The FDA has approved Ozempic to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease) and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease (CKD).

CKD affects approximately 37 million adults in the US and is expected to rise with an aging demographic and increasing prevalence of diabetes, the leading cause of CKD and kidney failure. CKD is a common complication of type 2 diabetes, with approximately 40% of people with type 2 diabetes also experiencing CKD. For people with type 2 diabetes, CKD can be a significant burden and can cause additional sickness, including increased risk of cardiovascular problems and death.
This FDA approval is based on results from the FLOW phase 3b kidney outcomes trial investigating the effects of once-weekly Ozempic injection on major kidney and cardiovascular outcomes in adults with type 2 diabetes and CKD.1 The FLOW trial achieved its primary endpoint with Ozempic 1mg, demonstrating a statistically significant and superior 24% relative risk reduction of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease (4.9% absolute risk reduction at 3 years) compared to placebo, when added to standard of care.
“Type 2 diabetes can be challenging enough to manage without the added risk of chronic kidney disease, and I have seen in my own practice that patients with type 2 diabetes and chronic kidney disease need extra support from medications that may have a profound clinical impact by lowering the risk of major kidney and cardiovascular outcomes,” said Dr Richard E Pratley, Medical Director at the AdventHealth Diabetes Institute Orlando, FL, and Co-Chair of the FLOW Trial. “A large portion of patients I treat experience serious kidney complications and comorbidities, with some even requiring dialysis. Today’s decision by the FDA offers hope for the millions of adults living with both conditions and provides an additional treatment option, representing a significant advancement for my patients.”
FLOW was an international, randomised, double-blind, parallel-group, placebo-controlled, event-driven superiority trial comparing once-weekly Ozempic®1mg with placebo as an adjunct to standard of care on kidney outcomes for reducing the incidence of the primary composite endpoint of a sustained decline in eGFR of ≥50%, sustained eGFR <15mL/min/1.73m2, chronic renal replacement therapy, renal death, and CV death in adults with type 2 diabetes and CKD. 3,533 adults (1,767 in the Ozempic group and 1,766 in the placebo group) were enrolled in the trial conducted in 28 countries at approximately 400 investigator sites.
The FLOW trial was initiated in 2019. At the recommendation from an Independent Data Monitoring Committee, the FLOW study was stopped early due to meeting pre-specified efficacy criteria after a median follow-up of 3.4 years.
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