LOWER DOSE DIURETIC THERAPY IN THE TREATMENT OF PATIENTS WITH MILD-TO-MODERATE HYPERTENSION

Indapamide (Lozol), an indoline antihypertensive drug with diuretic an d vasodilating activities, was evaluated in 195 patients with mild to moderate essential hypertension (sitting DBP between 95 and 110 mmHg) in a multicentre, randomised, double-blind, parallel-group design tria l. A four week single-blind placebo wash-out period was followed by an eight week double-blind period. Patients were randomised to indapamid e 1.25 mg/day or to placebo. The primary efficacy endpoint was the mea n change in sitting DBP from baseline to week 8. Ninety patients in th e placebo group (93%) and 82 patients (84%) in the indapamide group co mpleted the eight weeks of double-blind therapy. Indapamide produced a mean (SE) decrease in sitting DBP of 7.4 (0.63) mmHg (from 100.1 to 9 2.8 mmHg) compared with it decrease of 3.6 (0.75) mmHg (from 99.6 to 9 5.8 mmHg) produced by placebo (p < 0.0001). Indapamide and placebo als o produced mean decreases in standing DBP of 6.8 (0.75) and 2.8 (0.77) mmHg, respectively (p = 0.0002), in sitting SBP of 11.1 (1.18) and 3. 2 (1.35) mmHg, respectively (p = 0.0001) and in standing SBP of 11.4 ( 1.29) and 4.0 (1.43) mmHg, respectively (P = 0.0002). Reduction in BP of greater than or equal to 10 mmHg or to a DBP of less than or equal to 90 mmHg was more frequent (P = 0.0005) among indapamide (46.6%) com pared with placebo (23.7%) treated patients. During the eight week dou ble-blind treatment period, incidence rates for all adverse experience s and for drug-related adverse experiences were similar between the tw o treatment groups. Three patients in the indapamide group and two pat ients in the placebo group were discontinued due to adverse events. Of 15 patients in the indapamide group who had normal potassium values a t baseline and abnormally low Values during treatment, only four conti nued to have low potassium levels at week 8. Three of these patients r eceived potassium supplements concomitant with double-blind medication . There were no clinically meaningful change in cholesterol or glucose in the indapamide group. In summary, indapamide given in a low dose p roved to be safe and highly effective in the treatment of mild to mode rate hypertension.