Study title and authors:
Expanded Clinical Evaluation of Lovastatin (EXCEL) Study Results: 1. Efficacy in Modifying Plasma Lipoproteins and Adverse Event Profile in 8245 Patients With Moderate Hypercholesterolemia
Reagan H. Bradford, MD, PhD; Charles L. Shear, DPH; Athanassios N. Chremos, MD; Carlos Dujovne,
MD; Maria Downton, MS; Frank A. Franklin, MD, PhD; A. Lawrence Gould, PhD; Michael Hesney, MS; Jim Higgins, PhD; Dennis P. Hurley, DSc; Alexandra Langendorfer, MS; David T. Nash, MD; James L. Pool, MD; Harold Schnaper, MDThis study can be accessed at: http://archinte.ama-assn.org/cgi/reprint/151/1/43
The study investigated the relationship between statins and death rates. In the study 8,245 'patients', aged 18 to 70, with cholesterol levels between 232mg/dL (6.0 mmol/l) and 300mg/dL (7.8 mmol/l) received one of four different doses of lovastatin (Mevacor) or a placebo.
The study found after 1 year:
(a) Higher transaminase levels (which may be an indicator of liver damage) were found in the subjects taking statins.
(b) Higher incidence of clinical adverse experiences requiring patients to discontinue the 'treatment' were found in the subjects taking statins.
(i) 16% more patients taking 20 mg/day statins discontinued their treatment compared to patients taking a placebo.
(ii) 50% more patients taking 80 mg/day statins discontinued their treatment compared to patients taking a placebo.
(c) Higher levels of muscle damage were detected in the subjects taking statins.
(d) The four groups taking lovastatin lowered their low density lipoprotein (LDL) cholesterol levels by 24%-40%.
(e) The four groups taking lovastatin lowered their cholesterol levels by 17%-29%.
(f) The death rate of the four groups taking various doses of lovastatin was 150-300% higher than the placebo group.
