Post hoc analysis of SUSTAIN 6 and PIONEER 6 trials suggests that people with type 2 diabetes at high cardiovascular risk treated with semaglutide experience more stable kidney function compared with placebo

Abstract

Glucagon-like peptide-1 receptor agonists reduce albuminuria and may stabilize the estimated glomerular filtration rate (eGFR) in people with type 2 diabetes (T2D). In this post hoc analysis of the SUSTAIN 6/PIONEER 6 trials encompassing 6480 participants at high cardiovascular risk (semaglutide, 3239 participants; placebo, 3241 participants), we investigated the effects of semaglutide versus placebo on eGFR decline. Pooled data by treatment were evaluated for annual eGFR change (total annual eGFR slope in ml/min per 1.73 m2) from baseline to end of treatment and time to persistent eGFR reductions of 30%, 40%, 50% and 57% or more, including subgroup analyses by baseline eGFR (30 to under 60 or 60 and over ml/min per 1.73 m2). In the overall population, the estimated treatment difference (ETD; semaglutide versus placebo) in annual eGFR slope was significant at 0.59 ml/min per 1.73 m2 (95% confidence interval 0.29; 0.89). The ETD was numerically largest in the 30 to under 60 ml/min per 1.73 m2 eGFR subgroup, 1.06 ml/min per 1.73 m2 (0.45; 1.67), but no significant interaction was observed for treatment effect by subgroup. Hazard ratios (semaglutide versus placebo) for time to persistent eGFR decline were under 1.0 for all eGFR thresholds in the overall population; and were numerically lower in the baseline eGFR 30 to under 60 ml/min per 1.73 m2 subgroup versus the overall population, although no significant interaction was observed for treatment effect by subgroup. Thus, pooled analyses of clinical trial data in patients with T2D suggest that semaglutide may reduce the rate of eGFR decline. Glucagon-like peptide-1 receptor agonists reduce albuminuria and may stabilize the estimated glomerular filtration rate (eGFR) in people with type 2 diabetes (T2D). In this post hoc analysis of the SUSTAIN 6/PIONEER 6 trials encompassing 6480 participants at high cardiovascular risk (semaglutide, 3239 participants; placebo, 3241 participants), we investigated the effects of semaglutide versus placebo on eGFR decline. Pooled data by treatment were evaluated for annual eGFR change (total annual eGFR slope in ml/min per 1.73 m2) from baseline to end of treatment and time to persistent eGFR reductions of 30%, 40%, 50% and 57% or more, including subgroup analyses by baseline eGFR (30 to under 60 or 60 and over ml/min per 1.73 m2). In the overall population, the estimated treatment difference (ETD; semaglutide versus placebo) in annual eGFR slope was significant at 0.59 ml/min per 1.73 m2 (95% confidence interval 0.29; 0.89). The ETD was numerically largest in the 30 to under 60 ml/min per 1.73 m2 eGFR subgroup, 1.06 ml/min per 1.73 m2 (0.45; 1.67), but no significant interaction was observed for treatment effect by subgroup. Hazard ratios (semaglutide versus placebo) for time to persistent eGFR decline were under 1.0 for all eGFR thresholds in the overall population; and were numerically lower in the baseline eGFR 30 to under 60 ml/min per 1.73 m2 subgroup versus the overall population, although no significant interaction was observed for treatment effect by subgroup. Thus, pooled analyses of clinical trial data in patients with T2D suggest that semaglutide may reduce the rate of eGFR decline. Lay SummaryPatients with type 2 diabetes (T2D) often develop chronic kidney disease. Semaglutide is a medicine used to treat T2D; previous studies have shown these medicines may also reduce the decline of kidney function. However, more studies are needed to confirm the kidney benefits with semaglutide. In 2 clinical trials, 6480 patients with T2D and at high risk of a cardiovascular event were treated with semaglutide or placebo. We used the results of kidney function tests from these studies to assess how fast kidney function declined in those treated with semaglutide or placebo. Our analysis showed that semaglutide significantly slowed the rate of kidney function decline and non-significantly extended the time taken to reach specified estimated glomerular filtration rate thresholds. We also saw that kidney function at the start of the trial did not impact these findings. Patients with type 2 diabetes (T2D) often develop chronic kidney disease. Semaglutide is a medicine used to treat T2D; previous studies have shown these medicines may also reduce the decline of kidney function. However, more studies are needed to confirm the kidney benefits with semaglutide. In 2 clinical trials, 6480 patients with T2D and at high risk of a cardiovascular event were treated with semaglutide or placebo. We used the results of kidney function tests from these studies to assess how fast kidney function declined in those treated with semaglutide or placebo. Our analysis showed that semaglutide significantly slowed the rate of kidney function decline and non-significantly extended the time taken to reach specified estimated glomerular filtration rate thresholds. We also saw that kidney function at the start of the trial did not impact these findings. Type 2 diabetes (T2D) markedly increases the risk of both cardiovascular (CV) disease and chronic kidney disease (CKD).1Thomas M.C. Cooper M.E. Zimmet P. Changing epidemiology of type 2 diabetes mellitus and associated chronic kidney disease.Nat Rev Nephrol. 2016; 12: 73-81Crossref PubMed Scopus (371) Google Scholar,2Sarwar N. Gao P. Seshasai S.R. et al.Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies.Lancet. 2010; 375: 2215-2222Abstract Full Text Full Text PDF PubMed Scopus (3347) Google Scholar Approximately 40% of patients with T2D will develop CKD, and T2D is now the most common cause of progression to kidney failure worldwide.3Drüeke T.B. Floege J. Cardiovascular complications of chronic kidney disease: pioneering studies.Kidney Int. 2020; 98: 522-526Abstract Full Text Full Text PDF PubMed Scopus (9) Google Scholar,4Alicic R.Z. Rooney M.T. Tuttle K.R. Diabetic kidney disease: challenges, progress, and possibilities.Clin J Am Soc Nephrol. 2017; 12: 2032-2045Crossref PubMed Scopus (1284) Google Scholar Moreover, most of the diabetes-associated excess CV disease risk in with with the population, in those with T2D also have Cardiovascular complications of kidney Full Text Full Text PDF PubMed Scopus Google M.C. et disease and risk in type 2 Am Soc Nephrol. PubMed Scopus Google Scholar Glucagon-like peptide-1 receptor agonists are treatment for people with T2D and have shown to have a effect on and of and in type 2 diabetes 2020; Scopus Google Scholar from CV trials with have the CV of these with the CV benefits in with et and cardiovascular in patients with type 2 J 2016; 375: PubMed Scopus Google et semaglutide and cardiovascular in patients with type 2 J PubMed Scopus Google et risk with analysis of the 2020; PubMed Scopus Google et and cardiovascular in type 2 diabetes a Full Text Full Text PDF PubMed Scopus Google Scholar a clinical that in with T2D at high risk or with CV disease or CKD, or with CV clinical for diabetes in chronic kidney Int. Scopus Google Scholar the estimated glomerular filtration rate (eGFR) is ml/min per 1.73 et al.Diabetes in chronic kidney disease: a by the and PubMed Scopus Google Scholar of the CV trials of kidney disease and the that have effects on R.Z. et in kidney disease: and clinical Rev Nephrol. 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