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Final Results

James D. Neaton, PhD; Richard H. Grimm, Jr, MD, PhD; Ronald J. Prineas, MB, PhD; Jeremiah Stamler, MD; Greg A. Grandits, MS; Patricia J. Elmer, PhD; Jeffrey A. Cutler, MD; John M. Flack, MD; James A. Schoenberger, MD; Robert McDonald, MD; Cora Elizabeth Lewis, MD, MSPH; Philip R. Liebson, MD; the Treatment of Mild Hypertension Study Research Group; Cora Elizabeth Lewis, MD, MSPH; Janet Raines, MS, RD; Isabelle Joffrion, RN, MAE; Ralph E. Allen, PAC; Linda Jones, CRNP, MN; Deborah Parker; Jacqueline K. De Worth, MS, RD; Evelyn Anzelone; Doris Gunn; Ann George; JoAnn Montgomery; James A. Schoenberger, MD; Philip R. Liebson, MD; Gilberto S. Neri, MD; Eleanor Betz, RD; Barbara Mascitti, RD; Ellen Plank, RNNP; Brenda Peterson, RN; Tracy Remijas, MPH; Walter Washington; Irene Turner, MT; Laura Stefanie; Pamela Aye, MS, RD; Susan Madnek-Oxman, MS, RD; Helen Jones; John M. Flack, MD; Stephen R. Mascioli, MD, MPH; Nancy Van Heel, MS, RD; Cindy Bjerk, MS, RD; Fran Galle, RN; Patricia Laqua, RD; Margaret Miller, MT (ASCP); Liv Marit Bell, RN, MPH; Mary Ellen Robinson, MS, RD; Carolyn Thorson; Robert McDonald, MD; Raymond Townsend, MD; Arlene Caggiula, PhD; Sinda Dianzumba, MD; Carole Ciak, RN, BSN; Marcella Link, MS, RD; Beth Hall, RD; Mary Monske, RN, BSN; Therese M. Theobald, BS, RDCS; Michelle Berry, MS, RD; Terry Coyne, MS, RD; Claire A. Bunker, PhD; Kaye Kramer, RN, BSN; James D. Neaton, PhD; Greg A. Grandits, MS; Alain G. DuChene; Leslie A. Holland; Sylvia Tze, MS; Serena Sjolund; Cynthia A. Launer, MS; John Lagus, MS; Cynthia M. Miller; Kenneth H. Svendsen, MS; Arthur Leon, MD; Richard H. Grimm, Jr, MD, PhD; Patricia J. Elmer, PhD; Brian Laing, MS; Marsha McDonald, MA; Dean Surbey, MBA; Mary Kay Wiche, RD, MPH; Kimberly Kuiper; Richard Remington, PhD; Thomas J. Coates, PhD; Richard Devereux, MD; Ray W. Gifford, Jr, MD; Herbert Langford, MD; Laurence McCullough, PhD; Herman A. Tyroler, MD

JAMA. 1993;270(6):713-724.

Abstract
Objective.
—To compare six antihypertensive interventions for the treatment of mild hypertension.

Design.
—Randomized, double-blind, placebo-controlled clinical trial.

Setting.
—Four hypertension screening and treatment centers in the United States.

Participants.
—Hypertensive men and women, aged 45 to 69 years, with diastolic blood pressure less than 100 mm Hg.

Intervention.
—Sustained nutritional-hygienic advice to all participants to reduce weight, dietary sodium intake, and alcohol intake, and increase physical activity. Participants were randomly allocated to take (1) placebo (n=234); (2) chlorthalidone (n=136); (3) acebutolol (n=132); (4) doxazosin mesylate (n=134); (5) amlodipine maleate (n=131); or (6) enalapril maleate (n=135).

Main Outcome Measures.
—Blood pressure, quality of life, side effects, blood lipid levels and analysis of other serum components, echocardiographic and electrocardiographic changes, and incidence of cardiovascular events over an average of 4.4 years of follow-up.

Results.
—Blood pressure reductions were sizable in all six groups, and were significantly greater for participants assigned to drug treatment than placebo ( — 15.9 vs — 9.1 mm Hg for systolic blood pressure and — 12.3 vs —8.6 mm Hg for diastolic blood pressure; p<.0001). After 4 years, 59% of participants assigned to placebo and 72% of participants given drug treatment continued on their initial medication as monotherapy. A smaller percentage of participants assigned to the drug-treatment groups died or experienced a major nonfatal cardiovascular event than those assigned to the placebo group (5.1% vs 7.3%; P=.21). After including other clinical events, the percentage of participants affected was 11.1% for those in the drug-treatment groups and 16.2% for those in the placebo group (P=.03). Incidence rates of most resting electrocardiographic abnormalities were lower and quality of life was improved more for those assigned to drug-treatment groups rather than the placebo group. Differences among the five drug treatments did not consistently favor one group in terms of regression of left ventricular mass, blood lipid levels, and other outcome measures.

Conclusions.
—As an initial regimen, drug treatment in combination with nutritional-hygienic intervention was more effective in preventing cardiovascular and other clinical events than was nutritional-hygienic treatment alone. Drug-treatment group differences were minimal. Pending results from large-scale clinical trials to evaluate drug treatments for their effect on cardiovascular clinical events, these findings support the recommendations of the new fifth Joint National Committee report regarding treatment choices for people with stage 1 ("mild") hypertension.

(JAMA. 1993;270:713-724)

Author Affiliations
From the Divisions of Biostatistics (Dr Neaton and Mr Grandits) and Epidemiology (Dr Elmer), School of Public Health, and the Divisions of Cardiovascular Diseases (Dr Grimm) and General Medicine (Dr Flack), School of Medicine, University of Minnesota, Minneapolis; the Department of Epidemiology and Public Health, University of Miami (Fla) (Dr Prineas); the Department of Community Health and Preventive Medicine, Northwestern University, Chicago, Ill (Dr Stamler); the Prevention and Demonstration Research Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Md (Dr Cutler); the Department of Preventive Medicine (Dr Schoenberger) and the Section of Cardiology (Dr Liebson), Rush-Presbyterian-St Luke's Medical Center, Chicago, Ill; the School of Medicine, University of Pittsburgh (Pa) (Dr McDonald); and the Division of General and Preventive Medicine, University of Alabama at Birmingham (Dr Lewis).

Birmingham Clinic.—Division of General and Geriatric Medicine, University of Alabama at Birmingham; Chicago Clinic.—Department of Preventive Medicine, Rush-Presbyterian-St Luke's Medical Center, Chicago, Ill; Minneapolis Clinic.—Berman Center for Clinical Research, of Healthspan, Minneapolis, Minn; Pittsburgh Clinic.—Division of Nephrology and Hypertension, Allegheny General Hospital, Pittsburgh, Pa; Statistical and Data Coordinating Center.—Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis; Administrative Center.—Division of Epidemiology, School of Public Health, University of Minnesota, Minneapolis; Data Safety and Monitoring Board

Footnotes
A complete list of the members of the Treatment of Mild Hypertension Study Research Group appears at the end of this article.

Reprint requests to Division of Biostatistics, School of Public Health, University of Minnesota, 2221 University Ave SE, Room 200, Minneapolis, MN 55414 (Dr Neaton).

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