Seung Ha Park1, Dong Joon Kim2, Young Seok Kim3, Hyung Joon Yim4, Won Young Tak5, Heon Ju Lee6, Joo Hyun Sohn7, Ki Tae Yoon8, In Hee Kim9, Hyoung Su Kim10, Soon Ho Um11, Soon Koo Baik12, June Sung Lee13, Ki Tae Suk14, Sang Gyune Kim3, Sang Jun Suh4, Soo Young Park5, Tae Yeob Kim7, Jae Young Jang15. 1. Department of Internal Medicine, Inje University Haeundae Paik-Hospital, Inje University College of Medicine, Busan, Republic of Korea. 2. Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Republic of Korea. Electronic address: djkim@hallym.ac.kr. 3. Department of Internal Medicine, Soonchunhyang University College of Medicine, Bucheon, Republic of Korea. 4. Department of Internal Medicine, Korea University College of Medicine, Ansan, Republic of Korea. 5. Department of Internal Medicine, Kyungpook National University College of Medicine, Daegu, Republic of Korea. 6. Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Republic of Korea. 7. Department of Internal Medicine, Hanyang University College of Medicine, Guri, Republic of Korea. 8. Department of Internal Medicine, Pusan National University School of Medicine, Yangsan, Republic of Korea. 9. Department of Internal Medicine, Chonbuk National University Medical School, Jeonju, Republic of Korea. 10. Department of Internal Medicine, Hallym University College of Medicine, Seoul, Republic of Korea. 11. Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea. 12. Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea. 13. Department of Internal Medicine, Inje University College of Medicine, Goyang, Republic of Korea. 14. Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Republic of Korea. 15. Department of Internal Medicine, Soonchunhyang University College of Medicine, Seoul, Republic of Korea.
Abstract
BACKGROUND & AIMS: Both corticosteroid and pentoxifylline reduce short-term mortality in severe alcoholic hepatitis. However, few studies have directly compared the efficacy of pentoxifylline and corticosteroid in patients with this condition. METHODS: In this multicentre, open-labelled, randomised non-inferiority trial, we assigned 121 patients with severe alcoholic hepatitis (Maddrey's discriminant function ⩾32) to receive either pentoxifylline (400 mg, 3 times daily, in 62 subjects) or prednisolone (40 mg daily, in 59 subjects). The primary end point was non-inferiority in survival at the 1 month time point for the pentoxifylline treatment compared with prednisolone. RESULTS: The 1-month survival rate of patients receiving pentoxifylline was 75.8% (15 deaths) compared with 88.1% (7 deaths) in those, taking prednisolone, for a treatment difference of 12.3% (95% confidence interval, -4.2% to 28.7%; p = 0.08). The 95% confidence interval for the observed difference exceeded the predefined margin of non-inferiority (Δ15%) and included zero. The 6-month survival rate was not significantly different between the pentoxifylline and prednisolone groups (64.5% vs. 72.9%; p = 0.23). At 7 days, the response to therapy assessed by the Lille model was significantly lower in the prednisolone group (n = 58) than in the pentoxifylline group (n = 5 9): 0.35 vs. 0.50 (p = 0.012). Hepatitis complications, including hepatorenal syndrome and side effects, such as infection and gastrointestinal bleeding, were similar in the two groups. CONCLUSIONS: The findings demonstrate that the efficacy of the pentoxifylline is not statistically equivalent to the efficacy of prednisolone, supporting the use of prednisolone as a preferred treatment option in patients with severe alcoholic hepatitis.
RCT Entities:
BACKGROUND & AIMS: Both corticosteroid and pentoxifylline reduce short-term mortality in severe alcoholic hepatitis. However, few studies have directly compared the efficacy of pentoxifylline and corticosteroid in patients with this condition. METHODS: In this multicentre, open-labelled, randomised non-inferiority trial, we assigned 121 patients with severe alcoholic hepatitis (Maddrey's discriminant function ⩾32) to receive either pentoxifylline (400 mg, 3 times daily, in 62 subjects) or prednisolone (40 mg daily, in 59 subjects). The primary end point was non-inferiority in survival at the 1 month time point for the pentoxifylline treatment compared with prednisolone. RESULTS: The 1-month survival rate of patients receiving pentoxifylline was 75.8% (15 deaths) compared with 88.1% (7 deaths) in those, taking prednisolone, for a treatment difference of 12.3% (95% confidence interval, -4.2% to 28.7%; p = 0.08). The 95% confidence interval for the observed difference exceeded the predefined margin of non-inferiority (Δ15%) and included zero. The 6-month survival rate was not significantly different between the pentoxifylline and prednisolone groups (64.5% vs. 72.9%; p = 0.23). At 7 days, the response to therapy assessed by the Lille model was significantly lower in the prednisolone group (n = 58) than in the pentoxifylline group (n = 5 9): 0.35 vs. 0.50 (p = 0.012). Hepatitis complications, including hepatorenal syndrome and side effects, such as infection and gastrointestinal bleeding, were similar in the two groups. CONCLUSIONS: The findings demonstrate that the efficacy of the pentoxifylline is not statistically equivalent to the efficacy of prednisolone, supporting the use of prednisolone as a preferred treatment option in patients with severe alcoholic hepatitis.
Authors: Elena Buzzetti; Maria Kalafateli; Douglas Thorburn; Brian R Davidson; Maja Thiele; Lise Lotte Gluud; Cinzia Del Giovane; Gro Askgaard; Aleksander Krag; Emmanuel Tsochatzis; Kurinchi Selvan Gurusamy Journal: Cochrane Database Syst Rev Date: 2017-03-31
Authors: Fátima Higuera-de la Tijera; Alfredo I Servín-Caamaño; Aurora E Serralde-Zúñiga; Javier Cruz-Herrera; Eduardo Pérez-Torres; Juan M Abdo-Francis; Francisco Salas-Gordillo; José L Pérez-Hernández Journal: World J Gastroenterol Date: 2015-04-28 Impact factor: 5.742
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