Risks Associated With Statin Therapy: A Systematic Overview of Randomized Clinical Trials
Open accessAbstract
Background— Although statins reduce the risk of cardiovascular events, concerns about adverse effects may deter physicians from prescribing these agents. We performed a systematic overview of randomized statin trials to quantify the risks of musculoskeletal, renal, and hepatic complications associated with therapy. Methods and Results— Major statin trials were identified by electronic search of the MEDLINE database from 1966 to December 2005. We included English language reports of adults with documented hyperlipidemia; double-blind, random allocation of ≥100 patients to statin monotherapy versus placebo; and reports of myalgia, creatine kinase elevations, rhabdomyolysis, transaminase elevations, and discontinuation due to adverse events. Among 74 102 subjects enrolled in 35 trials (follow-up range, 1 to 65 months), statin therapy (excluding cerivastatin) did not result in significant absolute increases in risks of myalgias (risk difference/1000 patients [RD], 2.7; 95% CI, −3.2 to 8.7), creatine kinase elevations (RD, 0.2; 95% CI, −0.6 to 0.9), rhabdomyolysis (RD, 0.4; 95% CI, −0.1 to 0.9), or discontinuation due to any adverse event (RD, −0.5; 95% CI, −4.3 to 3.3). The absolute risk of transaminase elevations was significantly higher with statin therapy (RD, 4.2; 95% CI, 1.5 to 6.9). Conclusions— On the basis of data available from published clinical trials, statin therapy is associated with a small excess risk of transaminase elevations, but not of myalgias, creatine kinase elevations, rhabdomyolysis, or withdrawal of therapy compared with placebo. Further study is necessary to determine whether the results from these published clinical trials are similar to what occurs in routine practice, particularly among patients who are older, have more severe comorbid conditions, or receive higher statin doses than most patients in these clinical trials.
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Reported rates of muscle symptoms are invariably lower in blinded RCTs when compared with those in registries and observational studies, with myalgia rates similar in subjects on statin or placebo.
“As indicated above, reported rates of muscle symptoms are invariably lower in blinded RCTs when compared with those in registries and observational studies, with myalgia rates similar in subjects on statin or placebo.2–4,20,21”
Muscle complaints in other clinical trials have been similar in statin-treated and placebo subjects.
“Muscle complaints in other clinical trials have been similar in statin-treated and placebo subjects.4,20,23,24”
In randomized controlled trials, adverse event rates (including complaints of muscle pain) are similar in statin and placebo groups.
“In randomized, controlled trials (RCTs), adverse event rates (including complaints of muscle pain) are similar in statin and placebo groups”
The AIM-HIGH study did not show suppressive effects of nicotinic acid derivative added to statin on ASCVD incidence.
“The AIM-HIGH study698), which examined the effect of nicotinic acid derivative (NA) added-on to statin in the subjects with low HDL-C and hypertriglyceridemia together with ASCVD history, did not show suppressive effects of NA on ASCVD incidence.”
From Japan Atherosclerosis Society (JAS) guidelines for prevention of atherosclerotic cardiovascular diseases 2017 (2018) · cites this paper as [698]
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- Authors
- Kashani, A., Phillips, C. O., Foody, J. M., Wang, Y., Mangalmurti, S., Ko, D. T., & Krumholz, H. M.
- Affiliations
- Cleveland Clinic (US)
- Venue
- Circulation
- Published
- 2006-12-19
- Volume
- 114
- Issue
- 25
- Pages
- 2788-2797
- ISSN
- 0009-7322 (ISSN-L)
- 1524-4539
- OpenAlex
- W2051160165
- Cited by
- 474
- References
- 74
- Citations by year
- 2026: 6 · 2025: 6 · 2024: 7 · 2023: 11 · 2022: 16 · 2021: 17 · 2020: 18 · 2019: 24 · 2018: 21 · 2017: 23 · 2016: 42 · 2015: 40 · 2014: 45 · 2013: 35 · 2012: 31
- FWCI
- 24.07
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Circulation (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Heart and Stroke Foundation of Canada
- National Heart, Lung, and Blood Institute (R01HL080228, R01 HL)
- Topics
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer, Lipids, and Metabolism
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Acute Myocardial Infarction Research
- Keywords
- statins, adverse drug reactions, rhabdomyolysis, myalgia, creatine kinase elevation, transaminase elevation, drug discontinuation, hyperlipidemia, statin safety, randomized controlled trials
- MeSH terms
- Adult, Documentation, Dose-Response Relationship, Drug, Humans, Muscular Diseases, Pain, Placebos, United States, United States Food and Drug Administration, Reproducibility of Results, Randomized Controlled Trials as Topic, Risk Assessment, Patient Selection, Hydroxymethylglutaryl-CoA Reductase Inhibitors
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