The impact of obesity on cardiovascular and kidney outcomes in patients with chronic kidney disease and type 2 diabetes treated with finerenone: Post hoc analysis of the FIDELITY study
Aim To assess the effect of finerenone on the risk of cardiovascular and kidney outcomes in patients with chronic kidney disease and type 2 diabetes, with and without obesity. Materials and methods A post hoc analysis of the prespecified pooled FIDELITY dataset assessed the association between waist...
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creator | Rossing, Peter Anker, Stefan D. Filippatos, Gerasimos Pitt, Bertram Ruilope, Luis M. Billings, Liana K. Green, Jennifer B. Koya, Daisuke Mosenzon, Ofri Pantalone, Kevin M. Ahlers, Christiane Lage, Andrea Lawatscheck, Robert Scalise, Andrea Bakris, George L. |
description | Aim
To assess the effect of finerenone on the risk of cardiovascular and kidney outcomes in patients with chronic kidney disease and type 2 diabetes, with and without obesity.
Materials and methods
A post hoc analysis of the prespecified pooled FIDELITY dataset assessed the association between waist circumference (WC), composite cardiovascular and kidney outcomes, and the effects of finerenone. Participants were stratified by WC risk groups (representing visceral obesity) as low‐risk or high–very high‐risk (H‐/VH‐risk).
Results
Of 12 986 patients analysed, 90.8% occupied the H‐/VH‐risk WC group. Incidence of the composite cardiovascular outcome was similar between finerenone and placebo in the low‐risk WC group (hazard ratio [HR] 1.03; 95% confidence interval [CI], 0.72‐1.47); finerenone reduced the risk in the H‐/VH‐risk WC group (HR 0.85; 95% CI, 0.77‐0.93). For the kidney outcome, the risk was similar in the low‐risk WC group (HR 0.98; 95% CI, 0.66‐1.46) and reduced within the H‐/VH‐risk WC group (HR 0.75; 95% CI, 0.65‐0.87) with finerenone versus placebo. There was no significant heterogeneity between the low‐risk and H‐/VH‐risk WC groups for cardiovascular and kidney composite outcomes (P interaction = .26 and .34, respectively). The apparent greater benefit of finerenone on cardiorenal outcomes but lack of significant heterogeneity observed in H‐/VH‐risk WC patients may be because of the small size of the low‐risk group. Adverse events were consistent across WC groups.
Conclusion
In FIDELITY, benefits of finerenone in lowering the risk of cardiovascular and kidney outcomes were not significantly modified by patient obesity. |
doi_str_mv | 10.1111/dom.15197 |
format | Article |
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To assess the effect of finerenone on the risk of cardiovascular and kidney outcomes in patients with chronic kidney disease and type 2 diabetes, with and without obesity.
Materials and methods
A post hoc analysis of the prespecified pooled FIDELITY dataset assessed the association between waist circumference (WC), composite cardiovascular and kidney outcomes, and the effects of finerenone. Participants were stratified by WC risk groups (representing visceral obesity) as low‐risk or high–very high‐risk (H‐/VH‐risk).
Results
Of 12 986 patients analysed, 90.8% occupied the H‐/VH‐risk WC group. Incidence of the composite cardiovascular outcome was similar between finerenone and placebo in the low‐risk WC group (hazard ratio [HR] 1.03; 95% confidence interval [CI], 0.72‐1.47); finerenone reduced the risk in the H‐/VH‐risk WC group (HR 0.85; 95% CI, 0.77‐0.93). For the kidney outcome, the risk was similar in the low‐risk WC group (HR 0.98; 95% CI, 0.66‐1.46) and reduced within the H‐/VH‐risk WC group (HR 0.75; 95% CI, 0.65‐0.87) with finerenone versus placebo. There was no significant heterogeneity between the low‐risk and H‐/VH‐risk WC groups for cardiovascular and kidney composite outcomes (P interaction = .26 and .34, respectively). The apparent greater benefit of finerenone on cardiorenal outcomes but lack of significant heterogeneity observed in H‐/VH‐risk WC patients may be because of the small size of the low‐risk group. Adverse events were consistent across WC groups.
Conclusion
In FIDELITY, benefits of finerenone in lowering the risk of cardiovascular and kidney outcomes were not significantly modified by patient obesity.</description><identifier>ISSN: 1462-8902</identifier><identifier>EISSN: 1463-1326</identifier><identifier>DOI: 10.1111/dom.15197</identifier><identifier>PMID: 37402696</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>cardiovascular disease ; Cardiovascular diseases ; Diabetes ; Diabetes mellitus (non-insulin dependent) ; Kidney diseases ; Obesity ; phase III study ; Placebos ; randomized trial ; Risk groups ; type 2 diabetes</subject><ispartof>Diabetes, obesity & metabolism, 2023-10, Vol.25 (10), p.2989-2998</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-c3887-780570dd9cf4a422d0f1e9d2e845233eafbb06eaac62da2f00e81fba82bfd2563</citedby><cites>FETCH-LOGICAL-c3887-780570dd9cf4a422d0f1e9d2e845233eafbb06eaac62da2f00e81fba82bfd2563</cites><orcidid>0000-0002-3897-4551 ; 0000-0002-5702-7584 ; 0000-0002-1531-4294 ; 0000-0003-1183-1267</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.15197$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fdom.15197$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37402696$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Rossing, Peter</creatorcontrib><creatorcontrib>Anker, Stefan D.</creatorcontrib><creatorcontrib>Filippatos, Gerasimos</creatorcontrib><creatorcontrib>Pitt, Bertram</creatorcontrib><creatorcontrib>Ruilope, Luis M.</creatorcontrib><creatorcontrib>Billings, Liana K.</creatorcontrib><creatorcontrib>Green, Jennifer B.</creatorcontrib><creatorcontrib>Koya, Daisuke</creatorcontrib><creatorcontrib>Mosenzon, Ofri</creatorcontrib><creatorcontrib>Pantalone, Kevin M.</creatorcontrib><creatorcontrib>Ahlers, Christiane</creatorcontrib><creatorcontrib>Lage, Andrea</creatorcontrib><creatorcontrib>Lawatscheck, Robert</creatorcontrib><creatorcontrib>Scalise, Andrea</creatorcontrib><creatorcontrib>Bakris, George L.</creatorcontrib><title>The impact of obesity on cardiovascular and kidney outcomes in patients with chronic kidney disease and type 2 diabetes treated with finerenone: Post hoc analysis of the FIDELITY study</title><title>Diabetes, obesity & metabolism</title><addtitle>Diabetes Obes Metab</addtitle><description>Aim
To assess the effect of finerenone on the risk of cardiovascular and kidney outcomes in patients with chronic kidney disease and type 2 diabetes, with and without obesity.
Materials and methods
A post hoc analysis of the prespecified pooled FIDELITY dataset assessed the association between waist circumference (WC), composite cardiovascular and kidney outcomes, and the effects of finerenone. Participants were stratified by WC risk groups (representing visceral obesity) as low‐risk or high–very high‐risk (H‐/VH‐risk).
Results
Of 12 986 patients analysed, 90.8% occupied the H‐/VH‐risk WC group. Incidence of the composite cardiovascular outcome was similar between finerenone and placebo in the low‐risk WC group (hazard ratio [HR] 1.03; 95% confidence interval [CI], 0.72‐1.47); finerenone reduced the risk in the H‐/VH‐risk WC group (HR 0.85; 95% CI, 0.77‐0.93). For the kidney outcome, the risk was similar in the low‐risk WC group (HR 0.98; 95% CI, 0.66‐1.46) and reduced within the H‐/VH‐risk WC group (HR 0.75; 95% CI, 0.65‐0.87) with finerenone versus placebo. There was no significant heterogeneity between the low‐risk and H‐/VH‐risk WC groups for cardiovascular and kidney composite outcomes (P interaction = .26 and .34, respectively). The apparent greater benefit of finerenone on cardiorenal outcomes but lack of significant heterogeneity observed in H‐/VH‐risk WC patients may be because of the small size of the low‐risk group. Adverse events were consistent across WC groups.
Conclusion
In FIDELITY, benefits of finerenone in lowering the risk of cardiovascular and kidney outcomes were not significantly modified by patient obesity.</description><subject>cardiovascular disease</subject><subject>Cardiovascular diseases</subject><subject>Diabetes</subject><subject>Diabetes mellitus (non-insulin dependent)</subject><subject>Kidney diseases</subject><subject>Obesity</subject><subject>phase III study</subject><subject>Placebos</subject><subject>randomized trial</subject><subject>Risk groups</subject><subject>type 2 diabetes</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>WIN</sourceid><recordid>eNp1kc1u1DAUhSMEoqWw4AWQJTawSOufjJOwQ_2BkQaVxbBgFd3Y1xqXxB5shypvxuPhmbQskLAXvvL9ztG9OkXxmtFzls-F9uM5W7G2flKcskqKkgkunx5rXjYt5SfFixjvKKWVaOrnxYmoK8plK0-L39sdEjvuQSXiDfE9Rptm4h1RELT1vyCqaYBAwGnyw2qHuTkl5UeMxDqyh2TRpUjubdoRtQveWfUIahsRIh61ad4j4fkLekxZmwJCQr3ojHUY0HmHH8hXHxPZeZVVMMzRxsNcKU95s7663qy330lMk55fFs8MDBFfPbxnxbeb6-3l53Jz-2l9-XFTKtE0dVk3dFVTrVtlKqg419QwbDXHplpxIRBM31OJAEpyDdxQig0zPTS8N5qvpDgr3i2---B_ThhTN9qocBjAoZ9ixxshZJUvzejbf9A7P4W8xYGSlFPJRJup9wulgo8xoOn2wY4Q5o7R7hBnl-PsjnFm9s2D49SPqP-Sj_ll4GIB7u2A8_-duqvbL4vlH8KvrFw</recordid><startdate>202310</startdate><enddate>202310</enddate><creator>Rossing, Peter</creator><creator>Anker, Stefan D.</creator><creator>Filippatos, Gerasimos</creator><creator>Pitt, Bertram</creator><creator>Ruilope, Luis M.</creator><creator>Billings, Liana K.</creator><creator>Green, Jennifer B.</creator><creator>Koya, Daisuke</creator><creator>Mosenzon, Ofri</creator><creator>Pantalone, Kevin M.</creator><creator>Ahlers, Christiane</creator><creator>Lage, Andrea</creator><creator>Lawatscheck, Robert</creator><creator>Scalise, Andrea</creator><creator>Bakris, George L.</creator><general>Blackwell Publishing Ltd</general><general>Wiley Subscription Services, Inc</general><scope>24P</scope><scope>WIN</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/0000-0002-3897-4551</orcidid><orcidid>https://orcid.org/0000-0002-5702-7584</orcidid><orcidid>https://orcid.org/0000-0002-1531-4294</orcidid><orcidid>https://orcid.org/0000-0003-1183-1267</orcidid></search><sort><creationdate>202310</creationdate><title>The impact of obesity on cardiovascular and kidney outcomes in patients with chronic kidney disease and type 2 diabetes treated with finerenone: Post hoc analysis of the FIDELITY study</title><author>Rossing, Peter ; Anker, Stefan D. ; Filippatos, Gerasimos ; Pitt, Bertram ; Ruilope, Luis M. ; Billings, Liana K. ; Green, Jennifer B. ; Koya, Daisuke ; Mosenzon, Ofri ; Pantalone, Kevin M. ; Ahlers, Christiane ; Lage, Andrea ; Lawatscheck, Robert ; Scalise, Andrea ; Bakris, George L.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3887-780570dd9cf4a422d0f1e9d2e845233eafbb06eaac62da2f00e81fba82bfd2563</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>cardiovascular disease</topic><topic>Cardiovascular diseases</topic><topic>Diabetes</topic><topic>Diabetes mellitus (non-insulin dependent)</topic><topic>Kidney diseases</topic><topic>Obesity</topic><topic>phase III study</topic><topic>Placebos</topic><topic>randomized trial</topic><topic>Risk groups</topic><topic>type 2 diabetes</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Rossing, Peter</creatorcontrib><creatorcontrib>Anker, Stefan D.</creatorcontrib><creatorcontrib>Filippatos, Gerasimos</creatorcontrib><creatorcontrib>Pitt, Bertram</creatorcontrib><creatorcontrib>Ruilope, Luis M.</creatorcontrib><creatorcontrib>Billings, Liana K.</creatorcontrib><creatorcontrib>Green, Jennifer B.</creatorcontrib><creatorcontrib>Koya, Daisuke</creatorcontrib><creatorcontrib>Mosenzon, Ofri</creatorcontrib><creatorcontrib>Pantalone, Kevin M.</creatorcontrib><creatorcontrib>Ahlers, Christiane</creatorcontrib><creatorcontrib>Lage, Andrea</creatorcontrib><creatorcontrib>Lawatscheck, Robert</creatorcontrib><creatorcontrib>Scalise, Andrea</creatorcontrib><creatorcontrib>Bakris, George L.</creatorcontrib><collection>Wiley Online Library (Open Access Collection)</collection><collection>Wiley Online Library Free Content</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>Rossing, Peter</au><au>Anker, Stefan D.</au><au>Filippatos, Gerasimos</au><au>Pitt, Bertram</au><au>Ruilope, Luis M.</au><au>Billings, Liana K.</au><au>Green, Jennifer B.</au><au>Koya, Daisuke</au><au>Mosenzon, Ofri</au><au>Pantalone, Kevin M.</au><au>Ahlers, Christiane</au><au>Lage, Andrea</au><au>Lawatscheck, Robert</au><au>Scalise, Andrea</au><au>Bakris, George L.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The impact of obesity on cardiovascular and kidney outcomes in patients with chronic kidney disease and type 2 diabetes treated with finerenone: Post hoc analysis of the FIDELITY study</atitle><jtitle>Diabetes, obesity & metabolism</jtitle><addtitle>Diabetes Obes Metab</addtitle><date>2023-10</date><risdate>2023</risdate><volume>25</volume><issue>10</issue><spage>2989</spage><epage>2998</epage><pages>2989-2998</pages><issn>1462-8902</issn><eissn>1463-1326</eissn><abstract>Aim
To assess the effect of finerenone on the risk of cardiovascular and kidney outcomes in patients with chronic kidney disease and type 2 diabetes, with and without obesity.
Materials and methods
A post hoc analysis of the prespecified pooled FIDELITY dataset assessed the association between waist circumference (WC), composite cardiovascular and kidney outcomes, and the effects of finerenone. Participants were stratified by WC risk groups (representing visceral obesity) as low‐risk or high–very high‐risk (H‐/VH‐risk).
Results
Of 12 986 patients analysed, 90.8% occupied the H‐/VH‐risk WC group. Incidence of the composite cardiovascular outcome was similar between finerenone and placebo in the low‐risk WC group (hazard ratio [HR] 1.03; 95% confidence interval [CI], 0.72‐1.47); finerenone reduced the risk in the H‐/VH‐risk WC group (HR 0.85; 95% CI, 0.77‐0.93). For the kidney outcome, the risk was similar in the low‐risk WC group (HR 0.98; 95% CI, 0.66‐1.46) and reduced within the H‐/VH‐risk WC group (HR 0.75; 95% CI, 0.65‐0.87) with finerenone versus placebo. There was no significant heterogeneity between the low‐risk and H‐/VH‐risk WC groups for cardiovascular and kidney composite outcomes (P interaction = .26 and .34, respectively). The apparent greater benefit of finerenone on cardiorenal outcomes but lack of significant heterogeneity observed in H‐/VH‐risk WC patients may be because of the small size of the low‐risk group. Adverse events were consistent across WC groups.
Conclusion
In FIDELITY, benefits of finerenone in lowering the risk of cardiovascular and kidney outcomes were not significantly modified by patient obesity.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>37402696</pmid><doi>10.1111/dom.15197</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0002-3897-4551</orcidid><orcidid>https://orcid.org/0000-0002-5702-7584</orcidid><orcidid>https://orcid.org/0000-0002-1531-4294</orcidid><orcidid>https://orcid.org/0000-0003-1183-1267</orcidid><oa>free_for_read</oa></addata></record> |
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subjects | cardiovascular disease Cardiovascular diseases Diabetes Diabetes mellitus (non-insulin dependent) Kidney diseases Obesity phase III study Placebos randomized trial Risk groups type 2 diabetes |
title | The impact of obesity on cardiovascular and kidney outcomes in patients with chronic kidney disease and type 2 diabetes treated with finerenone: Post hoc analysis of the FIDELITY study |
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