Circulation, Vol 85, 1293-1303, Copyright © 1992 by American Heart Association
CL Shear, FA Franklin, S Stinnett, DP Hurley, RH Bradford, AN Chremos, DT Nash and A Langendorfer
BACKGROUND. Lovastatin produces consistent dose-related reductions in
plasma levels of low density lipoprotein (LDL) cholesterol along with
variable decreases in triglycerides and increases in high density
lipoprotein (HDL) cholesterol. Patient characteristics from the Expanded
Clinical Evaluation of Lovastatin (EXCEL) study were examined to determine
their association with the magnitude of lovastatin-induced changes in these
lipids and lipoproteins. METHODS AND RESULTS. After a baseline period
consisting of dietary therapy, 8,245 patients with moderate
hypercholesterolemia were randomized to five groups that received 48 weeks
of treatment with either placebo or daily doses of lovastatin ranging from
20 to 80 mg. By use of linear statistical models, 20 different patient
characteristics were examined for modification of the dose-dependent
responses observed. For LDL cholesterol, the following were associated with
enhanced lowering (p less than 0.05; percent changes are placebo-corrected,
adjusted mean changes from baseline for the 80-mg/day lovastatin group):
full drug compliance (-41.9%) versus 80% compliance (-20.3%); an age of 65
(- 43.4%) versus 45 years (-38.1%) for women; white race (-40.9%) versus
black race (-38.0%); and 4.5-kg weight gain (-42.6%) versus 4.5-kg weight
loss (-37.9%). Similar relations for enhanced triglyceride lowering were
found with older age and weight gain. Patients with initially low HDL
cholesterol (less than 0.91 mmol/l) and high triglycerides (greater than
2.26 mmol/l) had enhanced responses for these parameters: placebo-corrected
percent changes at 80 mg/day were - 27.4% for triglycerides and +12.3% for
HDL cholesterol. CONCLUSIONS. Overall, patient characteristics had very
little impact of clinical importance on the dose-dependent LDL cholesterol
lowering found with lovastatin. In patients with initially high levels of
triglycerides and low levels of HDL cholesterol, the elevation of HDL
cholesterol produced by lovastatin appears to be enhanced.
ARTICLES
Expanded Clinical Evaluation of Lovastatin (EXCEL) study results. Effect of patient characteristics on lovastatin-induced changes in plasma concentrations of lipids and lipoproteins
Merck Sharp and Dohme Research Laboratories, West Point, PA 19422.
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