[Randomized, double-blind comparative study between pravastatin and lovastatin. Evaluation of efficacy and safety]. / Estudo comparativo duplo-cego, randomizado entre pravastatina e lovastatina. Análise da eficácia e segurança.

ABSTRACT

PURPOSE: To verify eventual difference observed in the efficacy and safety of lovastatin (L) when compared to pravastatin (P), considering increasing doses up to the maximum and recommended ones in clinical practice. METHODS: Forty-eight hypercholesterolemic patients (LDL-C > 160 mg/dl after a placebo seven-day period) were studied and randomly assigned to constitute groups of 24 patients (GL and GP groups). The patients from GL group received L 20 mg/day and those from GP group P 10 mg/day, in a double-blind fashion. Six and 12 weeks later, the those were doubled. At the end of the placebo period and at weeks 6, 12 and 18 they were evaluated for clinical data and laboratorial parameters, such as lipid profile (TC, TG, HDL-C and LDL-C); enzymes AST, ALT, CPK, gamma-GT, alkalin phosphatase); biochemical data (urea, creatinine, bilirubin, uric acid, glucose); complete blood count and urinalysis. RESULTS: Both drugs have shown significant reductions in TC and LDL-C levels at the lowest clinical doses (L 20 mg/day; P 10 mg/day), which became more marked as doses were gradually increased. However, the responses were always significantly greater for L in all doses employed. No adverse effects requiring treatment discontinuation were observed for both drugs. CONCLUSION: L showed a higher TC and LDL-C lowering effect than that observed with P, when the doses recommended by the respective manufacturers were compared.