Department of Epidemiology, University of Alabama at Birmingham, Birmingham, Alabama; Department of Functional Sciences, University of Medicine and Pharmacy Victor Babes Timisoara, Romania.
Department of Epidemiology, University of Alabama at Birmingham, Birmingham, Alabama.
J Am Coll Cardiol. 2017 Mar 21;69(11):1386-1395. doi: 10.1016/j.jacc.2016.12.036.
Many patients report adverse reactions to, and may not tolerate, statin therapy. These patients may be at increased risk for coronary heart disease (CHD) events and mortality.
This study evaluated the risk for recurrent myocardial infarction (MI), CHD events, and all-cause mortality in Medicare beneficiaries with statin intolerance and in those with high adherence to statin therapy.
We studied 105,329 Medicare beneficiaries who began a moderate- or high-intensity statin dosage after hospitalization for MI between 2007 and 2013. Statin intolerance was defined as down-titrating statins and initiating ezetimibe therapy, switching from statins to ezetimibe monotherapy, having International Classification of Diseases, 9th revision, diagnostic codes for rhabdomyolysis or an antihyperlipidemic adverse event, followed by statin down-titration or discontinuation, or switching between ≥3 types of statins within 1 year after initiation. High statin adherence over the year following hospital discharge was defined as proportion of days covered ≥80%. Recurrent MI, CHD events (recurrent MI or a coronary revascularization procedure), and mortality were identified from 1 year after hospital discharge through December 2014.
Overall, 1,741 patients (1.65%) had statin intolerance, and 55,567 patients (52.8%) had high statin adherence. Over a median of 1.9 to 2.3 years of follow-up, there were 4,450 recurrent MIs, 6,250 CHD events, and 14,311 deaths. Compared to beneficiaries with high statin adherence, statin intolerance was associated with a 36% higher rate of recurrent MI (41.1 vs. 30.1 per 1,000 person-years, respectively), a 43% higher rate of CHD events (62.5 vs. 43.8 per 1,000 person-years, respectively), and a 15% lower rate of all-cause mortality (79.9 vs. 94.2 per 1,000 person-years, respectively). The multivariate-adjusted hazard ratios (HR) comparing beneficiaries with statin intolerance versus those with high statin adherence were 1.50 (95% confidence interval [CI]: 1.30 to 1.73) for recurrent MI, 1.51 (95% CI: 1.34 to 1.70) for CHD events, and 0.96 (95% CI: 0.87 to 1.06) for all-cause mortality.
Statin intolerance was associated with an increased risk for recurrent MI and CHD events but not all-cause mortality.
许多患者报告对他汀类药物治疗有不良反应，并且可能无法耐受。这些患者可能有更高的冠心病（CHD）事件和死亡率风险。
本研究评估了他汀类药物不耐受的医疗保险受益人和他汀类药物高依从性的医疗保险受益人的复发性心肌梗死（MI）、CHD 事件和全因死亡率的风险。
我们研究了 105329 名医疗保险受益人，他们在 2007 年至 2013 年期间因 MI 住院后开始使用中等或高强度他汀类药物剂量。他汀类药物不耐受定义为降低他汀类药物剂量并开始使用依折麦布治疗、将他汀类药物转换为依折麦布单药治疗、出现国际疾病分类第 9 版诊断代码为横纹肌溶解症或抗血脂不良事件，随后降低他汀类药物剂量或停药，或在开始后 1 年内他汀类药物之间转换≥3 种类型、出院后 1 年内的他汀类药物高依从性定义为覆盖率比例≥80%。在出院后 1 年至 2014 年 12 月期间，通过医院出院后 1 年识别复发性 MI、CHD 事件（复发性 MI 或冠状动脉血运重建术）和死亡率。
总体而言，有 1741 名患者（1.65%）存在他汀类药物不耐受，有 55567 名患者（52.8%）具有他汀类药物高依从性。在中位时间为 1.9 至 2.3 年的随访期间，有 4450 例复发性 MI、6250 例 CHD 事件和 14311 例死亡。与他汀类药物高依从性的受益相比，他汀类药物不耐受与复发性 MI 发生率增加 36%相关（分别为每 1000 人年 41.1 次和 30.1 次），CHD 事件发生率增加 43%（分别为每 1000 人年 62.5 次和 43.8 次），全因死亡率降低 15%（分别为每 1000 人年 79.9 次和 94.2 次）。与他汀类药物高依从性相比，比较他汀类药物不耐受与他汀类药物高依从性的患者的多变量调整后的危险比（HR）分别为复发性 MI 为 1.50（95%置信区间[CI]：1.30 至 1.73），CHD 事件为 1.51（95% CI：1.34 至 1.70），全因死亡率为 0.96（95% CI：0.87 至 1.06）。
他汀类药物不耐受与复发性 MI 和 CHD 事件风险增加相关，但与全因死亡率无关。
