Once‐weekly semaglutide use in patients with type 2 diabetes: Real‐world data from the SURE Italy observational study
Aims SURE Italy, a multicentre, prospective, open‐label, observational, real‐world study, investigated once‐weekly semaglutide in patients with type 2 diabetes (T2D) in routine clinical practice. Materials and Methods Adults with T2D and ≥1 documented glycated haemoglobin (HbA1c) level within 12 wee...
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| Veröffentlicht in: | Diabetes, obesity & metabolism obesity & metabolism, 2023-06, Vol.25 (6), p.1658-1667 |
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| creator | Napoli, Raffaele Berra, Cesare Catarig, Andrei‐Mircea Di Loreto, Chiara Donatiello, Emily Berentzen, Tina Landsvig Pitocco, Dario Giorgino, Francesco |
| description | Aims
SURE Italy, a multicentre, prospective, open‐label, observational, real‐world study, investigated once‐weekly semaglutide in patients with type 2 diabetes (T2D) in routine clinical practice.
Materials and Methods
Adults with T2D and ≥1 documented glycated haemoglobin (HbA1c) level within 12 weeks of semaglutide initiation were enrolled. The primary endpoint was change in HbA1c from baseline to end of study (EOS; ~30 weeks). Other endpoints included changes in body weight, waist circumference and patient‐reported outcomes, and the proportion of patients achieving HbA1c |
| doi_str_mv | 10.1111/dom.15020 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2777012260</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2808507721</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3880-aea1acaf3987ea6e5193ba7128983a1238958adac7f69b7e344cac013936339f3</originalsourceid><addsrcrecordid>eNp1kc1O3DAQgK0KVGDbAy-ALHEph4B_dmObW7XQshJoJVrO0SSZQMCJF9thlVsfoc_YJ6lhKYdK-DI-fPNppI-Qfc6OeXonteuO-YwJ9oHs8mkuMy5FvvXyF5k2TOyQvRDuGWNTqdVHsiNzpU2uxS4Zl32Ff379XiM-2JEG7ODWDrGtkQ4BadvTFcQW-xjouo13NI4rpILWLZQYMZzSawT7vO-8rWkNEWjjXUfjHdIfN9fndBEheV0Z0D8lk-vB0hCHevxEthuwAT-_zgm5-Xb-c36RXS6_L-ZfL7NKas0yQOBQQSONVgg5zriRJSgutNESuJDazDTUUKkmN6VCOZ1WUDEujcylNI2ckC8b78q7xwFDLLo2VGgt9OiGUAilFONC5Cyhh_-h927w6eJEaaZnTCnBE3W0oSrvQvDYFCvfduDHgrPiuUeRehQvPRJ78Gocyg7rN_JfgAScbIB1a3F831ScLa82yr96u5Yp</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2808507721</pqid></control><display><type>article</type><title>Once‐weekly semaglutide use in patients with type 2 diabetes: Real‐world data from the SURE Italy observational study</title><source>Wiley-Blackwell Journals</source><source>MEDLINE</source><creator>Napoli, Raffaele ; Berra, Cesare ; Catarig, Andrei‐Mircea ; Di Loreto, Chiara ; Donatiello, Emily ; Berentzen, Tina Landsvig ; Pitocco, Dario ; Giorgino, Francesco</creator><creatorcontrib>Napoli, Raffaele ; Berra, Cesare ; Catarig, Andrei‐Mircea ; Di Loreto, Chiara ; Donatiello, Emily ; Berentzen, Tina Landsvig ; Pitocco, Dario ; Giorgino, Francesco</creatorcontrib><description><![CDATA[Aims
SURE Italy, a multicentre, prospective, open‐label, observational, real‐world study, investigated once‐weekly semaglutide in patients with type 2 diabetes (T2D) in routine clinical practice.
Materials and Methods
Adults with T2D and ≥1 documented glycated haemoglobin (HbA1c) level within 12 weeks of semaglutide initiation were enrolled. The primary endpoint was change in HbA1c from baseline to end of study (EOS; ~30 weeks). Other endpoints included changes in body weight, waist circumference and patient‐reported outcomes, and the proportion of patients achieving HbA1c <7.0% or <6.5%, weight loss ≥5% and a post‐hoc composite endpoint (HbA1c reduction of ≥1%‐point and weight loss ≥5%). These endpoints were reported for patients on semaglutide at EOS [effectiveness analysis set (EAS)]. Safety data were reported in the full analysis set.
Results
Of 579 patients who initiated semaglutide (full analysis set), 491 completed the study on treatment (EAS). Mean baseline HbA1c was 8.0%, and 20.7% (120 of 579) of patients had HbA1c <7.0%. Mean semaglutide dose at EOS was 0.66 ± 0.28 mg. In the EAS, mean HbA1c and body weight decreased by 1.1%‐point (95% confidence interval 1.20, 1.05; P < .0001) and 4.2 kg (95% confidence interval 4.63, 3.67; P < .0001), respectively. At EOS, 61.7% and 40.8% of patients achieved HbA1c <7.0% and <6.5%, respectively, 40.5% achieved weight loss ≥5% and 25.3% achieved the post‐hoc composite endpoint. Patient‐reported outcomes improved from baseline to EOS. No new safety concerns were identified.
Conclusions
In routine clinical practice in Italy, patients with T2D treated with once‐weekly semaglutide for 30 weeks achieved clinically significant improvements in HbA1c, body weight and other outcomes.]]></description><identifier>ISSN: 1462-8902</identifier><identifier>EISSN: 1463-1326</identifier><identifier>DOI: 10.1111/dom.15020</identifier><identifier>PMID: 36789682</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Adult ; Antidiabetics ; Body Weight ; Body weight loss ; Clinical medicine ; Confidence intervals ; Diabetes ; Diabetes mellitus (non-insulin dependent) ; Diabetes Mellitus, Type 2 - chemically induced ; Diabetes Mellitus, Type 2 - complications ; Diabetes Mellitus, Type 2 - drug therapy ; GLP‐1 analogue ; Glucagon-Like Peptides - adverse effects ; glycaemic control ; Glycated Hemoglobin ; Hemoglobin ; Humans ; Hypoglycemic Agents - adverse effects ; Observational studies ; observational study ; Patients ; Prospective Studies ; real‐world evidence ; semaglutide ; type 2 diabetes ; Weight Loss</subject><ispartof>Diabetes, obesity & metabolism, 2023-06, Vol.25 (6), p.1658-1667</ispartof><rights>2023 The Authors. published by John Wiley & Sons Ltd.</rights><rights>2023 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.</rights><rights>2023. This article is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3880-aea1acaf3987ea6e5193ba7128983a1238958adac7f69b7e344cac013936339f3</citedby><cites>FETCH-LOGICAL-c3880-aea1acaf3987ea6e5193ba7128983a1238958adac7f69b7e344cac013936339f3</cites><orcidid>0000-0002-3366-2321 ; 0000-0001-7372-2678</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fdom.15020$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fdom.15020$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36789682$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Napoli, Raffaele</creatorcontrib><creatorcontrib>Berra, Cesare</creatorcontrib><creatorcontrib>Catarig, Andrei‐Mircea</creatorcontrib><creatorcontrib>Di Loreto, Chiara</creatorcontrib><creatorcontrib>Donatiello, Emily</creatorcontrib><creatorcontrib>Berentzen, Tina Landsvig</creatorcontrib><creatorcontrib>Pitocco, Dario</creatorcontrib><creatorcontrib>Giorgino, Francesco</creatorcontrib><title>Once‐weekly semaglutide use in patients with type 2 diabetes: Real‐world data from the SURE Italy observational study</title><title>Diabetes, obesity & metabolism</title><addtitle>Diabetes Obes Metab</addtitle><description><![CDATA[Aims
SURE Italy, a multicentre, prospective, open‐label, observational, real‐world study, investigated once‐weekly semaglutide in patients with type 2 diabetes (T2D) in routine clinical practice.
Materials and Methods
Adults with T2D and ≥1 documented glycated haemoglobin (HbA1c) level within 12 weeks of semaglutide initiation were enrolled. The primary endpoint was change in HbA1c from baseline to end of study (EOS; ~30 weeks). Other endpoints included changes in body weight, waist circumference and patient‐reported outcomes, and the proportion of patients achieving HbA1c <7.0% or <6.5%, weight loss ≥5% and a post‐hoc composite endpoint (HbA1c reduction of ≥1%‐point and weight loss ≥5%). These endpoints were reported for patients on semaglutide at EOS [effectiveness analysis set (EAS)]. Safety data were reported in the full analysis set.
Results
Of 579 patients who initiated semaglutide (full analysis set), 491 completed the study on treatment (EAS). Mean baseline HbA1c was 8.0%, and 20.7% (120 of 579) of patients had HbA1c <7.0%. Mean semaglutide dose at EOS was 0.66 ± 0.28 mg. In the EAS, mean HbA1c and body weight decreased by 1.1%‐point (95% confidence interval 1.20, 1.05; P < .0001) and 4.2 kg (95% confidence interval 4.63, 3.67; P < .0001), respectively. At EOS, 61.7% and 40.8% of patients achieved HbA1c <7.0% and <6.5%, respectively, 40.5% achieved weight loss ≥5% and 25.3% achieved the post‐hoc composite endpoint. Patient‐reported outcomes improved from baseline to EOS. No new safety concerns were identified.
Conclusions
In routine clinical practice in Italy, patients with T2D treated with once‐weekly semaglutide for 30 weeks achieved clinically significant improvements in HbA1c, body weight and other outcomes.]]></description><subject>Adult</subject><subject>Antidiabetics</subject><subject>Body Weight</subject><subject>Body weight loss</subject><subject>Clinical medicine</subject><subject>Confidence intervals</subject><subject>Diabetes</subject><subject>Diabetes mellitus (non-insulin dependent)</subject><subject>Diabetes Mellitus, Type 2 - chemically induced</subject><subject>Diabetes Mellitus, Type 2 - complications</subject><subject>Diabetes Mellitus, Type 2 - drug therapy</subject><subject>GLP‐1 analogue</subject><subject>Glucagon-Like Peptides - adverse effects</subject><subject>glycaemic control</subject><subject>Glycated Hemoglobin</subject><subject>Hemoglobin</subject><subject>Humans</subject><subject>Hypoglycemic Agents - adverse effects</subject><subject>Observational studies</subject><subject>observational study</subject><subject>Patients</subject><subject>Prospective Studies</subject><subject>real‐world evidence</subject><subject>semaglutide</subject><subject>type 2 diabetes</subject><subject>Weight Loss</subject><issn>1462-8902</issn><issn>1463-1326</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>EIF</sourceid><recordid>eNp1kc1O3DAQgK0KVGDbAy-ALHEph4B_dmObW7XQshJoJVrO0SSZQMCJF9thlVsfoc_YJ6lhKYdK-DI-fPNppI-Qfc6OeXonteuO-YwJ9oHs8mkuMy5FvvXyF5k2TOyQvRDuGWNTqdVHsiNzpU2uxS4Zl32Ff379XiM-2JEG7ODWDrGtkQ4BadvTFcQW-xjouo13NI4rpILWLZQYMZzSawT7vO-8rWkNEWjjXUfjHdIfN9fndBEheV0Z0D8lk-vB0hCHevxEthuwAT-_zgm5-Xb-c36RXS6_L-ZfL7NKas0yQOBQQSONVgg5zriRJSgutNESuJDazDTUUKkmN6VCOZ1WUDEujcylNI2ckC8b78q7xwFDLLo2VGgt9OiGUAilFONC5Cyhh_-h927w6eJEaaZnTCnBE3W0oSrvQvDYFCvfduDHgrPiuUeRehQvPRJ78Gocyg7rN_JfgAScbIB1a3F831ScLa82yr96u5Yp</recordid><startdate>202306</startdate><enddate>202306</enddate><creator>Napoli, Raffaele</creator><creator>Berra, Cesare</creator><creator>Catarig, Andrei‐Mircea</creator><creator>Di Loreto, Chiara</creator><creator>Donatiello, Emily</creator><creator>Berentzen, Tina Landsvig</creator><creator>Pitocco, Dario</creator><creator>Giorgino, Francesco</creator><general>Blackwell Publishing Ltd</general><general>Wiley Subscription Services, Inc</general><scope>24P</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>7T5</scope><scope>7TK</scope><scope>H94</scope><scope>K9.</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-3366-2321</orcidid><orcidid>https://orcid.org/0000-0001-7372-2678</orcidid></search><sort><creationdate>202306</creationdate><title>Once‐weekly semaglutide use in patients with type 2 diabetes: Real‐world data from the SURE Italy observational study</title><author>Napoli, Raffaele ; Berra, Cesare ; Catarig, Andrei‐Mircea ; Di Loreto, Chiara ; Donatiello, Emily ; Berentzen, Tina Landsvig ; Pitocco, Dario ; Giorgino, Francesco</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3880-aea1acaf3987ea6e5193ba7128983a1238958adac7f69b7e344cac013936339f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Adult</topic><topic>Antidiabetics</topic><topic>Body Weight</topic><topic>Body weight loss</topic><topic>Clinical medicine</topic><topic>Confidence intervals</topic><topic>Diabetes</topic><topic>Diabetes mellitus (non-insulin dependent)</topic><topic>Diabetes Mellitus, Type 2 - chemically induced</topic><topic>Diabetes Mellitus, Type 2 - complications</topic><topic>Diabetes Mellitus, Type 2 - drug therapy</topic><topic>GLP‐1 analogue</topic><topic>Glucagon-Like Peptides - adverse effects</topic><topic>glycaemic control</topic><topic>Glycated Hemoglobin</topic><topic>Hemoglobin</topic><topic>Humans</topic><topic>Hypoglycemic Agents - adverse effects</topic><topic>Observational studies</topic><topic>observational study</topic><topic>Patients</topic><topic>Prospective Studies</topic><topic>real‐world evidence</topic><topic>semaglutide</topic><topic>type 2 diabetes</topic><topic>Weight Loss</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Napoli, Raffaele</creatorcontrib><creatorcontrib>Berra, Cesare</creatorcontrib><creatorcontrib>Catarig, Andrei‐Mircea</creatorcontrib><creatorcontrib>Di Loreto, Chiara</creatorcontrib><creatorcontrib>Donatiello, Emily</creatorcontrib><creatorcontrib>Berentzen, Tina Landsvig</creatorcontrib><creatorcontrib>Pitocco, Dario</creatorcontrib><creatorcontrib>Giorgino, Francesco</creatorcontrib><collection>Wiley Online Library</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Diabetes, obesity & metabolism</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Napoli, Raffaele</au><au>Berra, Cesare</au><au>Catarig, Andrei‐Mircea</au><au>Di Loreto, Chiara</au><au>Donatiello, Emily</au><au>Berentzen, Tina Landsvig</au><au>Pitocco, Dario</au><au>Giorgino, Francesco</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Once‐weekly semaglutide use in patients with type 2 diabetes: Real‐world data from the SURE Italy observational study</atitle><jtitle>Diabetes, obesity & metabolism</jtitle><addtitle>Diabetes Obes Metab</addtitle><date>2023-06</date><risdate>2023</risdate><volume>25</volume><issue>6</issue><spage>1658</spage><epage>1667</epage><pages>1658-1667</pages><issn>1462-8902</issn><eissn>1463-1326</eissn><abstract><![CDATA[Aims
SURE Italy, a multicentre, prospective, open‐label, observational, real‐world study, investigated once‐weekly semaglutide in patients with type 2 diabetes (T2D) in routine clinical practice.
Materials and Methods
Adults with T2D and ≥1 documented glycated haemoglobin (HbA1c) level within 12 weeks of semaglutide initiation were enrolled. The primary endpoint was change in HbA1c from baseline to end of study (EOS; ~30 weeks). Other endpoints included changes in body weight, waist circumference and patient‐reported outcomes, and the proportion of patients achieving HbA1c <7.0% or <6.5%, weight loss ≥5% and a post‐hoc composite endpoint (HbA1c reduction of ≥1%‐point and weight loss ≥5%). These endpoints were reported for patients on semaglutide at EOS [effectiveness analysis set (EAS)]. Safety data were reported in the full analysis set.
Results
Of 579 patients who initiated semaglutide (full analysis set), 491 completed the study on treatment (EAS). Mean baseline HbA1c was 8.0%, and 20.7% (120 of 579) of patients had HbA1c <7.0%. Mean semaglutide dose at EOS was 0.66 ± 0.28 mg. In the EAS, mean HbA1c and body weight decreased by 1.1%‐point (95% confidence interval 1.20, 1.05; P < .0001) and 4.2 kg (95% confidence interval 4.63, 3.67; P < .0001), respectively. At EOS, 61.7% and 40.8% of patients achieved HbA1c <7.0% and <6.5%, respectively, 40.5% achieved weight loss ≥5% and 25.3% achieved the post‐hoc composite endpoint. Patient‐reported outcomes improved from baseline to EOS. No new safety concerns were identified.
Conclusions
In routine clinical practice in Italy, patients with T2D treated with once‐weekly semaglutide for 30 weeks achieved clinically significant improvements in HbA1c, body weight and other outcomes.]]></abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>36789682</pmid><doi>10.1111/dom.15020</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0002-3366-2321</orcidid><orcidid>https://orcid.org/0000-0001-7372-2678</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | Diabetes, obesity & metabolism, 2023-06, Vol.25 (6), p.1658-1667 |
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| source | Wiley-Blackwell Journals; MEDLINE |
| subjects | Adult Antidiabetics Body Weight Body weight loss Clinical medicine Confidence intervals Diabetes Diabetes mellitus (non-insulin dependent) Diabetes Mellitus, Type 2 - chemically induced Diabetes Mellitus, Type 2 - complications Diabetes Mellitus, Type 2 - drug therapy GLP‐1 analogue Glucagon-Like Peptides - adverse effects glycaemic control Glycated Hemoglobin Hemoglobin Humans Hypoglycemic Agents - adverse effects Observational studies observational study Patients Prospective Studies real‐world evidence semaglutide type 2 diabetes Weight Loss |
| title | Once‐weekly semaglutide use in patients with type 2 diabetes: Real‐world data from the SURE Italy observational study |
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