Publications by authors named "Rutugandha Paranjpe"

19 Publications

  • Page 1 of 1

Predictors and Healthcare Utilization of Sepsis Post-Ureteroscopy in a US-Based Population : Results from the Endourological Society TOWER Collaborative.

J Endourol 2022 Jul 13. Epub 2022 Jul 13.

The University of British Columbia, 8166, Urologic Sciences, Vancouver, British Columbia, Canada.

Purpose To investigate the incidence, predictive factors, and healthcare utilization of sepsis post-ureteroscopy (URS) in patients enrolled in commercial insurance plans. Materials and Methods A retrospective claims analysis was conducted using the IBM® MarketScan® commercial database. Patients ≥18 years were included if they had URS between January 2015-October 2019 and developed sepsis within 30 days of URS. Multivariate logistic regression was used to identify various clinical and demographic predictors of sepsis post-URS. All-cause healthcare utilization (i.e., inpatient admissions and intensive care unit stays) and all-cause healthcare costs up to 1 month post-septic event were measured. Results Among the 104,100 URS patients meeting the inclusion criteria, 5.5% developed sepsis. Patients with diabetes (OR=1.52; p<0.0001), older age (age 55-64 versus 18-34; OR=1.35; p<0.0001), baseline sepsis (OR=3.51; p<0.0001), baseline inpatient visits (OR=1.17; p=0.0012), and higher Elixhauser comorbidity scores (OR=1.09; p<0.0001) had a significantly higher likelihood of developing sepsis post-URS. In septic patients, 94.8% required inpatient care and 35% were admitted to the ICU. Mean hospital stay for septic patients was 6.86 days. Average all-cause healthcare cost per patient at 1 month in the septic cohort was $49,625 versus $17,782 in the non-septic cohort indicating an incremental all-cause cost of $31,843 (p<0.0001). Conclusions A total of 5.5% of commercially insured patients undergoing URS developed sepsis post-URS. Diabetes, older age, baseline sepsis, baseline inpatient visit, and higher comorbidity score were all found to be independent predictors of post-URS sepsis. Patients with sepsis post-URS had higher healthcare utilization and costs indicating that sepsis is both a significant clinical and economic event.
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http://dx.doi.org/10.1089/end.2022.0010DOI Listing
July 2022

Group based trajectory modeling to assess adherence to oral anticoagulants among atrial fibrillation patients with comorbidities: a retrospective study.

Int J Clin Pharm 2022 Jul 1. Epub 2022 Jul 1.

Department of Pharmaceutical Health Outcomes and Policy, University of Houston College of Pharmacy, 4849 Calhoun Rd Suite 4050, Houston, TX, USA.

Background: Poor adherence to oral anticoagulants is a significant problem in atrial fibrillation (AF) patients with comorbidities as it increases the risk for cardiac and thromboembolic events.

Aim: The primary objective was to evaluate adherence to direct oral anticoagulants (DOACs) or warfarin using group-based trajectory modeling (GBTM). The secondary objective was to identify the predictors of adherence to oral anticoagulants. Finally, to report the drug interactions with DOACs/warfarin.

Method: This retrospective study was conducted among continuously enrolled Medicare Advantage Plan members from January 2016-December 2019. AF patients with comorbid hypertension, diabetes and hyperlipidemia using warfarin/DOACs were included. Monthly adherence to DOAC/warfarin was measured using proportion of days covered (PDC) and then modeled in a logistic GBTM to identify the distinct patterns of adherence. Logistic regression model was conducted to identify the predictors of adherence to oral anticoagulants adjusting for all baseline characteristics. Concomitant use of DOACs/warfarin with CYP3A4,P-gp inhibitors were measured.

Results: Among 317 patients, 137 (43.2%) and 79 (24.9%) were DOAC, and warfarin users, respectively. The adherence trajectory model for DOACs included gradual decline (40.4%), adherent (38.8%), and rapid decline (20.8%). The adherence trajectories for warfarin adherence included gradual decline (8.9%), adherent (59.4%), and gaps in adherence (21.7%). Predictors of adherence included type of oral anticoagulant, stroke risk score, low-income subsidy, and baseline PDC. CYP3A4,P-gp drugs were co-administered with DOACs /warfarin resulting in adverse events.

Conclusion: Adherence to oral anticoagulants is suboptimal. Interventions tailored according to past adherence trajectories may be effective in improving patient's adherence.
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http://dx.doi.org/10.1007/s11096-022-01417-4DOI Listing
July 2022

Evaluating adherence to concomitant diabetes, hypertension, and hyperlipidemia treatments and intermediate outcomes among elderly patients using marginal structural modeling.

Pharmacotherapy 2022 Jul 9;42(7):518-528. Epub 2022 Jun 9.

University of Houston, Texas, USA.

Purpose: Medication adherence to concomitant oral antidiabetics, statins, and renin-angiotensin system (RAS) antagonists (triple therapy) is vital to manage glycated hemoglobin (A1C) and low-density lipoprotein cholesterol (LDL-C) control among patients with comorbid diabetes, hyperlipidemia, and hypertension. The objective of the current study was to evaluate the association between adherence to concomitant triple therapy and A1C as well as LDL-C outcomes, among elderly patients using marginal structural modeling.

Methods: A retrospective cohort study with patients on concurrent triple therapy was conducted using a Texas Medicare Advantage database from January 2016 until December 2019. Medication adherence to concurrent triple therapy was measured every 6 months using proportion of days covered (PDC) to determine the different adherence groups. A1C and LDL-C control was also measured every 6 months. A marginal structural model controlling for baseline covariates and time-varying confounders affected by prior adherence was conducted to evaluate the association between adherence to concomitant triple therapy and A1C and LDL-C control.

Results: The LDL-C cohort was comprised of 4803 patients and the A1C cohort was comprised of 5314 patients on triple therapy. Patients who were adherent to triple therapy [odds ratio(OR):1.84, 95% confidence interval (CI): 1.62-2.10] and adherent to double therapy (OR:1.42, 95% CI: 1.24-1.62) were more likely to have their LDL-C in control as compared to patient's adherent to monotherapy/none. Similarly, patients who were adherent to triple therapy (OR:1.30, 95% CI: 1.11-1.52) and adherent to double therapy (OR:1.32, 95% CI: 1.12-1.55) were more likely to have their A1C in control as compared to patient's adherent to monotherapy/none.

Conclusion: The current study demonstrated the beneficial effects of adherence to concurrent oral antidiabetics, statins, and RAS antagonists among elderly patients in a real-world setting.
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http://dx.doi.org/10.1002/phar.2705DOI Listing
July 2022

Adherence to concomitant diabetes, hypertension, and hyperlipidemia treatments among older patients.

J Am Pharm Assoc (2003) 2022 Jul-Aug;62(4):1351-1358. Epub 2022 Mar 16.

Background: Diabetes, hypertension, and hyperlipidemia have been identified as common modifiable risk factors of cardiovascular disease, frequently occurring together, especially among older people. Medication adherence to concomitant triple therapy is of vital importance among this population.

Objectives: The objective of the current study was to examine adherence to concurrent oral antidiabetics, renin-angiotensin system antagonists, and statins (triple therapy) among older patients and further evaluate the predictors associated with adherence to concurrent triple therapy among older patients.

Methods: Patients on concurrent triple therapy were identified using a Texas Medicare Advantage dataset. Patients had to have an overlap of 30 days of triple therapy and a second prescription of each component of triple therapy within the identification period. Medication adherence was measured using Proportion of Days Covered during the 1-year follow-up period to determine different adherence groups. A multinomial logistic regression was further conducted to determine various demographic and clinical factors associated with each adherence group.

Results: The final patient cohort comprised 7847 patients. Of these, 68.05% were adherent to triple therapy, 21.43% were adherent to double therapy, and 10.51% were adherent to monotherapy or none. Compared with the triple therapy adherent group, females had a higher likelihood of being in the triple therapy nonadherent groups, while a refill of 90 days or more and prevalent use of triple therapy was associated with a lower likelihood of being in the triple therapy nonadherent groups. Finally, predictors associated with the adherent to monotherapy or none group included older age and a higher number of total other medications.

Conclusion: Adherence to triple therapy among older patients was 68.05%, and several demographic and clinical factors were associated with the different adherence groups.
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http://dx.doi.org/10.1016/j.japh.2022.03.011DOI Listing
July 2022

Identifying adherent patients to newly initiated statins using previous adherence to chronic medications.

J Manag Care Spec Pharm 2021 Feb;27(2):186-197

Department of Pharmaceutical Health Outcomes and Policy, University of Houston College of Pharmacy, Houston, TX.

Statins are one of the most frequently prescribed medications in the United States. Despite well-documented benefits in managing hyperlipidemia and reducing cardiovascular risks, statin adherence remains suboptimal. Several effective interventions have been implemented to improve adherence to statins. However, identifying patients who are at risk for developing poor medication adherence at the time of treatment initiation could assist in planning early targeted interventions. Studies have suggested that previous adherence to chronic medications is a strong predictor of future adherence to newly initiated medications. To investigate patients' adherence to newly initiated statins by measuring previous adherence to angiotensin-converting enzyme inhibitors (ACEIs), angiotensin II receptor blockers (ARBs), and oral antidiabetic drugs (OADs). A retrospective cohort study was conducted using administrative claims data from January 2016 to May 2018. New statin initiators were identified and included in the study if they were continuously enrolled in the health plan and had at least 1 prescription for ACEIs, ARBs, or OADs 1 year before statin initiation (pre-index period). Baseline adherence to ACEIs/ARBs, OADs, or both was calculated during a 1-year pre-index period using proportion of days covered (PDC) and defined as PDC ≥ 0.80. Adherence to statins was assessed 1 year after statin initiation and was the primary outcome, with a PDC ≥ 0.80 considered as adherent. Patient demographics were measured during the pre-index period. Multivariable logistic regression was conducted for each cohort separately to determine an association between baseline adherence and future statin adherence controlling for various demographic and clinical characteristics. 1,223 ACEI/ARB users, 714 OAD users, and 452 concomitant ACEI/ARB and OAD users were identified. In the regression model, adherence to baseline medications was significantly associated with 1-year adherence to statins (ACEI/ARB users: OR = 1.75, 95% CI = 1.37-2.25; OAD users: OR = 2.02, 95% CI = 1.46-2.79; concomitant ACEI/ARB and OAD users: OR = 1.73, 95% CI = 1.16-2.58). Past adherence to baseline medications may predict future adherence to newly initiated statins. Identifying patients likely to become nonadherent during treatment initiation could enable health care providers in recognizing individuals at risk of nonadherence and intervene earlier to enhance future adherence. No funding was received for this study. Abughosh reports grants from Regeneron-Sanofi, BMS-Pfizer, and Valeant, unrelated to this work. Majd, Mohan, and Paranjpe have nothing to disclose.
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http://dx.doi.org/10.18553/jmcp.2021.27.2.186DOI Listing
February 2021

Group-Based Trajectory Modeling to Identify Patterns of Adherence and Its Predictors Among Older Adults on Angiotensin-Converting Enzyme Inhibitors (ACEIs)/Angiotensin Receptor Blockers (ARBs).

Patient Prefer Adherence 2020 13;14:1935-1947. Epub 2020 Oct 13.

Pharmaceutical Health Outcomes and Policy, University of Houston, Houston, TX, USA.

Purpose: Commonly prescribed medications among patients with comorbid diabetes mellitus and hypertension include ARBs and ACEIs. However, these medications are associated with suboptimal adherence leading to inadequately controlled blood pressure. Unlike traditional single estimates of proportion of days covered (PDC), group-based trajectory modeling (GBTM) can graphically display the dynamic nature of adherence. The objective of this study was to evaluate adherence using GBTMs among patients prescribed ACEI/ARBs and identify predictors associated with each adherence trajectory.

Patients And Methods: Patients with an ACEI/ARBs prescription were identified between July 2017 and December 2017 using a Medicare Advantage dataset. PDC was used to measure monthly patient adherence during the one-year follow-up period. The monthly PDC was added to a logistic group-based trajectory model to provide distinct patterns of adherence. Further, a multinomial logistic regression was conducted to determine predictors of each identified adherence trajectory. Predictors included various socio-demographic and clinical patient characteristics.

Results: A total of 22,774 patients were included in the analysis and categorized into 4 distinct adherence trajectories: rapid decline (12.6%); adherent (58.5%); gaps in adherence (12.2%), and gradual decline (16.6%). Significant predictors associated with all lower adherence trajectories included 90 days refill, >2 number of other medications, ≥1 hospitalizations, and prevalent users. Significant predictors associated with the rapid decline trajectory included male sex, comorbidities, and increased CMS risk score. Further, significant predictors associated with the gaps in adherence trajectory included increasing age, and comorbidities. Lastly, significant predictors associated with the gradual decline trajectory included increasing age, no health plan subsidy, comorbidities, and increasing CMS risk score.

Conclusion: Identifying various patient characteristics associated with non-adherent trajectories can guide the development of tailored interventions to enhance adherence to ACEI/ARBs.
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http://dx.doi.org/10.2147/PPA.S270809DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7568634PMC
October 2020

Patient-reported barriers to statin adherence: Excerpts from a motivational interviewing intervention in older adults.

J Am Pharm Assoc (2003) 2021 Jan-Feb;61(1):60-67.e1. Epub 2020 Oct 6.

Objective: Despite a known benefit in the reduction of cardiovascular risk, adherence to statins remains suboptimal. A qualitative analysis was conducted within an intervention that identified trajectories of statin adherence in patients and used motivational interviewing (MoI) to improve adherence. The objective of this qualitative study was to evaluate transcripts of an MoI telephonic intervention to identify potential, past, and current barriers to statin adherence and barriers specific to distinct adherence trajectories.

Methods: The MoI intervention was customized by past 1-year adherence trajectories (rapid discontinuation, gradual decline, and gaps in adherence). Two authors independently extracted and documented barriers from phone transcripts. Themes were derived from literature a priori and by cataloging recurring themes from the transcripts.

Results: The transcripts of calls made to 157 patients were reviewed of which 25.2% did not communicate a specific adherence barrier despite falling into a low-adherence trajectory when examining refill data. The most commonly reported barriers to statin adherence included adverse effects (40.1%), forgetfulness (30.0%), and lack of skills or knowledge pertaining to statins (25%). More patients in the rapid discontinuation group perceived medication as unnecessary, whereas more patients in the gaps in adherence group reported a communication barrier with their health care provider. Several barriers among patients who fell into low-adherence trajectories were reported. Some patients did not report any barriers, which may have indicated denial. MoI phone calls were useful in providing knowledge, clarifying medication regimens, and reinforcing the need to take statins.

Conclusion: This study identified patient-reported barriers to statin adherence elicited during an MoI telephonic intervention conducted by student pharmacists. There were differences in barriers reported by patients from each trajectory, which emphasize the need for additional tailored interventions to improve patient adherence.
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http://dx.doi.org/10.1016/j.japh.2020.09.002DOI Listing
August 2021

Cost-effectiveness analysis of antihypertensive triple combination therapy among patients enrolled in a Medicare advantage plan.

Expert Rev Pharmacoecon Outcomes Res 2021 Aug 1;21(4):829-836. Epub 2020 Aug 1.

Department of Pharmaceutical Health Outcomes and Policy, College of Pharmacy, University of Houston, Houston, TX, USA.

Objective: To assess the cost-effectiveness of single pill fixed dose triple combination therapy vs. free triple combination therapy for the prevention of cardiovascular events among patients with hypertension.

Methods: A Markov model with a five year cycle was constructed. Two decision models incorporating strict and more relaxed adherence definitions estimated quality adjusted life years (QALYs) and health-care costs for single pill fixed triple combination therapy vs. free-drug combination therapy.

Results: When the measurement criteria were applied, the total QALYs loss and cost/patient were 6.38 QALYs, $486,026.20 for the single pill triple combination therapy and 8.64 QALYs, $406,405.26 for the free combination therapy. ICER for single pill combination therapy compared to free combination therapy was 33,826.46/QALY. When the measurement criteria were applied, the total QALYs loss and cost/patient were 8.09 QALYs, $493,404.26 for the single pill triple combination therapy and 8.76 QALYs, $436,415.14 for the free combination therapy. ICER for single pill combination compared with free combination therapy was 84,932.26.

Conclusion: This study suggested that single pill triple combination therapy was cost-effective in comparison with free combination therapy under a willingness to pay threshold of 50,000 when the strict adherence measurement criteria was applied.
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http://dx.doi.org/10.1080/14737167.2020.1800457DOI Listing
August 2021

Evaluating trajectories of statin adherence after a motivational interviewing intervention.

J Am Pharm Assoc (2003) 2020 Nov - Dec;60(6):892-898. Epub 2020 Jul 14.

Objective: The objective of the current study was to compare postintervention adherence trajectories with preintervention trajectories for those receiving a telephonic motivational interviewing (MoI) intervention to determine predictors associated with each distinct postintervention trajectory and any association between pre- and postintervention trajectories.

Design: Retrospective study design using group-based trajectory modeling.

Settings And Participants: A telephonic MoI intervention was conducted by trained student pharmacists to improve statin adherence in a Medicare Advantage plan. Four preintervention adherence trajectories were previously identified: rapid decline (RD), gradual decline (GD), gaps in adherence (GA), and adherent and were used to customize the MoI intervention. Patients from the 3 nonadherent preintervention trajectories were randomized to control or intervention groups and were followed for 6 months from the date of MoI intervention.

Outcome Measures: Group-based trajectory modeling was performed to identify 3 relevant postintervention trajectories. Descriptive statistics were used to assess differences in pre- and postintervention adherence trajectories. Multinomial logistic regression was conducted to determine predictors associated with each identified postintervention trajectory.

Results: There were 152 intervention patients and 304 randomly selected controls. The prominent postintervention trajectories that were identified differed from the preintervention trajectories and were (1) GD (17.2%), (2) adherent (61.9%), and (3) discontinuation (20.9%). Among the intervention group, more patients in the GA preintervention trajectory (58.65%) moved to the adherent trajectory postintervention than those in the RD and GD preintervention trajectories. Furthermore, the predictors associated with the postintervention trajectories included MoI intervention, prescriber specialty, presence of diabetes, presence of congestive heart failure, Centers for Medicare & Medicaid Services risk score, and preintervention trajectories.

Conclusion: The postintervention adherence trajectory patterns differed from the preintervention trajectory patterns with many patients moving into an adherent trajectory especially among those receiving the intervention.
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http://dx.doi.org/10.1016/j.japh.2020.06.011DOI Listing
June 2021

Oral Endocrine Therapy Agent, Race/Ethnicity, and Time on Therapy Predict Adherence in Breast Cancer Patients in a Large Academic Institution.

Clin Breast Cancer 2020 12 13;20(6):520-526. Epub 2020 Jun 13.

Department of Pharmacy Practice and Translational Research, University of Houston College of Pharmacy, Houston, TX. Electronic address:

Introduction: Adherence to oral endocrine therapy (OET) reduces recurrence risk for hormone receptor (HR)-positive breast cancer (BC). Refill data accessed through electronic health records may provide objective assessment of OET adherence. Our goal was to (1) determine the feasibility of reviewing electronic health records for assessing OET adherence, (2) evaluate 6 months' OET adherence in HR-positive BC patients, and (3) identify predictors of low adherence.

Patients And Methods: A single-center, retrospective study from May through December 2018 was conducted. Primary end point was adherance rate at 6 months. Chi-square and Student t tests were used to compare adherent and nonadherent groups. Multivariable logistic regression models were used to assess predictors of adherence.

Results: Of 492 patients, 338 patients were included in adherence analysis. Of 338 patients identified, 82% (n = 277) were adherent at 6 months. In the multivariable logistic model, race/ethnicity, type of endocrine therapy, and time on therapy were found to be significantly associated with adherence. Asian/non-Hispanic and white/Hispanic patients were less likely to be adherent compared to white/non-Hispanics (Asian/non-Hispanic: odds ratio [OR], 0.3; 95% confidence interval [CI], 0.11-0.82; white/Hispanic: OR, 0.27; 95% CI, 0.11-0.64). Patients prescribed aromatase inhibitors were more likely to be adherent compared to patients prescribed tamoxifen (OR, 2.06; 95% CI, 1.02-4.14). Last, patients prescribed OET for 3 to 5 years had lower adherence compared to patients given OET for 2 years or less (OR, 0.29; 95% CI, 0.09-0.91).

Conclusion: Accessing refill data through electronic health records was found to be feasible. Tamoxifen therapy, Asian/non-Hispanic and white/Hispanic origin, and longer time on therapy predicted nonadherence in our patients.
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http://dx.doi.org/10.1016/j.clbc.2020.06.004DOI Listing
December 2020

Value of pharmacy services in an outpatient, preoperative, anesthesia clinic.

J Am Pharm Assoc (2003) 2020 Nov - Dec;60(6):e264-e278. Epub 2020 Apr 15.

Objective: This pilot study assessed the expansion of pharmacy services to a preoperative, anesthesia clinic.

Setting: Tertiary care academic medical center.

Practice Description: Medication histories were routinely obtained by clinic nurses, and pharmacy services were not available.

Practice Innovation: A prospective, single-center, pilot study enrolled English-speaking patients aged 65 years or older in a preoperative clinic before a scheduled surgery. Patient attributes including health literacy and preparatory activities were measured using verbal and written questionnaires. Home medication lists were obtained by both clinic nurses (routine care) and a pharmacist (research), and the 2 lists were compared to identify medication discrepancies for each patient. Discrepancies were categorized by type and severity.

Evaluation: This study evaluated the potential impact of medication histories obtained by pharmacists compared with those obtained by clinic nurses during geriatric preoperative clinic visits.

Results: Of the 44 patients who gave their consent and were included in this pilot study, 25% (n = 11) had limited/marginal written and verbal health literacy, and 20% (n = 9) had limited/marginal numerical health literacy. Of the 38 patients who completed the pharmacist medication history interview, only 21% (n = 8) brought a complete list of their current medications to the preoperative clinic, 95% (n = 36) had at least 1 medication discrepancy, and 61% (n = 23) had at least 1 clinically meaningful discrepancy. Clinically meaningful discrepancies were identified for 8% (35 of 459) of medications and occurred most commonly for blood pressure medications, nonsteroidal anti-inflammatory drugs, and beta blockers.

Conclusion: In this study, medication history discrepancies identified by pharmacists suggest that the expansion of pharmacy services into the preoperative clinic is feasible and could potentially prevent meaningful medication errors among geriatric patients being admitted for a scheduled surgery.
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http://dx.doi.org/10.1016/j.japh.2020.03.014DOI Listing
June 2021

Use of disease modifying agents in patients with multiple sclerosis: Analysis of ten years of national data.

Res Social Adm Pharm 2020 Dec 11;16(12):1670-1676. Epub 2020 Mar 11.

Pharmaceutical Health Outcomes and Policy, College of Pharmacy, University of Houston, TX, USA. Electronic address:

Background: Disease modifying agents (DMAs) are used to reduce relapses and decrease disability progression in Multiple Sclerosis (MS) patients. However, limited national level data exists regarding the prescribing patterns for MS, especially after the introduction of oral DMAs.

Objective: This study examined the prescribing patterns and trends of DMAs using national level data and determined the factors associated with prescribing DMAs among MS patients in the United States.

Methods: This cross-sectional study utilized 2006-2015 National Ambulatory Medical Care Survey (NAMCS) data to examine office-based visits involving MS (ICD-9-CM code 340). Descriptive weighted analyses were performed to assess the prescribing patterns of DMAs. Multivariable logistic regression model within the conceptual framework of Andersen Behavioral Model was used to determine the factors associated with prescribing of DMAs among MS patients.

Results: An estimated 8.5 million (95% Confidence Interval [CI] 7.01-10.09 million) MS patient visits were identified from 2006 to 2015. During the ten-year study period, 3.84 million (45%) MS visits involved prescribing of DMAs. The majority of DMA prescriptions were injectables (78%), followed by infusions (11%) and orals (11%). Oral DMAs use increased (from 11% in 2010-2011 to 40% in 2014-2015), whereas the use of injectable DMAs decreased (from 96% in 2006-2007 to 52% in 2014-2015) during the study period. Multivariable analyses revealed that predisposing (age and region) and enabling (physician specialty) factors were significantly associated with prescribing of DMAs among MS patients. Visits to neurologists (Odds Ratio [OR] 6.61, 95% CI 3.66-11.93) were associated with higher odds of being prescribed with DMAs.

Conclusion: During the ten-year study period, increasing use of oral DMAs and declining use of injectable DMAs was observed. Both predisposing and enabling factors influenced the prescribing of DMAs. With increasing availability of oral DMAs, the DMAs use is likely to increase among MS patients.
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http://dx.doi.org/10.1016/j.sapharm.2020.02.016DOI Listing
December 2020

Risk of Cardiovascular Outcomes and Antihypertensive Triple Combination Therapy Among Elderly Patients with Hypertension Enrolled in a Medicare Advantage Plan (MAP).

Am J Cardiovasc Drugs 2020 Dec;20(6):591-602

Department of Pharmaceutical Health Outcomes and Policy, College of Pharmacy, University of Houston, 4849 Calhoun Road, Houston, TX, 77204-5047, USA.

Objectives: The aim was to evaluate the risk of cardiovascular-specific hospitalizations with different types of antihypertensive triple combination therapy among patients enrolled in a Medicare Advantage Plan (MAP).

Methods: A retrospective cohort study was conducted among patients with hypertension enrolled in a Texas MAP between January 2014 and December 2016. Antihypertensive combination therapy users were classified into three treatment groups: single-pill triple combination, fixed-dose dual combination plus a third agent, and free triple combination. Group differences were assessed using Chi-square tests for binary variables and Student's t tests for continuous variables. Cox proportional hazards model was performed to assess the association between type of combination therapy and risk of cardiovascular-specific hospitalization adjusting for potential confounders.

Results: A total of 10,836 triple combination users were identified. The risk of cardiovascular disease (CVD) hospitalization for the fixed-dose dual combination plus a third agent group [hazard ratio (HR) 3.82, 95% confidence interval (CI) 1.80-8.12] and for the free triple combination therapy group (HR 3.65, 95% CI 1.43-9.31) was significantly higher than for the single-pill triple combination group.

Conclusion: Single-pill triple combination therapy was significantly associated with a lower risk of CVD hospitalizations in comparison to other types of triple combination therapy.
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http://dx.doi.org/10.1007/s40256-020-00395-0DOI Listing
December 2020

Warfarin vs. apixaban in nonvalvular atrial fibrillation, and analysis by concomitant antiarrhythmic medication use: A national retrospective study.

Res Pract Thromb Haemost 2019 Oct 17;3(4):674-683. Epub 2019 Jun 17.

Department of Pharmaceutical Health Outcomes and Policy University of Houston College of Pharmacy Houston Texas.

Background: No real-world data exist on outcomes in patients on anticoagulants and concomitant antiarrhythmic medications. This study aims to compare the safety and effectiveness of apixaban and warfarin, first in patients with nonvalvular atrial fibrillation (NVAF) and then in patients on concurrent antiarrhythmic medications.

Methods: A retrospective cohort study was conducted using a large US electronic medical record database (2012-2016). Patients with NVAF on warfarin or apixaban were included. The primary endpoint was a composite of stroke (ischemic or hemorrhagic) or systemic embolism. The primary safety endpoint was major bleeding (ISTH definition). Patients were matched using propensity scoring. Univariate survival analyses were conducted by using the log-rank test and Kaplan-Meier survival curves. A subgroup analysis was conducted to assess outcomes on patients on concurrent antiarrhythmic medications.

Results: A total of 332 100 patients with NVAF were identified, and 20 378 were included in the propensity-matching analysis. No baseline differences were seen in age, comorbidities, or CHA DS -VASc score. The primary endpoint occurred in 122 (1.2%) patients on apixaban compared to 166 (1.63%) on warfarin (hazard ratio, 0.84; 95% confidence interval [CI], 0.79-0.88). Major bleeding occurred at a lower rate in the apixaban group (n = 600, 5.89%) compared to warfarin (n = 887, 8.71%) (odds ratio, 0.65; 95% CI, 0.58-0.73). In patients on concurrent antiarrhythmic medications (n = 2498), there was no difference in thrombotic (1.04% vs. 1.37%;  = 0.42) or bleeding events (5.29% vs. 6.89%;  = 0.08).

Conclusion: Apixaban was associated with reduced stroke/systemic embolism and bleeding when compared with warfarin. No difference was seen in thrombotic or bleeding events in patients on concurrent antiarrhythmic medications.
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http://dx.doi.org/10.1002/rth2.12221DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6781914PMC
October 2019

Medication Adherence to Antihypertensive Triple-Combination Therapy Among Patients Enrolled in a Medicare Advantage Plan.

J Manag Care Spec Pharm 2019 Jun;25(6):678-686

1 Department of Pharmaceutical Health Outcomes and Policy, University of Houston College of Pharmacy, Houston, Texas.

Background: Approximately 32% (75 million) of adults have hypertension in the United States, leading to 1,100 daily deaths and costing more than $48 billion annually in medical expenditures. Approximately 25% of patients with hypertension require triple combination therapy to reach recommended blood pressure. Currently, only 3 single-pill triple-combination therapies are available in the market for the treatment of hypertension. Medication adherence has become a major concern for the health care system, and nonadherence is associated with higher risks of morbidity and mortality.

Objective: To compare medication adherence rates among single-pill triple-combination therapy, free triple-combination therapy, and fixed-dose dual-combination therapy plus a third agent in hypertensive patients enrolled in a Medicare Advantage prescription drug plan using 2 adherence definitions.

Methods: A retrospective cohort study was conducted using Cigna-HealthSpring's medical claims database from January 2014 to December 2016. Antihypertensive combination therapy users were classified into a single-pill triple-combination group, a fixed-dose dual-combination plus a third agent group, and a free triple-combination group. Adherence rates using proportion of days covered (PDC) were calculated for each group within a 1-year follow-up period using 2 definitions: a strict one requiring all antihypertensive agents during follow-up and a more relaxed definition requiring any antihypertensive agent during follow-up. Descriptive statistics were examined, and group differences were assessed using chi-square and analysis of variance. Multivariate logistic regression was conducted to control confounders of adherence using both definitions.

Results: 10,836 triple-combination users were identified. In the multivariate model using the first definition, fixed-dose dual-combination plus a third agent was significantly associated with lower adherence compared with single-pill triple therapy (OR = 0.177; 95% CI = 0.119-0.263; < 0.001). No significant difference was detected between single-pill triple-combination therapy in comparison with free-combination therapy. In the multivariate model using the second definition, fixed-dose dual-combination plus a third agent and free-combination therapy were significantly associated with better adherence in comparison with single-pill triple combination therapy (OR = 3.62, 95% CI = 2.59-5.05; OR = 4.31, 95% CI = 2.15-8.64, respectively). Younger age, female gender, language (Spanish), some comorbidities, and previous hospitalization had a negative effect on adherence.

Conclusions: Measuring adherence to multiple concurrent regimens is complicated and different adherence definitions can result in significant variations in adherence measures. Future research evaluating clinical outcomes with various definitions is needed.

Disclosures: No outside funding supported this study. Abughosh reports grants from Sanofi, Regeneron, Valeant Pharmaceuticals, BMS/Pfizer, and PhRMA, not related to this study. Serna reports employement with CareAllies, a Cigna company. The other authors have no conflicts of interest to disclose.
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http://dx.doi.org/10.18553/jmcp.2019.25.6.678DOI Listing
June 2019

Neratinib in HER2-Positive Breast Cancer Patients.

Ann Pharmacother 2019 06 4;53(6):612-620. Epub 2019 Jan 4.

1 University of Houston College of Pharmacy, Houston, TX, USA.

Objective: To review the chemistry, pharmacology, pharmacokinetics, safety, and efficacy of neratinib in human epidermal growth factor receptor (HER2)+ breast cancer (BC).

Data Sources: A PubMed search was performed using the term neratinib between September 12, 2018, and November 21, 2018. References of published articles and reviews were also assessed for additional information.

Study Selection And Data Extraction: English-language preclinical and clinical studies on the chemistry, pharmacology, pharmacokinetics, safety, and efficacy of neratinib were evaluated.

Data Synthesis: Neratinib, an irreversible inhibitor of HER1, HER2, and HER4, is Food and Drug Administration approved for the extended adjuvant treatment of stage I-III HER2+ BC to follow trastuzumab-based therapy. A phase III study has demonstrated statistically significant improvement in 5-year disease-free survival rate (90.2 vs 87.7; hazard ratio = 0.73, 95% CI = 0.57-0.92, P = 0.0083). Its most common adverse effect is diarrhea, observed in more than 90% of patients. The incidence of grade 3/4 diarrhea (~40%) is reduced by half with loperamide prophylaxis, which is recommended for the first 8 weeks of neratinib therapy. Other common adverse reactions are nausea and fatigue. The patients need to be monitored for liver function tests and drug interactions with acid-reducing agents, CYP3A4 inhibitors/inducers, and P-glycoprotein substrates with narrow therapeutic window. Relevance to Patient Care and Clinical Practice: American Society of Clinical Oncology and National Comprehensive Cancer Network clinical guidelines suggest the use of neratinib for extended adjuvant therapy following 1-year trastuzumab in stage I to III HER2+ BC. Diarrhea remains a clinically significant but manageable adverse event.

Conclusion: Neratinib significantly improves treatment outcomes and has manageable toxicity in stage I to III HER2+ BC patients.
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http://dx.doi.org/10.1177/1060028018824088DOI Listing
June 2019

Identifying adherence barriers to oral endocrine therapy among breast cancer survivors.

Breast Cancer Res Treat 2019 Apr 6;174(2):297-305. Epub 2018 Dec 6.

Departments of Pharmaceutical Health Outcomes and Policy, University of Houston, College of Pharmacy, 4849 Calhoun Road, Houston, TX, 77204-5047, USA.

Purpose: Approximately 70-80% of breast cancers are hormone receptor-positive (HR+). OET, including tamoxifen and aromatase inhibitors, is considered standard adjuvant therapy for HR+ breast cancer. Despite demonstrated benefits, nearly half of patients are non-adherent and over two-thirds discontinue therapy before the recommended 5 years. Our objective was to identify and summarize literature-reported barriers associated with non-adherence/non-persistence to OET among breast cancer survivors.

Methods: A PUBMED literature search was conducted using the following terms: 'breast cancer,' 'oral endocrine therapy' or 'Tamoxifen' or 'Aromatase Inhibitors,' 'adherence,' or 'barriers.' The search was restricted to past six years. The abstracts of each result were reviewed and categorized as either patient-reported or physician-reported. All patient- and physician-reported factors that affected adherence and persistence were listed and grouped together into the three main categories: Socio-demographic and medical parameters, general psychosocial parameters, and psychosocial parameters related to OET.

Results: A total of 320 articles were identified, of which 19 met inclusion criteria. Adverse drug reactions were the most commonly reported barrier but were generally underreported among physicians. Among patient-reported barriers, common social-demographic and medical parameters were age, comorbidity, and financial status. General psychosocial variables were lack of patient-provider communication, depressive symptoms, and lack of perceived self-efficacy. Treatment toxicity was the most commonly reported psychosocial parameter related to OET.

Conclusion: The determinants of non-adherence and non-persistence are multi-dimensional and influenced by several factors. The three categories of adherence barriers should be evaluated and considered when designing future interventions to enhance OET adherence for a tailored approach.
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http://dx.doi.org/10.1007/s10549-018-05073-zDOI Listing
April 2019

Hydroxychavicol, a betel leaf component, inhibits prostate cancer through ROS-driven DNA damage and apoptosis.

Toxicol Appl Pharmacol 2014 Oct 23;280(1):86-96. Epub 2014 Jul 23.

Department of Biology, Georgia State University, Atlanta, GA 30303, USA. Electronic address:

Dietary phytochemicals are excellent ROS-modulating agents and have been shown to effectively enhance ROS levels beyond toxic threshold in cancer cells to ensure their selective killing while leaving normal cells unscathed. Here we demonstrate that hydroxychavicol (HC), extracted and purified from Piper betel leaves, significantly inhibits growth and proliferation via ROS generation in human prostate cancer, PC-3 cells. HC perturbed cell-cycle kinetics and progression, reduced clonogenicity and mediated cytotoxicity by ROS-induced DNA damage leading to activation of several pro-apoptotic molecules. In addition, HC treatment elicited a novel autophagic response as evidenced by the appearance of acidic vesicular organelles and increased expression of autophagic markers, LC3-IIb and beclin-1. Interestingly, quenching of ROS with tiron, an antioxidant, offered significant protection against HC-induced inhibition of cell growth and down regulation of caspase-3, suggesting the crucial role of ROS in mediating cell death. The collapse of mitochondrial transmembrane potential by HC further revealed the link between ROS generation and induction of caspase-mediated apoptosis in PC-3 cells. Our data showed remarkable inhibition of prostate tumor xenografts by ~72% upon daily oral administration of 150mg/kg bw HC by quantitative tumor volume measurements and non-invasive real-time bioluminescent imaging. HC was well-tolerated at this dosing level without any observable toxicity. This is the first report to demonstrate the anti-prostate cancer efficacy of HC in vitro and in vivo, which is perhaps attributable to its selective prooxidant activity to eliminate cancer cells thus providing compelling grounds for future preclinical studies to validate its potential usefulness for prostate cancer management.
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http://dx.doi.org/10.1016/j.taap.2014.07.012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4363134PMC
October 2014

Piper betel leaf extract: anticancer benefits and bio-guided fractionation to identify active principles for prostate cancer management.

Carcinogenesis 2013 Jul 21;34(7):1558-66. Epub 2013 Feb 21.

Department of Biology, Georgia State University, Atlanta, GA 30303, USA.

Plant extracts, a concoction of bioactive non-nutrient phytochemicals, have long served as the most significant source of new leads for anticancer drug development. Explored for their unique medicinal properties, the leaves of Piper betel, an evergreen perennial vine, are a reservoir of phenolics with antimutagenic, antitumor and antioxidant activities. Here, we show that oral feeding of betel leaf extract (BLE) significantly inhibited the growth of human prostate xenografts implanted in nude mice compared with vehicle-fed controls. To gain insights into the 'active principles', we performed a bioactivity-guided fractionation of methanolic BLE employing solvents of different polarity strengths using classical column chromatography. This approach yielded 15 fractions, which were then pooled to 10 using similar retention factors on thin-layer chromatographs. Bioactivity assays demonstrated that one fraction in particular, F2, displayed a 3-fold better in vitro efficacy to inhibit proliferation of prostate cancer cells than the parent BLE. The presence of phenols, hydroxychavicol (HC) and chavibetol (CHV), was confirmed in F2 by nuclear magnetic resonance, high-performance liquid chromatography and mass spectroscopy. Further, the HC containing F2 subfraction was found to be ~8-fold more potent than the F2 subfraction that contained CHV, in human prostate cancer PC-3 cells as evaluated by the 3-(4,5-dimethylthiazole-2-yl)-2,5-diphenyl tetrazolium bromide assay. Removing CHV from F2 remarkably decreased the IC50 of this fraction, indicating that HC is perhaps the major bioactive constituent, which is present to an extent of 26.59% in BLE. These data provide evidence that HC is a potential candidate for prostate cancer management and warrants further preclinical evaluation.
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http://dx.doi.org/10.1093/carcin/bgt066DOI Listing
July 2013
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