Statin and statin-fibrate use was significantly associated with increased myositis risk in a managed care population

Statin and statin-fibrate use was significantly associated with increased myositis risk in a managed care population
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DOI:
10.1016/j.jclinepi.2006.11.006
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发表时间:
2007-08-01
影响因子:
7.2
通讯作者:
Hokanson, John E.
Hokanson, John E.
中科院分区:
医学2区
文献类型:
--
作者:
McClure, David L.;Valuck, Robert J.;Hokanson, John E.

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目的:我们量化了与他汀类药物和贝特类药物的使用与其他协变量在管理式医疗机构(MCO)population.Study设计和设置:这项研究跨越了1999年至2003年的肌炎的风险。肌炎病例的肌酸激酶(CK)>= 10 x正常上限并诊断为肌病。他汀类药物、贝特类药物和其他药物的暴露与年龄、性别和疑似肌病风险指标相关。首先在CK监测队列中分析暴露,然后在更一般的次要队列中分析暴露。经Poisson回归分析得出肌炎的校正相对危险度(RR)和发病率。肌炎与他汀类药物单药治疗显著相关(RR 2.8 [95%置信区间,CI = 1.3-5.9]),他汀类药物-贝特类药物联合治疗(9.1 [95% CI = 3.5-23]),共病肝病(4.3 [95% CI = 1.5-13])和/或肾病(2.5 [95% CI = 1.3-5.0])。每种协变量模式的肌炎发生率范围为33 - 6,400例/100,000人-年。使用他汀类药物和贝特类药物的平均事件发生时间为1.7年,单独使用他汀类药物为2.0年,未暴露者为2.1年。在次要队列中,RR增加了10倍,进一步远离null.Conclusion:他汀类药物,有或没有贝特类药物,肝脏和肾脏疾病与MCO人群中肌炎风险增加显著相关。(C)2007年爱思唯尔公司All rights reserved.
Objective: We quantified the risk of myositis associated with statin and fibrate drug use with other covariates within a managed care organization (MCO) population.Study Design and Setting: The study spanned the years 1999-2003. Myositis cases had creatine kinase (CK) >= 10x upper limit of normal and a myopathy diagnosis. Exposures of statins, fibrates, and other drugs were assessed with age, gender, and indicators of suspected myopathy risk. Exposures were first analyzed within a cohort with CK monitoring and then within a more general secondary cohort. Adjusted relative risks (RRs) and incidence rates of myositis were generated by Poisson regression.Results: Myositis was significantly associated with statin monotherapy (RR 2.8 [95% confidence interval, CI = 1.3-5.9]), statin-fibrate combination therapy (9.1 [95% CI = 3.5-23]), comorbid liver disease (4.3 [95% CI = 1.5-13], and/or renal disease (2.5 [95% CI = 1.3-5.0]). Myositis rates per covariate pattern ranged from 33 to 6,400 per 100,000 person-years. The mean time to event was 1.7 years for statin-fibrate use, 2.0 years for statins alone, and 2.1 years for unexposed. Within the secondary cohort, RRs increased up to 10 times further away from the null.Conclusion: Statins, with or without fibrates, and liver and renal disease were significantly associated with increased myositis risk in an MCO population. (C) 2007 Elsevier Inc. All rights reserved.