Dietary psyllium supplementation in patients taking 10 mg of simvastatin is as effective in lowering cholesterol as 20 mg of simvastatin alone. Psyllium soluble fiber should be considered as a safe and well-tolerated dietary supplement option to enhance LDL-C and apolipoprotein B lowering.
It is now well established that individuals with elevated low-density lipoprotein cholesterol (LDL-C) levels are at increased risk for coronary heart disease. Early clinical trials for primary and secondary prevention of coronary artery disease demonstrated that lowering LDL-C levels with 3-hydroxy-3-methylglutaryl coenzyme A reductase enzyme inhibitors (statins) is effective in reducing morbidity and mortality among patients with elevated cholesterol.1,2 Statins are now widely used in combination with dietary intervention in the treatment of hyperlipidemia, and the National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III) has recently issued an update based on the evidence of more recent statin trials that emphasizes the integral importance of therapeutic lifestyle changes.3 The NCEP ATP III guidelines recommend increased viscous (soluble) fiber (10-25 g/d) as a therapeutic option to enhance LDL-C lowering.4
The cholesterol-lowering effect of the soluble fiber in psyllium husk has been evaluated in several studies and was found to lower serum cholesterol levels reproducibly. Two meta-analyses5,6 covering published and unpublished investigations report an overall 7% lowering of LDL-C and an absolute lowering of LDL-C by 1.12 mg/dL (0.03 mmol/L) per gram of psyllium soluble fiber. Long-term treatment with 10.2 g/d of psyllium for 26 weeks resulted in a reduction of serum total cholesterol by 4.7%, LDL-C by 6.7%, and the ratio of LDL-C to high-density lipoprotein cholesterol (HDL-C) by 3.3%.7 Although the exact mechanism of action of psyllium in lowering cholesterol is not fully understood, it has been suggested that the hypocholesterolemic effect may be mainly due to inhibition of bile acid reabsorption.7 In support of this, psyllium combined with half the usual dose of colestipol hydrochloride (a bile acid sequestrant resin) was reported to be as effective as using the full dose of colestipol.8 The method of administration of psyllium soluble fiber can also affect its ability to lower serum cholesterol; the maximum effect is seen when it is mixed with foods.9
To our knowledge, there have been no controlled studies of the use of psyllium in combination with a statin. To evaluate the additional cholesterol-lowering effect of psyllium when added to simvastatin, we designed a study among patients with hyperlipidemia, comparing the effect of a low dose of simvastatin (10 mg) supplemented with psyllium (5 g three times daily with meals) with that of simvastatin (10 or 20 mg) with placebo powder in lowering serum cholesterol levels.
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