Incidence of Hospitalized Rhabdomyolysis with Statin and Fibrate Use in an Insured US Population
Incidence of Hospitalized Rhabdomyolysis with Statin and Fibrate Use in an Insured US Population
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DOI：
10.1345/aph.1q110
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发表时间：
2011-10-01
影响因子：
2.9
通讯作者：
McAfee, Andrew
中科院分区：
文献类型：
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作者：
Amend, Kandace L.;Landon, Joan;McAfee, Andrew
背景：在接受他汀类药物和贝特联合治疗的患者中，横纹肌溶解的住院发生率并不是很好的特征。目的：评估和比较在不同他汀类药物和贝特类药物暴露期间住院横纹肌溶解的发生率。方法：我们使用美国一家大型健康保险公司的数据库，对1998年1月1日至2007年12月31日期间开始应用他汀类或贝特类药物的患者进行了回顾性研究。通过对病历的临床回顾，对患者进行住院横纹肌溶解的发生追踪。研究期间的暴露状态通过他汀类药物和贝特类药物分配的电子记录来确定。结果：共有1116805名接受他汀类药物和/或他汀类药物的患者接受了240万人年的观察。确诊住院横纹肌溶解症70例。调整后的分析显示，联合治疗持续增加横纹肌溶解的风险，而单用他汀类药物和贝特治疗显示出类似的、不显著的风险增加。与单用他汀类药物相比，他汀类药物和非诺贝特治疗的调整后IRA为3.26(95%CI为1.21~8.80)，而他汀类药物和吉非罗齐的调整后IRA为11.93(95%CI为3.96~35.93)。他汀类药物单一治疗的个人IRS值为每10万人年0.00到3.34。他汀类药物联合吉非罗齐治疗所需伤害次数(2753例)低于单用他汀类药物(445,545例)。结论：他汀类药物联合吉非罗齐治疗的患者住院期间横纹肌溶解的发生率较低，但联合应用他汀类药物的患者的横纹肌溶解发生率高于单用他汀类药物的患者。这项研究中发现的比率与他汀类药物-贝特治疗混合性血脂异常的已知情况是一致的。
BACKGROUND: The incidence of hospitalized rhabdomyolysis is not well characterized among patients taking statin-fibrate combination therapies.OBJECTIVE: To estimate and compare the rates of hospitalized rhabdomyolysis during periods of exposure to different statins and fibrates.METHODS: We retrospectively identified a cohort of patients who initiated a statin or fibrate between January 1, 1998, and December 31, 2007, using a database of a large US health insurer. Patients were followed for the occurrence of hospitalized rhabdomyolysis, determined by clinical review of medical records. Exposure status during the study period was determined by electronic records of statin and fibrate dispensing. Incidence rates (IRs) and incidence rate ratios (IRRs) for various combinations of fibrate and statin exposure were modeled, using Poisson regression.RESULTS: There were 1,116,805 patients who initiated statin and/or fibrate therapy, with 2.4 million person-years of observation. Seventy cases of hospitalized rhabdomyolysis were confirmed. Adjusted analyses showed a persistent increased risk of rhabdomyolysis with combination therapy, while statin and fibrate therapy alone showed similar, nonsignificant increases in risk. The adjusted IRA for a statin and fenofibrate was 3.26 (95% CI 1.21 to 8.80), while the adjusted IRA for a statin and gemfibrozil was 11.93 (95% CI 3.96 to 35.93) versus statin therapy alone. The individual IRs for statin monotherapy ranged from 0.00 to 3.34 per 100,000 person-years. The number needed to harm was lower for combination statin-gemfibrozil therapy (2753) compared with that for statin therapy alone (454,545).CONCLUSIONS: The incidence of hospitalized rhabdomyolysis is rare, but higher in patients with concomitant statin-fibrate treatment than in patients on statin therapy alone. The rate found in this study is consistent with the known profile of the statin-fibrate treatment option for mixed dyslipidemia.