A multicenter open study was carried out in 111 patients with nonazotemic cirrhosis and ascites to confirm the efficacy and safety of torasemide. Patients were assigned to receive torasemide (10 mg/d) and potassium canrenoate or spironolactone (200 to 300 mg/d) for as long as necessary to cause the disappearance or significant reduction of ascites, as assessed by ultrasonography. At each visit, body weight, ankle circumference, abdominal girth, blood pressure, and heart rate were recorded; 24-hour urine volume, electrolyte balance, and other laboratory values were determined before and at the end of the study. Safety was evaluated by means of adverse events during treatment and laboratory test results. Ninety patients were evaluable for efficacy and 111 for safety. 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 ankle circumference. Only 3 patients required a dose reduction because of hyponatremia. Otherwise, torasemide had no negative effect on electrolyte balance and did not alter serum ammonia and glucose levels or creatinine clearance. Seventeen patients (15.3%) reported 26 adverse events, most of which were mild, transient, and self-limiting. A dose reduction to 5 mg/d was required in 6 patients, and 1 patient each discontinued treatment because of persisting portosystemic encephalopathy and persisting hyperazotemia plus hyponatremia. No clinically relevant changes in laboratory safety parameters were noted at the end of treatment.
|Number of pages||15|
|Journal||Advances in Therapy|
|Publication status||Published - 1997|
ASJC Scopus subject areas