke unit 5 days a week. All patients were visited by a member of the stroke pharmacist team within the first two days of their admission to conduct a thorough review of drug therapy for every patient and provided appropriate recommendation to the multidisciplinary team either verbally during the ward round or with written information in the patients' medical charts, as appropriate. Main Outcome Measure (a) incidence and characteristics of DRPs (b) types and the acceptance of pharmacists' interventions. Results A total of 859 patients were admitted, of those, 768 patients had ≥ 1 DRPs and a total of 796 DRPs were identified. Clinical pharmacists provided 659 interventions to the multidisciplinary team. The most common DRPs identified were "untreated indications" (22.6%) and "non-compliance" (21.0%). Of all DRPs, 74.6% were stroke related issues. The most implicated drugs were antihypertensive drugs, followed by antithrombotic therapies. The multidisciplinary team accepted 84.7% of pharmacists' interventions. Conclusion DRP in a stroke unit is common. Clinical pharmacists in a stroke unit can effectively reduce and prevent DRPs with the focus on performing medication reconciliation, providing recommendation on dosage adjustment and proper drug selection for stroke patients.
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http://dx.doi.org/10.1007/s11096-019-00832-4DOI Listing
August 2019

Cost-Effectiveness Analysis of Non-Vitamin K Antagonist Oral Anticoagulants Versus Warfarin in Thai Patients With Non-Valvular Atrial Fibrillation.

Heart Lung Circ 2020 Mar 27;29(3):390-400. Epub 2019 Mar 27.

Department of Pharmaceutical Care, Faculty of Pharmacy, Chiang Mai University, Chiang Mai, Thailand. Electronic address:

Background: Non-vitamin K antagonist oral anticoagulants (NOACs) have been recommended as preferred options for stroke prevention in patients with atrial fibrillation (AF) versus warfarin by guidelines worldwide.

Aim: This study aimed to evaluate the cost-effectiveness of each NOAC in a Thai health care environment, a country with upper middle-income economies based on the World Bank's classification.

Method: A lifetime Markov model was created from a Thai societal perspective. The model consisted of 19 health states separated into two cycles: event cycle and consequence cycle. The consequences of AF included in the model were ischaemic stroke, intracranial haemorrhage, extracranial haemorrhage, and myocardial infarction. All NOACs available in Thailand (dabigatran 150 mg and 110 mg twice daily; rivaroxaban 20 mg once daily; apixaban 5 mg twice daily; edoxaban 60 mg and 30 mg once daily) were assessed using warfarin with an international normalised ratio of 2-3 as the reference. Inputs were a combination of published literature and local data when available. A willingness-to-pay of 160,000 Thai baht (THB)/quality-adjusted life year (QALY) was used as the threshold of being cost-effective. Incremental cost-effectiveness ratios and cost-effectiveness acceptability curves were estimated.

Results: All NOACs were not cost-effective strategies for the Thai AF population. The ranking of incremental cost-effectiveness ratios from lowest to highest were apixaban 5 mg twice daily (THB 692,136 or US$21,862) followed by edoxaban 60 mg once daily (THB 911,772 or US$28,799), edoxaban 30 mg once daily (THB 913,749 or US$28,861), dabigatran 150 mg twice daily (THB 1,102,106 or US$34,811), dabigatran 110 mg twice daily (THB 1,195,347 or US$37,756), and rivaroxaban 20 mg once daily (THB 1,347,650 or US$42,566). Cost-effectiveness acceptability curve indicated that apixaban had the highest potential to be a cost-effective strategy versus other NOACs.

Conclusions: Our findings indicated that all NOACs were not cost-effective in the Thai AF population. Of the NOACs, apixaban may be the most likely to be cost-effective. These data may be useful for policymakers to perform a comprehensive evaluation of these agents for formulary decision and pricing negotiation.
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http://dx.doi.org/10.1016/j.hlc.2019.02.187DOI Listing
March 2020

Efficacy and safety of celecoxib on the incidence of recurrent colorectal adenomas: a systematic review and meta-analysis.

Cancer Manag Res 2019 9;11:561-571. Epub 2019 Jan 9.

School of Pharmacy, Monash University Malaysia, Bandar Sunway, Selangor, Malaysia,

Background: Celecoxib has previously been shown to be effective in reducing recurrent colorectal adenomas, but its long-term effects are unknown. In addition, safety issues are of major concern. Therefore, we examined the efficacy and safety of celecoxib as a chemopreventive agent along with its posttreatment effect.

Methods: We performed a meta-analysis based on a systematic review of randomized controlled trials (RCTs) comparing celecoxib at various doses (400 mg once daily, 200 mg twice daily, and 400 mg twice daily) vs placebo in persons with history of colorectal adenomas. Several databases were searched from inception up to April 2018. Long-term follow-ups of RCTs were also included to evaluate posttreatment effect. Primary outcome was the incidence of recurrent colorectal adenomas. Various safety outcomes were evaluated, especially cardiovascular (CV) events. Risk-benefit integrated analyses were also performed.

Results: A total of three RCTs (4,420 patients) and three post-trial studies (2,159 patients) were included in the analysis. Use of celecoxib at any dose for 1-3 years significantly reduced the incidence of recurrent advanced adenomas (risk ratio, 0.42 [95% CI, 0.34-0.53]) and any adenomas (0.67 [95% CI, 0.62-0.72]) compared with placebo. Subgroup analysis on different dosing suggested a greater effect with 400 mg twice daily. However, celecoxib 400 mg twice daily significantly increased the risk of serious adverse (1.2 [95% CI, 1.0-1.5]) and CV events (3.42 [95% CI, 1.56-7.46]), while celecoxib at 400 mg/day, especially with once daily dosing, did not increase CV risk (1.01 [95% CI, 0.70-1.46]). Analysis of post-trial studies indicated that the treatment effect disappeared (1.15 [95% CI, 0.88-1.49]) after discontinuing celecoxib for >2 years.

Conclusion: Celecoxib 400 mg once daily dosing could potentially be considered as a viable chemopreventive option in patients with high risk of adenomas but with low CV risk. Long-term trials on celecoxib at a dose of ≤400 mg either once or twice daily are warranted.
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http://dx.doi.org/10.2147/CMAR.S180261DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6331068PMC
January 2019

Roles of pharmacogenomics in non-anthracycline antineoplastic-induced cardiovascular toxicities: A systematic review and meta-analysis of genotypes effect.

Int J Cardiol 2019 04 19;280:190-197. Epub 2018 Dec 19.

School of Pharmacy, Monash University Malaysia, Selangor, Malaysia; Asian Centre for Evidence Synthesis in Population, Implementation and Clinical Outcomes (PICO), Health and Well-being Cluster, Global Asia in the 21st Century (GA21) Platform, Monash University Malaysia, Selangor, Malaysia; School of Pharmacy, Taylor's University Lakeside Campus, Jalan Taylors, 47500 Subang Jaya, Selangor, Malaysia. Electronic address:

Background: Exploration on genetic roles in antineoplastic-related cardiovascular toxicity has increased with the advancement of genotyping technology. However, knowledge on the extent of genetic determinants in affecting the susceptibility to the cardiovascular toxicities of antineoplastic is limited. This study aims to identify potential single nucleotide polymorphism (SNP) in predicting non-anthracycline antineoplastic-related cardiovascular toxicity.

Methods: We systematically searched for original research in PubMed, Cochrane Central Register of Controlled Studies, CINAHL Plus, EMBASE and HuGE Navigator from database inception until January 2018. Studies on association between polymorphism and antineoplastic-induced cardiovascular toxicity in patients treated for cancer of all antineoplastic agents were included except for anthracycline. Case reports, conference abstracts, reviews and non-patient studies were excluded. Data extracted by two independent reviewers were combined with random-effects model and reported according to PRISMA and MOOSE guidelines.

Results: The 35 studies included examined a total of 219 SNPs in 80 genes, 11 antineoplastic and 5 types of cardiovascular toxicities. Meta-analyses showed that human epidermal growth factor receptor 2 (HER2) rs1136201, a risk variants (pooled OR: 2.43; 1.17-5.06, p = 0.018) is a potential predictors for trastuzumab-related cardiotoxicity. Gene dose effect analysis showed number of variant allele may contribute to the risk too.

Conclusions: This review found that HER2 rs1136201 can have the potential in predicting trastuzumab-related heart failure. As such, further studies are needed to confirm the validity of these results as well as determine the economic aspect of using SNPs prior to its implementation as a clinical practice.
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http://dx.doi.org/10.1016/j.ijcard.2018.12.049DOI Listing
April 2019

Antithrombotic Regimens in Patients With Percutaneous Coronary Intervention Whom an Anticoagulant Is Indicated: A Systematic Review and Network Meta-Analysis.

Front Pharmacol 2018 19;9:1322. Epub 2018 Nov 19.

Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand.

Patients undergoing percutaneous coronary intervention (PCI) who require anticoagulant therapy are at increased risk of bleeding. The optimal regimen for these patients is uncertain. This study aimed to compare safety and efficacy of antithrombotic regimens used in patients undergoing PCI with concomitant anticoagulant therapy. A systematic review and network meta-analysis was performed among studies comparing antithrombotic regimens for anticoagulated patients undergoing PCI. The primary outcome of interest was major bleeding. The secondary outcomes were coronary events. The reference intervention was classic triple therapy (aspirin plus clopidogrel plus VKA). Cluster rank incorporating risk (major bleeding) and benefit (all-cause death) was performed to identify the most appropriate regimen(s). There were 3 RCTs (6 interventions) and 29 non-RCTs (8 interventions) that met the inclusion criteria with 22,179 patients. Network meta-analysis of RCTs indicated that dual therapy (DT), either with vitamin K antagonist (VKA) or direct anticoagulant (DOAC) plus an antiplatelet, significantly reduced the risk of major bleeding compared to triple therapy (TT) [pooled RR of 0.51 (0.30-0.87) and 0.68 (0.49-0.94), respectively]. In addition, VKA-DT significantly reduced the risk of all-cause death compared to TT [pooled RR of 0.40 (0.17-0.93)]. Results from network meta-analysis of non-RCT paralleled that of RCTs. No significant differences of coronary events were found. In conclusion, for anticoagulated patients undergoing PCI, dual therapy, either with warfarin or DOAC plus an antiplatelet, should be considered due to its optimal balance on efficacy and safety.
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http://dx.doi.org/10.3389/fphar.2018.01322DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6252311PMC
November 2018

Relationship of medication adherence and quality of life among heart failure patients.

Heart Lung 2019 Mar - Apr;48(2):105-110. Epub 2018 Oct 30.

Faculty of Pharmacy, Chiang Mai University, Suthep, Muang, Chiang Mai, Chiang Mai 50200, Thailand. Electronic address:

Background: Little is known regarding the relationship between medication adherence and quality of life in heart failure patients. We therefore aimed to examine the nature of relationship between medication adherence and quality of life.

Methods: A prospective, cross-sectional study of chronic heart failure patients with reduced ejection fraction was performed at a tertiary-care, university hospital in Thailand. Quality of life and medication adherence were assessed using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and Morisky Medication Adherence Scale-8 (MMAS-8), respectively. Relationship of MLHFQ and MMAS-8 were examined using Spearman's correlation coefficient and multiple regression analysis for covariates adjustment.

Results: Among 180 patients, 38.3%, 50.0% and 11.7% were found to have high, medium and poor adherence, respectively. For quality of life, the overall median score on the MLHFQ was relatively low. A positive relationship was identified between medication adherence and quality of life. After covariate adjustment, medication adherence was found to have the strongest relationship with quality of life, compared to other covariates.

Conclusions: Medication adherence has a small and positive relationship with quality of life among heart failure patients.
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http://dx.doi.org/10.1016/j.hrtlng.2018.09.009DOI Listing
January 2020

Efficacy and safety of chemopreventive agents on colorectal cancer incidence and mortality: systematic review and network meta-analysis.

Clin Epidemiol 2018 10;10:1433-1445. Epub 2018 Oct 10.

School of Pharmacy, Monash University Malaysia, Subang Jaya, Malaysia,

Background: Various interventions have been tested as primary prevention of colorectal cancers (CRC), but comprehensive evidence comparing them is absent. We examined the effects of various chemopreventive agents (CPAs) on CRC incidence and mortality.

Methods: We did a network meta-analysis based on a systematic review of randomized controlled trials (RCTs) that compared at least one CPA (aspirin, antioxidants, folic acid, vitamin B6, vitamin B12, calcium, vitamin D, alone or in combination) to placebo or other CPA in persons without history of CRC. Several databases were searched from inception up to March 2017. Primary outcomes were early and long-term CRC incidence and mortality.

Results: Twenty-one RCTs comprising 281,063 participants, 9 RCTS comprising 160,101 participants, and 7 RCTs comprising 24,001 participants were included in the network meta-analysis for early risk of CRC incidence, long-term risk of CRC incidence and mortality, respectively. For early CRC incidence, no CPAs were found to be effective. For long-term CRC incidence and mortality, aspirin was the only intervention that showed protective effects with potential dose-dependent effects (risk ratio [RR], 0.74 [95% CI, 0.57-0.97] for high-dose [≥325 mg/day] and RR, 0.81 [95% CI, 0.67-0.98] for very-low-dose [≤100 mg/day]). Similar trend was found for mortality (RR, 0.43 [95% CI, 0.23-0.81] for low-dose [>100-325 mg/day] and RR, 0.65 [95% CI, 0.45-0.94] for very-low-dose). However, in net clinical benefit analysis, when combining risk estimates on mortality from CRC, cardiovascular disease, and pooled risk estimates of major gastrointestinal bleeding, low-dose aspirin provided the highest net survival gain (%) of 1.736 [95% CI, 1.010-2.434].

Conclusion: Aspirin at the dose range of 75-325 mg/day is a safe and effective primary prevention for long-term CRC among people at average risk. None of the other CPAs were found to be effective. There may potentially be differential effects among various doses of aspirin that needs further investigation.
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http://dx.doi.org/10.2147/CLEP.S174120DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6186891PMC
October 2018

Interventions and Strategies to Improve Oral Anticoagulant Use in Patients with Atrial Fibrillation: A Systematic Review of Systematic Reviews.

Clin Drug Investig 2018 Jul;38(7):579-591

School of Pharmacy, Monash University Malaysia, Bandar Sunway, Selangor, Malaysia.

Introduction: Anticoagulation therapy is the fundamental approach for stroke prevention in atrial fibrillation (AF) patients. Numerous systematic reviews comparing anticoagulation strategies have been published. We aim to summarize the efficacy and safety evidence of these strategies in AF patients from previously published systematic reviews.

Methods: We searched PubMed, EMBASE and Cochrane library from inception to Feb 24th, 2017, to identify systematic reviews and meta-analyses of randomized controlled trials that assessed interventions or strategies to improve oral anticoagulant use in AF patients.

Results: Thirty-four systematic reviews were eligible for inclusion but only 11 were included in the qualitative analyses, corresponding to 40 unique meta-analyses, as the remaining systematic reviews had overlapping primary studies. There was insufficient evidence to support the efficacy of genotype-guided dosing and pharmacist-managed anticoagulation clinics for stroke prevention in AF patients. Conversely, patient's self-management and novel oral anticoagulants (NOACs), in general were superior to warfarin for preventing stroke and reducing mortality. All interventions showed comparable risk of major bleeding with warfarin.

Conclusion: Findings from this overview support the superiority of NOACs and patient's self-management for preventing stroke in AF patients. However, uncertainties remain on the benefits of genotype-guided dosing and pharmacist-managed anticoagulation clinics due to poor quality evidence, and future research is warranted.
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http://dx.doi.org/10.1007/s40261-018-0641-5DOI Listing
July 2018

Comparative performance of pharmacogenetics-based warfarin dosing algorithms derived from Caucasian, Asian, and mixed races in Thai population.

Cardiovasc Ther 2018 Apr 3;36(2). Epub 2018 Jan 3.

Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand.

Aim: This study was conducted to compare predictive accuracy of the available pharmacogenetics (PGx)-guided warfarin dosing algorithms derived from Caucasian, Asian, and mixed population to identify a suitable algorithm for Thai population.

Methods: Ten warfarin dosing algorithms derived from different population including Caucasian, East Asian, South-East Asian, and mixed races were selected and tested with clinical and genetic data of Thai patients. Comparative performances of these algorithms were tested using mean dose error (MDE) between actual warfarin maintenance dose (AWMD) and predicted dose generated by each dosing algorithm, and percentage of ideal dose prediction (IDP). Sensitivity analysis for predictive accuracy was also conducted by stratifying patients into low (AWMD ≤21 mg/wk), intermediate (AWMD >21 to <49 mg/wk), and high maintenance dose (AWMD ≥49 mg/wk) groups.

Results: Data of 165 patients were included for the analyses. Mean actual warfarin dose of the study population was 25.03 ± 10.53 mg/wk. Large variability of MDE, ranging from -12.11 to 11.24 mg/wk, among algorithms was observed. International Warfarin Pharmacogenetics Consortium, Gage et al, and Ohno et al algorithms had comparable performances to Sangviroon et al algorithm, as observed by MDE of <1 mg/wk with percentage of IDP ≥40%. Further sensitivity analyses among patients requiring low and intermediate maintenance doses confirmed such findings with IDP percentage ranging from 37.8% to 59.2%. Among high-dose group, only Ohno et al and Sarapakdi et al algorithms had acceptable performance.

Conclusions: Warfarin PGx-guided dosing algorithms derived from large, mixed population performed comparably to Sangviroon et al algorithm. Certain algorithms should be avoided due to significant dose prediction error.
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http://dx.doi.org/10.1111/1755-5922.12315DOI Listing
April 2018

Comparative efficacy and safety of reperfusion therapy with fibrinolytic agents in patients with ST-segment elevation myocardial infarction: a systematic review and network meta-analysis.

Lancet 2017 Aug;390(10096):747-759

School of Pharmacy, Monash University Malaysia, Selangor, Malaysia; Center of Pharmaceutical Outcomes Research (CPOR), Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand; School of Pharmacy, University of Wisconsin, Madison, WI, USA; Asian Centre for Evidence Synthesis in Population, Implementation and Clinical Outcomes (PICO), Health and Well-being Cluster, Global Asia in the 21st Century (GA21) Platform, Monash University Malaysia, Bandar Sunway, Selangor, Malaysia. Electronic address:

Background: Fibrinolytic therapy offers an alternative to mechanical reperfusion for ST-segment elevation myocardial infarction (STEMI) in settings where health-care resources are scarce. Comprehensive evidence comparing different agents is still unavailable. In this study, we examined the effects of various fibrinolytic drugs on clinical outcomes.

Methods: We did a network meta-analysis based on a systematic review of randomised controlled trials comparing fibrinolytic drugs in patients with STEMI. Several databases were searched from inception up to Feb 28, 2017. We included only randomised controlled trials that compared fibrinolytic agents as a reperfusion therapy in adult patients with STEMI, whether given alone or in combination with adjunctive antithrombotic therapy, against other fibrinolytic agents, a placebo, or no treatment. Only trials investigating agents with an approved indication of reperfusion therapy in STEMI (streptokinase, tenecteplase, alteplase, and reteplase) were included. The primary efficacy outcome was all-cause mortality within 30-35 days and the primary safety outcome was major bleeding. This study is registered with PROSPERO (CRD42016042131).

Findings: A total of 40 eligible studies involving 128 071 patients treated with 12 different fibrinolytic regimens were assessed. Compared with accelerated infusion of alteplase with parenteral anticoagulants as background therapy, streptokinase and non-accelerated infusion of alteplase were significantly associated with an increased risk of all-cause mortality (risk ratio [RR] 1·14 [95% CI 1·05-1·24] for streptokinase plus parenteral anticoagulants; RR 1·26 [1·10-1·45] for non-accelerated alteplase plus parenteral anticoagulants). No significant difference in mortality risk was recorded between accelerated infusion of alteplase, tenecteplase, and reteplase with parenteral anticoagulants as background therapy. For major bleeding, a tenecteplase-based regimen tended to be associated with lower risk of bleeding compared with other regimens (RR 0·79 [95% CI 0·63-1·00]). The addition of glycoprotein IIb or IIIa inhibitors to fibrinolytic therapy increased the risk of major bleeding by 1·27-8·82-times compared with accelerated infusion alteplase plus parenteral anticoagulants (RR 1·47 [95% CI 1·10-1·98] for tenecteplase plus parenteral anticoagulants plus glycoprotein inhibitors; RR 1·88 [1·24-2·86] for reteplase plus parenteral anticoagulants plus glycoprotein inhibitors).

Interpretation: Significant differences exist among various fibrinolytic regimens as reperfusion therapy in STEMI and alteplase (accelerated infusion), tenecteplase, and reteplase should be considered over streptokinase and non-accelerated infusion of alteplase. The addition of glycoprotein IIb or IIIa inhibitors to fibrinolytic therapy should be discouraged.

Funding: None.
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http://dx.doi.org/10.1016/S0140-6736(17)31441-1DOI Listing
August 2017

Genotypic detection of the bla gene among extended-spectrum β-lactamase-producing Enterobacteriaceae.

J Glob Antimicrob Resist 2017 06 21;9:87-93. Epub 2017 Apr 21.

Department of Microbiology, Faculty of Pharmacy, Mahidol University, 447 Sri Ayudthaya Road, Rajthevi, Bangkok 10400, Thailand. Electronic address:

Objectives: Extended-spectrum β-lactamases (ESBLs), a group of β-lactamase enzymes produced by bacteria in the family Enterobacteriaceae, are becoming a major problem in the healthcare community worldwide. Although many attempts have been made in the detection of ESBL-producing bacteria, the cost and speed of detection remains an important challenge. Therefore, this study aimed to develop a rapid, effective and affordable method for detection of the bla ESBL gene by a loop-mediated isothermal amplification (LAMP) technique.

Methods: Clinical ESBL-producing Enterobacteriaceae, including Escherichia coli and Klebsiella pneumoniae, were isolated and were used as representative strains. The double-disk synergy method was performed to detect ESBL-producing Enterobacteriaceae. Performance of the LAMP method in the detection of bla was compared with conventional PCR in terms of sensitivity and specificity.

Results: The developed LAMP method efficiently identified the presence of the bla gene in ESBL-producing Enterobacteriaceae. It provided similar results to conventional PCR, but the LAMP technique required only 20min of testing time. The accuracy of the LAMP method was confirmed by restriction digestion, which showed the predicted size of the bla gene. In addition, the developed method was comparable with PCR that amplified only the target bla gene in terms of specificity, but LAMP was ca. 1000-fold more sensitive than PCR.

Conclusions: A rapid assay to detect ESBL-producing Enterobacteriaceae by a LAMP technique was developed in this study. The developed method is sensitive and suitable for rapid screening of bla in routine laboratories with limited resources.
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http://dx.doi.org/10.1016/j.jgar.2017.01.011DOI Listing
June 2017

Renin angiotensin system blockers-associated angioedema in the Thai population: analysis from Thai National Pharmacovigilance Database.

Asian Pac J Allergy Immunol 2015 Sep;33(3):227-35

Faculty of Pharmacy, Mahidol University, Bangkok, Thailand.

Background: Renin-angiotensin-aldosterone system (RAS) blockers are commonly used for cardiovascular diseases. Currently, little information exists for the Asian population on angioedema, a rare yet serious adverse event.

Objective: This study aimed to describe characteristics of RAS blockers-associated angioedema (RASBA) in Thai patients.

Methods: A retrospective study using the national pharmacovigilance database of Thailand was undertaken. Cases indicating the presence of angioedema with RAS blockers uses from 1984-2011 were identified. Patient demographics, co-morbidities, concomitant drugs, information for the RAS blockers and angioedema were obtained as well as causality assessment and quality of reports.

Results: A total of 895 cases were identified. Mean age was 59.9+12.8 years and 66.5% being female. Most angioedema events (48.6%) occurred during the first week of treatment. Angiotensin converting enzyme inhibitors (87.7%) were the most commonly implicated agents followed by angiotensin receptor blockers (10.5%), aldosterone antagonist (2.1%) and direct renin inhibitor (0.2%). Out of the 895 cases incorporated in this study, 165 (18.4%) were classified as serious events and resulted in hospitalization. The overall case fatality rate was 0.4%. Respiratory disturbance occurred in 46 cases (5.1%). Patients with respiratory complications tended to be younger (53.4+13.9 vs 60.3+12.7 years old; p=0.002) and with higher frequency of allergy history (26.1% vs 14.7%; p=0.032) compared to those without respiratory complications. Based on multivariate logistic regression, the adjusted OR for history of allergy was 2.23 (95%CI: 1.04 - 4.78, p = 0.041).

Conclusions: RASBA in Thai population occurred mostly in elderly female patients and often led to hospitalization. Since large number of patients is regularly exposed to RAS-blockers, a nationwide attempt to raise awareness of clinicians when prescribing RAS-blockers is prudent.
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http://dx.doi.org/10.12932/AP0556.33.3.2015DOI Listing
September 2015

Cost-Effectiveness Analysis of Fondaparinux vs Enoxaparin in Non-ST Elevation Acute Coronary Syndrome in Thailand.

Heart Lung Circ 2015 Sep 14;24(9):860-8. Epub 2015 Mar 14.

Department of Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.

Background: Non-ST elevation acute coronary syndrome (NSTE-ACS) imposes a significant health and economic burden on a society. Anticoagulants are recommended as standard therapy by various clinical practice guidelines. Fondaparinux was introduced and evaluated in a number of large randomised, controlled trials. This study therefore aimed to determine the cost-effectiveness of fondaparinux versus enoxaparin in the treatment of NSTE-ACS in Thailand.

Methods: A two-part construct model comprising a one-year decision tree and a Markov model was developed to capture short and long-term costs and outcomes from the perspective of provider and society. Effectiveness data were derived from OASIS-5 trial while bleeding rates were derived from the Thai Acute Coronary Syndrome Registry (TACSR). Costs data were based on a Thai database and presented in the year of 2013. Both costs and outcomes were discounted by 3% annually. A series of sensitivity analyses were performed.

Results: The results showed that compared with enoxaparin, fondaparinux was a cost-saving strategy (lower cost with slightly higher effectiveness). Cost of revascularisation with major bleeding had a greater impact on the amount of cost saved both from societal and provider perspectives. With a threshold of 160,000 THB ((4,857.3 USD) per QALY in Thailand, fondaparinux was about 99% more cost-effective compared with enoxaparin.

Conclusion: Fondaparinux should be considered as a cost-effective alternative when compared to enoxaparin for NSTE-ACS based on Thailand's context, especially in the era of limited healthcare resources.
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http://dx.doi.org/10.1016/j.hlc.2015.02.018DOI Listing
September 2015

Loop-mediated isothermal amplification assay targeting the blaCTX-M9 gene for detection of extended spectrum β-lactamase-producing Escherichia coli and Klebsiella pneumoniae.

Microbiol Immunol 2014 Dec;58(12):655-65

Department of Microbiology.

Extended-spectrum β-lactamases (ESBLs) produced by Enterobacteriaceae are one of the resistance mechanisms to most β-lactam antibiotics. ESBLs are currently a major problem in both hospitals and community settings worldwide. Rapid and reliable means of detecting ESBL-producing bacteria is necessary for identification, prevention and treatment. Loop-mediated isothermal amplification (LAMP) is a technique that rapidly amplifies DNA with high specificity and sensitivity under isothermal conditions. This study was aimed to develop a convenient, accurate and inexpensive method for detecting ESBL-producing bacteria by a LAMP technique. ESBLs-producing Escherichia coli and Klebsiella pneumoniae were isolated from a tertiary hospital in Bangkok, Thailand and reconfirmed by double-disk synergy test. A set of four specific oligonucleotide primers of LAMP for detection of bla(CTX-M9) gene was designed based on bla(CTX-M9) from E. coli (GenBank Accession No. AJ416345). The LAMP reaction was amplified under isothermal temperature at 63°C for 60 min. Ladder-like patterns of band sizes from 226 bp of the bla(CTX-M9) DNA target was observed. The LAMP product was further analyzed by restriction digestion with MboI and TaqI endonucleases. The fragments generated were approximately 168, 177 and 250 bp in size for MboI digestion and 165, 193, 229, 281 and 314 bp for TaqI digestion, which is in agreement with the predicted sizes. The sensitivity of the LAMP technique to bla(CTX-M9) was greater than that of the PCR method by at least 10,000-fold. These results showed that the LAMP primers specifically amplified only the bla(CTX-M9) gene. Moreover, the presence of LAMP amplicon was simply determined by adding SYBR Green I in the reaction. In conclusion, this technique for detection of ESBLs is convenient, reliable and easy to perform routinely in hospitals or laboratory units in developing countries.
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http://dx.doi.org/10.1111/1348-0421.12205DOI Listing
December 2014
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