Long-term treatment with oral torsemide and its effect on body weight and fluid balance in patients with chronic renal insufficiency

Long-term treatment with oral torsemide was studied to determine its effectiveness in maintaining steady-state fluid balance in patients with chronic renal insufficiency by using a placebo-controlled, double-blind, random-off design. Patients with stable chronic renal insufficiency were initially titrated and then stabilized on torsemide. Once stabilized on torsemide, patients were randomly assigned in a double-blind fashion to continue on their titrated dose of torsemide or to receive a placebo. Of the 82 patients enrolled in the study, 68 were randomized to torsemide (n = 34) or placebo (n = 34). Patients who received the placebo showed a significantly greater (p <0.001) mean increase in body weight (3.55 lb) than did patients who remained on torsemide (0.46 lb). Approximately two-thirds of the w eight gain observed in the placebo group occurred during the first 3 days after randomization. Patients continued to receive treatment unless they developed fluid accumulation that was considered deleterious to their clinical state as determined by the investigator. In the placebo group a greater number of patients discontinued treatment because of weight gain or fluid accumulation. The mean number of days on treatment after randomization was significantly higher (p <0.001) for patients who received torsemide (26 days) than for patients who received the placebo (16 days). The lack of weight gain in the torsemide group was associated with a higher percentage of patients who showed no change or an improvement in peripheral edema status (79%) than in placebo patients (35%). No patient was withdrawn from the study because of hyperkalemia or hypokalemia. The adverse effects reported during the study were as anticipated for patients with chronic renal insufficiency that is often complicated by other underlying illnesses.