Goettsch W G, Heintjes E M, Kastelein J J P, Rabelink T J, Johansson Saga, Herings R M C
PHARMO Institute, Utrecht, The Netherlands.
Pharmacoepidemiol Drug Saf. 2006 Jul;15(7):435-43. doi: 10.1002/pds.1278.
Clinical benefits of statin therapy are accepted, but their safety profiles have been under scrutiny, particularly for the recently introduced statin, rosuvastatin, relating to serious adverse events involving muscle, kidney and liver. Therefore, a historical cohort study was performed to evaluate the association between rosuvastatin versus other statin use and the incidence of rhabdomyolysis, myopathy, acute renal failure and hepatic impairment.
Incident users of rosuvastatin or other statins in 2003-2004 and a cohort of patients not prescribed statins were included from the PHARMO database of >2 million Dutch residents. Cases of hospitalisations for myopathy, rhabdomyolysis, acute renal failure or hepatic impairment were identified for these cohorts. Potential cases were validated through a multi-step process using data obtained from hospital records. Additionally, cases of all cause deaths were identified from certification alone.
In 2003 and 2004, 10,147 incident rosuvastatin users, 37,396 incident other statin users and 99,935 patients without statin prescriptions were included. There were 26 validated outcome events in the three cohorts including one case each of myopathy (other statin group) and rhabdomyolysis (non-treated group). There were no significant differences in the incidence of outcome events between rosuvastatin and other statin users.
This study indicated that the number of outcome events is less than 1 per 3000 person years. This study in more than 45,000 Dutch statin users suggests that rosuvastatin does not lead to an increased incidence of rhabdomyolysis, myopathy, acute renal failure or hepatic impairment compared to other statins.
他汀类药物治疗的临床益处已被认可，但其安全性一直受到审视，尤其是最近引入的他汀类药物瑞舒伐他汀，涉及肌肉、肾脏和肝脏的严重不良事件。因此，进行了一项历史性队列研究，以评估瑞舒伐他汀与其他他汀类药物的使用与横纹肌溶解症、肌病、急性肾衰竭和肝功能损害发生率之间的关联。
从拥有超过200万荷兰居民的PHARMO数据库中纳入2003 - 2004年开始使用瑞舒伐他汀或其他他汀类药物的患者以及未开具他汀类药物处方的一组患者。确定这些队列中因肌病、横纹肌溶解症、急性肾衰竭或肝功能损害而住院的病例。潜在病例通过使用从医院记录获得的数据的多步骤过程进行验证。此外，仅从认证中确定全因死亡病例。
2003年和2004年，纳入了10147名开始使用瑞舒伐他汀的患者、37396名开始使用其他他汀类药物的患者以及99935名未开具他汀类药物处方的患者。三个队列中有26例经过验证的结局事件，包括肌病（其他他汀类药物组）和横纹肌溶解症（未治疗组）各1例。瑞舒伐他汀使用者和其他他汀类药物使用者之间结局事件的发生率没有显著差异。
这项研究表明，结局事件的数量每3000人年少于1例。这项对超过45000名荷兰他汀类药物使用者的研究表明，与其他他汀类药物相比，瑞舒伐他汀不会导致横纹肌溶解症、肌病、急性肾衰竭或肝功能损害的发生率增加。
