Nitish Rai1, Baljinder Singh2, Akash Singh3, Rajesh Vijayvergiya4, Navneet Sharma1, Ashish Bhalla1, Virendra Singh5. 1. Department of Internal Medicine, Postgraduate Institute of Medical Education & Research, Chandigarh, India. 2. Department of Nuclear Medicine, Postgraduate Institute of Medical Education & Research, Chandigarh, India. 3. Government Medical College and Hospital, Chandigarh, India. 4. Department of Cardiology, Postgraduate Institute of Medical Education & Research, Chandigarh, India. 5. Department of Hepatology, Postgraduate Institute of Medical Education & Research, Chandigarh, India.
Abstract
BACKGROUND: 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. METHODS: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). RESULTS: 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. CONCLUSIONS: 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.
RCT Entities:
BACKGROUND: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. METHODS: 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). RESULTS: 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. CONCLUSIONS: 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.
Authors: Amine Benmassaoud; Suzanne C Freeman; Davide Roccarina; Maria Corina Plaz Torres; Alex J Sutton; Nicola J Cooper; Laura Iogna Prat; Maxine Cowlin; Elisabeth Jane Milne; Neil Hawkins; Brian R Davidson; Chavdar S Pavlov; Douglas Thorburn; Emmanuel Tsochatzis; Kurinchi Selvan Gurusamy Journal: Cochrane Database Syst Rev Date: 2020-01-16