Tolerability of ramipril in a multicenter study of mild-to-moderate hypertension in general practice

J Cardiovasc Pharmacol. 1991:18 Suppl 2:S141-3.

Abstract

In this study, the tolerability and safety of ramipril, as monotherapy and in combination with a low dose of furosemide, were assessed in patients with mild-to-moderate hypertension in general practice. After a placebo run-in phase, patients received ramipril as monotherapy in a dose of 2.5 to 5 mg daily for 6 weeks. Nonresponders (diastolic blood pressure greater than 90 mm Hg) entered a double-blind treatment period, and received either 10 mg of ramipril daily, or 5 mg of ramipril in combination with 20 mg of furosemide daily. The tolerability of the study medication was assessed by reported adverse events, and by monitoring blood cell count, electrolytes, serum creatinine, fasting blood glucose, and apolipoproteins AI and B. Of a total of 770 patients who entered the placebo run-in phase, 661 patients were enrolled in the first active treatment period. The most commonly reported adverse events were headache, cough, dizziness, asthenia, cramps, diarrhea, and nausea, but not all of these events were related to ramipril treatment. A total of 38 patients discontinued active treatment due to nonserious adverse events, mainly cough, dizziness, or diarrhea. There appeared to be a relationship between the prevalence of cough and ramipril dosage; however, an increased incidence of cough was also observed during outbreaks of influenza in France. There were no significant changes in laboratory variables during the study.

Publication types

  • Clinical Trial
  • Comparative Study
  • Controlled Clinical Trial
  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Angiotensin-Converting Enzyme Inhibitors / adverse effects*
  • Angiotensin-Converting Enzyme Inhibitors / therapeutic use
  • Antihypertensive Agents / adverse effects*
  • Antihypertensive Agents / therapeutic use
  • Blood Cell Count
  • Bridged Bicyclo Compounds / adverse effects*
  • Bridged Bicyclo Compounds / therapeutic use
  • Cough / chemically induced
  • Double-Blind Method
  • Family Practice
  • Female
  • Furosemide / adverse effects
  • Furosemide / therapeutic use
  • Humans
  • Hypertension / blood
  • Hypertension / drug therapy*
  • Hypertension / physiopathology
  • Male
  • Middle Aged
  • Ramipril

Substances

  • Angiotensin-Converting Enzyme Inhibitors
  • Antihypertensive Agents
  • Bridged Bicyclo Compounds
  • Furosemide
  • Ramipril