Expanded Clinical Evaluation of Lovastatin (EXCEL) study results: two-year efficacy and safety follow-up - PubMed

Clinical Trial

Expanded Clinical Evaluation of Lovastatin (EXCEL) study results: two-year efficacy and safety follow-up

R H Bradford et al. Am J Cardiol. 1994.

Abstract

The Expanded Clinical Evaluation of Lovastatin study, a randomized, double-blind, placebo- and diet-controlled multicenter trial, evaluated the efficacy and tolerability of lovastatin over 48 weeks in 8,245 patients with moderately severe hypercholesterolemia. During year 1 of follow-up of the full cohort, lovastatin at 20 or 40 mg/day, or 20 or 40 mg twice daily, produced dose-dependent decreases in low-density lipoprotein (LDL) cholesterol (24% to 40%) and triglyceride levels (10% to 19%), and increases in high-density lipoprotein (HDL) cholesterol (6.6% to 9.5%). In all, 977 patients continued their original blinded treatment for an additional year. In year 2, the LDL cholesterol response to lovastatin was maintained, the triglyceride reductions were somewhat less, and the increases in HDL cholesterol were moderately greater than in year 1. Successive transaminase elevations > 3 times the upper limit of normal were observed in only 1 patient in year 2, yielding a cumulative 2-year incidence of from 0.1% (placebo or lovastatin 20 mg/day) to 1.9% (lovastatin 80 mg/day). Myopathy occurred in only 1 patient during year 2, and over the 2-year study was observed rarely and only at lovastatin dosages of 40 and 80 mg/day. This study indicates that lovastatin maintains its efficacy over long-term follow-up, particularly in effectively lowering LDL cholesterol, is generally well tolerated, and has a favorable safety profile.

Similar articles

• Expanded Clinical Evaluation of Lovastatin (EXCEL) study results. I. Efficacy in modifying plasma lipoproteins and adverse event profile in 8245 patients with moderate hypercholesterolemia.

  Bradford RH, Shear CL, Chremos AN, Dujovne C, Downton M, Franklin FA, Gould AL, Hesney M, Higgins J, Hurley DP, et al. Bradford RH, et al. Arch Intern Med. 1991 Jan;151(1):43-9. doi: 10.1001/archinte.151.1.43. Arch Intern Med. 1991. PMID: 1985608 Clinical Trial.

• Efficacy and tolerability of lovastatin in 3390 women with moderate hypercholesterolemia.

  Bradford RH, Downton M, Chremos AN, Langendörfer A, Stinnett S, Nash DT, Mantell G, Shear CL. Bradford RH, et al. Ann Intern Med. 1993 Jun 1;118(11):850-5. doi: 10.7326/0003-4819-118-11-199306010-00004. Ann Intern Med. 1993. PMID: 8480959 Clinical Trial.

• Expanded clinical evaluation of lovastatin (EXCEL) study results: IV. Additional perspectives on the tolerability of lovastatin.

  Dujovne CA, Chremos AN, Pool JL, Schnaper H, Bradford RH, Shear CL, Higgins J, Downton M, Franklin FA, Nash DT, et al. Dujovne CA, et al. Am J Med. 1991 Jul 31;91(1B):25S-30S. doi: 10.1016/0002-9343(91)90053-z. Am J Med. 1991. PMID: 1831006 Clinical Trial.

• Efficacy and long-term adverse effect pattern of lovastatin.

  Tobert JA. Tobert JA. Am J Cardiol. 1988 Nov 11;62(15):28J-34J. doi: 10.1016/0002-9149(88)90004-5. Am J Cardiol. 1988. PMID: 3055921 Review.

• Fluvastatin in combination with other lipid-lowering agents.

  Jokubaitis LA. Jokubaitis LA. Br J Clin Pract Suppl. 1996 Jan;77A:28-32. Br J Clin Pract Suppl. 1996. PMID: 8729588 Review.

Cited by

• The relationship between cholesterol and stroke: implications for antihyperlipidaemic therapy in older patients.

  Sarti C, Kaarisalo M, Tuomilehto J. Sarti C, et al. Drugs Aging. 2000 Jul;17(1):33-51. doi: 10.2165/00002512-200017010-00003. Drugs Aging. 2000. PMID: 10933514 Review.

• Neuropsychiatric adverse events associated with statins: epidemiology, pathophysiology, prevention and management.

  Tuccori M, Montagnani S, Mantarro S, Capogrosso-Sansone A, Ruggiero E, Saporiti A, Antonioli L, Fornai M, Blandizzi C. Tuccori M, et al. CNS Drugs. 2014 Mar;28(3):249-72. doi: 10.1007/s40263-013-0135-1. CNS Drugs. 2014. PMID: 24435290 Review.

• Effects of HMG-CoA reductase inhibitors on skeletal muscle: are all statins the same?

  Evans M, Rees A. Evans M, et al. Drug Saf. 2002;25(9):649-63. doi: 10.2165/00002018-200225090-00004. Drug Saf. 2002. PMID: 12137559 Review.

• Increases in creatine kinase with atorvastatin treatment are not associated with decreases in muscular performance.

  Ballard KD, Parker BA, Capizzi JA, Grimaldi AS, Clarkson PM, Cole SM, Keadle J, Chipkin S, Pescatello LS, Simpson K, White CM, Thompson PD. Ballard KD, et al. Atherosclerosis. 2013 Sep;230(1):121-4. doi: 10.1016/j.atherosclerosis.2013.07.001. Epub 2013 Jul 13. Atherosclerosis. 2013. PMID: 23958263 Free PMC article. Clinical Trial.

• Cholestin inhibits cholesterol synthesis and secretion in hepatic cells (HepG2).

  Man RY, Lynn EG, Cheung F, Tsang PS, O K. Man RY, et al. Mol Cell Biochem. 2002 Apr;233(1-2):153-8. doi: 10.1023/a:1017487815091. Mol Cell Biochem. 2002. PMID: 12083370

Publication types

MeSH terms

Substances

LinkOut - more resources

• Full Text Sources

  • Elsevier Science

• Medical

  • MedlinePlus Health Information