Liraglutide after diet-induced weight loss for pain and weight control in knee osteoarthritis: a randomized controlled trial
Weight loss is critical for preventing and managing obesity-related diseases. There is a notable lack of valid and reliable means to manage patients with overweight/obesity and knee osteoarthritis (KOA). To determine the efficacy and safety of liraglutide in a 30 mg/d dosing in patients with overwei...
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Veröffentlicht in: | The American journal of clinical nutrition 2021-02, Vol.113 (2), p.314-323 |
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creator | Gudbergsen, Henrik Overgaard, Anders Henriksen, Marius Wæhrens, Eva Ejlersen Bliddal, Henning Christensen, Robin Nielsen, Sabrina Mai Boesen, Mikael Knop, Filip Krag Astrup, Arne Rasmussen, Marianne Uggen Bartholdy, Cecilie Daugaard, Cecilie Laubjerg Ellegaard, Karen Heitmann, Berit Lilienthal Bartels, Else Marie Danneskiold-Samsøe, Bente Kristensen, Lars Erik |
description | Weight loss is critical for preventing and managing obesity-related diseases. There is a notable lack of valid and reliable means to manage patients with overweight/obesity and knee osteoarthritis (KOA).
To determine the efficacy and safety of liraglutide in a 30 mg/d dosing in patients with overweight/obesity and KOA.
The trial was designed as a randomized controlled trial including patients between the age of 18 and 74 y with KOA and a BMI ≥27 (measured in kg/m2). Patients underwent a pre–random assignment diet intervention (week –8 to 0). At week 0, patients having lost >5% of their body weight were randomly assigned to liraglutide 3 mg/d or placebo for 52 wk. The coprimary outcomes were changes in body weight and the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscale from week 0 to 52.
In total, 168 patients enrolled and 156 were randomly assigned to receive liraglutide or placebo. Patients experienced a significant reduction in body weight and KOOS pain during the pre–random assignment dietary intervention period (week −8 to 0). From week 0 to 52 there was a significant difference in body weight between the liraglutide and placebo group (mean changes: −2.8 and +1.2 kg, respectively; group difference, 3.9 kg; 95% CI: −6.9, −1.0; P = 0.008). There was, however, no group difference in KOOS pain (mean changes: 0.4 and –0.6 points, respectively; group difference, 0.9 points; 95% CI: −3.9, 5.7; P = 0.71). Treatment-emergent adverse events related to the gastrointestinal system were experienced by 50.2% and 39.2% of patients in the liraglutide and placebo groups, respectively.
In patients with KOA and overweight/obesity liraglutide added after an 8-wk pre–random assignment diet induced a significant weight loss at >52 wk but did not reduce knee pain compared to placebo. This trial was registered at clinicaltrials.gov as NCT02905864. |
doi_str_mv | 10.1093/ajcn/nqaa328 |
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To determine the efficacy and safety of liraglutide in a 30 mg/d dosing in patients with overweight/obesity and KOA.
The trial was designed as a randomized controlled trial including patients between the age of 18 and 74 y with KOA and a BMI ≥27 (measured in kg/m2). Patients underwent a pre–random assignment diet intervention (week –8 to 0). At week 0, patients having lost >5% of their body weight were randomly assigned to liraglutide 3 mg/d or placebo for 52 wk. The coprimary outcomes were changes in body weight and the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscale from week 0 to 52.
In total, 168 patients enrolled and 156 were randomly assigned to receive liraglutide or placebo. Patients experienced a significant reduction in body weight and KOOS pain during the pre–random assignment dietary intervention period (week −8 to 0). From week 0 to 52 there was a significant difference in body weight between the liraglutide and placebo group (mean changes: −2.8 and +1.2 kg, respectively; group difference, 3.9 kg; 95% CI: −6.9, −1.0; P = 0.008). There was, however, no group difference in KOOS pain (mean changes: 0.4 and –0.6 points, respectively; group difference, 0.9 points; 95% CI: −3.9, 5.7; P = 0.71). Treatment-emergent adverse events related to the gastrointestinal system were experienced by 50.2% and 39.2% of patients in the liraglutide and placebo groups, respectively.
In patients with KOA and overweight/obesity liraglutide added after an 8-wk pre–random assignment diet induced a significant weight loss at >52 wk but did not reduce knee pain compared to placebo. This trial was registered at clinicaltrials.gov as NCT02905864.</description><identifier>ISSN: 0002-9165</identifier><identifier>EISSN: 1938-3207</identifier><identifier>DOI: 10.1093/ajcn/nqaa328</identifier><identifier>PMID: 33471039</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adverse events ; Aged ; Arthritis ; Biomedical materials ; Body weight ; Body weight loss ; Clinical trials ; Diet ; Diet, Reducing ; Female ; Gastrointestinal system ; Humans ; Hypoglycemic Agents - therapeutic use ; intervention ; Knee ; liraglutide ; Liraglutide - therapeutic use ; Male ; Middle Aged ; Obesity ; Osteoarthritis ; Osteoarthritis, Knee - therapy ; Overweight ; Pain ; Pain - drug therapy ; Placebos ; Weight control ; Weight loss ; Weight Loss - drug effects</subject><ispartof>The American journal of clinical nutrition, 2021-02, Vol.113 (2), p.314-323</ispartof><rights>2021 American Society for Nutrition.</rights><rights>The Author(s) 2021. Published by Oxford University Press on behalf of the American Society for Nutrition. 2021</rights><rights>The Author(s) 2021. Published by Oxford University Press on behalf of the American Society for Nutrition.</rights><rights>Copyright American Society for Clinical Nutrition, Inc. Feb 2021</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c436t-4bbf038a1678239a9e125c681562fb17a5eae3c6f8d7129404e08f0a621894c53</citedby><cites>FETCH-LOGICAL-c436t-4bbf038a1678239a9e125c681562fb17a5eae3c6f8d7129404e08f0a621894c53</cites><orcidid>0000-0002-2273-5337</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33471039$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Gudbergsen, Henrik</creatorcontrib><creatorcontrib>Overgaard, Anders</creatorcontrib><creatorcontrib>Henriksen, Marius</creatorcontrib><creatorcontrib>Wæhrens, Eva Ejlersen</creatorcontrib><creatorcontrib>Bliddal, Henning</creatorcontrib><creatorcontrib>Christensen, Robin</creatorcontrib><creatorcontrib>Nielsen, Sabrina Mai</creatorcontrib><creatorcontrib>Boesen, Mikael</creatorcontrib><creatorcontrib>Knop, Filip Krag</creatorcontrib><creatorcontrib>Astrup, Arne</creatorcontrib><creatorcontrib>Rasmussen, Marianne Uggen</creatorcontrib><creatorcontrib>Bartholdy, Cecilie</creatorcontrib><creatorcontrib>Daugaard, Cecilie Laubjerg</creatorcontrib><creatorcontrib>Ellegaard, Karen</creatorcontrib><creatorcontrib>Heitmann, Berit Lilienthal</creatorcontrib><creatorcontrib>Bartels, Else Marie</creatorcontrib><creatorcontrib>Danneskiold-Samsøe, Bente</creatorcontrib><creatorcontrib>Kristensen, Lars Erik</creatorcontrib><title>Liraglutide after diet-induced weight loss for pain and weight control in knee osteoarthritis: a randomized controlled trial</title><title>The American journal of clinical nutrition</title><addtitle>Am J Clin Nutr</addtitle><description>Weight loss is critical for preventing and managing obesity-related diseases. There is a notable lack of valid and reliable means to manage patients with overweight/obesity and knee osteoarthritis (KOA).
To determine the efficacy and safety of liraglutide in a 30 mg/d dosing in patients with overweight/obesity and KOA.
The trial was designed as a randomized controlled trial including patients between the age of 18 and 74 y with KOA and a BMI ≥27 (measured in kg/m2). Patients underwent a pre–random assignment diet intervention (week –8 to 0). At week 0, patients having lost >5% of their body weight were randomly assigned to liraglutide 3 mg/d or placebo for 52 wk. The coprimary outcomes were changes in body weight and the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscale from week 0 to 52.
In total, 168 patients enrolled and 156 were randomly assigned to receive liraglutide or placebo. Patients experienced a significant reduction in body weight and KOOS pain during the pre–random assignment dietary intervention period (week −8 to 0). From week 0 to 52 there was a significant difference in body weight between the liraglutide and placebo group (mean changes: −2.8 and +1.2 kg, respectively; group difference, 3.9 kg; 95% CI: −6.9, −1.0; P = 0.008). There was, however, no group difference in KOOS pain (mean changes: 0.4 and –0.6 points, respectively; group difference, 0.9 points; 95% CI: −3.9, 5.7; P = 0.71). Treatment-emergent adverse events related to the gastrointestinal system were experienced by 50.2% and 39.2% of patients in the liraglutide and placebo groups, respectively.
In patients with KOA and overweight/obesity liraglutide added after an 8-wk pre–random assignment diet induced a significant weight loss at >52 wk but did not reduce knee pain compared to placebo. This trial was registered at clinicaltrials.gov as NCT02905864.</description><subject>Adverse events</subject><subject>Aged</subject><subject>Arthritis</subject><subject>Biomedical materials</subject><subject>Body weight</subject><subject>Body weight loss</subject><subject>Clinical trials</subject><subject>Diet</subject><subject>Diet, Reducing</subject><subject>Female</subject><subject>Gastrointestinal system</subject><subject>Humans</subject><subject>Hypoglycemic Agents - therapeutic use</subject><subject>intervention</subject><subject>Knee</subject><subject>liraglutide</subject><subject>Liraglutide - therapeutic use</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Obesity</subject><subject>Osteoarthritis</subject><subject>Osteoarthritis, Knee - therapy</subject><subject>Overweight</subject><subject>Pain</subject><subject>Pain - drug therapy</subject><subject>Placebos</subject><subject>Weight control</subject><subject>Weight loss</subject><subject>Weight Loss - drug effects</subject><issn>0002-9165</issn><issn>1938-3207</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkD1PHDEQhi0EgsuFjjqyRJGGBX_ser10COUD6SQaUltz3lnwZc8-bC9RIn48RnehQqLyyPPMO5qHkBPOzjnr5AWsrL_wjwBS6D0y453UlRSs3SczxpioOq6aI_IppRVjXNRaHZIjKeuWM9nNyPPCRbgfp-x6pDBkjLR3mCvn-8liT_-gu3_IdAwp0SFEugHnKfi3hg0-xzDS8vvbI9KQMgaI-SG67NIlBRoLHdbuXwnbwWMpc3QwfiYHA4wJj3fvnPz6_u3u-me1uP1xc321qGwtVa7q5XJgUgNXrRaygw65aKzSvFFiWPIWGgSUVg26b7noalYj0wMDJbjuatvIOTnd5m5ieJwwZbMKU_RlpSlCNJNcF21zcralbCzXRhzMJro1xL-GM_Oq2ryqNjvVBf-yC52Wa-zf4P9uC_B1C4Rp81GU2pJYJDw5jCZZh774dxFtNn1w7w--AFyxnUk</recordid><startdate>20210201</startdate><enddate>20210201</enddate><creator>Gudbergsen, Henrik</creator><creator>Overgaard, Anders</creator><creator>Henriksen, Marius</creator><creator>Wæhrens, Eva Ejlersen</creator><creator>Bliddal, Henning</creator><creator>Christensen, Robin</creator><creator>Nielsen, Sabrina Mai</creator><creator>Boesen, Mikael</creator><creator>Knop, Filip Krag</creator><creator>Astrup, Arne</creator><creator>Rasmussen, Marianne Uggen</creator><creator>Bartholdy, Cecilie</creator><creator>Daugaard, Cecilie Laubjerg</creator><creator>Ellegaard, Karen</creator><creator>Heitmann, Berit Lilienthal</creator><creator>Bartels, Else Marie</creator><creator>Danneskiold-Samsøe, Bente</creator><creator>Kristensen, Lars Erik</creator><general>Elsevier Inc</general><general>Oxford University Press</general><general>American Society for Clinical Nutrition, Inc</general><scope>6I.</scope><scope>AAFTH</scope><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>7QP</scope><scope>7T7</scope><scope>7TS</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>P64</scope><orcidid>https://orcid.org/0000-0002-2273-5337</orcidid></search><sort><creationdate>20210201</creationdate><title>Liraglutide after diet-induced weight loss for pain and weight control in knee osteoarthritis: a randomized controlled trial</title><author>Gudbergsen, Henrik ; Overgaard, Anders ; Henriksen, Marius ; Wæhrens, Eva Ejlersen ; Bliddal, Henning ; Christensen, Robin ; Nielsen, Sabrina Mai ; Boesen, Mikael ; Knop, Filip Krag ; Astrup, Arne ; Rasmussen, Marianne Uggen ; Bartholdy, Cecilie ; Daugaard, Cecilie Laubjerg ; Ellegaard, Karen ; Heitmann, Berit Lilienthal ; Bartels, Else Marie ; Danneskiold-Samsøe, Bente ; Kristensen, Lars Erik</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c436t-4bbf038a1678239a9e125c681562fb17a5eae3c6f8d7129404e08f0a621894c53</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Adverse events</topic><topic>Aged</topic><topic>Arthritis</topic><topic>Biomedical materials</topic><topic>Body weight</topic><topic>Body weight loss</topic><topic>Clinical trials</topic><topic>Diet</topic><topic>Diet, Reducing</topic><topic>Female</topic><topic>Gastrointestinal system</topic><topic>Humans</topic><topic>Hypoglycemic Agents - therapeutic use</topic><topic>intervention</topic><topic>Knee</topic><topic>liraglutide</topic><topic>Liraglutide - therapeutic use</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Obesity</topic><topic>Osteoarthritis</topic><topic>Osteoarthritis, Knee - therapy</topic><topic>Overweight</topic><topic>Pain</topic><topic>Pain - drug therapy</topic><topic>Placebos</topic><topic>Weight control</topic><topic>Weight loss</topic><topic>Weight Loss - drug effects</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Gudbergsen, Henrik</creatorcontrib><creatorcontrib>Overgaard, Anders</creatorcontrib><creatorcontrib>Henriksen, Marius</creatorcontrib><creatorcontrib>Wæhrens, Eva Ejlersen</creatorcontrib><creatorcontrib>Bliddal, Henning</creatorcontrib><creatorcontrib>Christensen, Robin</creatorcontrib><creatorcontrib>Nielsen, Sabrina Mai</creatorcontrib><creatorcontrib>Boesen, Mikael</creatorcontrib><creatorcontrib>Knop, Filip Krag</creatorcontrib><creatorcontrib>Astrup, Arne</creatorcontrib><creatorcontrib>Rasmussen, Marianne Uggen</creatorcontrib><creatorcontrib>Bartholdy, Cecilie</creatorcontrib><creatorcontrib>Daugaard, Cecilie Laubjerg</creatorcontrib><creatorcontrib>Ellegaard, Karen</creatorcontrib><creatorcontrib>Heitmann, Berit Lilienthal</creatorcontrib><creatorcontrib>Bartels, Else Marie</creatorcontrib><creatorcontrib>Danneskiold-Samsøe, Bente</creatorcontrib><creatorcontrib>Kristensen, Lars Erik</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Physical Education Index</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><jtitle>The American journal of clinical nutrition</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Gudbergsen, Henrik</au><au>Overgaard, Anders</au><au>Henriksen, Marius</au><au>Wæhrens, Eva Ejlersen</au><au>Bliddal, Henning</au><au>Christensen, Robin</au><au>Nielsen, Sabrina Mai</au><au>Boesen, Mikael</au><au>Knop, Filip Krag</au><au>Astrup, Arne</au><au>Rasmussen, Marianne Uggen</au><au>Bartholdy, Cecilie</au><au>Daugaard, Cecilie Laubjerg</au><au>Ellegaard, Karen</au><au>Heitmann, Berit Lilienthal</au><au>Bartels, Else Marie</au><au>Danneskiold-Samsøe, Bente</au><au>Kristensen, Lars Erik</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Liraglutide after diet-induced weight loss for pain and weight control in knee osteoarthritis: a randomized controlled trial</atitle><jtitle>The American journal of clinical nutrition</jtitle><addtitle>Am J Clin Nutr</addtitle><date>2021-02-01</date><risdate>2021</risdate><volume>113</volume><issue>2</issue><spage>314</spage><epage>323</epage><pages>314-323</pages><issn>0002-9165</issn><eissn>1938-3207</eissn><abstract>Weight loss is critical for preventing and managing obesity-related diseases. There is a notable lack of valid and reliable means to manage patients with overweight/obesity and knee osteoarthritis (KOA).
To determine the efficacy and safety of liraglutide in a 30 mg/d dosing in patients with overweight/obesity and KOA.
The trial was designed as a randomized controlled trial including patients between the age of 18 and 74 y with KOA and a BMI ≥27 (measured in kg/m2). Patients underwent a pre–random assignment diet intervention (week –8 to 0). At week 0, patients having lost >5% of their body weight were randomly assigned to liraglutide 3 mg/d or placebo for 52 wk. The coprimary outcomes were changes in body weight and the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscale from week 0 to 52.
In total, 168 patients enrolled and 156 were randomly assigned to receive liraglutide or placebo. Patients experienced a significant reduction in body weight and KOOS pain during the pre–random assignment dietary intervention period (week −8 to 0). From week 0 to 52 there was a significant difference in body weight between the liraglutide and placebo group (mean changes: −2.8 and +1.2 kg, respectively; group difference, 3.9 kg; 95% CI: −6.9, −1.0; P = 0.008). There was, however, no group difference in KOOS pain (mean changes: 0.4 and –0.6 points, respectively; group difference, 0.9 points; 95% CI: −3.9, 5.7; P = 0.71). Treatment-emergent adverse events related to the gastrointestinal system were experienced by 50.2% and 39.2% of patients in the liraglutide and placebo groups, respectively.
In patients with KOA and overweight/obesity liraglutide added after an 8-wk pre–random assignment diet induced a significant weight loss at >52 wk but did not reduce knee pain compared to placebo. This trial was registered at clinicaltrials.gov as NCT02905864.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>33471039</pmid><doi>10.1093/ajcn/nqaa328</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0002-2273-5337</orcidid><oa>free_for_read</oa></addata></record> |
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subjects | Adverse events Aged Arthritis Biomedical materials Body weight Body weight loss Clinical trials Diet Diet, Reducing Female Gastrointestinal system Humans Hypoglycemic Agents - therapeutic use intervention Knee liraglutide Liraglutide - therapeutic use Male Middle Aged Obesity Osteoarthritis Osteoarthritis, Knee - therapy Overweight Pain Pain - drug therapy Placebos Weight control Weight loss Weight Loss - drug effects |
title | Liraglutide after diet-induced weight loss for pain and weight control in knee osteoarthritis: a randomized controlled trial |
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