Background We conducted a multicenter trial comparing two angiotensin-converting-enzymeinhibitors to determine whether effects on quality of life duringantihypertensive therapy are uniform within this pharmacologicclass of agents, and to relate the effects of the drugs on qualityof life to objective adverse events, such as the loss of a jobor the death of a spouse.
Methods After a four-week washout period when they receivedplacebo, 379 men with mild-to-moderately-severe hypertensionwere randomly assigned to receive captopril (25 to 50 mg twicedaily, with or without hydrochlorothiazide) or enalapril (5to 20 mg per day, with or without hydrochlorothiazide) for 24weeks. Blood pressure, quality of life, and life events weremonitored. Differences between treatments were evaluated bycalibrating measures of quality of life with objective lifeevents.
Results Throughout the treatment period, no differences werefound in blood pressure, frequency of withdrawal of patientsfrom the study, or major side effects. Patients treated withcaptopril had more favorable changes in overall quality of life,general perceived health, vitality, health status, sleep, andemotional control (P<0.05 for each). The changes varied accordingto the quality of life at base line (P<0.001); patients witha low quality of life at base line remained stable or improvedwith either drug, whereas those with a higher quality of liferemained stable with captopril but worsened with enalapril.The quality-of-life scales correlated with life events and symptomdistress (P<0.001), and calibration analysis indicated thatdifferences between treatments were clinically important.
Conclusions Two angiotensin-converting-enzyme inhibitors, captopriland enalapril, indistinguishable according to clinical assessmentsof efficacy and safety, had different effects on quality oflife. Calibration with life events showed that drug-inducedchanges are substantial and that the different effects of thesetwo agents on quality of life can be clinically meaningful.
Source Information
From the Department of Biostatistics, Harvard School of Public Health, Boston (M.A.T.); Phase V Technologies, Inc., Wellesley Hills, Mass. (R.B.A., J.F.N.); and the Departments of Radiology and Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston (N.K.H.). Dr. Anderson and Ms. Nackley are employees of Phase V Technologies, which served as the data coordinating center for the trial. Drs. Testa and Hollenberg are paid consultants for Phase V Technologies. Dr. Hollenberg has served as a paid consultant to Bristol-Myers Squibb and Merck Sharp & Dohme, the companies that manufacture the drugs used in this study.The members of the study group are listed in Appendix 1.
Address reprint requests to Dr. Testa at the Department of Biostatistics, Harvard School of Public Health, 677 Huntington Ave., Boston, MA 02115.
Captopril, Enalapril, and Quality of Life
Santanello N. C., Guess H., Heyse J. F., Kaplan N. M., Waud D. R., Fletcher A., Ware J. E., Testa M. A., Hollenberg N. K.
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N Engl J Med 1993;
329:505-507, Aug 12, 1993.
Correspondence
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