Joel F. Farley

Effectiveness and Safety of Dabigatran and Warfarin in Real‐World US Patients With Non‐Valvular Atrial Fibrillation: A Retrospective Cohort Study

Background The recent availability of dabigatran, a novel oral anticoagulant, provided a new treatment option for stroke prevention in atrial fibrillation beyond warfarin, the main therapy for years. Little is known about their real‐world comparative effectiveness and safety, even less among patient demographic and clinical subgroups. Methods and Results Using a cohort of non‐valvular AF patients initiating anticoagulation from October 2010 to December 2012 drawn from a large US database of commercial and Medicare supplement claims, we applied propensity score weights to Cox proportional hazards regression to assess the comparative effectiveness and safety of dabigatran versus warfarin. Analyses were repeated among clinical and demographic subgroups using stratum‐specific propensity scores as an exploratory analysis. Of the 64 935 patients initiating anticoagulation, 32.5% used dabigatran. Compared with warfarin, dabigatran was associated with a lower risk of ischemic stroke or systemic embolism (composite adjusted Hazard Ratio [aHR], 95% CI: 0.86, 95% CI: 0.79 to 0.93), hemorrhagic stroke (aHR: 0.51, 0.40 to 0.65), and acute myocardial infarction (aHR: 0.88, 95% CI: 0.77 to 0.99), and no relation was seen between dabigatran and the composite harm outcome (aHR: 0.94, 95% CI: 0.87 to 1.01). However, dabigatran was associated with a higher risk of gastrointestinal bleeding (aHR: 1.11, 95% CI: 1.02 to 1.22). Estimates of effectiveness and safety appeared to be mostly similar across subgroups. Conclusions Dabigatran could be a safe and potentially more effective alternative to warfarin in patients with atrial fibrillation managed in routine practice settings.

Treating Depression After Initial Treatment Failure: Directly Comparing Switch and Augmenting Strategies in STAR*D

Objective Augmenting and switching antidepressant medications are the 2 most common next-step strategies for depressed patients failing initial medication treatment. These approaches have not been directly compared; thus, our objectives are to compare outcomes for medication augmentation versus switching for patients with major depressive disorder in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) clinical trial. Methods We conducted a retrospective analysis of participants aged 18 to 75 years with DSM-IV nonpsychotic depression who failed to remit with initial treatment in the STAR*D clinical trial (N = 1292). We compared depressive symptom remission, response, and quality of life among participants in each study arm using propensity score matching to minimize selection bias. Results The propensity-score-matched augment (N = 269) and switch (N = 269) groups were well balanced on measured characteristics. Neither the likelihood of remission (risk ratio, 1.14; 95% confidence level, 0.82–1.58) or response (risk ratio, 1.14; 95% confidence level, 0.82–1.58), nor the time to remission (log-rank test, P = 0.946) or response (log-rank test, P = 0.243) differed by treatment strategy. Similarly, quality of life did not differ. Post hoc analyses suggested that augmentation improved outcomes for patients tolerating 12 or more weeks of initial treatment and those with partial initial treatment response. Conclusions For patients receiving and tolerating aggressive initial antidepressant trials, there is no clear preference for next-step augmentation versus switching. Findings tentatively suggest that those who complete an initial treatment of 12 weeks or more and have a partial response with residual mild depressive severity may benefit more from augmentation relative to switching.

Risk stratification of serious adverse events after gastric bypass in the Bariatric Outcomes Longitudinal Database

BACKGROUND There is now sufficient demand for bariatric surgery to compare bariatric surgeons and bariatric centers according to their postsurgical outcomes, but few validated risk stratification measures are available to enable valid comparisons. The purpose of this study was to develop and validate a risk stratification model of composite adverse events related to Roux-en-Y gastric bypass (RYGB) surgery. METHODS The study population included 36,254 patients from the Bariatric Outcomes Longitudinal Database (BOLD) registry who were 18-70 years old and had RYGB between June 11, 2007, and December 2, 2009. This population was randomly divided into a 50% testing sample and a 50% validation sample. The testing sample was used to identify significant predictors of 90-day composite adverse events and estimate odds ratios, while the validation sample was used to assess model calibration. After validating the fit of the risk stratification model, the testing and validation samples were combined to estimate the final odds ratios. RESULTS The 90-day composite adverse event rate was 1.48%. The risk stratification model of 90-day composite adverse events included age (40-64, ≥ 65), indicators for male gender, body mass index (50-59.9, ≥ 60), obesity hypoventilation syndrome, back pain, diabetes, pulmonary hypertension, ischemic heart disease, functional status, and American Society of Anesthesiology classes 4 or 5. Our final gastric bypass model was predictive (c-statistic = .68) of serious adverse events 90 days after surgery. CONCLUSIONS With additional validation, this risk model can inform both the patient and surgeon about the risks of bariatric surgery and its different procedures, as well as enable valid outcomes comparisons between surgeons and surgical programs.

A Retrospective Cohort Study of Economic Outcomes and Adherence to Monotherapy With Metformin, Pioglitazone, or a Sulfonylurea Among Patients With Type 2 Diabetes Mellitus in the United States From 2003 to 2005

OBJECTIVES The aims of this study were to compare all-cause total health care costs and diabetes mellitus (DM)-specific health care costs between patients who were adherent or nonadherent to monotherapy with metformin, pioglitazone, or a sulfonylurea and to examine whether cost differences varied among patients using these oral antidiabetic drugs. METHODS This was a retrospective cohort study using data from the MEDSTAT MarketScan Research Databases. Patients aged 18 to 90 years who were continuously insured between 2003 and 2005 and had > or =2 outpatient claims or > or =1 inpatient claim with a diagnosis of DM (International Classification of Diseases, Ninth Revision, Clinical Modification code 250.xx) in 2003 were eligible for the study. To be part of the final sample, patients had to fill > or =2 prescriptions for metformin, pioglitazone, or a sulfonylurea during 2003, including > or =1 prescription during the last 3 months of the year. Patients were not eligible if they were taking polytherapy or a combination drug. All eligible patients were followed in 2004 and 2005. Adherence was calculated for each year using a medication possession ratio, and was dichotomized at > or =80% as either adherent or nonadherent. Annual all-cause health care costs and diabetes-specific costs were estimated using generalized linear models, adjusting for demographic characteristics, insurance, and comorbid conditions. RESULTS A total of 108,592 patients who met the inclusion criteria were identified. Their mean age was 63 years; 49.8% (54,037/108,592) were women. More pioglitazone users resided in the north-central or south regions (81.3% [9364/11,520]) compared with metformin (62.4% [32,550/52,156]) or sulfonylurea (62.6% [28,105/44,916]) users (P < 0.001). Mean comorbidity scores were higher in the sulfonylurea (1.78) and pioglitazone (1.69) group than in the metformin group (1.45) (P < 0.001). Mean adherence ranged from 61.3% to 73.8% during the 2 years of follow-up. After adjustment, all-cause health care costs were

Completeness of prescription information in US commercial claims databases

12,412 annually among adherent patients and

Impact of the 2008–2009 Economic Recession on Screening Colonoscopy Utilization Among the Insured

13,258 among nonadherent patients (difference,

Prescriber Continuity and Medication Adherence for Complex Patients

846 [95% CI,

Retrospective assessment of Medicaid step-therapy prior authorization policy for atypical antipsychotic medications

747 to

Racial variations in antiresorptive medication use: results from the 2000 Medical Expenditure Panel Survey (MEPS)

945]). Diabetes-related health care costs were

Patterns and Predictors of Prescription Medication Use in the Management of Headache: Findings From the 2000 Medical Expenditure Panel Survey

2230 annually among adherent patients and