The U.S. Food and Drug Administration has approved semaglutide (Ozempic) to reduce the risk of kidney disease progression, end-stage kidney disease, and cardiovascular mortality in adult patients with type 2 diabetes and chronic kidney disease. The approval makes semaglutide the only glucagon-like peptide-1 receptor agonist with this specific indication.
The approval was based on results from the phase IIIb FLOW kidney outcomes trial, which demonstrated a 24% relative risk reduction in the composite endpoint of kidney disease worsening, end-stage kidney disease, and cardiovascular mortality compared with placebo when added to standard of care. The absolute risk reduction was 4.9% at 3 years.
"Type 2 diabetes can be challenging enough to manage without the added risk of chronic kidney disease (CKD), and I have seen in my own practice that patients with type 2 diabetes and CKD need extra support from medications that may have a profound clinical impact by lowering the risk of major kidney and cardiovascular outcomes," emphasized Richard E. Pratley, MD, Medical Director at the AdventHealth Diabetes Institute Orlando and Co-Chair of the FLOW Trial in a press release from PR Newswire.
The FLOW trial, which was initiated in 2019, was an international, randomized, double-blind, parallel-group, placebo-controlled study involving 3,533 adult patients across 28 countries at approximately 400 investigator sites. The trial was terminated early as a result of meeting prespecified efficacy criteria after a median follow-up of 3.4 years.
According to Novo Nordisk, CKD affects 37 million U.S. adults and approximately 40% of patients with type 2 diabetes.
This marks the third U.S. Food and Drug Administration–approved indication for semaglutide, following its initial 2017 approval for glycemic control in type 2 diabetes and its 2020 approval for cardiovascular risk reduction in adult patients with type 2 diabetes and established cardiovascular disease.
The medication's safety profile remains consistent with previous findings. Important safety considerations include risk of thyroid tumors, pancreatitis, diabetic retinopathy complications, hypoglycemia when used with insulin or sulfonylureas, and kidney issues related to dehydration. Common side effects include nausea, vomiting, diarrhea, abdominal pain, and constipation.
The recommended dose for the newly approved indication follows the established dosing protocol for semaglutide's existing indications, available as 0.5 mg, 1 mg, or 2 mg injectable formulations.
