Midodrine and tolvaptan in patients with cirrhosis and refractory or recurrent ascites: a randomised pilot study.
Splanchnic arterial vasodilatation and subsequent sodium and water retention play an important role in cirrhotic ascites. Midodrine and tolvaptan have been used separately in these patients. However, there are no reports on the use of combination of midodrine and tolvaptan in the control of ascites. The aim of this study was to evaluate the safety and efficacy of midodrine, tolvaptan and their combination in control of refractory or recurrent ascites in cirrhotics.



Fifty cirrhotic patients with refractory or recurrent ascites were randomised to receive midodrine (n=13), tolvaptan (n=12) or both (n=13) plus standard medical therapy (SMT) or SMT alone (n=12).



A significant increase in urinary volume and urinary sodium at 1 and 3 months (P<.05) was observed in all groups except SMT. There was no worsening of renal or hepatic function in any group. There was deterioration of model for end-stage liver disease (MELD) in SMT. Midodrine as well as combination of midodrine and tolvaptan but not tolvaptan alone was superior to SMT in control of ascites at 3 months (P<.05). The combination therapy was also superior to midodrine in the control of ascites at 1 month. The morbidity and mortality were similar in all the groups except SMT.



The results of this pilot study suggest that midodrine and combination with tolvaptan better controls ascites without any renal or hepatic dysfunction. The combination therapy rapidly controls ascites as compared to midodrine or tolvaptan alone.
Department of Internal Medicine, Postgraduate Institute of Medical Education & Research, Chandigarh, India.
Nitish
N
Rai
Department of Nuclear Medicine, Postgraduate Institute of Medical Education & Research, Chandigarh, India.
Baljinder
B
Singh
Government Medical College and Hospital, Chandigarh, India.
Akash
A
Singh
Department of Cardiology, Postgraduate Institute of Medical Education & Research, Chandigarh, India.
Rajesh
R
Vijayvergiya
Department of Internal Medicine, Postgraduate Institute of Medical Education & Research, Chandigarh, India.
Navneet
N
Sharma
Department of Internal Medicine, Postgraduate Institute of Medical Education & Research, Chandigarh, India.
Ashish
A
Bhalla
Department of Hepatology, Postgraduate Institute of Medical Education & Research, Chandigarh, India.
Virendra
V
Singh
D000328:Adult; D001201:Ascites / Q000188:drug therapy* / Q000209:etiology; D001552:Benzazepines / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007194:India; D008103:Liver Cirrhosis / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D008879:Midodrine / Q000627:therapeutic use*; D010865:Pilot Projects; D012964:Sodium / Q000652:urine; D062606:Tertiary Care Centers; D013997:Time Factors; D000077602:Tolvaptan; D014662:Vasoconstrictor Agents / Q000627:therapeutic use*
D001552:Benzazepines; D014662:Vasoconstrictor Agents; D000077602:Tolvaptan; D008879:Midodrine; D012964:Sodium
aquaretics; ascites; cirrhosis; haemodynamics; splanchnic vasodilatation; vasopressors