[An evaluation of the efficacy and safety of pravastatin in patients with primary hypercholesterolemia. A Brazilian open multicenter study].
OBJECTIVE
To evaluate the efficacy and safety of pravastatin in patients with primary hypercholesterolemia


METHODS
In an open-label multicenter uncontrolled study under the usual conditions of clinical practice 1,850 patients with primary hypercholesterolemia were submitted, after one month of placebo control and low fat/low cholesterol diet, to 12 weeks of treatment with pravastatin 10mg o.d.


RESULTS
Significant reductions higher than 25% were obtained in plasma levels of total cholesterol and low density lipoprotein (LDL) cholesterol associated with an increase > 10% in the HDL cholesterol plasma concentration in 51% of the patients. The individual results were classified as satisfactory (higher than 20% decrease) in 70% of the studied population. The compliance of pravastatin was excellent, since 118 patients (6.4%) developed adverse reactions, but interruption of the treatment was necessary in only 18 (0.9%); 9 patients due to muscular pain, 3 by gastrointestinal symptoms, 2 by cutaneous reactions and 4 due to general complaints. The clinical conditions of diabetes, obesity, hypertension did not modify the efficacy of the drug. Previous unsatisfactory hypolipidemic treatment did not alter the results of the efficacy.


CONCLUSIONS
The satisfactory results in efficacy and safety and the facility of the pravastatin use, make this drug as a first line agent in the hypolipidemic treatment.
Giannini
S D
SD
Instituto do Coração, Hosp. Clínicas, INCOR, São Paulo.
D000328:Adult; D000704:Analysis of Variance; D001938:Brazil; D016009:Chi-Square Distribution; D005260:Female; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood / Q000188:drug therapy*; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D017035:Pravastatin / Q000009:adverse effects / Q000627:therapeutic use*
D008055:Lipids; D017035:Pravastatin
Avaliação da eficácia e segurança da pravastatina em portadores de hipercolesterolemia primária. Estudo aberto multicêntrico brasileiro.