Rationale and statistical methodology for the VISA studies

Drugs. 1989:38 Suppl 2:50-4. doi: 10.2165/00003495-198900382-00013.

Abstract

After examination of the epanolol ('Visacor') clinical package it became clear that, although efficacy and safety of epanolol were equivalent to efficacy and safety with other antianginal therapies, tolerability was improved. It was decided to initiate 2 studies with 500 patients in each to quantify the improved tolerability and examine patient preference for antianginal treatments. One study was a comparison of epanolol 200mg daily with metoprolol 100mg twice a day and the other compared epanolol 200mg daily with nifedipine retard 20mg twice a day. The rationale, design and statistical methodology are presented, together with a summary of the geographical spread of the study.

Publication types

  • Clinical Trial
  • Controlled Clinical Trial
  • Multicenter Study

MeSH terms

  • Adrenergic beta-Antagonists / adverse effects
  • Adrenergic beta-Antagonists / therapeutic use*
  • Angina Pectoris / drug therapy*
  • Angina Pectoris / physiopathology
  • Benzeneacetamides*
  • Europe
  • Humans
  • Multicenter Studies as Topic
  • Propanolamines / adverse effects
  • Propanolamines / therapeutic use*
  • Research Design

Substances

  • Adrenergic beta-Antagonists
  • Benzeneacetamides
  • Propanolamines
  • epanolol