Clinical efficacy and safety of indapamide in the treatment of edema.

Whether edema is caused by "overflow" or "underfill," the excess retention of salt and water is common to virtually all forms. The use of natriuretic agents has been shown to be effective in most cases of edema. The present study compares the efficacy of a new long-acting indoline compound, indapamide, with that of hydrochlorothiazide, both given once daily, in the treatment of edema. This double-blind study was conducted in 17 centers. Edema was evaluated by weight change and pitting of the lower extremities. Indapamide was given in doses of 2.5, 5.0, and 10.0 mg and was compared with 100 mg of hydrochlorothiazide. Active treatment was continued up to 12 weeks. Weight change efficacy evaluation was done on 219 patients, and efficacy analysis for pitting edema was done on 214 patients. Of the 219 subjects, 90 were men and 129 were women. Mean age was 57.4 years, and mean body weight was 88.5 kg. By the end of 2 weeks of active treatment, the percentages of patients with no edema were 26%, 44%, and 31% for the indapamide groups (2.5, 5.0, and 10.0 mg), respectively, and 40% for the hydrochlorothiazide group (100 mg). Early response to treatment as measured by weight loss was demonstrated by all patients in the study regardless of treatment group. Hypokalemia was the most frequently reported adverse reaction. Other adverse reactions were infrequent, with no significant difference among the treatment groups. This study concluded that indapamide in once-daily oral doses of 2.5, 5.0, or 10.0 mg was as safe and effective as a once-daily 100 mg dose of hydrochlorothiazide for the treatment of 219 patients with edema from various causes.