Global Phamacovigilance and Epidemiology, Sanofi, Bridgewater, New Jersey.
Global Phamacovigilance and Epidemiology, Sanofi, Bridgewater, New Jersey.
Clin Ther. 2014 Feb 1;36(2):264-72.e2. doi: 10.1016/j.clinthera.2014.01.002. Epub 2014 Jan 31.
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.
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.
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.
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.
使用美国 MarketScan 和 InVision 数据集市数据库进行了一项关于决奈达隆使用情况的研究，旨在评估以下情况的发生率：（1）在开始决奈达隆处方前 1 个月内，因心力衰竭（HF）恶化或因 HF 住院而被禁忌的患者使用决奈达隆；（2）同时开禁忌药物；（3）在开始决奈达隆后建议进行肌酐检测。
在这项回顾性队列研究中，分析了 MarketScan 数据库中 2009 年 7 月 20 日至 2011 年 12 月 31 日和 InVision 数据集市数据库中 2009 年 7 月 20 日至 2012 年 3 月 31 日的数据。研究人群包括在研究期间至少接受 1 次决奈达隆处方的患者。报告了以下变量：HF 恶化或住院、同时开具强细胞色素 P450 CYP3A4 抑制剂或 QT 延长药物、以及肌酐检测。
在 MarketScan 和 InVision 数据集市数据库中分别确定了 31408 例和 7025 例决奈达隆使用者。每个数据库中约有 86%至 90%的患者被诊断为心房颤动。在 MarketScan 数据库中，40%为女性，54%年龄≥65 岁。在 InVision 数据集市数据库中，31%为女性，32%年龄≥65 岁。每个数据库中 HF 恶化或住院的发生率分别为 6.4%（95%CI，6.2-6.7）和 4.7%（95%CI，4.2-5.2）。在开始或重新开决奈达隆处方前 30 天内，同时开具强细胞色素 P450 CYP3A4 抑制剂和 QT 延长药物的估计比例分别为 2.0%（95%CI，1.8-2.1）和 10.0%（95%CI，9.7-10.4），在 MarketScan 数据库中为 2.3%（95%CI，2.0-2.7）和 11.2%（95%CI，10.5-12.0）。每个数据库中超过 50%的患者在开始决奈达隆后进行了血清肌酐检测。
本分析基于长期随访（近 3 年）的结果与之前的发现一致，即决奈达隆主要是在美国目标人群中按照规定使用，符合规定。
