{"id":642785,"date":"2022-01-15T20:24:33","date_gmt":"2022-01-16T01:24:33","guid":{"rendered":"https:\/\/myendoconsult.com\/learn\/?p=642785"},"modified":"2023-03-16T05:59:22","modified_gmt":"2023-03-16T10:59:22","slug":"fidelio-dkd","status":"publish","type":"post","link":"https:\/\/myendoconsult.com\/learn\/fidelio-dkd\/","title":{"rendered":"FIDELIO-DKD (Journal Club)"},"content":{"rendered":"<ul>\n<li><strong>Finerenone<\/strong> in Subjects with Type 2 Diabetes Mellitus and Diabetic Kidney Disease. The FIDELIO-DKD clinical trial is summarized in this simple infographic.\n<p><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/endoconsult.b-cdn.net\/wp-content\/uploads\/FIDELIO-DKD-NEW-2021-min.png\" sizes=\"auto, (max-width: 1748px) 100vw, 1748px\" srcset=\"https:\/\/endoconsult.b-cdn.net\/wp-content\/uploads\/FIDELIO-DKD-NEW-2021-min.png 1748w, https:\/\/endoconsult.b-cdn.net\/wp-content\/uploads\/FIDELIO-DKD-NEW-2021-min-211x300.png 211w, https:\/\/endoconsult.b-cdn.net\/wp-content\/uploads\/FIDELIO-DKD-NEW-2021-min-768x1090.png 768w, https:\/\/endoconsult.b-cdn.net\/wp-content\/uploads\/FIDELIO-DKD-NEW-2021-min-1083x1536.png 1083w, https:\/\/endoconsult.b-cdn.net\/wp-content\/uploads\/FIDELIO-DKD-NEW-2021-min-1444x2048.png 1444w, https:\/\/endoconsult.b-cdn.net\/wp-content\/uploads\/FIDELIO-DKD-NEW-2021-min-624x885.png 624w, https:\/\/endoconsult.b-cdn.net\/wp-content\/uploads\/FIDELIO-DKD-NEW-2021-min-35x50.png 35w, https:\/\/endoconsult.b-cdn.net\/wp-content\/uploads\/FIDELIO-DKD-NEW-2021-min-70x100.png 70w\" alt=\"\" width=\"1748\" height=\"2480\" \/><a role=\"button\" href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02540993\" target=\"_blank\" rel=\"noopener\">Review study protocol<\/a><a role=\"button\" href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa2025845\" target=\"_blank\" rel=\"noopener\">Read Study Publication<\/a><\/p>\n<\/li>\n<\/ul>\n<h2>Rationale and Clinical Equipoise<\/h2>\n<p>Finerenone, a nonsteroidal, selective mineralocorticoid receptor antagonist, reduced albuminuria in patients with type 2 DM. Long term efficacy and safety in terms of renal and cardiovascular outcomes remains unknown.<\/p>\n<h2>Study Design<\/h2>\n<ul>\n<li>A multicenter, double-blind, randomized controlled trial<\/li>\n<li>2833 subjects were randomized to the intervention (<b>Finerenone<\/b>) arm and 2841 to the placebo arm.<\/li>\n<li>An intention-to-treat analysis<\/li>\n<li>Median follow-up 2.6 years<\/li>\n<li>Variable doses of finerenone, based on the patient&#8217;s baseline estimated GFR. If eGFR &gt; 60 (20mg daily), estimated GFR 25-60 (10mg daily with an increased in dose to 20mg after 1 month)<\/li>\n<\/ul>\n<h2>Study Eligibility Criteria<\/h2>\n<ul>\n<li>Age &gt;18 years with a diagnosis of Type 2 <a href=\"https:\/\/myendoconsult.com\/learn\/diabetes-mellitus\/\">Diabetes Mellitus<\/a><\/li>\n<li>Urinary albumin-to-creatinine ratio of 30-300mg\/g<\/li>\n<li>Estimated GFR 25-60 ml\/min\/1.73m\u00b2<\/li>\n<li>On optimal renin-angiotensin-aldosterone blockade<\/li>\n<li>Serum potassium less than 4.8 mEq<\/li>\n<li>On at least 2 contraceptives if a female of child-bearing age.<\/li>\n<\/ul>\n<h2>Primary Outcome<\/h2>\n<p>Composite of kidney failure, 40% decline in estimated GFR and death (renal-related). Comparison of finerenone versus placebo ; 17.8% versus 21.1% (Hazard ratio, 0.82 ; 95% CI, 0.73 to 0.93; P value = 0.001)<\/p>\n<h2>Secondary Outcomes<\/h2>\n<p><b>Death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke,or hospitalization for heart failure<\/b>Comparison of finerenone vs placebo; 13.0% vs 14.8% (Hazard Ratio, 0.86; 95% CI 0.75-0.99; P=0.03)<b>Death from any cause<\/b>Comparison of finerenone vs placebo; 7.7% vs 8.6% (HR 0.90; 95% CI 0.75-1.07; P=0.02)<\/p>\n<h2>Critical Appraisal<\/h2>\n<p>Patients with nonalbuminuric chronic kidney disease and <a href=\"https:\/\/myendoconsult.com\/learn\/management-of-diabetes-in-ckd\/\">CKD in the absence of diabetes<\/a> were excluded, thus limiting the generalizability of the findings.<\/p>\n<h2>Practice Changing Pearls (Conclusion)<\/h2>\n<ul>\n<li>In patients with CKD and <a href=\"https:\/\/myendoconsult.com\/learn\/egregious-eleven-of-type-2-diabetes-mellitus\/\">type 2 diabetes<\/a>, treatment with finerenone resulted in lower risks of CKD progression and cardiovascular events than placebo.<\/li>\n<li>Involvement of the study sponsor in the design, conduct and analysis of the study is a significant limitation. A single site was also excluded due to violations of <a href=\"https:\/\/database.ich.org\/sites\/default\/files\/E6_R2_Addendum.pdf\" target=\"_blank\" rel=\"noopener\">Good Clinical Practice<\/a> guidelines.<\/li>\n<\/ul>\n<h2>References<\/h2>\n<ul>\n<li>Bakris GL et al; FIDELIO-DKD Investigators. Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes. N Engl J Med. 2020 Dec 3;383(23):2219-2229. doi: <a href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa2025845\" target=\"_blank\" rel=\"noopener\">10.1056\/NEJMoa2025845.<\/a><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Finerenone in Subjects with Type 2 Diabetes Mellitus and Diabetic Kidney Disease. The FIDELIO-DKD clinical trial is summarized in this simple infographic. Review study protocolRead Study Publication Rationale and Clinical Equipoise Finerenone, a nonsteroidal, selective mineralocorticoid receptor antagonist, reduced albuminuria in patients with type 2 DM. Long term efficacy and safety in terms of renal [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[101],"tags":[],"class_list":["post-642785","post","type-post","status-publish","format-standard","hentry","category-journal-club-endocrinology","post-wrapper","thrv_wrapper"],"_links":{"self":[{"href":"https:\/\/myendoconsult.com\/learn\/wp-json\/wp\/v2\/posts\/642785","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/myendoconsult.com\/learn\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/myendoconsult.com\/learn\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/myendoconsult.com\/learn\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/myendoconsult.com\/learn\/wp-json\/wp\/v2\/comments?post=642785"}],"version-history":[{"count":107,"href":"https:\/\/myendoconsult.com\/learn\/wp-json\/wp\/v2\/posts\/642785\/revisions"}],"predecessor-version":[{"id":4415969,"href":"https:\/\/myendoconsult.com\/learn\/wp-json\/wp\/v2\/posts\/642785\/revisions\/4415969"}],"wp:attachment":[{"href":"https:\/\/myendoconsult.com\/learn\/wp-json\/wp\/v2\/media?parent=642785"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/myendoconsult.com\/learn\/wp-json\/wp\/v2\/categories?post=642785"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/myendoconsult.com\/learn\/wp-json\/wp\/v2\/tags?post=642785"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}