Gemfibrozil

* Clinical Question What methods of lipid lowering decrease overall mortality for patients with hyperlipidemia?

Study Design Meta-analysis (randomized controlled trials)

Setting Various (meta-analysis)

Synopsis

Do all lipid-lowering drugs make people live longer, on average? These researchers searched 4 databases to find randomized trials addressing this question. Two authors then independently determined whether each study was suitable for inclusion, only including studies that were randomized and were conducted over at least 3 months. They included studies that enrolled patients without evidence of heart disease--primary prevention as well as secondary prevention studies that enrolled patients with known heart disease. They included studies written in any language, and ended up with 97 studies enrolling more than 275,000 patients.

Only statins and n-3 fatty acids (fish oils or linolenic acid) decreased overall mortality, and the effect of the n-3 fatty acids was only seen with patients with preexisting heart disease. In primary prevention trials, fibrates (fenofibrate, clofibrate, gemfibrozil) increased mortality, with 1 additional death in every 132 patients treated for an average 4.4 years (number needed to treat to harm=132; 95% confidence interval [CI], 69-662).

Many patients have to be treated with a statin to prevent 1 additional death; the number needed to treat for 3.3 years was 228 (95% CI, 123-2958). For patients with known heart disease, 50 patients (95% CI, 38-78) would have to be treated with a statin to prevent 1 additional death, and 44 patients (31-84) would need to be treated with fish oil to prevent 1 additional death, each over an average 4.4 years (excluding one low-quality study). Treatment with diet, resins (colestipol, cholestyramine), or niacin did not affect overall mortality.

* Bottom Line

Only statin lipid-lowering drugs have been shown to decrease overall mortality for patients with high cholesterol but without evidence of heart disease. However, most patients treated with one of these drugs do not benefit: 228 have to be treated for 3.3 years to prevent 1 additional death during this period.

For patients with known heart disease, statins and fish oil both have been shown to decrease mortality. Niacin, resins, and diet have not been shown to decrease mortality. Fibrates (gemfibrozil and others) actually increase overall mortality and at the same time decrease cardiac mortality. (Level of evidence [LOE]=1a)

FAST TRACK

Only statins and n-3 fatty acids decreased overall mortality; many patients have to be treated with statins to prevent one death

Studer M, Briel M, Leimenstoll B, Glass TR, Bucher HC. Effect of different antilipedimic agents and diets on mortality. A systematic review. Arch Intern Med 2005; 165:725-730

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