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Diet and pravastatin in moderate hypercholesterolaemia: a randomized trial in 215 middle‐aged men free from cardiovascular disease
Author(s) -
Annette Bak,
J. Huizer,
P.A. Leijten,
H. Rila,
D. E. Grobbee
Publication year - 1998
Publication title -
journal of internal medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.625
H-Index - 160
eISSN - 1365-2796
pISSN - 0954-6820
DOI - 10.1046/j.1365-2796.1998.00350.x
Subject(s) - pravastatin , medicine , placebo , cholesterol , randomized controlled trial , national cholesterol education program , population , blood lipids , endocrinology , gastroenterology , obesity , metabolic syndrome , alternative medicine , environmental health , pathology
. Bak AAA, Huizer J, Leijten PA, Rila H, Grobbee DE (Utrecht University Medical School, Utrecht; Andro Medical Research, Rotterdam; and Bristol‐Myers Squibb, Woerden, The Netherlands). Diet and pravastatin in moderate hypercholesterolaemia: a randomized trial in 215 middle‐aged men free from cardiovascular disease. J Intern Med 1998; 244 : 371–8. Objective To evaluate the effect of diet and drug intervention separately and combined in the treatment of primary hypercholesterolemia. Design The study was conducted as a randomized, placebo‐controlled factorial trial, double‐blinded for drug intervention. Setting Subjects were 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 Cholesterol 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 day −1 and step 2 diet. The intervention period was 6 months. Main outcome measurements Efficacy measurements included: serum total cholesterol, HDL cholesterol, triglycerides, apolipoproteins A1 and B. LDL cholesterol 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 the 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 pravastatin and the step 1 diet, there was a mean reduction in serum total cholesterol 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 show a reduction of 20.7% (1.55 mmol L −1 (95% CI: 1.30, 1.80)). Conclusions If drug therapy with a HMG‐CoA reductase inhibitor is considered necessary, a step 2 diet has no additional lipid‐lowering effect compared with a step 1 diet in men with primary hypercholesterolaemia. However, 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.