Abstract

A multicenter open-label study was conducted to evaluate the efficacy and safety of torsemide in 170 patients with New York Heart Association (NYHA) Class II to Class III congestive heart failure (CHF). Patients were assigned to receive torsemide for 2 months starting at 10 mg/d, to be adjusted after 14 or 30 days according to the diuretic effect and overall clinical condition of the individual. NYHA class, body weight, ankle circumference, blood pressure, heart rate, degree of dyspnea, and signs and symptoms of CHF were recorded monthly. Safety was evaluated by recording adverse events during the study and by monitoring electrocardiographic tracings and laboratory test results. All 170 study patients were eligible for the safety analysis, 150 of whom were included in the efficacy (perprotocol) analysis. Statistically significant changes in fluid mobilization with a progressive decrease in body weight and marked reduction of peripheral edema were observed. Functional status (NYHA class) improved in 66 patients (44%), and a lower degree of dyspnea, based on the World Health Organization classification, was detected in 98 patients (65.3%), with nocturnal coughing and pulmonary rales resolving in 30 of 34 and 81 of 87 patients, respectively. Torsemide did not significantly affect carbohydrate or lipid metabolism or serum electrolyte levels. Fourteen adverse events were reported for 9 patients (5.3%). Two of the 9 patients discontinued treatment, 1 because of persistent left ventricular failure and multiple episodes of dizziness and 1 because of hospitalization for suspected hepatoma. One patient with persistent dizziness, increased sweating, and asthenia required a dose change; the symptoms resolved after the dose was reduced. Results of this study suggest that torsemide was well tolerated and effective in the treatment of moderate CHF.

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