Incidence of hospitalized rhabdomyolysis in patients treated with lipid-lowering drugs
Incidence of hospitalized rhabdomyolysis in patients treated with lipid-lowering drugs
复制标题
DOI：
10.1001/jama.292.21.2585
复制
发表时间：
2004-12-01
影响因子：
120.7
通讯作者：
Platt, R
中科院分区：
文献类型：
--
作者：
Graham, DJ;Staffa, JA;Platt, R
背景降脂药在美国被广泛使用。各种降脂药物对横纹肌溶解症风险的可靠估计是不可用的。Objective To estimate the incidence of rhabdomyolysis in patients treated with different statins and fibrate，alone and in combination，in the ambulatory setting.Design，Setting，and Patients使用美国11个管理式医疗保健计划的索赔数据建立了他汀类药物和贝特类药物使用者的药物特异性初始队列。在1998年1月1日至2001年6月30日期间，入组队列的患者既往健康计划入组时间至少为180天。人-时间被归类为单一治疗或联合他汀类药物-贝特类therapeutic.Main Outcome Measure每10000人-年治疗的横纹肌溶解症的发病率，需要治疗的人数，以及横纹肌溶解症的相对风险。阿托伐他汀、普伐他汀或辛伐他汀单药治疗每10000人-年的平均发生率为0.44（95%置信区间[CI]，0.20-0.84）;西立伐他汀为5.34（95% CI，1.46-13.68）;贝特为2.82（95% CI，0.58-8.24）。相比之下，。在未暴露的人-时间内的发病率为0（95% CI，0-0.48; P= 0.056）。阿托伐他汀、普伐他汀或辛伐他汀与贝特类药物联合治疗的发生率增加至5.98（95% CI，0.72-216.0），西伐他汀-贝特类药物联合治疗的发生率增加至1035（95% CI，389-2117）。每一年的治疗中，观察到一例横纹肌溶解症所需治疗的人数，他汀类药物单药治疗为22727例，同时接受他汀类药物和贝特类药物治疗的老年糖尿病患者为484例，西立伐他汀加贝特类药物治疗的患者为9.7 - 12.7例。和辛伐他汀;联合使用他汀类药物和贝特类药物会增加风险，尤其是老年糖尿病患者。西立伐他汀与贝特类药物联合给药的风险约为每年1/10的治疗患者。
Context Lipid-lowering agents are widely prescribed in the United States. Reliable estimates of rhabdomyolysis risk with various lipid-lowering agents are not available.Objective To estimate the incidence of rhabdomyolysis in patients treated with different statins and fibrates, alone and in combination, in the ambulatory setting.Design, Setting, and Patients Drug-specific inception cohorts of statin and fibrate users were established using claims data from 11 managed care health plans across the United States. Patients with at least 180 days of prior health plan enrollment were entered into the cohorts between January 1, 1998, and June 30, 2001. Person-time was classified as monotherapy or combined statin-fibrate therapy.Main Outcome Measure Incidence rates of rhabdomyolysis per 10000 person-years of treatment, number needed to treat, and relative risk of rhabdomyolysis.Results In 252460 patients treated with lipid-lowering agents, 24 cases of hospitalized rhabdomyolysis occurred during treatment. Average incidence per 10000 person-years for monotherapy with atorvastatin, pravastatin, or simvastatin was 0.44 (95% confidence interval [CI], 0.20-0.84); for cerivastatin, 5.34 (95% Cl, 1.46-13.68); and for fibrate, 2.82 (95% Cl, 0.58-8.24). By comparison,. the incidence during unexposed person-time was 0 (95% Cl, 0-0.48; P=.056). The incidence increased to 5.98 (95% Cl, 0.72-216.0) for combined therapy of atorvastatin, pravastatin, or simvastatin with a fibrate, and to 1035 (95% Cl, 389-2117) for combined cerivastatin-fibrate use. Per year of therapy, the number needed to treat to observe 1 case of rhabdomyolysis was 22 727 for statin monotherapy, 484 for older patients with diabetes mellitus who were treated with both a statin and fibrate, and ranged from 9.7 to 12.7 for patients who were treated with cerivastatin plus fibrate.Conclusions Rhabdomyolysis risk was similar and low for monotherapy with atorvastatin, pravastatin, and simvastatin; combined statin-fibrate use increased risk, especially in older patients with diabetes mellitus. Cerivastatin combined with fibrate conferred a risk of approximately 1 in 10 treated patients per year.