通用阿托伐他汀与立普妥®在急性冠脉综合征住院患者中的疗效比较
Comparative Effectiveness of Generic Atorvastatin and Lipitor® in Patients Hospitalized with an Acute Coronary Syndrome.
作者信息
Jackevicius Cynthia A, Tu Jack V, Krumholz Harlan M, Austin Peter C, Ross Joseph S, Stukel Therese A, Koh Maria, Chong Alice, Ko Dennis T
机构信息
Department of Pharmacy Practice and Administration, College of Pharmacy, Western University of Health Sciences, Pomona, CA Institute for Clinical Evaluative Sciences, Toronto Ontario, Canada Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, CA Institute of Health Policy, Management and Evaluation, Faculty of Medicine, University of Toronto Ontario, Canada Division of Cardiology, Schulich Heart Center, Sunnybrook Health Sciences Center, University of Toronto Ontario, Canada
Institute for Clinical Evaluative Sciences, Toronto Ontario, Canada Institute of Health Policy, Management and Evaluation, Faculty of Medicine, University of Toronto Ontario, Canada University Health Network, Toronto, Ontario, Canada.
出版信息
J Am Heart Assoc. 2016 Apr 19;5(4):e003350. doi: 10.1161/JAHA.116.003350.
BACKGROUND
Although generic medications are approved based on bioequivalence with brand-name medications, there remains substantial concern regarding their clinical effectiveness and safety. Lipitor(®), available as generic atorvastatin, is one of the most commonly prescribed statins. Therefore, we compared the effectiveness of generic atorvastatin products and Lipitor(®).
METHODS AND RESULTS
We conducted a population-based cohort study, using propensity score matching to minimize potential confounding of patients ≥65 years, discharged alive after acute coronary syndrome (ACS) hospitalization between 2008 and 2012 in Ontario, Canada, who were prescribed Lipitor(®) or generic atorvastatin within 7 days of discharge. The primary outcome was 1-year death/recurrent ACS hospitalization. Secondary outcomes included hospitalization for heart failure, stroke, new-onset diabetes, rhabdomyolysis, and renal failure. In the 7863 propensity-matched pairs (15 726 patients), mean age was 76.9 years, 56.3% were male, 87.6% had myocardial infarction, and all patients had complete follow-up. At 1 year, 17.7% of those prescribed generic atorvastatin and 17.7% of those prescribed Lipitor(®) experienced death or recurrent ACS (hazard ratio, 1.00; 95% CI, 0.93-1.08; P=0.94). No significant differences in rates of secondary outcomes between groups were observed. Prespecified subgroup analyses by age, sex, diabetes, atorvastatin dose, or admission diagnosis found no outcome difference between groups.
CONCLUSIONS
Among older adults discharged alive after ACS hospitalization, we found no significant difference in cardiovascular outcomes or serious, infrequent side effects in patients prescribed generic atorvastatin compared with those prescribed Lipitor(®) at 1 year. Our findings support the use of generic atorvastatin in ACS, which could lead to substantial cost saving for patients and health care plans without diminishing population clinical effectiveness.
背景
尽管仿制药是基于与品牌药的生物等效性而获批的，但人们对其临床有效性和安全性仍存在重大担忧。可作为阿托伐他汀通用名药使用的立普妥（Lipitor®）是最常用的他汀类药物之一。因此，我们比较了阿托伐他汀仿制药产品和立普妥（Lipitor®）的有效性。
方法与结果
我们进行了一项基于人群的队列研究，使用倾向评分匹配法，以尽量减少2008年至2012年在加拿大安大略省因急性冠状动脉综合征（ACS）住院后存活出院的65岁及以上患者的潜在混杂因素，这些患者在出院后7天内被开具立普妥（Lipitor®）或阿托伐他汀仿制药。主要结局是1年死亡/复发性ACS住院。次要结局包括因心力衰竭、中风、新发糖尿病、横纹肌溶解症和肾衰竭住院。在7863对倾向评分匹配的患者（15726名患者）中，平均年龄为76.9岁，56.3%为男性，87.6%有心肌梗死，所有患者均有完整随访。1年后，服用阿托伐他汀仿制药的患者中有17.7%以及服用立普妥（Lipitor®）的患者中有17.7%发生死亡或复发性ACS（风险比，1.00；95%CI，0.93 - 1.08；P = 0.94）。两组间次要结局发生率无显著差异。按年龄、性别、糖尿病、阿托伐他汀剂量或入院诊断进行的预设亚组分析未发现两组间结局有差异。
结论
在ACS住院后存活出院的老年人中，我们发现服用阿托伐他汀仿制药的患者与服用立普妥（Lipitor®）的患者相比，1年后心血管结局或严重、罕见副作用无显著差异。我们的研究结果支持在ACS中使用阿托伐他汀仿制药，这可为患者和医疗保健计划节省大量成本，而不会降低总体临床有效性。
Zotero 插件