Double-masked comparison of the quality of life of hypercholesterolemic men treated with simvastatin or pravastatin. International Quality of Life Multicenter Group.
The efficacy, safety, and impact on quality of life of once-daily treatment with simvastatin 20 mg and pravastatin 40 mg were compared in a multinational, randomized, double-masked trial involving 387 men 21 to 72 years of age with primary mild-to-moderate hypercholesterolemia. The trial consisted of a 12-week baseline period, which included 6 weeks of single-masked placebo administration, and a 12-week double-masked active treatment period. Throughout the trial, patients were maintained on a standard lipid-lowering diet. Efficacy variables were plasma lipid levels and a measurement of health-related quality of life evaluated by means of a self-administered questionnaire (the Nottingham Health Profile [NHP]) and other questionnaires related to general health, sexual function, and stress/life events. Clinic visits were scheduled at study entry (week -12), at initiation and week 5 of placebo (weeks -6 and -1, respectively); at randomization (week 1, day 1); and after 4, 8, and 12 weeks of active treatment. At each visit, blood samples were collected for determination of lipid levels and the NHP, the principal measure of health-related quality of life, was administered. Primary safety measures were adverse events and laboratory test results. All statistical comparisons were two-sided, and significance was defined as P< or =0.05 except for the NHP questionnaire, which was P< or =0.01. Treatment with simvastatin 20 mg/d for 12 weeks (n = 194) resulted in significantly greater reductions in plasma total cholesterol and low-density lipoprotein cholesterol levels (25.7% and 33.6%, respectively) compared with pravastatin 40 mg/d for 12 weeks (n = 193) (19.0% and 26.3%, respectively) (P<0.001). No detrimental effects on health-related quality-of-life measurements were reported with either drug. A small but statistically significant improvement in emotional reaction from baseline (P<0.001) was observed after 12 weeks of treatment with simvastatin. At least 75% of simvastatin-treated patients indicated no change in response from baseline on NHP domain scores; these findings were similar to those for pravastatin-treated patients. The differences in the changes in lipid profiles between the 2 treatment groups were not associated with any observed differences in tolerability or health-related quality-of-life measures.
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Imperial College School of Medicine, Charing Cross Hospital, London, United Kingdom.
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D000328:Adult; D000368:Aged; D000924:Anticholesteremic Agents / Q000627:therapeutic use*; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D004311:Double-Blind Method; D006801:Humans; D006937:Hypercholesterolemia / Q000188:drug therapy* / Q000523:psychology; D008297:Male; D008875:Middle Aged; D017035:Pravastatin / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D012725:Sexual Behavior / Q000187:drug effects; D019821:Simvastatin / Q000009:adverse effects / Q000627:therapeutic use*
D000924:Anticholesteremic Agents; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D019821:Simvastatin; D017035:Pravastatin