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This observational cohort study compares the odds of cardiac events among new users of azithromycin relative to new users of amoxicillin using real-world data., Key Points Question Using a large health care database, what is the risk of cardiac events in azithromycin users compared with amoxicillin users? Findings In a cohort study of 2 141 285 episodes of azithromycin use that were matched to episodes of amoxicillin use with high-dimensional propensity scores, no difference in the rate of cardiac events occurred at 5, 10, and 30 days after therapy initiation. However, concurrent use of QT-prolonging drugs with azithromycin was associated with 40% greater odds of cardiac events compared with amoxicillin. Meaning Azithromycin and amoxicillin appear to pose similar odds of cardiac events except for concurrent use of QT-prolonging drugs with azithromycin; therefore, clinicians should use amoxicillin or another antibiotic among such patients., Importance Conflicting evidence exists on the association between azithromycin use and cardiac events. Objective To compare the odds of cardiac events among new users of azithromycin relative to new users of amoxicillin using real-world data. Design, Setting, and Participants This retrospective cohort study used data from Truven Health Analytics MarketScan database from January 1, 2009, to June 30, 2015. Patients receiving either amoxicillin or azithromycin and enrolled in a health care plan 365 days before (baseline period) the dispensing date (index date) were included in the study. Patients were matched 1:1 on high-dimensional propensity scores. Data were analyzed from October 1, 2018, to December 31, 2019. Exposures New use of azithromycin compared with new use of amoxicillin. Main Outcomes and Measures The primary outcome consisted of cardiac events, including syncope, palpitations, ventricular arrhythmias, cardiac arrest, or death as a primary diagnosis for hospitalization at 5, 10, and 30 days from the index date. Logistic regression models were used to estimate odds ratios (ORs) with 95% CIs. Results After matching, the final cohort included 2 141 285 episodes of each index therapy (N = 4 282 570) (mean [SD] age of patients, 35.7 [22.3] years; 52.6% female). Within 5 days after therapy initiation, 1474 cardiac events (0.03%) occurred (708 in the amoxicillin cohort and 766 in the azithromycin cohort). The 2 most frequent events were syncope (1032 [70.0%]) and palpitations (331 [22.5%]). The odds of cardiac events with azithromycin compared with amoxicillin were not significantly higher at 5 days (OR, 1.08; 95% CI, 0.98-1.20), 10 days (OR, 1.05; 95% CI, 0.97-1.15), and 30 days (OR, 0.98; 95% CI, 0.92-1.04). Among patients receiving any concurrent QT-prolonging drug, the odds of cardiac events with azithromycin were 1.40 (95% CI, 1.04-1.87) greater compared with amoxicillin. Among patients 65 years or older and those with a history of cardiovascular disease and other risk factors, no increased risk of cardiac events with azithromycin was noted. Conclusions and Relevance This study found no association of cardiac events with azithromycin compared with amoxicillin except among patients using other QT-prolonging drugs concurrently. Although azithromycin is a safe therapy, clinicians should carefully consider its use among patients concurrently using other QT-prolonging drugs.

Aims To compare adherence and persistence to oral antidiabetic drugs (OAD) between patients who are new users of second generation antipsychotics (SGA) versus new users of other depression therapies in adults with type 2 diabetes mellitus (T2DM) and major depressive disorder (MDD). Methods Adults 18–64 years with previously-treated T2DM and MDD (past OAD and SSRI/SNRI use) who are new users of SGA or non-SGA therapies (bupropion, lithium, mirtazapine, thyroid hormone, tricyclic antidepressant) were identified in the 2009–2015 MarketScan® Commercial Claims and Encounters database. Multivariate regression models were used to determine the odds of a ≥10% decline in OAD adherence over 180- and 365-days, and time to OAD discontinuation, adjusting for differences between groups. Results A total of 8664 (21.5% SGA), 8311 (22.1% SGA), and 17,524 (21.3% SGA) patients met inclusion criteria for the 180-day adherence, 365-day adherence, and persistence cohorts, respectively. Over 180-days, 16.6% of SGA and 13.3% of non-SGA initiators had a ≥10% decline in OAD adherence (adjusted odds ratio [OR] = 1.41, 95% CI 1.21–1.63). Over 365-days, 22.3% of SGA and 18.9% of non-SGA initiators had a ≥ 10% decline (OR = 1.34, 95% CI 1.17–1.53). Time to OAD discontinuation was similar between groups (adjusted hazard ratio = 1.03, 95% CI 0.94–1.12). Conclusion Use of SGA was associated with a 1.3–1.4 times higher odds of a ≥10% decline in OAD adherence. Adherence to OAD is critical for optimal diabetes control and reductions in this magnitude may impact A1C. Close monitoring of OAD adherence after SGA initiation is warranted.

The Clinical and Translational Science Award (CTSA) Workgroup for Comparative Effectiveness Research (CER) Education, Training, and Workforce Development identified a need to delineate the competencies that practitioners and users of CER for patient‐centered outcomes research, should acquire. With input from CTSA representatives and collaborators, we began by describing the workforce. We recognize the workforce that conducts CER and the end users who use CER to improve the health of individuals and communities. We generated a preliminary set of competencies and solicited feedback from the CER representatives at each member site of the CTSA consortium. We distinguished applied competencies (i.e., skills needed by individuals who conduct CER) from foundational competencies that are needed by the entire CER workforce, including end users of CER. Key competency categories of relevance to both practitioners and users of CER were: (1) asking relevant research questions; (2) recognizing or designing ideal CER studies; (3) executing or using CER studies; (4) using appropriate statistical analyses for CER; and (5) communicating and disseminating CER study results to improve health. Although CER is particularly broad concept, we anticipate that these preliminary, relatively generic competencies will be used in tailoring curricula to individual learners from a variety of programmatic perspectives. Clin Trans Sci 2012; Volume 5: 476–479

Glen T Schumock1, Robert D Gibbons2, Todd A Lee1,3,4,6, Min J Joo4, Robert J Valuck5, Leslie T Stayner61Center for Pharmacoeconomic Research, and Department of Pharmacy Practice, College of Pharmacy, University of Illinois at Chicago, Chicago, IL, USA; 2Center for Health Statistics, and Departments of Medicine and Health Studies, Pritzker School of Medicine, University of Chicago, Chicago, IL, USA; 3Center for Management of Complex Chronic Care, Hines VA Hospital, Hines, IL, USA; 4Section of Pulmonary, Critical Care, Sleep and Allergy, Department of Medicine, College of Medicine, University of Illinois at Chicago, Chicago, IL, USA; 5Department of Clinical Pharmacy, School of Pharmacy, University of Colorado, Aurora, CO, USA; 6Division of Epidemiology and Biostatistics, School of Public Health, University of Illinois at Chicago, Chicago, IL, USABackground: The US Food and Drug Administration has issued warnings about a potential link between leukotriene receptor-modifying agents (LTMA) and suicide. These warnings are based on case reports and there is controversy about the association. While spontaneous reporting of suicide-related events attributed to LTMA has risen dramatically, these data may be biased by the warnings. The objective of this study was to explore the relationship between LTMA and suicide deaths using event data preceding the Food and Drug Administration warnings.Methods: We conducted a mixed-effects Poisson regression analysis of the association between LTMA prescriptions dispensed and suicide deaths at the county level. Counts of suicide deaths in each US county, stratified by race, age group, gender, and year were obtained from the National Center for Health Statistics for the period January 1, 1999 to December 31, 2006. Counts of LTMA prescriptions dispensed in each US county were obtained from IMS Health Incorporated. The model estimated the overall suicide rate conditional on LTMA use, adjusted for age, gender, race, year, and antidepressant utilization. We also assessed the intracounty and intercounty associations.Results: There were 249,872 suicides in the US between 1999 and 2006, and the annual suicide rate ranged from 11.17 to 11.92 per 100,000 population. There were 118.63, 11.68, and 0.12 million prescriptions dispensed for montelukast, zafirlukast, and zileuton, respectively, between 1999 and 2006. The mean rate of LTMA prescriptions dispensed by county was 42.91 (95% confidence interval [CI] 42.78–43.04), 4.82 (95% CI 4.81–4.84), and 0.05 (95% CI 0.05–0.05) per 1000 for montelukast, zafirlukast, and zileuton, respectively. We found a negative within-county association between the rate of total LTMA prescriptions dispensed and the suicide rate by county (P = 0.0296). This association was primarily driven by montelukast.Conclusion: Our results, while subject to certain limitations, provide preliminary evidence that the association between LTMA and suicide could be different (ie, reduced risk) than that which might be anticipated based on previous warnings. Patient-level research is needed to understand more clearly the association between LTMA and suicide.Keywords: suicide, leukotriene-modifying agents, montelukast, drug safety

OBJECTIVE: The objective of this study was to determine the frequency and cost of prescription switches for 90-day vs. 30-day outpatient prescriptions dispensed by a VA pharmacy and to develop a model to determine the prescription fill policy with the lowest total costs. METHODS: VA outpatient prescription records for one year for simvastatin and lovastatin (30 or 90-days) were analyzed to determine the frequency, quantity and cost of medication wasted due to medication switches. The quantity wasted was defined as the difference between the quantity dispensed and the quantity of drug used before changing to a new drug or dosage. Differences in dispensing costs for a given time-period were also included. Sensitivity analyses were conducted for quantity wasted, drug costs, and dispensing costs. RESULTS: A total of 16,990 prescriptions were analyzed. The quantity and costs of medication wasted were higher for 90-day prescriptions than for 30-day prescriptions. However, average costs to the VA pharmacy were $2.45 higher per prescription for the 30-day supply because of additional dispensing costs for the 30-day fill. The model and sensitivity analyses show that a 90-day supply policy results in lower total pharmacy costs under several scenarios. Only in the case of high drug costs was the 30-day policy favorable to the 90-day policy in terms of total costs. CONCLUSION: Prescriptions given in a 90-day supply resulted in lower total costs. The projected cost savings of having a 90-day versus a 30-day policy would hold true for prescriptions with similar drug costs and similar rates of wastage that result from changes that physicians make to patients' prescriptions. In addition, the model provides a flexible framework for pharmacy administrators to assess refill policies in terms of excess or unnecessary cost for different classes of drugs, given patient and/or physician behavior.