Abstract
In summary, lovastatin ER was well tolerated in adults with hypercholesterolemia treated for 12 weeks with 10-, 20-, 40-, or 60-mg/day doses, and produced statistically significant and clinically meaningful dose-related reductions in LDL cholesterol, total cholesterol, and triglycerides, and increases in HDL cholesterol. These changes were generally as great as or greater than changes seen in a previous large-scale trial with corresponding doses of immediate-release lovastatin, including twice-daily administration of the immediate release formulation. Lovastatin ER is safe and effective for the treatment of adults with hypercholesterolemia, and may be associated with a lower risk of myalgia or myositis because of the lower peak plasma concentrations of 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors associated with the extended-release delivery system. 1. Bradford RH, Shear CL, Chremos AN, Dujovne C, Downton M, Franklin FA, Gould AL, Hesney M, Higgins J, Hurley DP, et al. Expanded Clinical Evaluation of Lovastatin (EXCEL) study results. I: Efficacy in modifying plasma lipoproteins and adverse event profile in 8245 patients with moderate hypercholesterolemia. Arch Intern Med 1991;151:43–49. 2. McClelland GA, Stubbs RJ, Fix JA, Pogany SA, Zentner GM. Enhancement of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor efficacy through administration of a controlled-porosity osmotic pump dosage form. Pharm Res 1991;8:873–876. 3. Sun JX, Phillips G, Shen J, Lukacsko P, Friedhoff L. Comparative pharmacokinetics of lovastatin extended-release tablets and lovastatin immediate-release tablets in humans. J Clin Pharmacol 2001;42:1–7. 4. Davidson MH, Lukacslo P, Friedhoff L, Sterman A. A multiple-dose safety, pharmacokinetic, and pharmacodynamic study of an extended-release formulation of lovastatin compared to immediate-release lovastatin. Clin Ther, in press. 5. Expert Panel on Detection Evaluation and Treatment of High Blood Cholesterol in Adults. Summary of the second report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel II). JAMA 1993;269:3015–3023. 6. Knopp RH. Drug treatment of lipid disorders. N Engl J Med 1999;341:498– 511. 7. Gruer PJ, Vega JM, Mercuri MF, Dobrinska MR, Tobert JA. Concomitant use of cytochrome P450 3A4 inhibitors and simvastatin. Am J Cardiol 1999;84:811– 815.
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