Today (17 September), at the 61st European Association for the Study of Diabetes (EASD) conference, during an oral abstract session on the topic of ‘GLP-1 trending: the latest developments’, Klara Klein, MD, PhD, presented findings of a pooled analysis study. Klein focused on Novo Nordisk’s semaglutide to highlight progress made in the dialysis patient population.
The findings presented at EASD showed that treatment with semaglutide was not associated with a higher proportion of adverse events, including major adverse cardiovascular events (MACE) and all-cause mortality, among those initiating dialysis. In addition, MACE and all-cause mortality event rates were numerically lower in the semaglutide group compared to placebo.
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This pooled analysis represents the largest prospective cohort of individuals who initiated dialysis while receiving semaglutide treatment. The study’s most crucial finding is that semaglutide continuation after dialysis initiation appears safe, with no increased risk of serious adverse events compared to placebo. Among the 307 participants who initiated dialysis during follow-up, semaglutide was associated with numerically lower all-cause mortality and MACE. This is particularly significant given that dialysis patients face very high cardiovascular (CV) mortality rates.
This pooled analysis of 34,064 participants across four major CV outcome trials – SUSTAIN-6, SELECT, FLOW, SOUL – represents a significant advancement in understanding semaglutide’s safety profile among dialysis patients. The study’s demonstration of continued safety after dialysis initiation could influence clinical guidelines and standard-of-care recommendations, further driving adoption of semaglutide. However, the study’s limitations – including lack of randomisation at dialysis initiation – necessitate additional research.
A key opinion leader interviewed by leading data and analytics company GlobalData states: “The theme with these drugs is that they are all out of the range of what people can afford. It depends on the insurance companies, what their criteria are for approving it, and then the company’s willingness to provide it when the appeals are denied.” The commercial impact of this pooled analysis will likely be progressive, building as additional supportive evidence emerges and clinical experience accumulates in this challenging patient population.
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By GlobalData
