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FLOW trial (revision 3)

Old revision·21:12, 9 Oct 2024·LotTraceLuka

This is an old revision of this page, as it stood at 21:12, 9 Oct 2024, saved by LotTraceLuka with the summary correct the endpoint hierarchy — that was a secondary endpoint. It may differ substantially from the current revision, and any error it contains may since have been corrected.
FLOW trial
DrugSemaglutide 1.0 mg weekly
PopulationType 2 diabetes with chronic kidney disease
Participants3,533
Primary resultKidney outcome HR 0.76 (95% CI 0.66–0.88)
Topic infobox · conventions

FLOW was a randomised, double-blind, placebo-controlled trial of weekly semaglutide 1.0 mg in 3,533 adults with type 2 diabetes and chronic kidney disease. It was stopped early for efficacy on the recommendation of its data monitoring committee.[1]

The primary composite comprised onset of kidney failure, a sustained fall of at least 50% in estimated glomerular filtration rate, or death from kidney or cardiovascular causes. It occurred less often on semaglutide, hazard ratio 0.76 (95% CI 0.66–0.88).[1]

Design

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Participants had type 2 diabetes with an estimated glomerular filtration rate and albumin-to-creatinine ratio within defined ranges, and were on maximum tolerated renin–angiotensin system blockade. The trial therefore tested semaglutide added to established renal protection rather than in its place.[1]

The dose studied was 1.0 mg weekly — the type 2 diabetes dose, not the 2.4 mg obesity dose. As elsewhere in this field, results at one dose do not transfer to another.[2]

References

  1. ^ a b c Perkovic V, Tuttle KR, Rossing P, et al. "Effects of semaglutide on chronic kidney disease in patients with type 2 diabetes." New England Journal of Medicine 391(2):109–121 (2024). DOI:10.1056/NEJMoa2403347. PMID 38785209.
  2. ^ Lincoff AM, Brown-Frandsen K, Colhoun HM, et al. "Semaglutide and cardiovascular outcomes in obesity without diabetes." New England Journal of Medicine 389(24):2221–2232 (2023). PMID 37952131.