DIET AND PRAVASTATIN IN MODERATE HYPERCHOLESTEROLEMIA - A RANDOMIZED TRIAL IN 215 MIDDLE-AGED MEN FREE FROM CARDIOVASCULAR-DISEASE

Objective. To evaluate the effect of diet and drug intervention separa tely and combined in the treatment of primary hypercholesterolemia. De sign. The study was conducted as a randomized, placebo-controlled fact orial trial, double-blinded for drug intervention. Setting. Subjects w ere recruited from a population-based cholesterol screening programme. Subjects. 215 middle-aged men with primary hypercholesterolemia, free from cardiovascular disease. Interventions. Subjects were randomized to one of four intervention groups: (1) placebo and US National Choles terol Education Program step 1 diet; (2) placebo and step 2 diet; (3) pravastatin 20 mg day(-1) and step 1 diet; or (4) pravastatin 20 mg da y(-1) and step 2 diet. The intervention period was 6 months. Main outc ome measurements. Efficacy measurements included: serum total choleste rol, HDL cholesterol, triglycerides, apolipoproteins Al and B. LDL cho lesterol was calculated. For safety, values of ALAT, ASAT and CK were measured. Results. In the group receiving the step 1 diet only, lipid values were stable during the study period. In the placebo group on th e step 2 diet, total cholesterol decreased by 6.3% (0.47 mmol L-1 (95% CI: 0.28, 0.67)) during 6 months. In the group receiving both pravast atin and the step 1 diet, there was a mean reduction in serum total ch olesterol of 19.4% (1.46 mmol L-1 (95% CI: 1,20, 1.72)). In the group treated with pravastatin and the step 2 diet, the 6 months of data sho w a reduction of 20.7% (1.55 mmol L-1 (95% CI: 1.30, 1.80)). Conclusio ns. If drug therapy with a HMG-CoA reductase inhibitor is considered n ecessary, a Step 2 diet has no additional lipid-lowering effect compar ed with a step 1 diet in men with primary hypercholesterolaemia. Howev er, favourable 'side-effects' of a lipid-lowering diet, such as weight loss and lowering of blood pressure, may still warrant a low-fat diet in these cases.