Assessment of quality of life in a double-blind, randomized clinical trial of imidapril and captopril for hypertensive Chinese in Taiwan

Cardiovasc Drugs Ther. 2002 May;16(3):221-6. doi: 10.1023/a:1020648405680.

Abstract

Purpose: Although the role of angiotensin-converting enzyme (ACE) inhibitors for the treatment of hypertension has been well established, no data has been generated regarding the influence of ACE inhibitors for health-related quality-of-life (QOL) dimensions for Chinese patients.

Materials: A double-blind, active-control, randomized clinical trial was used to compare the effects of two ACE inhibitors, imidapril and captopril, on quality-of-life dimensions in one outpatient clinic in one tertiary clinical-care facility. After a 2-3 week washout period with placebo, 59 patients with mild-to-moderate hypertension were randomly assigned to receive imidapril (5 to 10 mg per day) or captopril (25 to 50 mg twice per day) for 12 weeks. Patients completed the Short-form 36 (SF 36) health survey questionnaire, which evaluates 8 QOL dimensions, just before treatment, during the 8th week, and at the end of treatment (12th week). ANOVA for repeated measures was used to analyze the QOL-score changes over time and compare treatments, and to assess the interaction of treatment duration and group on these scores.

Results: No significant differences were demonstrated for changes in blood-pressure, frequency of adverse effects and withdrawal of patients from the study comparing the two drugs. Significant improvement, however, was demonstrated for mental-component summary scores after 12 weeks of treatment for both drugs (P = 0.029). No significant differences were established for individual QOL dimensions comparing the two drugs. A significantly higher baseline systolic blood pressure was found in the participants who did not complete the questionnaire than in those who did.

Conclusions: Similar and significant improvements were determined for the mental-component QOL summary scores for the two ACE inhibitors, imidapril and captopril, and no significant differences were demonstrated comparing treatments.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Angiotensin-Converting Enzyme Inhibitors / adverse effects
  • Angiotensin-Converting Enzyme Inhibitors / therapeutic use*
  • Asian People
  • Blood Pressure / drug effects
  • Captopril / adverse effects
  • Captopril / therapeutic use*
  • Double-Blind Method
  • Female
  • Humans
  • Hypertension / drug therapy*
  • Hypertension / ethnology
  • Hypertension / psychology
  • Imidazoles / adverse effects
  • Imidazoles / therapeutic use*
  • Imidazolidines*
  • Male
  • Middle Aged
  • Quality of Life*
  • Surveys and Questionnaires
  • Taiwan
  • Treatment Outcome

Substances

  • Angiotensin-Converting Enzyme Inhibitors
  • Imidazoles
  • Imidazolidines
  • Captopril
  • imidapril