Thalidomide for Recurrent Bleeding Due to Small-Intestinal Angiodysplasia

Recurrent bleeding from the small intestine accounts for 5 to 10% of cases of gastrointestinal bleeding and remains a therapeutic challenge. Thalidomide has been evaluated for the treatment of recurrent bleeding due to small-intestinal angiodysplasia (SIA), but confirmatory trials are lacking. We co...

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Veröffentlicht in:The New England journal of medicine 2023-11, Vol.389 (18), p.1649-1659
Hauptverfasser: Chen, Huimin, Wu, Shan, Tang, Mingyu, Zhao, Ran, Zhang, Qingwei, Dai, Zihao, Gao, Yunjie, Yang, Shiming, Li, Zhaoshen, Du, Yiqi, Yang, Aiming, Zhong, Liang, Lu, Lungen, Xu, Leiming, Shen, Xizhong, Liu, Side, Zhong, Jie, Li, Xiaobo, Lu, Hong, Xiong, Hua, Shen, Yufeng, Chen, Haiying, Gong, Shuai, Xue, Hanbing, Ge, Zhizheng
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container_end_page 1659
container_issue 18
container_start_page 1649
container_title The New England journal of medicine
container_volume 389
creator Chen, Huimin
Wu, Shan
Tang, Mingyu
Zhao, Ran
Zhang, Qingwei
Dai, Zihao
Gao, Yunjie
Yang, Shiming
Li, Zhaoshen
Du, Yiqi
Yang, Aiming
Zhong, Liang
Lu, Lungen
Xu, Leiming
Shen, Xizhong
Liu, Side
Zhong, Jie
Li, Xiaobo
Lu, Hong
Xiong, Hua
Shen, Yufeng
Chen, Haiying
Gong, Shuai
Xue, Hanbing
Ge, Zhizheng
description Recurrent bleeding from the small intestine accounts for 5 to 10% of cases of gastrointestinal bleeding and remains a therapeutic challenge. Thalidomide has been evaluated for the treatment of recurrent bleeding due to small-intestinal angiodysplasia (SIA), but confirmatory trials are lacking. We conducted a multicenter, double-blind, randomized, placebo-controlled trial to investigate the efficacy and safety of thalidomide for the treatment of recurrent bleeding due to SIA. Eligible patients with recurrent bleeding (at least four episodes of bleeding during the previous year) due to SIA were randomly assigned to receive thalidomide at an oral daily dose of 100 mg or 50 mg or placebo for 4 months. Patients were followed for at least 1 year after the end of the 4-month treatment period. The primary end point was effective response, which was defined as a reduction of at least 50% in the number of bleeding episodes that occurred during the year after the end of thalidomide treatment as compared with the number that occurred during the year before treatment. Key secondary end points were cessation of bleeding without rebleeding, blood transfusion, hospitalization because of bleeding, duration of bleeding, and hemoglobin levels. Overall, 150 patients underwent randomization: 51 to the 100-mg thalidomide group, 49 to the 50-mg thalidomide group, and 50 to the placebo group. The percentages of patients with an effective response in the 100-mg thalidomide group, 50-mg thalidomide group, and placebo group were 68.6%, 51.0%, and 16.0%, respectively (P
doi_str_mv 10.1056/NEJMoa2303706
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Thalidomide has been evaluated for the treatment of recurrent bleeding due to small-intestinal angiodysplasia (SIA), but confirmatory trials are lacking. We conducted a multicenter, double-blind, randomized, placebo-controlled trial to investigate the efficacy and safety of thalidomide for the treatment of recurrent bleeding due to SIA. Eligible patients with recurrent bleeding (at least four episodes of bleeding during the previous year) due to SIA were randomly assigned to receive thalidomide at an oral daily dose of 100 mg or 50 mg or placebo for 4 months. Patients were followed for at least 1 year after the end of the 4-month treatment period. The primary end point was effective response, which was defined as a reduction of at least 50% in the number of bleeding episodes that occurred during the year after the end of thalidomide treatment as compared with the number that occurred during the year before treatment. Key secondary end points were cessation of bleeding without rebleeding, blood transfusion, hospitalization because of bleeding, duration of bleeding, and hemoglobin levels. Overall, 150 patients underwent randomization: 51 to the 100-mg thalidomide group, 49 to the 50-mg thalidomide group, and 50 to the placebo group. The percentages of patients with an effective response in the 100-mg thalidomide group, 50-mg thalidomide group, and placebo group were 68.6%, 51.0%, and 16.0%, respectively (P&lt;0.001 for simultaneous comparison across the three groups). The results of the analyses of the secondary end points supported those of the primary end point. Adverse events were more common in the thalidomide groups than in the placebo group overall; specific events included constipation, somnolence, limb numbness, peripheral edema, dizziness, and elevated liver-enzyme levels. In this placebo-controlled trial, treatment with thalidomide resulted in a reduction in bleeding in patients with recurrent bleeding due to SIA. (Funded by the National Natural Science Foundation of China and the Shanghai Municipal Education Commission, Gaofeng Clinical Medicine; ClinicalTrials.gov number, NCT02707484.).</description><identifier>ISSN: 0028-4793</identifier><identifier>EISSN: 1533-4406</identifier><identifier>DOI: 10.1056/NEJMoa2303706</identifier><identifier>PMID: 37913505</identifier><language>eng</language><publisher>United States: Massachusetts Medical Society</publisher><subject>Administration, Oral ; Anemia ; Angiodysplasia - complications ; Angiodysplasia - drug therapy ; Bleeding ; Blood tests ; Blood transfusion ; China ; Clinical Medicine ; Clinical trials ; Constipation ; Double-Blind Method ; Edema ; Endoscopy ; Feces ; Gastroenterology ; Gastroenterology General ; Gastrointestinal Hemorrhage - drug therapy ; Gastrointestinal Hemorrhage - etiology ; Hematologic Agents - administration &amp; dosage ; Hematologic Agents - adverse effects ; Hematologic Agents - therapeutic use ; Hematology ; Hemoglobin ; Hospital-Based Clinical Medicine ; Humans ; Intestinal Diseases - complications ; Intestinal Diseases - drug therapy ; Intestine, Small - blood supply ; Oncology ; Patients ; Pilot projects ; Placebos ; Recurrence ; Small intestine ; Thalidomide ; Thalidomide - administration &amp; dosage ; Thalidomide - adverse effects ; Thalidomide - therapeutic use ; Treatment Outcome</subject><ispartof>The New England journal of medicine, 2023-11, Vol.389 (18), p.1649-1659</ispartof><rights>Copyright © 2023 Massachusetts Medical Society. All rights reserved.</rights><rights>Copyright © 2023 Massachusetts Medical Society.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c351t-b8f8e0dc0d6980ae0b687cfff63c94bf0f799e02d97eb4c29ff81e871cd4e8123</citedby><cites>FETCH-LOGICAL-c351t-b8f8e0dc0d6980ae0b687cfff63c94bf0f799e02d97eb4c29ff81e871cd4e8123</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.nejm.org/doi/pdf/10.1056/NEJMoa2303706$$EPDF$$P50$$Gmms$$H</linktopdf><linktohtml>$$Uhttps://www.nejm.org/doi/full/10.1056/NEJMoa2303706$$EHTML$$P50$$Gmms$$H</linktohtml><link.rule.ids>314,776,780,2746,2747,26080,27901,27902,52357,54039</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37913505$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Chen, Huimin</creatorcontrib><creatorcontrib>Wu, Shan</creatorcontrib><creatorcontrib>Tang, Mingyu</creatorcontrib><creatorcontrib>Zhao, Ran</creatorcontrib><creatorcontrib>Zhang, Qingwei</creatorcontrib><creatorcontrib>Dai, Zihao</creatorcontrib><creatorcontrib>Gao, Yunjie</creatorcontrib><creatorcontrib>Yang, Shiming</creatorcontrib><creatorcontrib>Li, Zhaoshen</creatorcontrib><creatorcontrib>Du, Yiqi</creatorcontrib><creatorcontrib>Yang, Aiming</creatorcontrib><creatorcontrib>Zhong, Liang</creatorcontrib><creatorcontrib>Lu, Lungen</creatorcontrib><creatorcontrib>Xu, Leiming</creatorcontrib><creatorcontrib>Shen, Xizhong</creatorcontrib><creatorcontrib>Liu, Side</creatorcontrib><creatorcontrib>Zhong, Jie</creatorcontrib><creatorcontrib>Li, Xiaobo</creatorcontrib><creatorcontrib>Lu, Hong</creatorcontrib><creatorcontrib>Xiong, Hua</creatorcontrib><creatorcontrib>Shen, Yufeng</creatorcontrib><creatorcontrib>Chen, Haiying</creatorcontrib><creatorcontrib>Gong, Shuai</creatorcontrib><creatorcontrib>Xue, Hanbing</creatorcontrib><creatorcontrib>Ge, Zhizheng</creatorcontrib><title>Thalidomide for Recurrent Bleeding Due to Small-Intestinal Angiodysplasia</title><title>The New England journal of medicine</title><addtitle>N Engl J Med</addtitle><description>Recurrent bleeding from the small intestine accounts for 5 to 10% of cases of gastrointestinal bleeding and remains a therapeutic challenge. Thalidomide has been evaluated for the treatment of recurrent bleeding due to small-intestinal angiodysplasia (SIA), but confirmatory trials are lacking. We conducted a multicenter, double-blind, randomized, placebo-controlled trial to investigate the efficacy and safety of thalidomide for the treatment of recurrent bleeding due to SIA. Eligible patients with recurrent bleeding (at least four episodes of bleeding during the previous year) due to SIA were randomly assigned to receive thalidomide at an oral daily dose of 100 mg or 50 mg or placebo for 4 months. Patients were followed for at least 1 year after the end of the 4-month treatment period. The primary end point was effective response, which was defined as a reduction of at least 50% in the number of bleeding episodes that occurred during the year after the end of thalidomide treatment as compared with the number that occurred during the year before treatment. Key secondary end points were cessation of bleeding without rebleeding, blood transfusion, hospitalization because of bleeding, duration of bleeding, and hemoglobin levels. Overall, 150 patients underwent randomization: 51 to the 100-mg thalidomide group, 49 to the 50-mg thalidomide group, and 50 to the placebo group. The percentages of patients with an effective response in the 100-mg thalidomide group, 50-mg thalidomide group, and placebo group were 68.6%, 51.0%, and 16.0%, respectively (P&lt;0.001 for simultaneous comparison across the three groups). The results of the analyses of the secondary end points supported those of the primary end point. Adverse events were more common in the thalidomide groups than in the placebo group overall; specific events included constipation, somnolence, limb numbness, peripheral edema, dizziness, and elevated liver-enzyme levels. In this placebo-controlled trial, treatment with thalidomide resulted in a reduction in bleeding in patients with recurrent bleeding due to SIA. (Funded by the National Natural Science Foundation of China and the Shanghai Municipal Education Commission, Gaofeng Clinical Medicine; ClinicalTrials.gov number, NCT02707484.).</description><subject>Administration, Oral</subject><subject>Anemia</subject><subject>Angiodysplasia - complications</subject><subject>Angiodysplasia - drug therapy</subject><subject>Bleeding</subject><subject>Blood tests</subject><subject>Blood transfusion</subject><subject>China</subject><subject>Clinical Medicine</subject><subject>Clinical trials</subject><subject>Constipation</subject><subject>Double-Blind Method</subject><subject>Edema</subject><subject>Endoscopy</subject><subject>Feces</subject><subject>Gastroenterology</subject><subject>Gastroenterology General</subject><subject>Gastrointestinal Hemorrhage - drug therapy</subject><subject>Gastrointestinal Hemorrhage - etiology</subject><subject>Hematologic Agents - administration &amp; dosage</subject><subject>Hematologic Agents - adverse effects</subject><subject>Hematologic Agents - therapeutic use</subject><subject>Hematology</subject><subject>Hemoglobin</subject><subject>Hospital-Based Clinical Medicine</subject><subject>Humans</subject><subject>Intestinal Diseases - complications</subject><subject>Intestinal Diseases - drug therapy</subject><subject>Intestine, Small - blood supply</subject><subject>Oncology</subject><subject>Patients</subject><subject>Pilot projects</subject><subject>Placebos</subject><subject>Recurrence</subject><subject>Small intestine</subject><subject>Thalidomide</subject><subject>Thalidomide - administration &amp; 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Wu, Shan ; Tang, Mingyu ; Zhao, Ran ; Zhang, Qingwei ; Dai, Zihao ; Gao, Yunjie ; Yang, Shiming ; Li, Zhaoshen ; Du, Yiqi ; Yang, Aiming ; Zhong, Liang ; Lu, Lungen ; Xu, Leiming ; Shen, Xizhong ; Liu, Side ; Zhong, Jie ; Li, Xiaobo ; Lu, Hong ; Xiong, Hua ; Shen, Yufeng ; Chen, Haiying ; Gong, Shuai ; Xue, Hanbing ; Ge, Zhizheng</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c351t-b8f8e0dc0d6980ae0b687cfff63c94bf0f799e02d97eb4c29ff81e871cd4e8123</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Administration, Oral</topic><topic>Anemia</topic><topic>Angiodysplasia - complications</topic><topic>Angiodysplasia - drug therapy</topic><topic>Bleeding</topic><topic>Blood tests</topic><topic>Blood transfusion</topic><topic>China</topic><topic>Clinical Medicine</topic><topic>Clinical trials</topic><topic>Constipation</topic><topic>Double-Blind Method</topic><topic>Edema</topic><topic>Endoscopy</topic><topic>Feces</topic><topic>Gastroenterology</topic><topic>Gastroenterology General</topic><topic>Gastrointestinal Hemorrhage - drug therapy</topic><topic>Gastrointestinal Hemorrhage - etiology</topic><topic>Hematologic Agents - administration &amp; 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Thalidomide has been evaluated for the treatment of recurrent bleeding due to small-intestinal angiodysplasia (SIA), but confirmatory trials are lacking. We conducted a multicenter, double-blind, randomized, placebo-controlled trial to investigate the efficacy and safety of thalidomide for the treatment of recurrent bleeding due to SIA. Eligible patients with recurrent bleeding (at least four episodes of bleeding during the previous year) due to SIA were randomly assigned to receive thalidomide at an oral daily dose of 100 mg or 50 mg or placebo for 4 months. Patients were followed for at least 1 year after the end of the 4-month treatment period. The primary end point was effective response, which was defined as a reduction of at least 50% in the number of bleeding episodes that occurred during the year after the end of thalidomide treatment as compared with the number that occurred during the year before treatment. Key secondary end points were cessation of bleeding without rebleeding, blood transfusion, hospitalization because of bleeding, duration of bleeding, and hemoglobin levels. Overall, 150 patients underwent randomization: 51 to the 100-mg thalidomide group, 49 to the 50-mg thalidomide group, and 50 to the placebo group. The percentages of patients with an effective response in the 100-mg thalidomide group, 50-mg thalidomide group, and placebo group were 68.6%, 51.0%, and 16.0%, respectively (P&lt;0.001 for simultaneous comparison across the three groups). The results of the analyses of the secondary end points supported those of the primary end point. Adverse events were more common in the thalidomide groups than in the placebo group overall; specific events included constipation, somnolence, limb numbness, peripheral edema, dizziness, and elevated liver-enzyme levels. In this placebo-controlled trial, treatment with thalidomide resulted in a reduction in bleeding in patients with recurrent bleeding due to SIA. (Funded by the National Natural Science Foundation of China and the Shanghai Municipal Education Commission, Gaofeng Clinical Medicine; ClinicalTrials.gov number, NCT02707484.).</abstract><cop>United States</cop><pub>Massachusetts Medical Society</pub><pmid>37913505</pmid><doi>10.1056/NEJMoa2303706</doi><tpages>11</tpages></addata></record>
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source MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; New England Journal of Medicine
subjects Administration, Oral
Anemia
Angiodysplasia - complications
Angiodysplasia - drug therapy
Bleeding
Blood tests
Blood transfusion
China
Clinical Medicine
Clinical trials
Constipation
Double-Blind Method
Edema
Endoscopy
Feces
Gastroenterology
Gastroenterology General
Gastrointestinal Hemorrhage - drug therapy
Gastrointestinal Hemorrhage - etiology
Hematologic Agents - administration & dosage
Hematologic Agents - adverse effects
Hematologic Agents - therapeutic use
Hematology
Hemoglobin
Hospital-Based Clinical Medicine
Humans
Intestinal Diseases - complications
Intestinal Diseases - drug therapy
Intestine, Small - blood supply
Oncology
Patients
Pilot projects
Placebos
Recurrence
Small intestine
Thalidomide
Thalidomide - administration & dosage
Thalidomide - adverse effects
Thalidomide - therapeutic use
Treatment Outcome
title Thalidomide for Recurrent Bleeding Due to Small-Intestinal Angiodysplasia
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