Randomized trial of treatment of hypertension in elderly patients in primary care

Completed

Phase N/A Results

Trial Description

To determine whether the treatment of hypertension in elderly patients reduces the incidence of stroke or coronary disease or affects cardiovascular or overall mortality.

Interventions

  • Antihypertensives Drug
    Intervention Desc: This category includes all BP lowering drugs in stroke prevention trials

Trial Design

Randomized, observation-controlled, unblinded trial of 884 patients at 13 centers.

Patient Involvement

Patients were randomized to participate in the treatment or control group. Those in the control group received no study medication unless they developed sustained blood pressures above 280/120 or had strokes. Those in the treatment group received antihypertensive agents in a stepwise order. During step 1, patients received atenolol 100 mg each morning for three months. If the systolic blood pressure was still > 170 mm Hg or the diastolic pressure > 105 mm Hg, the patient proceeded to step 2. During step 2, bendrofluazide 5 mg daily was added to the atenolol. Patients who could not tolerate 100 mg atenolol were given 50 mg atenolol or treated with bendrofluazide alone. If bendrofluazide and atenolol failed to lower the blood pressure, alpha-methyldopa 500 mg was added as a single dose in the evening. Patients who could not be effectively treated with any of the above regimens or who developed unacceptable side effects could be treated with any recognized therapy rather than remain untreated. After one year of participation in the trial, both groups of patients were given the same examination and tests that they were given at the beginning of the trial as well as a questionnaire to assess side effects. Another questionnaire was given to the patients' relatives (or close neighbor or friend) at this time to determine whether they had noticed any change in the patient's behavior. After two years of participation in the trial, biochemical tests and electrocardiograms were repeated for patients in both groups, but no medical examinations were performed. Average total follow-up was 4.4 years during which time events were recorded on trial cards from the medical notes.

Outcomes

Type Measure Time Frame Safety Issue
Primary Myocardial infarction, strokes including transient ischemic attacks and death.