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Treatment of Mild Hypertension Study. Final results. Treatment of Mild Hypertension Study Research Group
J D Neaton1, R H Grimm, R J Prineas
1Division of Biostatistics, School of Public Health, University of Minnesota 55414.
Insights
Drug treatment for mild hypertension, combined with lifestyle changes, proved more effective than lifestyle changes alone in preventing cardiovascular events. Differences between specific drug treatments were minimal, supporting current treatment guidelines.
Area of Science:
- Cardiology
- Clinical Pharmacology
- Public Health
Background:
- Mild hypertension (Stage 1) affects a significant portion of the adult population.
- Nutritional-hygienic interventions are recommended but their efficacy alone for preventing cardiovascular events is debated.
- Pharmacological interventions are a cornerstone of hypertension management, but optimal initial choices for mild cases require clarification.
Purpose of the Study:
- To compare the effectiveness of six different antihypertensive interventions for mild hypertension.
- To evaluate the impact of drug therapy versus nutritional-hygienic treatment on cardiovascular outcomes.
- To assess the comparative efficacy of five distinct drug classes as initial monotherapy.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving hypertensive individuals aged 45-69.
- Participants received sustained nutritional-hygienic advice, plus either placebo or one of five antihypertensive medications (chlorthalidone, acebutolol, doxazosin, amlodipine, enalapril).
- Outcomes included blood pressure, quality of life, cardiovascular events, and biochemical markers over an average of 4.4 years.
Main Results:
- All six interventions significantly reduced blood pressure, with drug treatments showing greater reductions than placebo.
- Drug treatment groups experienced fewer overall clinical events compared to the placebo group (11.1% vs 16.2%, P = .03).
- While drug therapy improved quality of life and reduced electrocardiographic abnormalities more than placebo, differences among the five drug treatments were not consistently significant.
Conclusions:
- Initial drug treatment, when combined with nutritional-hygienic interventions, is superior to nutritional-hygienic treatment alone for preventing cardiovascular and other clinical events in mild hypertension.
- The choice among the tested drug classes for initial monotherapy showed minimal differences in effectiveness.
- Findings support current guidelines for managing Stage 1 hypertension, emphasizing the benefit of pharmacological intervention alongside lifestyle modifications.
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.
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