Safety and efficacy of statin treatment alone and in combination with fibrates in patients with dyslipidemia: a meta-analysis

Abstract

Background:

Dyslipidemia is a major risk factor for cardiovascular disease and is treated with many effective lipid-lowering agents. Statins are often used alone or in combination with fibrates. Combination therapy is more effective due to their comparative actions, but the increased incidence of side effects should be considered carefully.

Research design and methods:

A meta-analysis of published data was conducted to compare the safety and efficacy of statins alone versus statins plus fibrates in patients with dyslipidemia. In total, nine articles were assessed for efficacy analysis and ten articles were assessed for safety analysis.

Results:

In the efficacy analysis, a combination of statins and fibrates provided significantly greater reductions in total cholesterol (SE = 0.430; 95% CI 0.315–0.545), LDL cholesterol (SE = 0.438; 95% CI 0.321–0.555) and triglycerides (SE = 0.747; 95% CI 0.618–0.876), and a significantly greater increase in HDL cholesterol (SE = 0.594; 95% CI 0.473–0.715) than treatment with statins alone. In the safety analysis, treatment with statins alone was associated with a significant reduction in the numbers of total adverse events (RR = 0.665; 95% CI 0.539–0.819), liver-related adverse events (RR = 0.396; 95% CI 0.206–0.760) and kidney-related adverse events (RR = 0.146; 95% CI 0.075–0.285).

Conclusion:

We suggest that treatment with statins plus fibrates provides clinical benefits over treatment with statins alone but increased risks, especially of hepatic or renal side effects, should be monitored carefully.

Keywords::

• Adverse events
• Dyslipidemia
• Fibrates
• Lipid profiles
• Statins

Transparency

Declaration of funding

This study was supported by the Research Institute of Pharmaceutical Sciences, College of Pharmacy, Seoul National University, Seoul, Korea.

Declaration of financial/other relationships

H.D.C. and W.G.S. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.