Looks pretty dodgy to me. Here is what one of the CKD dialysis companies thinks of the Ozempic announcement.
The trouble, as DaVita sees it, is that Novo’s patient inclusion parameters might have been too narrow. Patients enrolled in FLOW had to have both Type 2 diabetes and CKD, plus, they needed to have received treatment with standard kidney disease therapies such as ACE inhibitors. The trial subjects also needed to demonstrate a certain amount of proteinuria, or protein in the urine.
DaVita figures fewer than 10% of all current CKD patients would have this specific combination of factors. As such, more studies and research are needed to determine whether any findings from FLOW could benefit a CKD population beyond those included in the trial, the company said.
DaVita also took issue with the study’s five-pronged composite endpoint, which includes factors like whether patients need dialysis or a kidney transplant. Findings on any one or more of those measurements could have triggered FLOW’s early stop, DaVita said.
https://www.fiercepharma.com/pharma/after-novo-nordisks-ozempic-logs-apparent-victory-kidney-disease-dialysis-heavyweight-davita
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