title: Diet and pravastatin in moderate hypercholesterolaemia: a randomized trial in 215 middle-aged men free from cardiovascular disease.
abstract: OBJECTIVE
  To evaluate the effect of diet and drug intervention separately and combined in the treatment of primary hypercholesterolemia.
  
  
  METHODS
  The study was conducted as a randomized, placebo-controlled factorial trial, double-blinded for drug intervention.
  
  
  METHODS
  Subjects were recruited from a population-based cholesterol screening programme.
  
  
  METHODS
  215 middle-aged men with primary hypercholesterolemia, free from cardiovascular disease.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
authors.affiliation: Julius Center for Patient Orientated Research, Utrecht University Medical School, The Netherlands. a.a.a.bak@jc.azu.nl
authors.forename: A A
authors.initials: AA
authors.lastname: Bak
authors.forename: J
authors.initials: J
authors.lastname: Huizer
authors.forename: P A
authors.initials: PA
authors.lastname: Leijten
authors.forename: H
authors.initials: H
authors.lastname: Rila
authors.forename: D E
authors.initials: DE
authors.lastname: Grobbee
mesh_terms: D000924:Anticholesteremic Agents / Q000627:therapeutic use*; D001794:Blood Pressure; D001835:Body Weight; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D006937:Hypercholesterolemia / Q000097:blood / Q000178:diet therapy* / Q000188:drug therapy* / Q000503:physiopathology; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D017035:Pravastatin / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000924:Anticholesteremic Agents; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D008055:Lipids; D017035:Pravastatin