Combined versus sequential diuretic treatment of ascites in non-azotaemic patients with cirrhosis: results of an open randomised clinical trial.
OBJECTIVE
The aim of the study was to compare sequential versus combined diuretic therapy in patients with cirrhosis, moderate ascites and without renal failure.


METHODS
One hundred patients were randomly assigned to the two diuretic treatments. The sequential treatment provided potassium canrenoate at the initial dose of 200 mg/day, then increased to 400 mg/day. Non-responders were treated with 400 mg/day of potassium canrenoate and furosemide at an initial dose of 50 mg/day, then increased to 150 mg/day. The combined treatment provided the initial dose of 200 mg/day of potassium canrenoate and 50 mg/day of furosemide, then increased to 400 mg/day and 150 mg/day, respectively.


RESULTS
Most patients who received sequential treatment responded to potassium canrenoate alone (19% to 200 mg/day and 52.63% to 400 mg/day, respectively). Most patients who received the combined treatment responded to the first two steps (40% to the first step and 50% to the second, ie, 400 mg/day of potassium canrenoate plus 100 mg/day of furosemide). Adverse effects (38% vs 20%, p<0.05), in particular, hyperkalaemia (18% vs 4%, p<0.05), were more frequent in patients who received sequential therapy. As a consequence, the per cent of patients who resolved ascites without changing the effective diuretic step was higher in those who received the combined treatment (56% vs 76%, p<0.05).


CONCLUSIONS
The combined diuretic treatment is preferable to the sequential one in the treatment of moderate ascites in patients with cirrhosis and without renal failure. NCT00741663. This work is an open randomised clinical trial.
Angeli
P
P
Department of Clinical and Experimental Medicine, University of Padova, Via Giustiniani 2, Padova, Italy. pangeli@unipd.it
Fasolato
S
S
Mazza
E
E
Okolicsanyi
L
L
Maresio
G
G
Velo
E
E
Galioto
A
A
Salinas
F
F
D'Aquino
M
M
Sticca
A
A
Gatta
A
A
D000328:Adult; D000368:Aged; D001201:Ascites / Q000188:drug therapy* / Q000209:etiology; D002191:Canrenoic Acid / Q000008:administration & dosage / Q000009:adverse effects; D004232:Diuretics / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005665:Furosemide / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008103:Liver Cirrhosis / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D000451:Mineralocorticoid Receptor Antagonists / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
D004232:Diuretics; D000451:Mineralocorticoid Receptor Antagonists; D005665:Furosemide; D002191:Canrenoic Acid