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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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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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<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 & 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</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<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 & 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 & dosage</subject><subject>Thalidomide - adverse effects</subject><subject>Thalidomide - therapeutic use</subject><subject>Treatment Outcome</subject><issn>0028-4793</issn><issn>1533-4406</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BEC</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp10EtLxDAUBeAgio6jS7dSEMFN9abpI1nq-BrxAT7WJU1uxg5pMybtYv69lRkFBe_mbj4Oh0PIAYVTCll-9nh19-BkwoAVkG-QEc0Yi9MU8k0yAkh4nBaC7ZDdEOYwHE3FNtlhhaAsg2xEpq_v0tbaNbXGyDgfPaPqvce2iy4soq7bWXTZY9S56KWR1sbTtsPQ1a200Xk7q51ehoWVoZZ7ZMtIG3B__cfk7frqdXIb3z_dTCfn97FiGe3iihuOoBXoXHCQCFXOC2WMyZkSaWXAFEIgJFoUWKUqEcZwirygSqfIacLG5GSVu_Duox-6lE0dFForW3R9KBPOs4wVFGCgR3_o3PV-qL5SCeNJSgcVr5TyLgSPplz4upF-WVIovzYuf208-MN1al81qH_096gDOF6Bpglli_Pmn6BPkT6CBQ</recordid><startdate>20231102</startdate><enddate>20231102</enddate><creator>Chen, Huimin</creator><creator>Wu, Shan</creator><creator>Tang, Mingyu</creator><creator>Zhao, Ran</creator><creator>Zhang, Qingwei</creator><creator>Dai, Zihao</creator><creator>Gao, Yunjie</creator><creator>Yang, Shiming</creator><creator>Li, Zhaoshen</creator><creator>Du, Yiqi</creator><creator>Yang, Aiming</creator><creator>Zhong, Liang</creator><creator>Lu, Lungen</creator><creator>Xu, Leiming</creator><creator>Shen, Xizhong</creator><creator>Liu, Side</creator><creator>Zhong, Jie</creator><creator>Li, Xiaobo</creator><creator>Lu, Hong</creator><creator>Xiong, Hua</creator><creator>Shen, Yufeng</creator><creator>Chen, Haiying</creator><creator>Gong, Shuai</creator><creator>Xue, Hanbing</creator><creator>Ge, Zhizheng</creator><general>Massachusetts Medical Society</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>0TZ</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>8AO</scope><scope>8C1</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AN0</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BEC</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>HCIFZ</scope><scope>K0Y</scope><scope>LK8</scope><scope>M0R</scope><scope>M0T</scope><scope>M1P</scope><scope>M2M</scope><scope>M2O</scope><scope>M2P</scope><scope>M7P</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>20231102</creationdate><title>Thalidomide for Recurrent Bleeding Due to Small-Intestinal Angiodysplasia</title><author>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</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 & dosage</topic><topic>Hematologic Agents - adverse effects</topic><topic>Hematologic Agents - therapeutic use</topic><topic>Hematology</topic><topic>Hemoglobin</topic><topic>Hospital-Based Clinical Medicine</topic><topic>Humans</topic><topic>Intestinal Diseases - complications</topic><topic>Intestinal Diseases - drug therapy</topic><topic>Intestine, Small - blood supply</topic><topic>Oncology</topic><topic>Patients</topic><topic>Pilot projects</topic><topic>Placebos</topic><topic>Recurrence</topic><topic>Small intestine</topic><topic>Thalidomide</topic><topic>Thalidomide - 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Academic</collection><jtitle>The New England journal of medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Chen, Huimin</au><au>Wu, Shan</au><au>Tang, Mingyu</au><au>Zhao, Ran</au><au>Zhang, Qingwei</au><au>Dai, Zihao</au><au>Gao, Yunjie</au><au>Yang, Shiming</au><au>Li, Zhaoshen</au><au>Du, Yiqi</au><au>Yang, Aiming</au><au>Zhong, Liang</au><au>Lu, Lungen</au><au>Xu, Leiming</au><au>Shen, Xizhong</au><au>Liu, Side</au><au>Zhong, Jie</au><au>Li, Xiaobo</au><au>Lu, Hong</au><au>Xiong, Hua</au><au>Shen, Yufeng</au><au>Chen, Haiying</au><au>Gong, Shuai</au><au>Xue, Hanbing</au><au>Ge, Zhizheng</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Thalidomide for Recurrent Bleeding Due to Small-Intestinal Angiodysplasia</atitle><jtitle>The New England journal of medicine</jtitle><addtitle>N Engl J Med</addtitle><date>2023-11-02</date><risdate>2023</risdate><volume>389</volume><issue>18</issue><spage>1649</spage><epage>1659</epage><pages>1649-1659</pages><issn>0028-4793</issn><eissn>1533-4406</eissn><abstract>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<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 |
url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-08T07%3A59%3A15IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Thalidomide%20for%20Recurrent%20Bleeding%20Due%20to%20Small-Intestinal%20Angiodysplasia&rft.jtitle=The%20New%20England%20journal%20of%20medicine&rft.au=Chen,%20Huimin&rft.date=2023-11-02&rft.volume=389&rft.issue=18&rft.spage=1649&rft.epage=1659&rft.pages=1649-1659&rft.issn=0028-4793&rft.eissn=1533-4406&rft_id=info:doi/10.1056/NEJMoa2303706&rft_dat=%3Cproquest_cross%3E2885238241%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2885238241&rft_id=info:pmid/37913505&rfr_iscdi=true |