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Executive Summary

WYETH-AYERST's SECTRAL SHOWS QUALITY OF LIFE ADVANTAGE compared to placebo, the Treatment of Mild Hypertension Study concluded. Wyeth-Ayerst's beta blocker Sectral (acebutolol) and the diuretic chlorthalidone supplied by Boehringer-Ingelheim statistically significantly outperformed placebo "on the overall test for the combined seven quality-of-life indexes," the TOMHS investigators reported in the Aug. 11 Journal of the American Medical Association. The three other study drugs, Pfizer's alpha blocker Cardura (doxazosin) and calcium channel blocker Norvasc (amlodipine) and Merck's angiotensin-converting enzyme inhibitor Vasotec (enalapril), "were intermediate and did not differ significantly from the placebo group," James Neaton, PhD, University of Minnesota, et al., wrote. "Among the drug-treatment groups, participants given acebutolol had significantly greater improvement in quality of life compared with those given doxazosin," the article adds. In an editorial published in the same issue of JAMA, Henry Black, MD, Rush-Presbyterian-St. Luke's Medical Center, characterized the quality of life findings of the study as "surprising." The finding that the diuretic and the beta blocker had larger quality-of-life improvements than newer drug classes "is consistent with the Veterans Administration Cooperative Study," Black noted. However, "the conventional wisdom would have led us to believe otherwise." TOMHS randomized a total of 902 patients with Stage I hypertension (diastolic blood pressure between 90 mm Hg and 100 mm Hg) to the six study groups. All patients received dietary and lifestyle therapy. Follow-up was four years. TOMHS was funded by a grant from the National Heart, Lung & Blood Institute, with additional funding by Merck and Pfizer. All five drug classes showed significant reductions in blood pressure compared to nutritional-hygenic intervention alone, the JAMA article states. Doxazosin- and enalapril-treated patients "experienced slightly less blood pressure reduction than those in the other drug-treatment groups." A pooled comparison of the treated groups showed a trend in favor of reduced clinical events: 7.3% in the placebo group versus 5.1% in the treatment groups. "As a consequence of the size and duration of follow-up of TOMHS, there is inadequate power for comparing drug treatments with one another for efficacy in preventing cardiovascular events," the investigators noted. "Favorable lipid-measurement results were seen in all treatment groups," the authors stated. "The most favorable changes in lipid levels were observed in the doxazosin group in TOMHS, consistent with the extensive literature on alpha-antagonists and lipids." The "favorable effect of acebutolol on total and low- density lipoprotein cholesterol levels has not been reported previously," the article adds. "All five medications were well tolerated long term," the article states. Norvasc was "the best-tolerated drug treatment," the authors noted. Cardura was least-well tolerated. However, the authors added, "fewer side effects were reported by participants assigned to the drug-treatment groups than those assigned to the placebo group." "Pending findings from much larger trials evaluating the ability of newer classes of drugs to prevent major clinical events," the investigators concluded, the recommendations of the Fifth Joint National Committee on the Detection, Evaluation and Treatment of High Blood Pressure that "diuretics and beta blockers are preferred for initial drug therapy for most hypertensive patients unless contraindicated is appropriate." The JNC V report was issued in November ("The Pink Sheet" Nov. 9, 1992, T&G-12). On Aug. 5, NHLBI announced plans for a nine-year, $55 mil. trial to test four antihypertensive drugs (Cardura, Norvasc, Chlorthalidone and Lisinopril) and lipid-lowering drugs for reduction of coronary heart disease in older patients. The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) will enroll 40,000 men at 270 sites nationwide, NHLBI said. The study is expected to be under way by autumn 1994 following completion of a six-month pilot study.

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