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Purpose There are few data on the risk for peripheral neuropathy associated with dronedarone, a newer antiarrhythmic medicine. The objective of this study was to assess whether dronedarone is potentially associated with an increased risk for peripheral neuropathy compared with other antiarrhythmics, including amiodarone, sotalol, flecainide, and propafenone. Methods The MarketScan database was used for identifying patients who were at least 18 years of age, had atrial fibrillation or flutter, and had not been diagnosed with peripheral neuropathy in the 180-day period prior to or on the date of the first prescription of an antiarrhythmic between July 20, 2009, and December 31, 2011. Peripheral neuropathy that occurred during the treatment period for a study drug was ascertained using ICD-9-CM diagnostic codes. For each antiarrhythmic, the incidence rate of peripheral neuropathy was calculated. The adjusted hazard ratio (aHR) for peripheral neuropathy for dronedarone compared with another antiarrhythmic was obtained, with control for age, sex, diabetes mellitus status, and the presence of other comorbidities. Findings The study population included 106,933 patients treated with dronedarone (n = 12,989), amiodarone (n = 45,173), sotalol (n = 22,036), flecainide (n = 14,244), or propafenone (n = 12,491). The incidence rates (per 1000 person–years) of peripheral neuropathy were 1.33 for dronedarone, 2.38 for amiodarone, 1.20 for sotalol, 1.08 for flecainide, and 1.97 for propafenone. The aHRs for peripheral neuropathy for dronedarone relative to other drugs ranged from 0.53 (95% CI, 0.21–1.34) compared with propafenone, to 0.94 (95% CI, 0.38–2.30) compared with sotalol. A new-user analysis showed similar results. Implications The risks for peripheral neuropathy were not significantly different between dronedarone and other antiarrhythmics. [ABSTRACT FROM AUTHOR]

This study aimed to understand the importance of criteria describing methods (eg, duration, costs, validity, and outcomes) according to decision makers for each decision point in the medical product lifecycle (MPLC) and to determine the suitability of a discrete choice experiment, swing weighting, probabilistic threshold technique, and best-worst scale cases 1 and 2 at each decision point in the MPLC. Applying multicriteria decision analysis, an online survey was sent to MPLC decision makers (ie, industry, regulatory, and health technology assessment representatives). They ranked and weighted 19 methods criteria from an existing performance matrix about their respective decisions across the MPLC. All criteria were given a relative weight based on the ranking and rating in the survey after which an overall suitability score was calculated for each preference elicitation method per decision point. Sensitivity analyses were conducted to reflect uncertainty in the performance matrix. Fifty-nine industry, 29 regulatory, and 5 health technology assessment representatives completed the surveys. Overall, "estimating trade-offs between treatment characteristics" and "estimating weights for treatment characteristics" were highly important criteria throughout all MPLC decision points, whereas other criteria were most important only for specific MPLC stages. Swing weighting and probabilistic threshold technique received significantly higher suitability scores across decision points than other methods. Sensitivity analyses showed substantial impact of uncertainty in the performance matrix. Although discrete choice experiment is the most applied preference elicitation method, other methods should also be considered to address the needs of decision makers. Development of evidence-based guidance documents for designing, conducting, and analyzing such methods could enhance their use. • Given that there is no gold standard method for eliciting preferences, the selection of a patient preference method should be based on decision makers' needs and performance of methods under consideration to meet those needs. Five commonly used preference elicitation methods were compared: discrete choice experiments, swing weighting, probabilistic threshold technique, and best-worst scale cases 1 and 2. • Whether a method estimates relative importance and trade-offs between treatment characteristics was considered important to decision makers across all medical product lifecycle (MPLC) decision points. Generally, obtaining qualitative information was more important during early lifecycle decisions, whereas internal and external validity and identifying preference heterogeneity were more important during later decision points. Methods performed relatively well on the criteria that were most important at the different decision points of the MPLC; nevertheless, the value of individual methods was sensitive to changes in the performance matrix. • Although discrete choice experiment is the most applied preference elicitation method, best-worst scale, swing weighting, and probabilistic threshold technique should also be considered to address the needs of decision makers throughout the MPLC as they comply with top-weighted methods criteria according to MPLC decision makers. [ABSTRACT FROM AUTHOR]

Purpose: To describe antiplatelet treatment patterns over 12 months in patients with acute cornary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). Methods: The AntiPlatelet Treatment Observational Registry (APTOR) is a prospective, international observational study that recruited ACS patients undergoing PCI in 2007-08, capturing practice patterns, treatment and ressources use over 12 months. Interventional cardiologists collected data from ACS event to hospital discharge and general practitioners and cardiologists collected follow-up data. Results: 483 eligible ACS-PCI patients had mean age 61 (13) years, mean weight 80 (15) kg, were 18% female, 47% with ST-elevation MI (STEMI) and 53% with unstable angina or non-ST elevation MI (UA/NSTEMI). Follow-up data up to 12 months are available for 396 (82%) patients. Among patients who were discharged and had follow-up data, 94% were receving clopidogrel at time of hospital discharge. Cardiovascular combination therapy was prescribed as follows: aspirin (95%), statins (82%), beta-blockers (82%), ACE inhibitors/ARBs (68%); each of these treatments was globally maintained over 12 months. Lifestyle therapies increased over 12 months from 12% to 57% for formal diet program and 11% to 48% for formal exercise program. Over 12 months, on 394 patients, overall clopidogrel use was 94% at 30 days, 80% at 6 months, and 75% at 12 months. Amongst 83 patients who stopped clopidogrel before 12 months, 48% discontinued during the first three months. Conclusions: These prospective data showed that after an ACS event 20% of patients have already dropped out their clopidogrel treatment at 6 months and 25% at 12 months. [Copyright &y& Elsevier]

Background: A dronedarone utilization study using US MarketScan and InVision Data Mart databases was conducted to estimate the prevalence of the following: (1) dronedarone use in contraindicated patients with worsening heart failure (HF) or hospitalization for HF within 1 month before dronedarone prescription; (2) concomitant prescribing of contraindicated drugs; and (3) recommended creatinine testing after dronedarone initiation among dronedarone users. Methods: In this retrospective cohort study, data in the MarketScan database between July 20, 2009, and December 31, 2011, and in the InVision Data Mart database between July 20, 2009, and March 31, 2012, were analyzed. The study population included patients who received ≥1 dronedarone prescription during the study period. The following variables were reported: worsening of or hospitalization for HF, concomitant prescribing of potent cytochrome P450 CYP 3A4 inhibitors or QT-prolonging drugs, and creatinine testing. Results: There were 31,408 and 7025 dronedarone users identified in the MarketScan and InVision Data Mart databases, respectively. Approximately 86% to 90% of patients had a diagnosis of atrial fibrillation in each database. In the MarketScan database, 40% were women and 54% were aged ≥65 years. In the InVision Data Mart database, 31% were women and 32% were aged ≥65 years. The corresponding prevalence of worsening or hospitalization for HF was 6.4% (95% CI, 6.2-6.7) and 4.7% (95% CI, 4.2-5.2) in each database, respectively. The corresponding estimates of concomitant prescribing of potent cytochrome P450 CYP 3A4 inhibitors and QT-prolonging drugs within 30 days before initiation or refilling of dronedarone were 2.0% (95% CI, 1.8-2.1) and 10.0% (95% CI, 9.7-10.4), respectively, in the MarketScan database, and 2.3% (95% CI, 2.0-2.7) and 11.2% (95% CI, 10.5-12.0) in the InVision Data Mart database. More than 50% of patients in each database had serum creatinine tests conducted after dronedarone initiation. Conclusions: The results of the present analysis based on a long-term follow-up (nearly 3 years) were consistent with the previous findings that dronedarone has mostly been used appropriately in compliance with US prescribing in the target populations. [ABSTRACT FROM AUTHOR]