Comparative clinical study of spironolactone and potassium canrenoate. A randomized evaluation with double cross-over

In the present study 54 cirrhotic patients were investigated in order to compare the clinical effects of spironolactone (100-200 mg/d) and potassium canrenoate (50-200 mg/d). Diagnosis was established on clinical and laboratory findings for at least 12 months and/or on liver biopsy: no patients had signs of hepatic decompensation. Patients entering the study without previous treatment, after a basal period of observation, were randomly allocated to one of the spirolactones (spironolactone or potassium canrenoate); those already under antialdosteronic treatment underwent a first observation period and were then all shifted to the other drug. After completing a second observation all patients underwent a second cross-over and a new assessment of clinical and laboratory parameters after the third period of observation. 31 patients completed all observations (3.5 months each, overall mean). No differences in liver function tests were present during follow-up. Maintenance of body weight was achieved with a dose of potassium canrenoate half that of spironolactone. Serum K+ was increased in each patient after spironolactone and potassium canrenoate as compared to the basal period. The 24-h urinary excretion of K+ was significantly decreased in each patient after both drugs. No significant changes were observed in both Na+ and Cl- plasmatic concentration and urinary excretion. Gynaecomastia was present in 3/11 patients during the basal observation, in 13/30 patients under spironolactone and in 5/25 patients under potassium canrenoate; this finding, however, was not correlated to changes in the basal serum concentration of prolactin.(ABSTRACT TRUNCATED AT 250 WORDS)