Background: We conducted a multicenter trial comparing two angiotensin-converting-enzyme inhibitors to determine whether effects on quality of life during antihypertensive therapy are uniform within this pharmacologic class of agents, and to relate the effects of the drugs on quality of life to objective adverse events, such as the loss of a job or the death of a spouse.
Methods: After a four-week washout period when they received placebo, 379 men with mild-to-moderately-severe hypertension were randomly assigned to receive captopril (25 to 50 mg twice daily, with or without hydrochlorothiazide) or enalapril (5 to 20 mg per day, with or without hydrochlorothiazide) for 24 weeks. Blood pressure, quality of life, and life events were monitored. Differences between treatments were evaluated by calibrating measures of quality of life with objective life events.
Results: Throughout the treatment period, no differences were found in blood pressure, frequency of withdrawal of patients from the study, or major side effects. Patients treated with captopril had more favorable changes in overall quality of life, general perceived health, vitality, health status, sleep, and emotional control (P < 0.05 for each). The changes varied according to the quality of life at base line (P < 0.001); patients with a low quality of life at base line remained stable or improved with either drug, whereas those with a higher quality of life remained stable with captopril but worsened with enalapril. The quality-of-life scales correlated with life events and symptom distress (P < 0.001), and calibration analysis indicated that differences between treatments were clinically important.
Conclusions: Two angiotensin-converting-enzyme inhibitors, captopril and enalapril, indistinguishable according to clinical assessments of efficacy and safety, had different effects on quality of life. Calibration with life events showed that drug-induced changes are substantial and that the different effects of these two agents on quality of life can be clinically meaningful.