A multicenter, double-blind, parallel-group study of 219 patients with pitting
edema of various causes was undertaken to determine the efficacy and safety of
indapamide, administered orally (PO) in a 2.5-, 5-, or 10-mg once-daily dose, as compared with
hydrochlorothiazide, administered PO in a 100-mg once-daily dose. Efficacy was evaluated by determining each patient's weight and degree of pitting
edema periodically during 12 weeks of active treatment. Lessening of
edema was measured by changes in the depth of pitting in the pretibial area, ten to 14 inches below the patella. The depth of pitting was assigned an arbitrary number between 0 and 4, with 0 equivalent to no
edema and 4 equivalent to more than 6 mm of pitting
edema. After one week of treatment, the mean reduction of pitting
edema from baseline, using the 0 to 4 scale, was 1.6 (30%) in both the
indapamide (mean of the three groups) and
hydrochlorothiazide groups. There were no significant differences among the three dosage levels of
indapamide. After 12 weeks of treatment the mean decrease from baseline was 1.8 (34%), indicating a stable reduction of
edema. The mean
weight loss at one week was 2.5 kg for the three
indapamide groups and 2.6 kg for the
hydrochlorothiazide group; this loss was maintained for the 12 weeks of the study. The mean decreases in weight and pitting
edema were clinically and statistically significant (P less than 0.05) for both medications.