Fibrates: What Have We Learned in the Past 40 Years?

James M. Backes, Pharm.D.; Cheryl A. Gibson, Ph.D.; Janelle F. Ruisinger, Pharm.D.; Patrick M. Moriarty, M.D.

Disclosures

Pharmacotherapy. 2007;27(3):412-424. 

In This Article

Adverse Effects

Overall, fibrates are generally well tolerated. The most common adverse effects are gastrointestinal complaints (e.g., nausea, abdominal pain),[20] which affect approximately 5% of patients and appear to be less common with fenofibrate than gemfibrozil.[48] Fibrates can also cause myopathy, occurring at a rate likely similar to that of statin therapy.[32] The risk for myopathy appears to be elevated in patients with renal dysfunction, and fibrates generally should be avoided in populations with severe renal impairment.[27] This may be especially true with fenofibrate, as this agent has been reported to increase serum creatinine concentrations to a greater extent than does gemfibrozil.[23,24] In one study, an increase in the range of mean serum creatinine level (8-18%) with fenofibrate was reported among patients with normal or impaired renal function.[24] Similar increases in serum creatinine level were reported for bezafibrate and ciprofibrate. It is suggested that this adverse effect is caused by fibrate inhibition of vasodilatory prostaglandins.[24]

Other notable adverse effects include cholelithiasis secondary to an increase in biliary cholesterol concentration, elevated transaminase concentrations, and an increase in the need for gallbladder surgery and/or appendectomy.[20,29,49] Less common adverse effects reported by fewer than 5% of patients in clinical trials, not statis-tically significantly different from placebo, included rash, nausea and/or vomiting, eczema, headache, fatigue, vertigo, taste perversion, and hair loss.[28,29]

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