Efficacy and safety of pravastatin in patients with primary hypercholesterolemia. II. Once-daily versus twice-daily dosing

Donald B. Hunninghake, Margot J. Mellies, Anne C. Goldberg, Peter T. Kuo, John B. Kostis, Helmut G. Schrott, William Insull, Henry Y. Pan

Research output: Contribution to journalArticlepeer-review

53 Scopus citations

Abstract

This 8-week multicenter, placebo-controlled trial compared. the efficacy and safety of the HMG-CoA reductase inhibitor, pravastatin, when administered either as single doses of 40 mg in the morning (AM) or evening (PM) or 20 mg twice daily (bid) in 196 diet-stabilized outpatients with primary type II hypercholesterolemia. Mean reductions in total and low-density lipoprotein (LDL) cholesterol concentrations were observed in all pravastatin groups after 1 week and were sustained throughout the study (P <= 0.001 versus baseline and placebo). At week 8, mean reductions from baseline in the pravastatin treatment groups were 23-27% for total cholesterol and 30-34% for LDL cholesterol. LDL cholesterol was reduced ≧ 15% by pravastatin in all patients in the group treated with 40 mg PM and in 88 and 96% in those receiving 20 mg bid and 40 mg AM, respectively. High density lipoprotein cholesterol was elevated (up to 8%) and triglycerides were reduced (up to 25%) by all pravastatin regimens (P <= 0.05). Pravastatin was well tolerated and was associated with a low incidence of adverse events. No patient withdrew from the study due to a pravastatin-related adverse event. Once-daily pravastatin is a safe and effective treatment for patients with primary hypercholesterolemia and has a favorable safety profile.

Original languageEnglish (US)
Pages (from-to)219-227
Number of pages9
JournalAtherosclerosis
Volume85
Issue number2-3
DOIs
StatePublished - Dec 1990

Keywords

  • Clinical trial
  • Efficacy
  • HMG-CoA reductase inhibitor
  • Pravastatin
  • Primary hypercholesterolemia
  • Treatment regimen

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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