Riaz Haris, Khan Abdur Rahman, Khan Muhammad Shahzeb, Rehman Karim Abdur, Alansari Shehab Ahmad Redha, Gheyath Bashaer, Raza Sajjad, Barakat Amr, Luni Faraz Khan, Ahmed Haitham, Krasuski Richard A
Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.
Department of Cardiovascular Medicine, University of Louisville, Louisville, Kentucky.
Am J Cardiol. 2017 Sep 1;120(5):774-781. doi: 10.1016/j.amjcard.2017.05.046. Epub 2017 Jun 13.
The prevalence of intolerance varies widely. Stopping statin therapy is associated with worse outcomes in patients with cardiovascular disease. Despite extensive studies, the benefits and risks of statins continue to be debated by clinicians and the lay public. We searched the PubMed, Medline, and Cochrane Central Register of Controlled Trials (CENTRAL) databases for all randomized controlled trials of statins compared with placebo. Studies were included if they had ≥1,000 participants, had patients who were followed up for ≥1 year, and reported rates of drug discontinuation. Studies were pooled as per the random effects model. A total of 22 studies (statins = 66,024, placebo = 63,656) met the inclusion criteria. The pooled analysis showed that, over a mean follow-up of 4.1 years, the rates of discontinuation were 13.3% (8,872 patients) for statin-treated patients and 13.9% (8,898 patients) for placebo-treated patients. The random effects model showed no significant difference between the placebo and statin arms (odds ratio [OR] = 0.99, 95% confidence interval [CI] = 0.93 to 1.06). The results were similar for both primary prevention (OR = 0.98, 95% CI = 0.92 to 1.05, p = 0.39) and secondary prevention (OR = 0.92, 95% CI = 0.83 to 1.05, p = 0.43) studies. The pooled analysis suggested that the rates of myopathy were also similar between the statins and placebos (OR = 1.2, 95% CI = 0.88 to 1.62, p = 0.25). In conclusion, this meta-analysis of >125,000 patients suggests that the rate of drug discontinuation and myopathy does not significantly differ between statin- and placebo-treated patients in randomized controlled trials. These findings are limited by the heterogeneity of results, the variable duration of follow-up, and the lower doses of statins compared with contemporary clinical practice.
不耐受的发生率差异很大。在心血管疾病患者中，停用他汀类药物治疗与更差的预后相关。尽管进行了广泛的研究，但他汀类药物的益处和风险仍在临床医生和普通公众中存在争议。我们在PubMed、Medline和Cochrane对照试验中央注册库（CENTRAL）数据库中搜索了所有将他汀类药物与安慰剂进行比较的随机对照试验。如果研究的参与者≥1000人、患者随访时间≥1年且报告了停药率，则纳入研究。根据随机效应模型对研究进行汇总。共有22项研究（他汀类药物组=66024人，安慰剂组=63656人）符合纳入标准。汇总分析显示，在平均4.1年的随访中，他汀类药物治疗患者的停药率为13.3%（8872例患者），安慰剂治疗患者的停药率为13.9%（8898例患者）。随机效应模型显示安慰剂组和他汀类药物组之间无显著差异（优势比[OR]=0.99，95%置信区间[CI]=0.93至1.06）。一级预防（OR=0.98，95%CI=0.92至1.05，p=0.39）和二级预防（OR=0.92，95%CI=0.83至1.05，p=0.43）研究的结果相似。汇总分析表明，他汀类药物组和安慰剂组之间的肌病发生率也相似（OR=1.2，95%CI=0.88至1.62，p=0.25）。总之，这项对超过125000名患者的荟萃分析表明，在随机对照试验中，他汀类药物治疗患者和安慰剂治疗患者的停药率和肌病发生率没有显著差异。这些发现受到结果异质性、随访时间长短不一以及与当代临床实践相比他汀类药物剂量较低的限制。
