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Published on: November 10, 2017
Risks associated with statin therapy: a systematic overview of randomized clinical trials
Amir Kashani1, Christopher O Phillips, JoAnne M Foody
1Section of Cardiovascular Medicine, Department of Medicine, Yale University School of Medicine, New Haven, Conn, USA.
Statins are generally safe, with no significant increase in muscle or liver damage risks compared to placebo. However, statin therapy is linked to a small rise in transaminase elevations.
Area of Science:
- Cardiovascular Medicine
- Pharmacology
- Clinical Trials
Background:
- Statins effectively reduce cardiovascular event risk.
- Concerns regarding adverse effects may limit statin prescription.
- This study systematically reviewed statin trials to assess complication risks.
Purpose of the Study:
- To quantify risks of musculoskeletal, renal, and hepatic complications from statin therapy.
- To evaluate the safety profile of statin monotherapy versus placebo in randomized trials.
Main Methods:
- Systematic overview of randomized statin trials (MEDLINE search, 1966-2005).
- Included adults with hyperlipidemia, double-blind statin vs. placebo, >=100 patients.
- Analyzed data on myalgia, creatine kinase, rhabdomyolysis, transaminase elevations, and adverse event discontinuation.
Main Results:
- 74,102 subjects in 35 trials (follow-up 1-65 months).
- No significant increase in myalgias, creatine kinase elevations, rhabdomyolysis, or therapy discontinuation.
- A significant absolute increase in transaminase elevations (RD, 4.2; 95% CI, 1.5 to 6.9) was observed.
Conclusions:
- Statin therapy shows a small excess risk of transaminase elevations, but not myalgias, creatine kinase elevations, rhabdomyolysis, or withdrawal.
- Further research is needed to confirm these findings in routine practice, especially for high-risk patient groups.
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