Effects of Semaglutide on Albuminuria and Kidney Function in People With Overweight or Obesity With or Without Type 2 Diabetes: Exploratory Analysis From the STEP 1, 2, and 3 Trials
These post hoc analyses of the Semaglutide Treatment Effect in People with obesity (STEP) 1-3 trials (NCT03548935, NCT03552757, and NCT03611582) explored the effects of semaglutide (up to 2.4 mg) on kidney function. STEP 1-3 included adults with overweight/obesity; STEP 2 patients also had type 2 di...
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Veröffentlicht in: | Diabetes care 2023-04, Vol.46 (4), p.801-810 |
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description | These post hoc analyses of the Semaglutide Treatment Effect in People with obesity (STEP) 1-3 trials (NCT03548935, NCT03552757, and NCT03611582) explored the effects of semaglutide (up to 2.4 mg) on kidney function.
STEP 1-3 included adults with overweight/obesity; STEP 2 patients also had type 2 diabetes. Participants received once-weekly subcutaneous semaglutide 1.0 mg (STEP 2 only), 2.4 mg, or placebo for 68 weeks, plus lifestyle intervention (STEP 1 and 2) or intensive behavioral therapy (STEP 3). Changes in urine albumin-to-creatinine ratio (UACR) and UACR status from baseline to week 68 were assessed for STEP 2. Changes in estimated glomerular filtration rate (eGFR) were assessed from pooled STEP 1-3 data.
In STEP 2, 1,205 (99.6% total cohort) patients had UACR data; geometric mean baseline UACR was 13.7, 12.5, and 13.2 mg/g with semaglutide 1.0 mg, 2.4 mg, and placebo, respectively. At week 68, UACR changes were -14.8% and -20.6% with semaglutide 1.0 mg and 2.4 mg, respectively, and +18.3% with placebo (between-group differences [95% CI] vs. placebo: -28.0% [-37.3, -17.3], P < 0.0001 for semaglutide 1.0 mg; -32.9% [-41.6, -23.0], P = 0.003 for semaglutide 2.4 mg). UACR status improved in greater proportions of patients with semaglutide 1.0 mg and 2.4 mg versus placebo (P = 0.0004 and P = 0.0014, respectively). In the pooled STEP 1-3 analyses, 3,379 participants had eGFR data; there was no difference between semaglutide 2.4 mg and placebo in eGFR trajectories at week 68.
Semaglutide improved UACR in adults with overweight/obesity and type 2 diabetes. In participants with normal kidney function, semaglutide did not have an effect on eGFR decline. |
doi_str_mv | 10.2337/dc22-1889 |
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STEP 1-3 included adults with overweight/obesity; STEP 2 patients also had type 2 diabetes. Participants received once-weekly subcutaneous semaglutide 1.0 mg (STEP 2 only), 2.4 mg, or placebo for 68 weeks, plus lifestyle intervention (STEP 1 and 2) or intensive behavioral therapy (STEP 3). Changes in urine albumin-to-creatinine ratio (UACR) and UACR status from baseline to week 68 were assessed for STEP 2. Changes in estimated glomerular filtration rate (eGFR) were assessed from pooled STEP 1-3 data.
In STEP 2, 1,205 (99.6% total cohort) patients had UACR data; geometric mean baseline UACR was 13.7, 12.5, and 13.2 mg/g with semaglutide 1.0 mg, 2.4 mg, and placebo, respectively. At week 68, UACR changes were -14.8% and -20.6% with semaglutide 1.0 mg and 2.4 mg, respectively, and +18.3% with placebo (between-group differences [95% CI] vs. placebo: -28.0% [-37.3, -17.3], P < 0.0001 for semaglutide 1.0 mg; -32.9% [-41.6, -23.0], P = 0.003 for semaglutide 2.4 mg). UACR status improved in greater proportions of patients with semaglutide 1.0 mg and 2.4 mg versus placebo (P = 0.0004 and P = 0.0014, respectively). In the pooled STEP 1-3 analyses, 3,379 participants had eGFR data; there was no difference between semaglutide 2.4 mg and placebo in eGFR trajectories at week 68.
Semaglutide improved UACR in adults with overweight/obesity and type 2 diabetes. In participants with normal kidney function, semaglutide did not have an effect on eGFR decline.</description><identifier>ISSN: 0149-5992</identifier><identifier>ISSN: 1935-5548</identifier><identifier>EISSN: 1935-5548</identifier><identifier>DOI: 10.2337/dc22-1889</identifier><identifier>PMID: 36801984</identifier><language>eng</language><publisher>United States: American Diabetes Association</publisher><subject>Adult ; Adults ; Albuminuria - drug therapy ; Antidiabetics ; Body weight ; Clinical trials ; Creatinine ; Diabetes ; Diabetes mellitus ; Diabetes mellitus (non-insulin dependent) ; Diabetes Mellitus, Type 2 - complications ; Diabetes Mellitus, Type 2 - drug therapy ; Diabetes Mellitus, Type 2 - urine ; Epidermal growth factor receptors ; Glomerular Filtration Rate ; Humans ; Kidney ; Kidneys ; Obesity ; Obesity - complications ; Obesity - drug therapy ; Original ; Overweight ; Overweight - complications ; Overweight - drug therapy ; Placebos ; Research design ; Treatment Outcome</subject><ispartof>Diabetes care, 2023-04, Vol.46 (4), p.801-810</ispartof><rights>2023 by the American Diabetes Association.</rights><rights>Copyright American Diabetes Association Apr 2023</rights><rights>2023 by the American Diabetes Association 2023</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c404t-ba3a544c56218d31e7bb22cff14d47403ed5077d69373d80a87f6b71df7c4bd63</citedby><cites>FETCH-LOGICAL-c404t-ba3a544c56218d31e7bb22cff14d47403ed5077d69373d80a87f6b71df7c4bd63</cites><orcidid>0000-0003-4164-0429 ; 0000-0001-8546-6245 ; 0000-0001-8324-3275 ; 0000-0002-3126-3730</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,27903,27904</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36801984$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Heerspink, Hiddo J L</creatorcontrib><creatorcontrib>Apperloo, Ellen</creatorcontrib><creatorcontrib>Davies, Melanie</creatorcontrib><creatorcontrib>Dicker, Dror</creatorcontrib><creatorcontrib>Kandler, Kristian</creatorcontrib><creatorcontrib>Rosenstock, Julio</creatorcontrib><creatorcontrib>Sørrig, Rasmus</creatorcontrib><creatorcontrib>Lawson, Jack</creatorcontrib><creatorcontrib>Zeuthen, Niels</creatorcontrib><creatorcontrib>Cherney, David</creatorcontrib><title>Effects of Semaglutide on Albuminuria and Kidney Function in People With Overweight or Obesity With or Without Type 2 Diabetes: Exploratory Analysis From the STEP 1, 2, and 3 Trials</title><title>Diabetes care</title><addtitle>Diabetes Care</addtitle><description>These post hoc analyses of the Semaglutide Treatment Effect in People with obesity (STEP) 1-3 trials (NCT03548935, NCT03552757, and NCT03611582) explored the effects of semaglutide (up to 2.4 mg) on kidney function.
STEP 1-3 included adults with overweight/obesity; STEP 2 patients also had type 2 diabetes. Participants received once-weekly subcutaneous semaglutide 1.0 mg (STEP 2 only), 2.4 mg, or placebo for 68 weeks, plus lifestyle intervention (STEP 1 and 2) or intensive behavioral therapy (STEP 3). Changes in urine albumin-to-creatinine ratio (UACR) and UACR status from baseline to week 68 were assessed for STEP 2. Changes in estimated glomerular filtration rate (eGFR) were assessed from pooled STEP 1-3 data.
In STEP 2, 1,205 (99.6% total cohort) patients had UACR data; geometric mean baseline UACR was 13.7, 12.5, and 13.2 mg/g with semaglutide 1.0 mg, 2.4 mg, and placebo, respectively. At week 68, UACR changes were -14.8% and -20.6% with semaglutide 1.0 mg and 2.4 mg, respectively, and +18.3% with placebo (between-group differences [95% CI] vs. placebo: -28.0% [-37.3, -17.3], P < 0.0001 for semaglutide 1.0 mg; -32.9% [-41.6, -23.0], P = 0.003 for semaglutide 2.4 mg). UACR status improved in greater proportions of patients with semaglutide 1.0 mg and 2.4 mg versus placebo (P = 0.0004 and P = 0.0014, respectively). In the pooled STEP 1-3 analyses, 3,379 participants had eGFR data; there was no difference between semaglutide 2.4 mg and placebo in eGFR trajectories at week 68.
Semaglutide improved UACR in adults with overweight/obesity and type 2 diabetes. In participants with normal kidney function, semaglutide did not have an effect on eGFR decline.</description><subject>Adult</subject><subject>Adults</subject><subject>Albuminuria - drug therapy</subject><subject>Antidiabetics</subject><subject>Body weight</subject><subject>Clinical trials</subject><subject>Creatinine</subject><subject>Diabetes</subject><subject>Diabetes mellitus</subject><subject>Diabetes mellitus (non-insulin dependent)</subject><subject>Diabetes Mellitus, Type 2 - complications</subject><subject>Diabetes Mellitus, Type 2 - drug therapy</subject><subject>Diabetes Mellitus, Type 2 - urine</subject><subject>Epidermal growth factor receptors</subject><subject>Glomerular Filtration Rate</subject><subject>Humans</subject><subject>Kidney</subject><subject>Kidneys</subject><subject>Obesity</subject><subject>Obesity - complications</subject><subject>Obesity - drug therapy</subject><subject>Original</subject><subject>Overweight</subject><subject>Overweight - complications</subject><subject>Overweight - drug therapy</subject><subject>Placebos</subject><subject>Research design</subject><subject>Treatment Outcome</subject><issn>0149-5992</issn><issn>1935-5548</issn><issn>1935-5548</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdktGK1DAYhYso7rh64QvID94obDVp0ibZGxnWGRUXZmFHvCxp83cmS9uMSbraB_P9bJ11UcnFIZyPwyE5SfKckjcZY-KtqbMspVKqB8mCKpanec7lw2RBKFdprlR2kjwJ4YYQwrmUj5MTVkhCleSL5OeqabCOAVwD19jpXTtEaxBcD8u2GjrbD95q0L2Bz9b0OMJ66OtoJ9_2cIXu0CJ8tXEPm1v039Hu9hGch02FwcbxaE33Wd0QYTseEDJ4b3WFEcM5rH4cWud1dH6EZa_bMdgAa-86iHuE6-3qCugZZGe_KzDYTm3a8DR51EyCz-70NPmyXm0vPqaXmw-fLpaXac0Jj2mlmc45r_Mio9IwiqKqsqxuGsoNF5wwNDkRwhSKCWYk0VI0RSWoaUTNK1Ow0-TdMfcwVB2aGvvodVsevO20H0unbfmv09t9uXO3JSVETYdOCa_uErz7NmCIZWdDjW2re3RDKDMhpBKFUmJCX_6H3rjBT08yU4oyXkxlJ-r1kaq9C8Fjc9-GknJeQzmvoZzXMLEv_q5_T_75fvYLAaKwlg</recordid><startdate>20230401</startdate><enddate>20230401</enddate><creator>Heerspink, Hiddo J L</creator><creator>Apperloo, Ellen</creator><creator>Davies, Melanie</creator><creator>Dicker, Dror</creator><creator>Kandler, Kristian</creator><creator>Rosenstock, Julio</creator><creator>Sørrig, Rasmus</creator><creator>Lawson, Jack</creator><creator>Zeuthen, Niels</creator><creator>Cherney, David</creator><general>American Diabetes Association</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>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0003-4164-0429</orcidid><orcidid>https://orcid.org/0000-0001-8546-6245</orcidid><orcidid>https://orcid.org/0000-0001-8324-3275</orcidid><orcidid>https://orcid.org/0000-0002-3126-3730</orcidid></search><sort><creationdate>20230401</creationdate><title>Effects of Semaglutide on Albuminuria and Kidney Function in People With Overweight or Obesity With or Without Type 2 Diabetes: Exploratory Analysis From the STEP 1, 2, and 3 Trials</title><author>Heerspink, Hiddo J L ; Apperloo, Ellen ; Davies, Melanie ; Dicker, Dror ; Kandler, Kristian ; Rosenstock, Julio ; Sørrig, Rasmus ; Lawson, Jack ; Zeuthen, Niels ; Cherney, David</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c404t-ba3a544c56218d31e7bb22cff14d47403ed5077d69373d80a87f6b71df7c4bd63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Adult</topic><topic>Adults</topic><topic>Albuminuria - drug therapy</topic><topic>Antidiabetics</topic><topic>Body weight</topic><topic>Clinical trials</topic><topic>Creatinine</topic><topic>Diabetes</topic><topic>Diabetes mellitus</topic><topic>Diabetes mellitus (non-insulin dependent)</topic><topic>Diabetes Mellitus, Type 2 - complications</topic><topic>Diabetes Mellitus, Type 2 - drug therapy</topic><topic>Diabetes Mellitus, Type 2 - urine</topic><topic>Epidermal growth factor receptors</topic><topic>Glomerular Filtration Rate</topic><topic>Humans</topic><topic>Kidney</topic><topic>Kidneys</topic><topic>Obesity</topic><topic>Obesity - complications</topic><topic>Obesity - drug therapy</topic><topic>Original</topic><topic>Overweight</topic><topic>Overweight - complications</topic><topic>Overweight - drug therapy</topic><topic>Placebos</topic><topic>Research design</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Heerspink, Hiddo J L</creatorcontrib><creatorcontrib>Apperloo, Ellen</creatorcontrib><creatorcontrib>Davies, Melanie</creatorcontrib><creatorcontrib>Dicker, Dror</creatorcontrib><creatorcontrib>Kandler, Kristian</creatorcontrib><creatorcontrib>Rosenstock, Julio</creatorcontrib><creatorcontrib>Sørrig, Rasmus</creatorcontrib><creatorcontrib>Lawson, Jack</creatorcontrib><creatorcontrib>Zeuthen, Niels</creatorcontrib><creatorcontrib>Cherney, David</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Diabetes care</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Heerspink, Hiddo J L</au><au>Apperloo, Ellen</au><au>Davies, Melanie</au><au>Dicker, Dror</au><au>Kandler, Kristian</au><au>Rosenstock, Julio</au><au>Sørrig, Rasmus</au><au>Lawson, Jack</au><au>Zeuthen, Niels</au><au>Cherney, David</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effects of Semaglutide on Albuminuria and Kidney Function in People With Overweight or Obesity With or Without Type 2 Diabetes: Exploratory Analysis From the STEP 1, 2, and 3 Trials</atitle><jtitle>Diabetes care</jtitle><addtitle>Diabetes Care</addtitle><date>2023-04-01</date><risdate>2023</risdate><volume>46</volume><issue>4</issue><spage>801</spage><epage>810</epage><pages>801-810</pages><issn>0149-5992</issn><issn>1935-5548</issn><eissn>1935-5548</eissn><abstract>These post hoc analyses of the Semaglutide Treatment Effect in People with obesity (STEP) 1-3 trials (NCT03548935, NCT03552757, and NCT03611582) explored the effects of semaglutide (up to 2.4 mg) on kidney function.
STEP 1-3 included adults with overweight/obesity; STEP 2 patients also had type 2 diabetes. Participants received once-weekly subcutaneous semaglutide 1.0 mg (STEP 2 only), 2.4 mg, or placebo for 68 weeks, plus lifestyle intervention (STEP 1 and 2) or intensive behavioral therapy (STEP 3). Changes in urine albumin-to-creatinine ratio (UACR) and UACR status from baseline to week 68 were assessed for STEP 2. Changes in estimated glomerular filtration rate (eGFR) were assessed from pooled STEP 1-3 data.
In STEP 2, 1,205 (99.6% total cohort) patients had UACR data; geometric mean baseline UACR was 13.7, 12.5, and 13.2 mg/g with semaglutide 1.0 mg, 2.4 mg, and placebo, respectively. At week 68, UACR changes were -14.8% and -20.6% with semaglutide 1.0 mg and 2.4 mg, respectively, and +18.3% with placebo (between-group differences [95% CI] vs. placebo: -28.0% [-37.3, -17.3], P < 0.0001 for semaglutide 1.0 mg; -32.9% [-41.6, -23.0], P = 0.003 for semaglutide 2.4 mg). UACR status improved in greater proportions of patients with semaglutide 1.0 mg and 2.4 mg versus placebo (P = 0.0004 and P = 0.0014, respectively). In the pooled STEP 1-3 analyses, 3,379 participants had eGFR data; there was no difference between semaglutide 2.4 mg and placebo in eGFR trajectories at week 68.
Semaglutide improved UACR in adults with overweight/obesity and type 2 diabetes. In participants with normal kidney function, semaglutide did not have an effect on eGFR decline.</abstract><cop>United States</cop><pub>American Diabetes Association</pub><pmid>36801984</pmid><doi>10.2337/dc22-1889</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0003-4164-0429</orcidid><orcidid>https://orcid.org/0000-0001-8546-6245</orcidid><orcidid>https://orcid.org/0000-0001-8324-3275</orcidid><orcidid>https://orcid.org/0000-0002-3126-3730</orcidid><oa>free_for_read</oa></addata></record> |
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subjects | Adult Adults Albuminuria - drug therapy Antidiabetics Body weight Clinical trials Creatinine Diabetes Diabetes mellitus Diabetes mellitus (non-insulin dependent) Diabetes Mellitus, Type 2 - complications Diabetes Mellitus, Type 2 - drug therapy Diabetes Mellitus, Type 2 - urine Epidermal growth factor receptors Glomerular Filtration Rate Humans Kidney Kidneys Obesity Obesity - complications Obesity - drug therapy Original Overweight Overweight - complications Overweight - drug therapy Placebos Research design Treatment Outcome |
title | Effects of Semaglutide on Albuminuria and Kidney Function in People With Overweight or Obesity With or Without Type 2 Diabetes: Exploratory Analysis From the STEP 1, 2, and 3 Trials |
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