Assessment of statin-associated muscle toxicity in Japan: a cohort study conducted using claims database and laboratory information.
Assessment of statin-associated muscle toxicity in Japan: a cohort study conducted using claims database and laboratory information.
复制标题
DOI：
10.1136/bmjopen-2012-002040
复制
发表时间：
2013
期刊：
影响因子：
2.9
通讯作者：
Akazawa M
中科院分区：
文献类型：
--
作者：
Chang CH;Kusama M;Ono S;Sugiyama Y;Orii T;Akazawa M
通过检查研究人群、药物暴露状况和结果定义，评估接受他汀类药物治疗的患者肌肉毒性的发生率。一项回溯性队列研究。日本境内的16家医疗机构，提供2004年4月1日至2010年12月31日期间在其机构内进行的实验室检测和收到的索赔的资料。研究了一个代表35名 903成人他汀类药物(阿托伐他汀、氟伐他汀、匹伐他汀、普伐他汀、瑞舒伐他汀和辛伐他汀)使用者队列的数据库。确定这些患者使用相互作用的药物(贝特类、三氮唑类、大环内酯类、胺碘酮和环孢素)。根据肌肉相关疾病(肌病或横纹肌溶解)和/或肌酸激酶(CK)浓度异常升高的诊断，确定他汀类药物相关的肌肉毒性(“事件”)。如果患者有CK升高相关的情况，而不是肌肉毒性，则排除事件。肌肉毒性的发生率每1000人年确定，95%的可信区间由泊松回归确定。在他汀类药物治疗的42 193人年中，共有18个 036患者，其中43个事件被确定。应用他汀类药物的患者肌肉毒性发生率为1.02(95%CI为0.76~1.37)/1000人年。当结果定义被修改时，估计值从0.09/1000人年，满足诊断和CK 10倍于正常范围上限(ULN)标准，到2.06/1000人年，满足诊断或CK 5×ULN标准。肌肉毒性的发生率也受所选他汀类药物的影响，但没有显著差异。他汀类药物联合用药2430例(13.5%)，仅发生3例肌肉毒性，发生率为1.69/1000人年。这项数据库研究表明，他汀类药物的使用总体上是耐受性和安全性很好的；然而，与使用相互作用的药物有关的肌肉毒性风险需要进一步探讨。
To estimate the incidence of muscle toxicity in patients receiving statin therapy by examining study populations, drug exposure status and outcome definitions. A retrospective cohort study. 16 medical facilities in Japan providing information on laboratory tests performed in and claims received by their facilities between 1 April 2004 and 31 December 2010. A database representing a cohort of 35 903 adult statin (atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin and simvastatin) users was studied. Use of interacting drugs (fibrates, triazoles, macrolides, amiodarone and ciclosporin) by these patients was determined. Statin-associated muscle toxicity (the ‘event’) was identified based on a diagnosis of muscle-related disorders (myopathy or rhabdomyolysis) and/or abnormal elevation of creatine kinase (CK) concentrations. Events were excluded if the patients had CK elevation-related conditions other than muscle toxicity. Incidence rates for muscle toxicity were determined per 1000 person-years, with 95% CI determined by Poisson regression. A total of 18 036 patients accounted for 42 193 person-years of statin therapy, and 43 events were identified. The incidence of muscle toxicity in the patients treated with statins was 1.02 (95% CI 0.76 to 1.37)/1000 person-years. The estimates varied when outcome definitions were modified from 0.09/1000 person-years, which met both diagnosis and CK 10× greater than the upper limit of normal range (ULN) criteria, to 2.06/1000 person-years, which met diagnosis or CK 5× ULN criterion. The incidence of muscle toxicity was also influenced by the statin therapies selected, but no significant differences were observed. Among 2430 patients (13.5%) received interacting drugs with statins, only three muscle toxicity cases were observed (incidence: 1.69/1000 person-years). This database study suggested that statin use is generally well tolerated and safe; however, the risk of muscle toxicity related to the use of interacting drugs requires further exploration.
登录
查看更多内容
影响因子：
2.6
作者：
Rowan, Christopher G.;Brunelli, Steven M.;Strom, Brian L.
通讯作者：
Strom, Brian L.
DOI：
10.1111/j.1365-2710.2004.00605.x
发表时间：
2005-02-01
影响因子：
2
作者：
Saito, M;Hirata-Koizumi, M;Hasegawa, R
通讯作者：
Hasegawa, R
影响因子：
2.9
作者：
Amend, Kandace L.;Landon, Joan;McAfee, Andrew
通讯作者：
McAfee, Andrew
DOI：
10.7326/0003-4819-127-8_part_2-199710151-00048
发表时间：
1997-10-15
影响因子：
39.2
作者：
Iezzoni, LI
通讯作者：
Iezzoni, LI
影响因子：
37.8
作者：
Grundy, SM;Cleeman, JI;Stone, NJ
通讯作者：
Stone, NJ