Treatment of Mild Hypertension Study - TOMHS

Jul 10, 2003
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Date Presented:
01/01/1993
Date Published:
01/01/1993
Date Updated:
07/10/2003
Original Posted Date:
07/10/2003
References

Description:

To compare five drug treatments with placebo for long-term treatment of mild hypertension.

Hypothesis:

The combination of dietary and behavioral changes with drug monotherapy will result in significant reduction in blood pressure.

Study Design

Study Design:

Patients Screened: Not reported
Patients Enrolled: 902
NYHA Class: Not Reported
Mean Follow Up: mean follow-up 4.4 years
Mean Patient Age: 45-69
Female: 38%
Mean Ejection Fraction: Not Evaluated

Patient Populations:

Diastolic blood pressure 90-99 mmHg, or if previously treated with antihypertensive drugs, 85-99 mmHg.

Exclusions:

History or evidence of cardiovascular disease or LV hypertrophy (based on ECG).

Primary Endpoints:

change in diastolic and sytolic blood pressure

Secondary Endpoints:

left ventricular mass, plasma lipid levels, death and major cardiovascular events (nonfatal MI, stroke, CHF, surgery for aortic aneurysm, CABG surgery, coronary angioplasty, thrombolytic therpay, hospitalization for unstable angina)

Drug/Procedures Used:

Chlorthalidone 15 mg/day (diuretic), acebutolol 400 mg/day (β-blocker), doxazosin 1 mg/day (alpha-1 agonist), amlodipine 5 mg/day, enalapril 5 mg/day, or placebo (all a.m. dosing). All patients received nutritional-hygienic advice (low weight, low sodium, low alcohol, increased exercise).

Principal Findings:

Drug therapy reductions were sizable and similar in all treatment groups (DBP decreased by 11.5 to 13.1 mmHg [vs 8.6 mmHg for placebo] and SBP decreased by 14.2 to 17.7 mmHg [vs 9.1 mmHg for placebo]). Drug groups had a nonsignificant reduction in death and major cardiovascular events (5.1% vs. 7.3%; p = 0.21). The only significant difference vs placebo for reduction in LV mass was with chlorthalidone (p=0.03). Drug therapy also was associated with better quality of life and decreased resting ECG abnormalities.

Interpretation:

The addition of any one of five different classes of drugs to dietary and behavioral modifications resulted in significant additional reduction in blood pressure with few side effects.

References:

JAMA 1993;270:713–724. Circulation 1995;91:698-706. LV mass assessment.

Keywords: Enalapril, Chlorthalidone, Sodium, Diuretics, Doxazosin, Electrocardiography, Calcium Channel Blockers, Diet, Sodium-Restricted, Quality of Life, Amlodipine, Hypertension


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