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Executive Summary

CAPOTEN IMPROVES QUALITY OF LIFE COMPARED TO VASOTEC IN STUDY published in the April 1 issue of The New England Journal of Medicine. The study, conducted by Marcia Testa, PhD, Harvard University School of Public Health, et al., found that hypertensive men treated with Bristol-Myers Squibb's Capoten (captopril) had a positive increase in overall quality of life, while men receiving Merck's Vasotec (enalapril) for blood pressure control had a negative change in overall quality of life. The study was funded in part by Bristol-Myers Squibb. The study authors concluded that "two angiotensin-converting enzyme inhibitors, captopril and enalapril, indistinguishable according to clinical assessments of efficacy and safety, had different effects on quality of life." They suggested that captopril may have "a positive influence on a number of central nervous system functions that are immediately relevant to quality of life." The double-blind study followed 379 men with mild-to- moderately severe hypertension (diastolic blood pressure of 90 to 115 mm Hg) who after a four week placebo lead-in period were titrated with captopril or enalapril for ten weeks and put on maintenance therapy for 14 weeks. Patients receiving captopril were titrated to doses of 25 mg, 50 mg, and 50 mg plus hydrochlorothiazide. Enalapril was given to patients in doses from 5 mg, 10 mg, 20 mg to 20 mg plus hydrochlorothiazide. The results show that patients receiving captopril treatment had a statistically significant postive change from baseline of 11 points on the overall quality of life scale. In comparison, patients treated with enalapril showed a negative change of 11 points on the same overall scale. Captopril also outperformed enalapril on most of the quality of life sub-indexes. There were no differences between captopril and enalapril in their effects on systolic or diastolic blood pressure. In an April 1 press release, Merck cited "many" previous quality of life studies that "show either positive or neutral effects with Vasotec." The validity of quality of life studies "remains a subject of discussion and a medical consensus has yet to emerge on what constitutes an adequate and well-controlled quality of life study," Merck maintained. "Some of the methodology used" in the Bristol-sponsored study "is not generally accepted by the medical community," Merck said. The "one clear conclusion that can be drawn" from the NEJM study, Merck declared, is "that Vasotec is an effective, well-tolerated and convenient treatment for hypertension."

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