Publications by authors named "Yonghua Jing"

43 Publications

Evaluation of Adherence and Persistence Differences Between Adalimumab Citrate-Free and Citrate Formulations for Patients with Immune-Mediated Diseases in the United States.

Rheumatol Ther 2021 Mar 21;8(1):109-118. Epub 2020 Nov 21.

AbbVie Inc, North Chicago, IL, USA.

Introduction: Our aim was to evaluate patient adherence and persistence with citrate-free adalimumab (ADA-CF), introduced in 2018 to reduce injection-site pain, compared with citrate-containing adalimumab (ADA-C).

Methods: This was a retrospective cohort study using a US claims database (IBM MarketScan Commercial and Medicare Supplemental Claims Database) from February 2018 to January 2020. Patients at least 18 years of age who were naïve to adalimumab 6 months before the index date (date of first adalimumab claim) and with at least 12 months of continuous medical and pharmacy coverage were eligible for the study. Adherence was assessed by determining the proportion of days covered (PDC) and the percentage of patients with PDC ≥ 80% during the 12-month follow-up period. Persistence was evaluated by measuring the rate of discontinuation and days to discontinuation (i.e., time on treatment) from the index date over the 12-month follow-up period. Continuous adherence outcomes (PDC) were evaluated using linear regression models. Binary adherence outcomes (PDC ≥ 80%) were assessed using logistic regression models. Kaplan-Meier analysis and Cox proportional hazards models were used to assess persistence outcomes.

Results: There were 2195 and 1005 patients in the ADA-CF and ADA-C cohorts, respectively, with most using adalimumab for rheumatoid arthritis (ADA-CF 29.7%, ADA-C 27.2%) and psoriasis (ADA-CF 24.5%, ADA-C 31.9%). Significantly greater adherence was achieved with ADA-CF compared with ADA-C (mean PDC [standard deviation] 0.68 [0.30] vs 0.61 [0.32], P < 0.0001). A significantly greater percentage of patients receiving ADA-CF (47.2%) vs ADA-C (39.6%) had PDC ≥ 80% (P < 0.0001). The discontinuation rate was significantly lower for the ADA-CF cohort (46.4%) compared with ADA-C (55.9%, P < 0.0001), resulting in a 27% lower likelihood of discontinuation during the 12-month follow-up period (hazard ratio 0.73; 95% confidence interval 0.66, 0.82; P < 0.0001) and longer time on treatment (260 vs 232 days, P < 0.0001).

Conclusion: Adherence and persistence are significantly improved with ADA-CF compared with ADA-C.
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http://dx.doi.org/10.1007/s40744-020-00256-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7991045PMC
March 2021

Deep phenotyping of 34,128 adult patients hospitalised with COVID-19 in an international network study.

Nat Commun 2020 10 6;11(1):5009. Epub 2020 Oct 6.

Clinical Pharmacology Unit, Zealand University Hospital, Køge, Denmark.

Comorbid conditions appear to be common among individuals hospitalised with coronavirus disease 2019 (COVID-19) but estimates of prevalence vary and little is known about the prior medication use of patients. Here, we describe the characteristics of adults hospitalised with COVID-19 and compare them with influenza patients. We include 34,128 (US: 8362, South Korea: 7341, Spain: 18,425) COVID-19 patients, summarising between 4811 and 11,643 unique aggregate characteristics. COVID-19 patients have been majority male in the US and Spain, but predominantly female in South Korea. Age profiles vary across data sources. Compared to 84,585 individuals hospitalised with influenza in 2014-19, COVID-19 patients have more typically been male, younger, and with fewer comorbidities and lower medication use. While protecting groups vulnerable to influenza is likely a useful starting point in the response to COVID-19, strategies will likely need to be broadened to reflect the particular characteristics of individuals being hospitalised with COVID-19.
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http://dx.doi.org/10.1038/s41467-020-18849-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7538555PMC
October 2020

An international characterisation of patients hospitalised with COVID-19 and a comparison with those previously hospitalised with influenza.

medRxiv 2020 Apr 25. Epub 2020 Apr 25.

Science Policy and Research, National Institute for Health and Care Excellence, UK.

Background: To better understand the profile of individuals with severe coronavirus disease 2019 (COVID-19), we characterised individuals hospitalised with COVID-19 and compared them to individuals previously hospitalised with influenza.

Methods: We report the characteristics (demographics, prior conditions and medication use) of patients hospitalised with COVID-19 between December 2019 and April 2020 in the US (Columbia University Irving Medical Center [CUIMC], STAnford Medicine Research data Repository [STARR-OMOP], and the Department of Veterans Affairs [VA OMOP]) and Health Insurance Review & Assessment [HIRA] of South Korea. Patients hospitalised with COVID-19 were compared with patients previously hospitalised with influenza in 2014-19.

Results: 6,806 (US: 1,634, South Korea: 5,172) individuals hospitalised with COVID-19 were included. Patients in the US were majority male (VA OMOP: 94%, STARR-OMOP: 57%, CUIMC: 52%), but were majority female in HIRA (56%). Age profiles varied across data sources. Prevalence of asthma ranged from 7% to 14%, diabetes from 18% to 43%, and hypertensive disorder from 22% to 70% across data sources, while between 9% and 39% were taking drugs acting on the renin-angiotensin system in the 30 days prior to their hospitalisation. Compared to 52,422 individuals hospitalised with influenza, patients admitted with COVID-19 were more likely male, younger, and, in the US, had fewer comorbidities and lower medication use.

Conclusions: Rates of comorbidities and medication use are high among individuals hospitalised with COVID-19. However, COVID-19 patients are more likely to be male and appear to be younger and, in the US, generally healthier than those typically admitted with influenza.
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http://dx.doi.org/10.1101/2020.04.22.20074336DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7239064PMC
April 2020

The impact of ribavirin on real-world adherence rates in hepatitis C patients treated with sofosbuvir plus simeprevir.

Clinicoecon Outcomes Res 2015 17;7:637-42. Epub 2015 Dec 17.

Health Economics and Outcomes Research, AbbVie Inc., North Chicago, IL, USA.

Background: Combination therapy with sofosbuvir (SOF) and simeprevir (SIM) is used to treat patients with hepatitis C virus infection. It is currently unknown whether adding ribavirin (RBV) to SOF + SIM, which raises the pill count from two up to eight pills a day, impacts adherence. The aim of this study is to examine the impact of pill count on real-world adherence rates in patients treated with SOF + SIM with and without RBV.

Methods: This retrospective study assessed composite adherence to SOF and SIM over 12 weeks of treatment for two cohorts of hepatitis C patients: one initiating SOF + SIM therapy, and the other initiating SOF + SIM + RBV therapy. Analyses were conducted using MarketScan(®) and Optum US commercial pharmacy claims and enrollment data. Adherence was adjusted by treatment regimen, age, sex, co-pay, presence/absence of cirrhosis, treatment history, and Charlson Comorbidity Index.

Results: There was a significant difference in composite unadjusted and adjusted adherence rates for SOF and SIM for the SOF + SIM vs SOF + SIM + RBV cohorts based on MarketScan data (unadjusted, 92.6% and 89.7%, respectively; P=0.0423; adjusted, 92.2% and 88.7%, respectively; P=0.0176), but not based on Optum data (unadjusted, 94.8% and 95.6%, respectively; P=0.5618; adjusted, 94.8% and 95.1%, respectively; P=0.8589). In the MarketScan and Optum databases, there were no statistical differences in unadjusted and adjusted adherence rates for SOF. Unadjusted and adjusted adherence rates for SIM were mixed, as they were for composite adherence.

Conclusion: The impact of the addition of RBV to SOF + SIM therapy was mixed. The impact of RBV on SOF adherence was not significant in either database.
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http://dx.doi.org/10.2147/CEOR.S87261DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4687623PMC
December 2015

Relationship of hospital-associated bleeding with length of stay and total hospitalization costs in patients hospitalized for atrial fibrillation.

J Med Econ 2016 22;19(5):490-6. Epub 2016 Jan 22.

d d Pfizer , New York , NY , USA.

Background: While literature has focused on the impact of bleeding beginning outside the hospital setting among patients with atrial fibrillation (AF), there is little information regarding bleeding that first occurs within a hospital setting. This study was performed to determine the association between hospital-associated bleeding in patients admitted for AF on outcomes of length of stay (LOS) and total hospitalization cost.

Methods And Results: The Premier research database was queried to identify adult inpatients discharged between 2008-2011 having a primary diagnosis code for AF where a bleeding diagnosis code was not present on admission. Regression was used to adjust for baseline differences in patients to estimate outcomes comparing patients with and without a hospital-associated bleed. There were 143,287 patients that met the study criteria. There were 2991 (2.1%) patients identified with a hospital associated bleed. After adjustment for covariates, the mean estimated LOS was significantly greater in the bleed group, at 6.0 days (95% CI = 5.8-6.1) vs the no bleed group at 3.3 days (95% CI = 3.3-3.3) (p < 0.0001). Similarly, the adjusted mean estimated total hospitalization cost was also significantly greater in the bleed group, $12,069 (95% CI = $11,779-$12,366) vs $6561 (95% CI = $6538-$6583) in the no bleed group (p < 0.0001).

Conclusions: After adjustments for baseline differences the data show that the 2.1% (n = 2991) of patients with hospital associated bleeding accounted for an estimated additional 8106 hospitalization days and $16.4 million dollars in cost over the study period compared to non-bleeders.
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http://dx.doi.org/10.3111/13696998.2015.1134545DOI Listing
January 2017

Comparison of hospital length of stay between hospitalized non-valvular atrial fibrillation patients treated with either apixaban or warfarin.

Hosp Pract (1995) 2015 27;43(3):172-9. Epub 2015 Jul 27.

Truven Health Analytics , 150 Cambridgepark Dr, Cambridge, MA 02140 , USA.

Background: Hospital length of stay (LOS) is an important cost driver for hospitals and payers alike. Hospitalized non-valvular atrial fibrillation (NVAF) patients treated with apixaban may have shorter LOS than those treated with warfarin because of the absence of need for INR monitoring in apixaban. Thus, this study compared hospital LOS between hospitalized NVAF patients treated with either apixaban or warfarin.

Methods: This was a retrospective, observational cohort study based on a large US database including diagnosis, procedure, and drug administration information from >600 acute-care hospitals. Patients selected for study were aged ≥18 years and had a hospitalization record with an ICD-9-CM diagnosis code for atrial fibrillation (AF) in any position from 1 January 2013 to 28 February 2014 (index hospitalization). Patients with diagnoses indicative of rheumatic mitral valvular heart disease or a valve replacement procedure during index hospitalization were excluded. Patients were required to have been treated with either apixaban or warfarin, and not treated with rivaroxaban or dabigatran, during index hospitalization. Apixaban patients were propensity score (PS) matched to warfarin patients at a 1:1 ratio, using patient demographic/clinical and hospital characteristics. The study outcome was hospital LOS, calculated as discharge date minus admission date; a sensitivity analysis calculated hospital LOS as discharge date minus first anticoagulant administration date. Sub-analyses were conducted among patients with a primary diagnosis of AF.

Results: The study included 832 apixaban patients matched to 832 warfarin patients. Mean [standard deviation (SD)] and median hospital LOS were significantly (p < 0.001) shorter in apixaban patients (4.5 [4.2] and 3 days) than in warfarin patients (5.4 [5.0] and 4). Results were consistent in the sensitivity and sub-analyses.

Conclusions: Among NVAF patients, apixaban treatment was associated with shorter hospital LOS when compared with warfarin treatment. These findings may have important clinical and economic implications for hospitals, payers, and patients.
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http://dx.doi.org/10.1080/21548331.2015.1071635DOI Listing
March 2016

Evaluation of medical costs avoided when new oral anticoagulants are used for extended treatment of venous thromboembolism based on clinical trial results.

J Thromb Thrombolysis 2015 Aug;40(2):131-8

Department of Medicine, Hospitalist Program, School of Medicine, University of California, Irvine, UCIMC; 101 The City Drive South, Building 58, Room 110, ZC-4076H, Irvine, CA, 92868, USA,

This study evaluated avoidances in medical costs associated with clinical endpoints from randomized clinical trials that evaluated the efficacy and safety of the new oral anticoagulants (NOACs), dabigatran, rivaroxaban, and apixaban for extended treatment of patients with venous thromboembolism (VTE). Event rates of efficacy and safety endpoints from the clinical trials (RE-SONATE, EINSTEIN-EXT, and AMPLIFY-EXT) were obtained from published literature. Incremental annual medical costs among patients with clinical events from a US payer perspective were obtained from the literature or healthcare claims databases and inflation adjusted to 2013 costs. Differences in total medical costs associated with clinical endpoints for patients treated with NOACs versus placebo were then estimated. One-way univariate and Monte Carlo sensitivity analyses were additionally carried out. In all three NOAC trials lower rates of recurrent VTE occurred with NOAC use versus placebo. As a result of the reduction in VTE recurrence the overall medical costs avoided were -$2,794, -$2,948, -$4,249, and -$4,244 for VTE patients treated with dabigatran, rivaroxaban, apixaban 2.5 mg, and apixaban 5 mg respectively versus patients treated with placebo. Apixaban was associated with the greatest avoidance in medical costs, which was driven mainly by a greater reduced rate in recurrent VTE than other NOACs versus placebo and also a reduction in major bleeding rate. Further evaluation is needed to validate these results in the real-world setting.
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http://dx.doi.org/10.1007/s11239-014-1158-2DOI Listing
August 2015

Reviewing a clinical decision aid for the selection of anticoagulation treatment in patients with nonvalvular atrial fibrillation: applications in a US managed care health plan database.

Clin Ther 2014 Nov 23;36(11):1566-1573.e3. Epub 2014 Oct 23.

Bristol-Myers Squibb Co, Plainsboro, New Jersey.

Purpose: The Clinical Decision Aid was created to assist in selecting anticoagulant therapies for patients with nonvalvular atrial fibrillation. The aid incorporates a patient's absolute risk for stroke and bleeding, relative stroke risk reduction, and increase in relative bleeding risk to identify the agent with the lowest net risk. We describe theoretical implications of utilizing the aid at a US managed care population level.

Methods: This retrospective study used claims data from a large US managed care database including enrollees in commercial and Medicare Advantage plans. The distribution of patients across each possible combination of scores on the HAS-BLED scale (evidence of hypertension, abnormal renal or liver function, stroke, bleeding, labile INR, age >65 years, and drugs or alcohol abuse or dependence) and the CHA2DS2-VASc scale (CHADS2 [congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism] with additional nonmajor stroke risk factors, including age 65-74 years, female sex, and vascular disease) was generated. We assessed the correlation between the HAS-BLED and CHA2DS2-VASc scores and derived the optimal treatment options based on various bleeding ratios.

Findings: Data from 48,260 patients were included in the analysis. The MAPD subset had a higher mean HAS-BLED score (2.17 vs 1.39; P < 0.001) and a higher mean CHA2DS2-VASc score (3.35 vs 2.05; P < 0.001) than did the commercial subset. Pearson coefficients suggested a moderate to strong positive correlation between the HAS-BLED and CHA2DS2-VASc scores among the commercial (0.730; P < 0.001) and MAPD (0.568; P < 0.001) enrollees. Based on a 2:1 bleeding-to-stroke risk ratio, 70.50% of patients would be recommended treatment with apixaban; 25.86%, no treatment; 3.62%, acetylsalicylic acid; and 0.01%, dabigatran 150 mg, if the Clinical Decision Aid were to be used for anticoagulant treatment selection.

Implications: Evidence-based clinical decision-making tools utilizing risk assessment for recommending a treatment may be valuable for not only health care providers but also health care payers in optimizing care at the population level.
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http://dx.doi.org/10.1016/j.clinthera.2014.09.016DOI Listing
November 2014

Medical Costs of Oral Anticoagulants vs Warfarin for Atrial Fibrillation Patients with Different Stroke Risks.

Cardiol Ther 2013 Dec 17;2(2):165-70. Epub 2013 Aug 17.

Ochsner Medical Center, New Orleans, LA, USA,

Introduction: The Apixaban for the Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE), Randomized Evaluation of Long-term Anticoagulation Therapy (RE-LY), and Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET-AF) trials demonstrated that the oral anticoagulants (OACs), apixaban, dabigatran, and rivaroxaban, respectively, are efficacious for stroke prevention among nonvalvular atrial fibrillation (NVAF) patients. Based on clinical trial results this study evaluated medical costs of clinical events associated with use of individual OACs relative to those of warfarin in NVAF patients with moderate and high stroke risk.

Methods: Rates for primary and secondary efficacy and safety outcomes (i.e., clinical events) among NVAF patients with CHADS2 = 2 and ≥3 were determined from the three OAC trials. One-year incremental costs among patients with clinical events from a US payer perspective were obtained from the literature and inflation adjusted to 2010 costs. Medical costs for clinical events associated with each OAC vs. warfarin were estimated and compared.

Results: For NVAF patients with moderate stroke risk (CHADS2 = 2) differences in clinical event medical costs vs. warfarin were -$298, -$143, and +$117 per patient year for apixaban, dabigatran (150 mg), and rivaroxaban, respectively (negative numbers indicate cost reduction). For NVAF patients with high stroke risk (CHADS2 ≥ 3) differences in clinical event medical costs vs. warfarin were -$697, +$2, and -$100 for apixaban, dabigatran (150 mg), and rivaroxaban, respectively.

Conclusions: Medical cost differences associated with OACs vs. warfarin vary according to stroke risk. Of the three OACs, apixaban demonstrated consistent medical cost reductions vs. warfarin for NVAF patients with moderate and high stroke risks.
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http://dx.doi.org/10.1007/s40119-013-0020-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4107424PMC
December 2013

Depression monitoring and patient behavior in the Clinical Outcomes in MEasurement-Based Treatment (COMET) trial.

Psychiatr Serv 2014 Aug;65(8):1058-61

Objective: In this secondary analysis of results of the Clinical Outcomes in MEasurement-Based Treatment (COMET) trial, patient behaviors that might account for the differences observed in clinical outcomes were examined.

Methods: Patients (N=914) diagnosed as having major depressive disorder participated in telephone interviews either monthly for six months (intervention) or at three and six months (usual care) asking about antidepressant medication-taking, use of psychotherapy or counseling, and participation in depression support groups. Physicians (N=83) in the intervention arm received monthly feedback regarding their patients' depression severity.

Results: A total of 664 (73%) patients completed the month 6 interview. The adjusted odds of current antidepressant use at six months were 85% greater (p=.01) for patients in the intervention (N=380) versus usual care (N=284) arms, according to multivariate regression analyses.

Conclusions: More frequent measurement of depression symptoms was associated with greater medication persistence, which in turn may have mediated clinical improvements.
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http://dx.doi.org/10.1176/appi.ps.201300326DOI Listing
August 2014

Evaluation of medical costs associated with use of new oral anticoagulants compared with standard therapy among venous thromboembolism patients.

J Med Econ 2014 Nov 12;17(11):763-70. Epub 2014 Aug 12.

University of California , Irvine, CA , USA.

Objective: This study evaluated differences in medical costs associated with clinical end-points from randomized clinical trials that compared the new oral anticoagulants (NOACs), dabigatran, rivaroxaban, apixaban, and edoxaban, to standard therapy for treatment of patients with venous thromboembolism (VTE).

Research Design And Methods: Event rates of efficacy and safety end-points from the clinical trials (RE-COVER, RE-COVER II, EINSTEIN-Pooled, AMPLIFY, Hokusai-VTE trial) were obtained from published literature. Incremental annual medical costs among patients with clinical events from a US payer perspective were obtained from the literature or healthcare claims databases and inflation adjusted to 2013 costs. Differences in total medical costs associated with clinical end-points for the NOACs vs standard therapy were then estimated. One-way and Monte Carlo sensitivity analyses were carried out.

Results: A lower rate of major bleedings was associated with use of any of the NOACs vs standard therapy. Except for dabigatran, use of NOACs was also associated with a lower rate of recurrent VTE/death. As a result of the reduction in clinical event rates, the overall medical cost differences were -$146, -$482, -$918, and -$344 for VTE patients treated with dabigatran, rivaroxaban, apixaban, and edoxaban, respectively, vs patients treated with standard therapy.

Conclusions: When any of the four NOACs are used instead of standard therapy for acute VTE, treatment medical costs are reduced. Apixaban is associated with the greatest reduction in medical costs, which is driven by medical cost reductions associated with both efficacy and safety end-points. Further evaluation may be needed to validate these results in the real-world setting.
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http://dx.doi.org/10.3111/13696998.2014.950670DOI Listing
November 2014

Estimation of the impact of warfarin's time-in-therapeutic range on stroke and major bleeding rates and its influence on the medical cost avoidance associated with novel oral anticoagulant use-learnings from ARISTOTLE, ROCKET-AF, and RE-LY trials.

J Thromb Thrombolysis 2014 ;38(2):150-9

Department of Medicine, Hospitalist Program, School of Medicine, University of California, UCIMC, 101 The City Drive South, Building 58, Room 110, ZC-4076H, Mail Code: 4076, Irvine, CA, 92868, USA,

Warfarin's time-in-therapeutic range (TTR) is highly variable among patients with nonvalvular atrial fibrillation (NVAF). The objective of this study was to estimate the impact of variations in wafarin's TTR on rates of stroke/systemic embolism (SSE) and major bleedings among NVAF patients in the ARISTOTLE, ROCKET-AF, and RE-LY trials. Additionally, differences in medical costs for clinical endpoints when novel oral anticoagulants (NOACs) were used instead of warfarin at different TTR values were estimated. Quartile ranges of TTR values and corresponding event rates (%/patient - year = %/py) of SSE and major bleedings among NVAF patients treated with warfarin were estimated from published literature and FDA documents. The associations of SSE and major bleeding rates with TTR values were evaluated by regression analysis and then the calculated regression coefficients were used in analysis of medical cost differences associated with use of each NOAC versus warfarin (2010 costs; US payer perspective) at different TTRs. Each 10 % increase in warfarin's TTR correlated with a -0.32%/py decrease in SSE rate (R(2) = 0.61; p < 0.001). Although, the rate of major bleedings decreased as TTR increased, it was not significant (-0.035%/py, p = 0.63). As warfarin's TTR increased from 30 to 90% the estimated medical cost decreased from -$902 to -$83 for apixaban, from -$506 to +$314 for rivaroxaban, and from -$596 to +$223 for dabigatran. Among NVAF patients there is a significant negative correlation between warfarin's TTR and SSE rate, but not major bleedings. The variations in warfarin's TTR impacted the economic comparison of use of individual NOACs versus warfarin.
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http://dx.doi.org/10.1007/s11239-013-1048-zDOI Listing
February 2015

Comparison of Medical Costs of Patients With Atrial Fibrillation Unsuitable for Warfarin Treatment With Apixaban or Aspirin Based on AVERROES Trial.

Clin Appl Thromb Hemost 2015 Apr 9;21(3):235-40. Epub 2013 Oct 9.

Medical Affairs, Bristol-Myers Squibb, Plainsboro, NJ, USA.

Background: The AVERROES trial name is the following: The Apixaban Versus Acetylsalicylic Acid (ASA) to Prevent Stroke in Atrial Fibrillation Patients Who Have Failed or Are Unsuitable for Vitamin K Antagonist Treatment (AVERROES) trial demonstrated that apixaban reduced the risk of stroke relative to aspirin, without significantly increasing major bleeding risk in patients with atrial fibrillation (AF) considered unsuitable for warfarin therapy. Based on AVERROES trial results, this study compared the medical costs for clinical end points among patients with AF treated with either apixaban or aspirin.

Methods: Medical costs per patient-year for clinical events were determined. Based on clinical event rates for patients in the AVERROES trial, medical costs excluding drug costs were estimated for apixaban- and aspirin-treated patient groups.

Results And Conclusions: Based on AVERROES trial results, among patients with AF unsuitable for warfarin therapy, apixaban use was estimated to be associated with a mean medical cost avoidance of US$735 in a patient-year relative to aspirin. The primary driver was the significant reduction in ischemic stroke rate. The medical cost reduction associated with apixaban use was consistent in sensitivity analyses.
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http://dx.doi.org/10.1177/1076029613507335DOI Listing
April 2015

Medical costs in the US of clinical events associated with oral anticoagulant (OAC) use compared to warfarin among non-valvular atrial fibrillation patients ≥75 and <75 years of age, based on the ARISTOTLE, RE-LY, and ROCKET-AF trials.

J Med Econ 2013 Sep 8;16(9):1163-8. Epub 2013 Aug 8.

Ochsner Clinic Foundation, New Orleans, LA, USA.

Objectives: Based on clinical trials the oral anticoagulants (OACs) apixaban, dabigatran, and rivaroxaban are efficacious for reducing stroke risk for non-valvular atrial fibrillation (NVAF) patients. Based on the clinical trials, this study evaluated the medical costs for clinical events among NVAF patients ≥75 and <75 years of age treated with individual OACs vs warfarin.

Methods: Rates for primary and secondary efficacy and safety outcomes (i.e., clinical events) among NVAF patients receiving warfarin or each of the OACs were determined for NVAF populations aged ≥75 years and <75 years of age from the OAC vs warfarin trials. One-year incremental costs among patients with clinical events were obtained from published literature and inflation adjusted to 2010 costs. Medical costs, excluding medication costs, for clinical events associated with each OAC and warfarin were then estimated and compared.

Results: Among NVAF patients aged ≥75, compared to warfarin, use of either apixaban or rivaroxaban was associated with a reduction in medical costs per patient year (apixaban = -$825, rivaroxaban =-$23), while dabigatran use was associated with increased medical costs of $180 per patient year. Among NVAF patients <75 years of age medical costs per patient year were estimated to be reduced -$254, -$367, and -$88, for apixaban, dabigatran, and rivaroxaban, respectively, in comparison to warfarin.

Limitations: This economic analysis was based on clinical trial data and, therefore, the direct application of the results to routine clinical practice will require further assessment.

Conclusions: Difference in medical costs between OAC and warfarin treated NVAF patients vary by age group and individual OACs. Although reductions in medical costs for NVAF patients aged ≥75 and <75 were observed for those using either apixaban or rivaroxaban vs warfarin, the reductions were greater per patient year for both the older and younger NVAF populations using apixaban.
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http://dx.doi.org/10.3111/13696998.2013.826664DOI Listing
September 2013

Warfarin use and stroke risk among patients with nonvalvular atrial fibrillation in a large managed care population.

Clin Ther 2013 Aug 16;35(8):1201-10. Epub 2013 Jul 16.

Ochsner Clinic Foundation, New Orleans, LA, USA.

Background: Stroke prevention is a goal of atrial fibrillation (AF) management, but discontinuation of warfarin anticoagulation therapy is common.

Objective: To investigate the association between warfarin discontinuation and hospitalization for stroke among nonvalvular AF (NVAF) patients enrolled in managed care.

Methods: Patients with NVAF who initiated warfarin therapy from January 2005 through June 2009 were included. Warfarin discontinuation was defined as a supply gap >60 days without evidence of International Normalized Ratio measurements. Follow-up, which was a variable time period from warfarin initiation until the earlier of death, disenrollment from the health plan, or June 30, 2010, was divided into periods of warfarin treatment and discontinuation. Stroke events were identified based on claims for inpatient stays with a primary diagnosis of stroke or transient ischemic attack. Cox proportional hazards models were constructed to assess the relationship between warfarin discontinuation and incident stroke while adjusting for baseline demographics, stroke and bleeding risk, and comorbidities, as well as time-dependent antiplatelet use, stroke, and bleeding events in the previous warfarin treatment period.

Results: Among warfarin initiators with NVAF (N = 16,253), 51.4% discontinued warfarin therapy at least once during a mean follow-up of 668 days. Stroke risk was significantly greater during warfarin discontinuation periods compared with therapy periods (hazard ratio = 1.60; 95% CI, 1.35-1.90; P < 0.001).

Conclusions: More than half of patients on warfarin had treatment gaps or discontinued therapy. Therapy gaps were associated with increased stroke risk.
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http://dx.doi.org/10.1016/j.clinthera.2013.06.005DOI Listing
August 2013

Dosing patterns of aripiprazole and quetiapine for adjunctive treatment of major depressive disorder (2006-2010).

Int Clin Psychopharmacol 2013 Mar;28(2):87-90

Bristol-Myers Squibb, Plainsboro, Connecticut, USA.

The aim of this study was to investigate the dosing patterns of adjunctive quetiapine or adjunctive aripiprazole in the treatment of major depressive disorder from 2006 to 2010, and to evaluate the impact of Food and Drug Administration (FDA) approval on these dosing patterns. Patients included in the study were adults diagnosed with major depressive disorder, and treated with adjunctive aripiprazole or quetiapine between the years 2006 and 2010. The average daily dose and dose distribution were calculated and assessed statistically over the same time period. The mean daily dose for patients treated with adjunctive aripiprazole decreased from 13.5 mg/day in 2006 to 6.9 mg/day in 2010, whereas the mean daily dose for patients treated with quetiapine increased from 129 mg/day in 2006 to 139 mg/day in 2007, decreasing to 123 mg/day in 2010. The proportion of patients receiving FDA-recommended doses increased significantly for aripiprazole (86.3% in 2006 to 94.5% in 2010; P<0.001) and remained relatively stable for quetiapine (21.3% in 2006 to 24.0% in 2010; NS). The majority of patients treated with quetiapine received doses below those recommended by the FDA throughout the study period. Aripiprazole was mostly prescribed at therapeutic doses (pre-FDA and post-FDA approval), although the mean dose decreased significantly over time.
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http://dx.doi.org/10.1097/YIC.0b013e32835ce232DOI Listing
March 2013

Medical care costs and hospitalization in patients with bipolar disorder treated with atypical antipsychotics.

Am Health Drug Benefits 2012 Sep;5(6):379-86

Executive Director of Health Economics and Outcomes Research, Bristol-Myers Squibb, Plainsboro, NJ.

Background: A large proportion of costs associated with the treatment of bipolar disorder are attributable to patient hospitalization.

Objective: To investigate medical care costs and hospitalization rates among patients with bipolar disorder who were managed with aripiprazole compared with olanzapine, quetiapine, risperidone, or ziprasidone.

Methods: This retrospective cohort study assessed patients who were aged 18 to 64 years, diagnosed with bipolar disorder, and who were receiving therapy with aripiprazole, olanzapine, quetiapine, risperidone, or ziprasidone. This study was based on data from the PharMetrics claims database between January 1, 2003, and September 30, 2008. The study used a time-to-event framework. Cox proportional hazards models were used to assess the impact of each atypical antipsychotic on time to hospitalization, including all-cause and mental health-related reasons. Generalized linear models were used to compare costs per treated patient per month between the groups. Aripiprazole therapy was the reference group for all comparisons.

Results: Aripiprazole therapy showed a significantly lower hazard ratio (HR) for all-cause hospitalizations compared with olanzapine (HR, 1.4), quetiapine (HR, 1.4), risperidone (HR, 1.2), and ziprasidone (HR, 1.7); and for mental health-related hospitalizations compared with olanzapine, quetiapine, risperidone (HR, 1.3 each), and ziprasidone (HR, 1.7). Ziprasidone had higher unadjusted all-cause medical costs (US $1151 ± $2928) and unadjusted mental health-related costs (US $711 ± $2263) than the other antipsychotics that were included in this study, whereas aripiprazole had the lowest all-cause (US $804 ± $2523) and mental health-related costs (US $475 ± $2145) compared with the other antipsychotics. Quetiapine had the highest all-cause costs (US $1221; 95% confidence interval [CI], 1180-1263), and ziprasidone had the highest mental health-related costs (US $823; 95% CI, 754-898). Adjusted inpatient and emergency department all-cause costs were significantly lower for aripiprazole compared with all other atypical antipsychotics (P <.05), except olanzapine; however, the adjusted inpatient and emergency department mental health-related costs were significantly lower for aripiprazole only when compared with ziprasidone (P <.05).

Conclusions: The costs of medical care for patients with bipolar disorder differ based on the type of medication used, which can affect the rate of hospitalization. Treatment with aripiprazole was associated with fewer hospitalizations, longer time to hospitalization, and therefore the lowest all-cause and mental health-related medical costs compared with olanzapine, quetiapine, risperidone, or ziprasidone. Therefore, aripiprazole may offer an economic advantage over other atypical antipsychotics in patients with bipolar disorder.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4031693PMC
September 2012

Exposure to potentially dangerous drug-drug interactions involving antipsychotics.

Psychiatr Serv 2012 Nov;63(11):1080-8

Division of Pharmacy Practice and Administrative Sciences, College of Pharmacy, University of Cincinnati Medical Center, 3225 Eden Ave., Cincinnati, OH 45267, USA.

Objective: Antipsychotic drug therapy is the cornerstone of treatment of persons with schizophrenia. Because most antipsychotics are metabolized by the hepatic cytochrome P450 system, concomitant use of an antipsychotic and medications that are competitively metabolized by the same system may cause a potentially harmful drug-drug interaction. This study used a large state's Medicaid claims database to examine the proportion of patients exposed to such interactions and the risk factors associated with exposure.

Methods: Claims from January 2000 through December 2003 for adult patients with a diagnosis of schizophrenia and at least one prescription for an antipsychotic (N=27,909) were examined for pairs of medications identified as potentially causing moderate or severe adverse drug effects. Logistic regression models were estimated to determine potential risk factors associated with exposure to the interaction pairs.

Results: A total of 6,417 (23%) patients were exposed to 14,213 potentially harmful interactions; 4,725 patients had at least one exposure from the same pharmacy, and 4,032 patients were exposed by the same physician. The greatest number of exposures (N=1,353) to potentially harmful combinations involved olanzapine and haloperidol. Patients prescribed risperidone were most likely to be exposed to an interaction (13.1%), followed by patients prescribed olanzapine (10.3%), quetiapine (3.3%), and clozapine (3.2%). A higher risk of exposure was associated with being female (odds ratio [OR]=.94), being white (OR=1.43), having depression (OR=1.21), or having impulse-control disorder (OR=1.98).

Conclusions: Interventions by physicians and pharmacies to reduce the prescribing and dispensing of potentially harmful pairs of medications to patients with schizophrenia are recommended.
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http://dx.doi.org/10.1176/appi.ps.201100443DOI Listing
November 2012

Clinical Outcomes in Measurement-based Treatment (Comet): a trial of depression monitoring and feedback to primary care physicians.

Depress Anxiety 2012 Oct 16;29(10):865-73. Epub 2012 Jul 16.

Depression Clinical and Research Program, Massachusetts General Hospital, Boston, Massachusetts 02114, USA.

Background: Despite the availability of effective treatments for depression, many patients under the care of primary care physicians do not achieve remission. Clinical Outcomes in Measurement-based Treatment (COMET) was designed to assess whether communicating patient-reported depression symptom severity to primary care physicians affects patient outcomes at 6 months.

Methods: Nine hundred fifteen patients (intervention: n = 503; control: n = 412) diagnosed with major depressive disorder were enrolled in a prospective trial in which physician practice sites were assigned to either the intervention or control study arm. Only patients who were prescribed an antidepressant by their physician were eligible, but medication type was independent of the study protocol. Intervention-arm physicians received monthly updates on their patients' depression severity, which was determined with the nine-item Patient Health Questionnaire (PHQ-9) administered during telephone interviews. Remission was defined as a PHQ-9 score <5 at 6 months; response was defined as a score reduction ≥50%.

Results: Among patients with baseline PHQ-9 score ≥5, 45.0% achieved remission (46.7% intervention versus 42.8% control) and 63.9% responded (67.0% intervention versus 59.7% control) at 6 months. After adjusting for baseline demographic and clinical variables, odds of remission (odds ratio [OR], 1.59 [95% CI, 1.07-2.37]) or response (OR, 2.02 [95% CI, 1.36-3.02]) were significantly greater for the intervention group than for control patients.

Conclusions: This study demonstrated that regular patient symptom monitoring with feedback to physicians improved outcomes of depression treatment in the primary care setting. Determining reasons for the high observed nonremission rates requires further investigation.
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http://dx.doi.org/10.1002/da.21983DOI Listing
October 2012

Why is warfarin underused for stroke prevention in atrial fibrillation? A detailed review of electronic medical records.

Curr Med Res Opin 2012 Sep 26;28(9):1407-14. Epub 2012 Jul 26.

Indiana University, Indianapolis, IN 46202, USA.

Objective: Automated electronic queries of structured data fields in electronic medical records (EMR) found no barriers to warfarin in 42% of patients with atrial fibrillation or atrial flutter (AF) with moderate or high risk of stroke and no warfarin. A thorough manual review of records (including text reports) from the same EMR may better identify physicians' reasons for not using warfarin.

Methods: This was a cross-sectional, retrospective, manual EMR review. Patients identified in a previous automated EMR study with a CHADS2 (Chronic heart failure, Hypertension, Age >75 years, Diabetes mellitus, Stroke) score≥2, no record of warfarin, no barrier to warfarin use, and (in the present study) confirmation of AF diagnosis were included in the manual EMR review. A structured chart abstraction form was used to extract data visible in the clinicians' EMR user interface. Reasons why warfarin had not been prescribed were reported using descriptive statistics.

Results: Among 408 patients with 'no barriers' to warfarin in the automated EMR review, AF diagnosis was confirmed in 319 patients (mean age 74.8; 65% female). Forty-one percent (n=132) did not have chart records explaining why they were not on warfarin. Among the 59% (187) with a rationale against warfarin found in the records, the most common category (52%) was indicative of the risk of bleeding, either risk of fall or history of recent bleeding. The second most common category (16%) reflected that the patient was back in sinus rhythm. These findings are subject to inherent limitations of retrospective chart reviews.

Conclusions: Many patients with AF and moderate-to-high risk of stroke are not treated with warfarin, and reasons for not using warfarin could not always be identified in patient records. Among patients with documented reasons, risk of bleeding (risk of fall or recent bleeding) was the most common category.
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http://dx.doi.org/10.1185/03007995.2012.708653DOI Listing
September 2012

Cost-effectiveness of adjunctive therapy with atypical antipsychotics for acute treatment of major depressive disorder.

Ann Pharmacother 2012 May 1;46(5):642-9. Epub 2012 May 1.

Policy Analysis Inc., Brookline, MA, USA.

Background: While the clinical utility of atypical antipsychotics has been established in patients with major depressive disorder (MDD) who are refractory to antidepressant therapy, their cost-effectiveness is unknown.

Objective: To examine the cost-effectiveness of aripiprazole, quetiapine, and olanzapine/fluoxetine in adults with MDD who are refractory to antidepressant therapy.

Methods: Using techniques of decision analysis, we estimated expected outcomes and costs over 6 weeks in adults with MDD receiving (1) aripiprazole 2-20 mg/day and antidepressant therapy; (2) quetiapine 150 mg/day or 300 mg/day and antidepressant therapy; (3) the fixed-dose combination of olanzapine 6, 12, or 18 mg/day with fluoxetine 50 mg/day; or (4) antidepressant therapy alone. Cost-effectiveness was assessed in terms of the cost per additional responder at 6 weeks, defined as the ratio of the difference in the cost of MDD-related care over 6 weeks versus antidepressant therapy alone to the difference in the number of patients achieving clinical response by 6 weeks. We estimated the model using data from Phase 3 clinical trials of atypical antipsychotics along with other secondary data sources.

Results: With antidepressant therapy alone, the estimated clinical response rate at 6 weeks was 30%. Aripiprazole, quetiapine 150 mg/day, quetiapine 300 mg/day, and olanzapine/fluoxetine were estimated to increase clinical response at 6 weeks to 49%, 34%, 38%, and 45%, respectively. Costs of MDD-related care over 6 weeks were estimated to be $192 for antidepressant therapy, $847 for aripiprazole, $541 for quetiapine 150 mg/day, $672 for quetiapine 300 mg/day plus antidepressant therapy, and $791 for olanzapine/fluoxetine. Costs per additional responder (vs antidepressant therapy) over a 6-week period were estimated to be $3447 for aripiprazole, $8725 for quetiapine 150 mg/day, $6000 for quetiapine 300 mg/day, and $3993 for olanzapine/fluoxetine.

Conclusions: Atypical antipsychotics substantially increase clinical response at 6 weeks. Cost per additional responder is lower for aripiprazole than for quetiapine or olanzapine/fluoxetine.
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http://dx.doi.org/10.1345/aph.1Q326DOI Listing
May 2012

Medical cost reductions associated with the usage of novel oral anticoagulants vs warfarin among atrial fibrillation patients, based on the RE-LY, ROCKET-AF, and ARISTOTLE trials.

J Med Econ 2012 13;15(4):776-85. Epub 2012 Apr 13.

Ochsner Clinic Foundation, New Orleans, LA, USA.

Objective: The randomized clinical trials, RE-LY, ROCKET-AF, and ARISTOTLE, demonstrate that the novel oral anticoagulants (NOACs) are effective options for stroke prevention among non-valvular atrial fibrillation (AF) patients. This study aimed to evaluate the medical cost reductions associated with the use of individual NOACs instead of warfarin from the US payer perspective.

Methods: Rates for efficacy and safety clinical events for warfarin were estimated as the weighted averages from the RE-LY, ROCKET-AF and ARISTOTLE trials, and event rates for NOACs were determined by applying trial hazard ratios or relative risk ratios to such weighted averages. Incremental medical costs to a US health payer of an AF patient experiencing a clinical event during 1 year following the event were obtained from published literature and inflation adjusted to 2010 cost levels. Medical costs, excluding drug costs, were evaluated and compared for each NOAC vs warfarin. Sensitivity analyses were conducted to determine the influence of variations in clinical event rates and incremental costs on the medical cost reduction.

Results: In a patient year, the medical cost reduction associated with NOAC usage instead of warfarin was estimated to be -$179, -$89, and -$485 for dabigatran, rivaroxaban, and apixaban, respectively. When clinical event rates and costs were allowed to vary simultaneously, through a Monte Carlo simulation, the 95% confidence interval of annual medical costs differences ranged between -$424 and +$71 for dabigatran, -$301 and +$135 for rivaroxaban, and -$741 and -$252 for apixaban, with a negative number indicating a cost reduction. Of the 10,000 Monte-Carlo iterations 92.6%, 79.8%, and 100.0% were associated with a medical cost reduction >$0 for dabigatran, rivaroxaban, and apixaban, respectively.

Conclusions: Usage of the NOACs, dabigatran, rivaroxaban, and apixaban may be associated with lower medical (excluding drug costs) costs relative to warfarin, with apixaban having the most substantial medical cost reduction.
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http://dx.doi.org/10.3111/13696998.2012.680555DOI Listing
October 2012

Impact of cost-sharing on treatment augmentation in patients with depression.

Am J Manag Care 2012 Jan 1;18(1):e15-22. Epub 2012 Jan 1.

Thomson Reuters, 777 E. Eisenhower Pkwy, Ann Arbor, MI 48108.

Objectives: Many patients with depression do not respond to first-line antidepressant therapy and may require augmentation with another concurrent treatment such as a second antidepressant, a stimulant, a mood stabilizer, or a second-generation antipsychotic (SGA). The objective of this study was to examine the relationship between patient cost-sharing and the use of augmentation among a sample of commercially insured patients.

Study Design: Retrospective observational study of adult patients diagnosed with depression and receiving antidepressant therapy (n = 48,807).

Methods: Logistic regression models estimated the likelihood of augmentation as a function of patient cost-sharing amounts. An alternative-specific conditional logit model of the likelihood of each augmentation class, varying the cost-sharing prices faced for each class, was also estimated. All models controlled for sociodemographic characteristics, physical and mental comorbidities, health plan type, and year of index antidepressant therapy initiation.

Results: The range of mean copayments paid by patients for augmentation therapy was from $27.05 (antidepressant) to $38.81 (SGA). A $10- higher cost-sharing index for all augmentation classes was associated with lower odds of augmentation (adjusted odds ratio = 0.85; 95% confidence interval 0.79-0.91). Doubling the costsharing amount for each augmentation class was associated with a smaller percentage of patients utilizing each class of augmentation therapy.

Conclusions: Employers and payers should consider the relationship between cost-sharing and medication utilization patterns of patients with depression.
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January 2012

Coronary artery bypass graft surgery in acute coronary syndrome: incidence, cost impact, and acute clopidogrel interruption.

Hosp Pract (1995) 2012 Feb;40(1):15-23

Research Leader, Thomson Reuters, Washington, DC 20008, USA.

Background: Guidelines stipulate that clopidogrel should be interrupted ≥ 5 days prior to elective coronary artery bypass graft (CABG) surgery to reduce the risk of bleeding unless the need for revascularization and/or the net benefit of the clopidogrel outweighs the potential risks of bleeding. This study describes real-world patterns of acute clopidogrel use, CABG surgery, and inpatient costs among patients with acute coronary syndrome (ACS).

Methods: The study used the MarketScan® Commercial, Medicare Supplemental, and Hospital Drug databases, comprising health care data for > 63 million individuals in the United States. Acute coronary syndrome episodes, defined as hospitalizations for ACS (primary International Classification of Diseases, Ninth Revision, Clinical Modification codes 410.xx, 411.1x) occurring between January 1, 2005 and June 30, 2009, were identified from patients aged ≥ 18 years. Outcomes included cost of and length of stay (LOS) for ACS episodes and, among patients experiencing ACS episodes treated with acute clopidogrel administration followed by CABG surgery, the duration of clopidogrel interruption prior to CABG surgery. Analyses were descriptive.

Results: A total of 160 168 ACS episodes were identified, and the mean patient age was 63.5 years. Coronary artery bypass graft surgery episodes comprised 9.3% (14 896 of 160 168) of all ACS episodes. The mean LOS was 9.8 (standard deviation [SD], 6.8) days per CABG surgery episode, and mean inpatient costs were $71 140 (SD, $68 012) per CABG surgery episode. Among patients experiencing ACS episodes with inpatient drug data and to whom acute clopidogrel was administered followed by CABG surgery (n = 8101), the mean duration of clopidogrel interruption was 3.3 (SD, 2.6) days, and the majority (62.1%) of these patients underwent surgery within 1 to 3 days after their last acute clopidogrel dose. The mean incremental increase in inpatient costs associated with 1 extra LOS day was $1991.

Conclusion: Coronary artery bypass graft surgery is used relatively infrequently among patients who experience ACS episodes. When CABG surgery is performed in a real-world setting, the majority or procedures are performed < 5 days after the last acute clopidogrel dose. However, among patients for whom urgent CABG surgery is not indicated, withholding CABG surgery to allow for clopidogrel interruption may only minimally affect inpatient costs and must be considered in the broader context of patient management.
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http://dx.doi.org/10.3810/hp.2012.02.944DOI Listing
February 2012

Effect of communicating depression severity on physician prescribing patterns: findings from the Clinical Outcomes in MEasurement-based Treatment (COMET) trial.

Gen Hosp Psychiatry 2012 Mar-Apr;34(2):105-12. Epub 2012 Jan 20.

Depression Clinical and Research Program, Massachusetts General Hospital, Boston, MA 02114, USA.

Objective: In this secondary analysis from the Clinical Outcomes in MEasurement-based Treatment trial (COMET), we evaluated whether providing primary care physicians with patient-reported feedback regarding depression severity affected pharmacological treatment patterns.

Method: Intervention-arm physicians received their patients' 9-item Patient Health Questionnaire scores monthly. Odds of having no change in antidepressant treatment during the 6-month study period were calculated. Relationships between depression symptom status (partial or nonresponse) at month 3 and treatment changes in months 3 through 6 were assessed.

Results: Among 503 intervention and 412 usual care (UC) patients with major depressive disorder, most received antidepressant monotherapy at baseline (79.4% UC vs. 88.4% intervention; P=.047). Few switched their baseline antidepressant (17.4%), increased their dose (12.4%) or augmented with a second medication (2%). Odds of having no change in antidepressant therapy did not differ significantly between study arms (odds ratio 1.21; 95% confidence interval 0.78-1.88; P=.392). Few month 3 partial or nonresponders had a regimen change over the following 3 months; the study arms did not differ significantly (partial responders: 4.1% UC vs. 7.7% intervention; P=.429; nonresponders: 14.6% UC vs. 15.9% intervention; P=.888).

Conclusions: Among depressed patients treated in primary care, little active management was observed. The lack of treatment modification for the majority of partial and nonresponders was notable.
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http://dx.doi.org/10.1016/j.genhosppsych.2011.12.003DOI Listing
July 2012

Association between second-generation antipsychotic medication half-life and hospitalization in the community treatment of adult schizophrenia.

J Med Econ 2012 28;15(1):105-11. Epub 2011 Oct 28.

Bristol-Myers Squibb Company, Plaisboro, NJ, USA.

Objective: To examine the effect of antipsychotic medication half-life on the risk of psychiatric hospital admission and emergency department (ED) visits among adults with schizophrenia.

Methods: Retrospective claims-based cohort study of adult Medicaid patients with schizophrenia who were prescribed second-generation antipsychotic monotherapy following hospital discharge between 1/1/04 and 12/31/06. Cox proportional hazards models were applied to compare adjusted hazards of mental disorder admission among patients treated with oral antipsychotics that have either a long [risperidone (t(1/2) = 20 h), olanzapine (t(1/2) = 30 h), aripiprazole (t(1/2) = 75 h)] (n = 1479) or short [quetiapine (t(1/2) = 6 h), ziprasidone (t(1/2) = 7 h)] (n = 837) half-life. Day-level models controlled for baseline background characteristics and antipsychotic adherence over time as measured by gaps in the prescription record. Similar analyses examined either hospitalization or ED visits as separate endpoints.

Results: A significantly lower rate of hospitalization/ED visits was evident for long (0.74/patient-year) vs short (1.06/patient-year) half-life antipsychotics (p < 0.001). The unadjusted rate of hospitalization alone was significantly lower for long (0.38/patient-year) vs short (0.52/patient-year) half-life antipsychotics (p = 0.005). Compared with short half-life antipsychotic drugs, the adjusted hazard ratio associated with long half-life medications was 0.77 (95% CI = 0.67-0.88) for combined hospitalization/ED visits and 0.80 (95% CI = 0.67-0.96) for hospitalization. The corresponding number needed to treat with long, rather than short, half-life medications to avoid one hospitalization was 16 patients for 1 year and to avoid one hospitalization or ED visit was 11 patients for 1 year.

Limitations: This study demonstrated an association between antipsychotic medication half-life and hospitalization, not a causal link. Patients using long half-life medications had fewer comorbid mental health conditions and took fewer psychiatric medications at baseline. Other unmeasured differences may have existed between groups and may partially account for the findings.

Conclusions: In schizophrenia management, longer-acting second-generation antipsychotics were associated with a lower risk of hospital admission/ED visits for mental disorders.
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http://dx.doi.org/10.3111/13696998.2011.632042DOI Listing
June 2012

Comparison of second-generation antipsychotic treatment on psychiatric hospitalization in Medicaid beneficiaries with bipolar disorder.

J Med Econ 2011 29;14(6):777-86. Epub 2011 Sep 29.

Bristol-Myers Squibb Company, Plainsboro, NJ, USA.

Objective: To compare second-generation antipsychotics on time to and cost of psychiatric hospitalization in Medicaid beneficiaries with bipolar disorder.

Methods: Retrospective study using healthcare claims from 10 US state Medicaid programs. Included beneficiaries were aged 18-64, initiated a single second-generation antipsychotic (aripiprazole, olanzapine, quetiapine, risperidone, or ziprasidone) between 1/1/2003-6/30/2008 (initiation date=index), and had a medical claim with an ICD-9-CM diagnosis code for bipolar disorder. A 360-day post-index period was used to measure time to and costs of psychiatric hospitalization (inpatient claims with a diagnosis code for a mental disorder [ICD-9-CM 290.xx-319.xx] in any position). Cox proportional hazards models and Generalized Linear Models compared time to and costs of psychiatric hospitalization, respectively, in beneficiaries initiating aripiprazole vs each other second-generation antipsychotic, adjusting for beneficiaries' baseline characteristics.

Results: Included beneficiary characteristics: mean age 36 years, 77% female, 80% Caucasian, aripiprazole (n=2553), mean time to psychiatric hospitalization or censoring=85 days; olanzapine (n=4702), 81 days; quetiapine (n=9327), 97 days; risperidone (n=4377), 85 days; ziprasidone (n=1520), 82 days. After adjusting for baseline characteristics, time to psychiatric hospitalization in beneficiaries initiating aripiprazole was longer compared to olanzapine (hazard ratio [HR]=1.52, p<0.001), quetiapine (HR=1.40, p<0.001), ziprasidone (HR=1.33, p=0.032), and risperidone, although the latter difference did not reach significance (HR=1.18, p=0.13). The adjusted costs of psychiatric hospitalization in beneficiaries initiating aripiprazole were significantly lower compared to those initiating quetiapine (incremental per-patient per-month difference=$42, 95% CI=$16-66, p<0.05), but not significantly lower for the other comparisons.

Limitations: This study was based on a non-probability convenience sample of the Medicaid population. Analyses of administrative claims data are subject to coding and classification error.

Conclusions: Medicaid beneficiaries with bipolar disorder initiating aripiprazole had significantly longer time to psychiatric hospitalization than those initiating olanzapine, quetiapine, or ziprasidone, and significantly lower adjusted costs for psychiatric hospitalization than those initiating quetiapine.
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http://dx.doi.org/10.3111/13696998.2011.625066DOI Listing
March 2012

Impact of dyspnea on medical utilization and affiliated costs in patients with acute coronary syndrome.

Hosp Pract (1995) 2011 Aug;39(3):16-22

Thomson Reuters, Andover, MA, USA.

Background: Current clinical practice guidelines recommend dual antiplatelet therapy with aspirin and clopidogrel or prasugrel for patients with acute coronary syndrome (ACS). Ticagrelor, an experimental antiplatelet therapy, has been shown to be associated with significantly higher rates of dyspnea than clopidogrel in clinical trials. Patients with ACS presenting with dyspnea require additional medical attention to rule out possible heart failure or other serious diagnoses. This study used real-world data to quantify the direct medical costs of dyspnea among patients with a history of ACS.

Objective: To determine the clinical and economic impact of a dyspnea episode for patients with a history of ACS using commercial and Medicare supplemental claims data.

Methods: Patients with an emergency room (ER) visit with a primary diagnosis of dyspnea (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] diagnosis code, 786.0x) in 2008 or 2009 were identified using Thomson Reuters MarketScan(®) Research Databases. Patients were required to have 6 months of continuous medical enrollment prior to an ER visit and a history of ACS (ie, ≥ 1 inpatient claim, ≥ 1 ER visit, or ≥ 2 outpatient claims, with an ICD-9-CM diagnosis code for ACS [410.xx or 411.1x] in any position on the outpatient claim during either the baseline period or on the index date). An episode of dyspnea was defined as all ER and outpatient services on the day of an ER claim with a primary diagnosis of dyspnea, and any inpatient admissions occurring on the day of or day following the ER visit. Procedure utilization and expenditures were evaluated for the ER visit and associated outpatient services, as well as the proportion of ER visits that led to an inpatient stay. Costs were allowed charges (ie, provider payment plus member cost-share) adjusted to 2009 US constant dollars.

Results: A total of 8433 ER visits for dyspnea were identified during 2008 to 2009 from these databases of approximately 74 million beneficiaries. The average cost per dyspnea episode was $6958, of which $1621 were outpatient costs associated with the ER visit (standard deviation, $3269). Along with physician services, assessment of dyspnea often included electrocardiogram (71.3%), chest radiograph (75.9%), and, occasionally, a B-type natriuretic peptide test (14.9%) or chest computed axial tomography scan (12.2%). More than one-fourth (25.8%) of dyspnea ER visits preceded an inpatient stay, with an average cost of $20 693 per patient.

Conclusions: Dyspnea is a significant event associated with high medical resource utilization and hospital costs. Ticagrelor, an experimental antiplatelet agent not yet available on the market, has been shown to be associated with significantly higher rates of dyspnea than clopidogrel in clinical trials. Considering that the increased risk of dyspnea for ticagrelor is well documented, these costs may be important to health plan decision-makers when evaluating costs associated with each antiplatelet therapy.
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http://dx.doi.org/10.3810/hp.2011.08.575DOI Listing
August 2011

Intent-to-treat analysis of health care expenditures of patients treated with atypical antipsychotics as adjunctive therapy in depression.

Clin Ther 2011 Sep 12;33(9):1246-57. Epub 2011 Aug 12.

Bristol-Myers Squibb, Plainsboro, New Jersey, USA.

Objective: To compare health care utilization and expenditures in patients with depression whose initial antidepressant (AD) treatment was augmented with a second-generation antipsychotic.

Methods: Claims data from January 1, 2001, through June 30, 2009, were used to select patients aged 18 to 64 years with depression treated with ADs augmented with aripiprazole, olanzapine, or quetiapine. Patients were required to have 6 months of continuous eligibility before the first AD prescription and 6 months after the second-generation antipsychotic augmentation (index) date. Utilization and expenditures were assessed for 6 months after the index date. Multivariate regression was used to estimate adjusted expenditures and risks for hospitalizations and emergency department visits.

Results: A total of 483 patients treated with aripiprazole, 978 with olanzapine, and 2471 with quetiapine were selected. Mean adjusted expenditures for aripiprazole were significantly lower than those for olanzapine for each service category (all-cause, all-cause medical care, mental health-related, and mental health-related medical care) and were significantly lower than those for quetiapine for each category with the exception of mental health-related. The adjusted risks for hospitalization and emergency department visits were significantly higher for quetiapine than for aripiprazole.

Conclusions: Compared with patients treated with ADs and aripiprazole, those treated with ADs and olanzapine or quetiapine had greater utilization and higher expenditures.
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http://dx.doi.org/10.1016/j.clinthera.2011.07.015DOI Listing
September 2011

A real-world data analysis of dose effect of second-generation antipsychotic therapy on hemoglobin A1C level.

Prog Neuropsychopharmacol Biol Psychiatry 2011 Jul 15;35(5):1326-32. Epub 2011 Apr 15.

Bristol-Myers Squibb, Wallingford, CT 06492, USA.

Previous studies have demonstrated an association between certain second-generation antipsychotics (SGAs) and diabetes mellitus. The study assessed the impact of SGA dose on hemoglobin A1C (HbA(1c) >6.0) levels in a real-world setting. Patients aged ≥ 18 years during 2002-2006 in Ingenix LabRx claims database were included. The database collects medical and prescription claims and a subset of laboratory results for an employed, commercially insured population distributed throughout the United States. Patients with previously diagnosed diabetes, identified by the ICD-9-CM code of 250.x or use of antidiabetic agents, were excluded. The main exposure measure was the cumulative dose over a 30 day period before the HbA(1c) test, calculated as [sum of (number of pills per day×strength)]/100. A logistic regression was used to examine the relation with HbA(1c) >6.0 by tertile of the cumulative dose and average daily dose, adjusted for the covariates. The study included 391 patients on olanzapine, 467 on quetiapine, and 262 on risperidone. Patients treated with aripiprazole or ziprasidone (n=212) were included as a secondary reference because of their minimal metabolic risk. Compared to lower (Tertiles 1 and 2) cumulative doses of risperidone, patients with a high cumulative dose of risperidone (Tertile 3) had a significantly higher odds ratio (OR) for HbA(1c) >6.0 (adjusted OR=2.45; 95% confidence interval=1.13-5.32; P=0.023). A similar increase in OR was seen in patients with high cumulative dose of olanzapine (2.41; 1.19-4.89; P=0.015). Analyses of average daily dose revealed that quetiapine ≥ 400 mg/day and risperidone ≥ 2 mg/day had an OR of 2.29 (1.04-5.06; P=0.041) and 2.28 (1.08-4.83; P=0.032), respectively, compared to aripiprazole/ziprasidone. Both olanzapine groups (≥ 10 and <10mg/day) were associated with a significantly increased OR. All results remained similar after further adjustment for the predicated probability of having an HbA(1c) test and additional medication covariates. In this claims data study, use of olanzapine was associated with elevated HbA(1c) and risperidone and quetiapine appeared to have dose-related association with elevated HbA(1c). One of the limitations of a claims data analysis is the lack of information on potential confounders such as ethnicity and weight.
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http://dx.doi.org/10.1016/j.pnpbp.2011.03.020DOI Listing
July 2011