Efficacy of pravastatin as a hypolipidemic agent in patients with polygenic hypercholesterolemia
Aldrete-Velasco, J.; Casanova, J.M.; Mejía, P.; Martínez, P.
Archives of Medical Research 23(3): 117-122
1992
ISSN/ISBN: 0188-4409 PMID: 1308800 Document Number: 4071
In Mexico, hypercholesterolemia has become a major public health problem particularly in the states of the north of the country and in Mexico City, where a prevalence of 20% has been reported. Schemes of treatment have now been reinforced by the appearance of new cholesterol reducing drugs. The objective of the study was to demonstrate efficacy and safety of a 10 mg daily dose of oral Pravastatin (a new 3-hydroxy-3-methyl glutaryl CoA inhibitor) in a group of patients positive for hyperlipidemia, after 6 months of treatment. Twenty-five patients were included (14 men, 11 women) with an average age of 54 and 50 years, respectively. The main outcome measure was total cholesterol (T-CHOL), low density lipoprotein-cholesterol (LDL-C), triglycerides (TGL), high density lipoprotein cholesterol (HDL-C) and adverse drug reactions report. Twenty-one out of 25 patients completed the study. T-CHOL diminished 21%, LDL-C was reduced by 28%, TGL decreased 6% and HDL-C increased 32%. No adverse reactions were observed throughout the study. Our study shows that the use of a low dose of Pravastatin satisfactorily reduced T-CHOL and LDL-C levels while significantly increasing HDL-C after 27 weeks of treatment, without untoward effects. In the present study low doses of Pravastatin accomplished changes in plasma cholesterol levels agreeably with those reported by others (16,17). In this specific group of patients, LDL-cholesterol was more sensitive to treatment than total cholesterol; HDL was affected by raising its level 32% at week 27, but minor changes were observed at early determinations. Triglycerides was the variable showing the least differences and we considered that it was strongly influenced by patient 14, who had an outlayer behavior as can be seen in Table 1; excluding this patient it would have brought a total 14% reduction in triglycerides instead of the 6% reported in this study. Others have reported up to 25 and 39% reduction of triglycerides with the use of Pravastatin (16,18). Adverse reactions such as liver enzymes elevation, myalgias or lens opacities, as described with the use of other HMG CoA inhibitors, were not reported during this trial (13). Perhaps it has been influenced by the sample size, dose size and length of observation. Four patients were excluded from the study and not taken into account for the efficacy assessment, but safety evaluation was based on their report also. When data are analyzed by occupation, housewives showed the smallest reduction of cholesterol levels. Regarding those educational levels at the extreme, both illiterates and college graduates showed the lowest changes in T-ChO, suggesting that less attention was paid by these patients to dietary recommendations. Whether these observations are true remains to be cleared by further research specifically designed for this purpose. We conclude that Pravastatin was shown to be effective for treating patients with polygenic hypercholesterolemia in the 10 mg daily dose and was safe up to 6 months of follow-up.
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