Abstract 17797: Gaining Insights Into Statin Intolerance: A Meta Analysis of Placebo Controlled Randomized Controlled Trials
Introduction: Statin intolerance is reported in > 10% patients and is a common cause of drug discontinuation which in turn is linked with worse outcomes in cardiovascular disease (CVD) patients. Despite extensive use, statin intolerance remains an elusive phenomenon.
Hypothesis: The rate of statin discontinuation should be significantly greater than the discontinuation rates of placebos in the historical randomized controlled trials (RCT’s).
Methods: All RCT’s from the PubMed database were included if they had at least 1000 patients, were followed for at least 1 year and reported the rates of discontinuation. We also examined the reference lists of the systematic reviews of statins to identify additional studies. The studies were pooled as per the random effects model.
Results: A total of 20 studies (125,309 patients) met the inclusion criteria. Among the included studies, 14 (93,988 patients) were for primary prevention and 6 (31,321 patients) were for the secondary prevention of coronary artery disease. The pooled analysis suggested that with a mean follow up of 4.4 years, the rates of discontinuation of statin therapy was 13.8 % (8639 patients) in the statin arm and 14.1% (8863 patients) in the placebo arm. Random effect model showed no significant difference between the placebo and statin arms (OR=0.97, 95% CI= 0.92-1.03). Also, sub group analysis revealed no significant differences among the different statin therapies.
Conclusions: Our meta-analysis suggests that the rates of discontinuation of statin therapy is not significantly different compared with the placebos in the historical RCT’s. These findings are limited by the heterogeneity of results, variable duration of follow up and lower doses of statins used in the trials compared with the contemporary clinical practice. Physicians should provide reassurance to the patients when they present with statin intolerance given the consistent and proven track record of statins for CVD prevention.
Author Disclosures: H. Riaz: None. M.S. Khan: None. T. Riaz: None. A.R. Khan: None. F.K. Luni: None. R.A. Krasuski: None.
- © 2016 by American Heart Association, Inc.