Abstract | BACKGROUND & AIMS: METHODS: In a prospective study, consecutive patients with decompensated cirrhosis seen at the Institute of Liver and Biliary Sciences, New Delhi (from May 2011 through June 2012) were randomly assigned to groups given subcutaneous G-CSF (5 μg/kg/d) for 5 days and then every third day (12 total doses), along with subcutaneous darbopoietin α(40 mcg/wk) for 4 weeks ( GDP group, n = 29), or only placebos (control group, n = 26). All patients also received standard medical therapy and were followed for 12 months. Histology was performed on liver biopsies. The primary end point was survival at 12 months. RESULTS: Baseline characteristics of patients were comparable; alcohol intake was the most common etiology of cirrhosis. A higher proportion of patients in the GDP group than controls survived until 12 months (68.6% vs 26.9%; P = .003). At 12 months, Child-Turcotte Pugh scores were reduced by 48.6% in the GDP group and 39.1% in the control group, from baseline (P = .001); Model for End Stage Liver Disease scores were reduced by 40.4% and 33%, respectively (P = .03). The need for large-volume paracentesis was significantly reduced in GDP group, compared with controls (P < .05). A lower proportion of patients in the GDP group developed septic shock (6.9%) during follow-up compared with controls (38.5%; P = .005). No major adverse events were observed in either group. CONCLUSIONS: In a single-center randomized trial, a significantly larger proportion of patients with decompensated cirrhosis given a combination of G-CSF and darbopoietin α survived for 12 months more than patients given only placebo. The combination therapy also reduced liver severity scores and sepsis to a greater extent than placebo. Clinicaltrials.gov ID: NCT01384565.
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Authors | Chandan Kumar Kedarisetty, Lovkesh Anand, Ankit Bhardwaj, Ajeet Singh Bhadoria, Guresh Kumar, Ashish Kumar Vyas, Paul David, Nirupama Trehanpati, Archana Rastogi, Chhagan Bihari, Rakhi Maiwall, Hitendra Kumar Garg, Chitranshu Vashishtha, Manoj Kumar, Vikram Bhatia, Shiv Kumar Sarin |
Journal | Gastroenterology
(Gastroenterology)
Vol. 148
Issue 7
Pg. 1362-70.e7
(Jun 2015)
ISSN: 1528-0012 [Electronic] United States |
PMID | 25749502
(Publication Type: Journal Article, Randomized Controlled Trial)
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Copyright | Copyright © 2015 AGA Institute. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Erythropoietin
- Granulocyte Colony-Stimulating Factor
- Darbepoetin alfa
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Topics |
- Adult
- Biopsy
- Darbepoetin alfa
- Disease Progression
- Double-Blind Method
- Drug Administration Schedule
- Drug Therapy, Combination
- Erythropoietin
(administration & dosage, adverse effects, analogs & derivatives)
- Female
- Granulocyte Colony-Stimulating Factor
(administration & dosage, adverse effects)
- Humans
- India
- Injections, Subcutaneous
- Kaplan-Meier Estimate
- Liver
(drug effects, pathology, physiopathology)
- Liver Cirrhosis
(diagnosis, drug therapy, etiology, mortality, physiopathology)
- Liver Regeneration
(drug effects)
- Male
- Middle Aged
- Paracentesis
- Proportional Hazards Models
- Prospective Studies
- Risk Factors
- Severity of Illness Index
- Shock, Septic
(etiology, prevention & control)
- Time Factors
- Treatment Outcome
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