EVALUATION OF INDAPAMIDE 1.25 MG ONCE-DAILY IN ELDERLY PATIENTS WITH MILD-TO-MODERATE HYPERTENSION

The objective of this study was to evaluate the safety and efficacy of indapamide 1.25 mg once daily as monotherapy in elderly patients (65 years and older) with mild to moderate essential hypertension. Two hun dred and seventy-nine (279) elderly patients were enrolled in a washou t period, during which patients received single-blind placebo for 4 we eks. Patients demonstrating supine diastolic pressures between 95 mm H g and 114 mm Hg at the end of the 4-week placebo washout period were e ntered into the 8-week double-blind treatment period, Two hundred and four (204) patients qualified for the study and were randomized to the double-blind treatment; 103 patients received indapamide 1.25 mg and 101 patients received placebo for 8 weeks, Overall, 177 patients (92 i ndapamide and 85 placebo) completed the study. The primary efficacy cr iterion was the mean change in supine diastolic blood pressure (DBP) f rom double-blind baseline to the end of 8 weeks of therapy. By week 8 of the double-blind treatment period, indapamide 1.25 mg produced a st atistically significant (P = 0.0037) decrease in supine DBP of 8.2 mm Hg compared to a decrease of 5.3 mm Hg produced in the placebo group. Additionally, indapamide 1.25 mg was statistically (P = 0.0028) more e ffective than placebo in reducing supine systolic BP (SEP) (-10.1 vs - 4.2 mm Hg), The incidence of drug-related adverse events during the do uble-blind treatment period was similar between the two treatment grou ps. A low dose of indapamide, 1.25 mg, given once daily for 8 weeks wa s effective as monotherapy with respect to BP reduction in an elderly population with mild to moderate hypertension. Indapamide 1.25 mg was safe and generally well tolerated in this elderly patient population.