EFFICACY AND SAFETY OF TORASEMIDE IN NONAZOTEMIC CIRRHOTIC-PATIENTS WITH ASCITES - AN OPEN MULTICENTER STUDY

A multicenter open study was carried out in 111 patients with nonazote mic cirrhosis and ascites to confirm the efficacy and safety of torase mide. Patients were assigned to receive torasemide (10 mg/d) and potas sium canrenoate or spironolactone (200 to 300 mg/d) for as long as nec essary to cause the disappearance or significant reduction of ascites, as assessed by ultrasonography. At each visit, body weight, ankle cir cumference, abdominal girth, blood pressure, and heart rate were recor ded; 24-hour urine volume, electrolyte balance, and other laboratory v alues were determined before and at the end of the study. Safety was e valuated by means of adverse events during treatment and laboratory te st results. Ninety patients were evaluable for efficacy and 111 for sa fety. A complete response to treatment occurred in 53 patients (59%), a partial response in 23 (25.5%), and an unsatisfactory response in 14 (15.5%). The positive effect of torasemide on fluid mobilization was evidenced by marked decreases in body weight, abdominal girth, and ank le circumference. Only 3 patients required a dose reduction because of hyponatremia. Otherwise, torasemide had no negative effect on electro lyte balance and did not alter serum ammonia and glucose levels or cre atinine clearance. Seventeen patients (15.3%) reported 26 adverse even ts, most of which were mild, transient, and self-limiting. A dose redu ction to 5 mg/d was required in 6 patients, and 1 patient each discont inued treatment because of persisting portosystemic encephalopathy and persisting hyperazotemia plus hyponatremia. No clinically relevant ch anges in laboratory safety parameters were noted at the end of treatme nt.