The safety of rosuvastatin as used in common clinical practice - A postmarketing analysis
The safety of rosuvastatin as used in common clinical practice - A postmarketing analysis
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DOI：
10.1161/circulationaha.105.555482
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发表时间：
2005-06-14
期刊：
影响因子：
37.8
通讯作者：
Karas, RH
中科院分区：
文献类型：
--
作者：
Alsheikh-Ali, AA;Ambrose, MS;Karas, RH
背景-他汀类药物目前是心血管疾病一级和二级预防中血脂异常管理的主要药物。基于上市前研究和一些上市后报告，新上市的他汀类药物瑞舒伐他汀的安全性引起了争议。方法和结果：我们回顾了瑞舒伐他汀上市第一年向美国食品和药物管理局报告的相关不良事件。根据从IMS Health获得的处方数据，计算了每百万张处方的不良事件报告率。将瑞舒伐他汀与阿托伐他汀、辛伐他汀和普伐他汀在同一时间段和各自上市第一年的AERs发生率进行比较。还与cervastatin上市第一年进行了比较。初步分析检查了横纹肌溶解、蛋白尿、肾病或肾功能衰竭的AERs复合终点。无论是哪一种时间框架比较，瑞舒伐他汀与横纹肌溶解、蛋白尿、肾病或肾功能衰竭AERs的复合终点明显更相关。报告的横纹肌溶解、蛋白尿或肾功能衰竭的病例往往发生在治疗开始后早期，瑞舒伐他汀的剂量相对较小。在二级分析中，当检查其他类型的aer时，包括严重后果的不良事件、肝毒性和无横纹肌溶解的肌肉毒性，也观察到瑞舒伐他汀相关aer相对于其他广泛使用的他汀类药物的发生率增加。结论：目前的分析支持了瑞舒伐他汀在普通临床实践中使用剂量范围内相对安全性的担忧。
Background - Statins are currently the mainstay of dyslipidemia management for the primary and secondary prevention of cardiovascular disease. Controversial concerns about the safety of the newly marketed statin rosuvastatin have been raised on the basis of premarketing studies and a few postmarketing reports.Methods and Results - We reviewed rosuvastatin-associated adverse events reported to the US Food and Drug Administration over its first year of marketing. On the basis of prescription data obtained from IMS Health, rates of adverse event reports ( AERs) per million prescriptions were calculated. Rates of rosuvastatin-associated AERs over its first year of marketing were compared with those seen with atorvastatin, simvastatin, and pravastatin over the concurrent timeframe and during their respective first years of marketing. Comparison was also made to the first year of marketing of cerivastatin. The primary analysis examined the composite end point of AERs of rhabdomyolysis, proteinuria, nephropathy, or renal failure. With either timeframe comparison, rosuvastatin was significantly more likely to be associated with the composite end point of rhabdomyolysis, proteinuria, nephropathy, or renal failure AERs. Reported cases of rhabdomyolysis, proteinuria, or renal failure tended to occur early after the initiation of therapy and at relatively modest doses of rosuvastatin. The increased rate of rosuvastatin-associated AERs relative to other widely used statins was also observed in secondary analyses when other categories of AERs were examined, including adverse events with serious outcomes, liver toxicity, and muscle toxicity without rhabdomyolysis.Conclusions - The present analysis supports concerns about the relative safety of rosuvastatin at the range of doses used in common clinical practice in the general population.