COMBINATION THERAPY WITH COLESTIPOL AND PSYLLIUM MUCILLOID IN PATIENTS WITH HYPERLIPIDEMIA

Objective: To test whether combining psyllium mucilloid with half the usual dose of colestipol reduces the adverse effects associated with c olestipol and maintains or increases its efficacy in the treatment of hyperlipidemia. This strategy might make bile acid sequestrants, which are seldom used because they cause adverse effects such as bloating a nd constipation, more tolerable and less expensive. Design: A randomiz ed, parallel-group, double-blind, controlled trial. Setting: An outpat ient clinic in a tertiary care hospital. Patients: 121 patients who ha d moderate primary hypercholesterolemia (total cholesterol level >6 mm ol/L and <8 mmol/L; triglyceride level <3 mmol/L) after following a lo w-fat diet for 1 year (National Cholesterol Education Program Step Two diet). Intervention: 5 g of cellulose placebo; 5 g of colestipol; 2.5 g of colestipol plus 2.5 g of psyllium; or 5 g of psyllium three time s daily before meals for 10 weeks. Main Outcome Measures: At baseline and at weeks 4 and 10, fasting blood lipid levels and apoprotein conce ntrations were measured and a quality-of-life instrument was completed . Results: A combination of 2.5 g of psyllium and 2.5 g of colestipol was better tolerated than and as effective as either 5 g of colestipol alone or 5 g of psyllium alone. The combination therapy and colestipo l alone did not differ significantly with respect to changes in indivi dual lipid values. The ratio of total cholesterol to high-density lipo protein cholesterol (HDL) was reduced by 18.2% (95% CI, 12.3% to 24%) with the combination therapy; by 10.6% (CI, 2.0% to 15.4%) with colest ipol alone; by 6.1% (CI, 1.5% to 10.6%) with psyllium alone; and by 0. 1% (CI, -4.8% to 7%) with placebo (P = 0.0002). Combination therapy re duced the ratio of total cholesterol to HDL significantly more than di d colestipol alone or psyllium alone (P < 0.05). Conclusions: These fi ndings suggest that adding psyllium to half the usual dose of bile aci d sequestrant resins maintains the efficacy and improves the tolerabil ity of these resins.