Multicenter dose-response study of the effect of indapamide in the treatment of patients with mild to moderate hypertension.

This study, carried out in three centers in the United States, investigated the antihypertensive effect of three dosages of indapamide in 87 patients with mild to moderate hypertension. The dosages studied were 1 mg, 2.5 mg, and 5 mg daily. A double-blind, parallel study design was used with a six-week placebo run-in period followed by an eight-week treatment period and a two-week follow-up period. Compared with placebo, all dosages caused a significant decrease (P less than 0.05) in blood pressure, with an average decrease of approximately 6 mmHg diastolic and 13 mmHg systolic. The antihypertensive effect seemed to be fully manifest after six weeks of treatment. At all dosage levels, indapamide produced markedly greater therapeutic success rates than did the placebo. Success was defined as either a standing phase-5 diastolic blood pressure of less than 90 mmHg or a decrease by at least 10 mmHg from baseline. Although the decrease in mean serum potassium concentration was dose-related, the decrease was not clinically significant with any dose. A reduction in serum chloride and increases in serum uric acid and glucose were also observed. These changes were slight and did not cause the discontinuation of treatment for any patient. The most frequently observed side effects were mild to moderately severe dizziness, weakness, and headaches.

RCT Entities:   Population Interventions Outcomes