Pravachol Clinical Pharmacology

Drug Library
Pravachol - Clinical Pharmacology [Pravastatin]

After two weeks of once-daily 20 mg oral pravastatin administration, the geometric means of AUC were 80.7 (CV 44%) and 44.8 (CV 89%) ng* hr/ mL for children (8-11 years, n= 14) and adolescents (12-16 years, n= 10), respectively. The corresponding values for C max were 42.4 (CV 54%) and 18.6 ng/ mL (CV 100%) for children and adolescents, respectively. No conclusion can be made based on these findings due to the small number of samples and large variability.

Clinical Studies Prevention of Coronary Heart Disease

In the Pravastatin Primary Prevention Study (West of Scotland Coronary Prevention Study Ð WOS), 1 the effect of PRAVACHOL on fatal and nonfatal coronary heart disease (CHD) was assessed in 6595 men 45-64 years of age, without a previous myocardial infarction (MI), and with LDL-C levels between 156-254 mg/ dL (4-6.7 mmol/ L). In this randomized, double-blind, placebo-controlled study, patients were treated with standard care, including dietary advice, and either PRAVACHOL 40 mg daily (N= 3302) or placebo (N= 3293) and followed for a median duration of 4.8 years.

Median (25 th , 75 th percentile) percent changes from baseline after 6 months of pravastatin treatment in Total C, LDL-C, TG, and HDL were -20.3 (-26.9, -11.7), -27.7 (-36.0, -16.9), -9.1 (-27.6, 12.5), and 6.7 (-2.1, 15.6), respectively. PRAVACHOL significantly reduced the rate of first coronary events (either coronary heart disease [CHD] death or nonfatal MI) by 31% [248 events in the placebo group (CHD death= 44, nonfatal MI= 204) vs 174 events in the PRAVACHOL group (CHD death= 31, nonfatal MI= 143), p= 0.0001 (see figure below)].

The risk reduction with PRAVACHOL was similar and significant throughout the entire range of baseline LDL cholesterol levels. This reduction was also similar and significant across the age range studied with a 40% risk reduction for patients younger than 55 years and a 27% risk reduction for patients 55 years and older. The Pravastatin Primary Prevention Study included only men and therefore it is not clear to what extent these data can be extrapolated to a similar population of female patients.