EFFICACIOUS RESPONSE WITH LOWER DOSE INDAPAMIDE THERAPY IN THE TREATMENT OF ELDERLY PATIENTS WITH MILD-TO-MODERATE HYPERTENSION

A low dose (1.25 mg) of indapamide (Lozol(R), Rhone-Poulenc Rorer Phar maceuticals, Collegeville, PA) was evaluated in 222 elderly patients ( greater than or equal to 50 years) with mild to moderate essential hyp ertension in a multicenter, randomized, double-blind, parallel-group c linical trial. A 4-week single-blind placebo washout period was follow ed by an 8-week double-blind treatment period. Patients were randomize d to receive indapamide 1.25 mg/day or to receive placebo. The primary efficacy variable was the mean change in sitting diastolic blood pres sure from baseline to week 8. Eighty-one patients in the indapamide gr oup (73%) and 87 patients in the placebo group (78%) completed the 8 w eeks of double-blind therapy. Therapy with 1.25 mg of indapamide produ ced greater reductions compared with placebo in sitting diastolic bloo d pressure after 8 weeks of therapy, with statistical significance (P less than or equal to 0.0015) seen after only 2 weeks of therapy and c ontinuing throughout the 8 weeks. All secondary efficacy measures (sit ting systolic blood pressure, standing systolic and diastolic blood pr essures, and greater than or equal to 10 mm Hg decrease or final value of less than or equal to 90 mm Hg in sitting diastolic blood pressure ) also showed superior (P less than or equal to 0.0014) improvement in the indapamide group compared with placebo after 8 weeks of double-bl ind treatment. During the 8-week double-blind treatment period, incide nce rates for all adverse events and for drug-related adverse events w ere similar between the two treatment groups. Among patients who recei ved indapamide, the only drug-related adverse events that occurred wit h an incidence of greater than or equal to 2% were headache (4%), dizz iness (4%), asthenia (2%), pain (2%), abnormal vision (2%), and impote nce (2%). Similar incidence rates for these adverse events were seen i n the placebo group. Among indapamide patients, mean changes in potass ium (-0.27 mEq/L), uric acid (0.76 mg/dL), and BUN (1.42 mg/dL) were n oted but not clinically significant.