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Comparison of one-year efficacy and safety of atorvastatin versus lovastatin in primary hypercholesterolemia. Atorvastatin Study Group I.

Abstract
This double-blind study to evaluate long-term efficacy and safety of atorvastatin was performed in 31 community- and university-based research centers in the USA to directly compare a new 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitor (reductase inhibitor) to an accepted drug of this class in patients with moderate hypercholesterolemia. Participants remained on a cholesterol-lowering diet throughout the study. One thousand forty-nine patients were randomized to receive atorvastatin 10 mg, lovastatin 20 mg, or placebo. At 16 weeks the placebo group was randomized to either atorvastatin or lovastatin treatment. At 22 weeks, patients who had not met low-density lipoprotein (LDL) cholesterol target levels doubled the dose of reductase inhibitor. Efficacy evaluation was mean percent change from baseline in LDL cholesterol, triglycerides, total cholesterol, high-density-lipoprotein cholesterol, and apolipoprotein B (apoB). Safety profiles as determined by change from baseline in laboratory evaluations, ophthalmologic parameters, and reporting of adverse events were similar for the 2 reductase inhibitors. After 52 weeks, the atorvastatin group maintained a significantly greater reduction in LDL cholesterol (-37% vs -29%), triglyceride (-16% vs -8%), total cholesterol (-27% vs -21%), and apoB (-30% vs -22%) (p <0.05). More patients receiving atorvastatin achieved LDL cholesterol target levels than did lovastatin patients (78% vs 63%, respectively), particularly those with coronary heart disease (37% vs 11%, respectively). Atorvastatin is highly effective and well tolerated in patients with primary hypercholesterolemia with no increased risk of adverse events.
AuthorsM Davidson, J McKenney, E Stein, H Schrott, R Bakker-Arkema, R Fayyad, D Black
JournalThe American journal of cardiology (Am J Cardiol) Vol. 79 Issue 11 Pg. 1475-81 (Jun 01 1997) ISSN: 0002-9149 [Print] United States
PMID9185636 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
Chemical References
  • Anticholesteremic Agents
  • Heptanoic Acids
  • Pyrroles
  • Cholesterol
  • Lovastatin
  • Atorvastatin
Topics
  • Analysis of Variance
  • Anticholesteremic Agents (adverse effects, therapeutic use)
  • Atorvastatin
  • Cholesterol (blood)
  • Double-Blind Method
  • Female
  • Heptanoic Acids (adverse effects, therapeutic use)
  • Humans
  • Hypercholesterolemia (blood, drug therapy)
  • Lovastatin (adverse effects, therapeutic use)
  • Male
  • Middle Aged
  • Pyrroles (adverse effects, therapeutic use)
  • Treatment Outcome

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