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Am J Cardiol. 2017 Sep 1;120(5):774-781. doi: 10.1016/j.amjcard.2017.05.046. Epub 2017 Jun 13.

Meta-analysis of Placebo-Controlled Randomized Controlled Trials on the Prevalence of Statin Intolerance.

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Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address:
Department of Cardiovascular Medicine, University of Louisville, Louisville, Kentucky.
Department of Internal Medicine, John H Stroger Jr. Hospital of Cook County, Chicago, Illinois.
Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.
Department of Cardiac Surgery, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.
Department of Cardiovascular Medicine, Mercy Saint Vincent Medical Center, Toledo, Ohio.
Section of Preventive Cardiology, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.
Department of Cardiovascular Medicine, Duke University Medical Center, Durham, North Carolina.


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.

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