Empagliflozin does not increase amputation risk
Study participants with type 2 diabetes receiving the SGLT2 inhibitor empagliflozin had a lower-limb amputation rate similar to those receiving placebo, according to findings from the EMPA-REG Outcome trial.
Endocrine Today previously reported on results from the EMPA-REG Outcome trial indicating that empagliflozin (Jardiance, Boehringer Ingelheim) significantly reduces the risk for cardiovascular death and all-cause mortality in patients with type 2 diabetes.
Silvio E. Inzucchi, MD, professor of endocrinology and director of the Yale Diabetes Center at Yale School of Medicine, and colleagues evaluated data from the EMPA-REG Outcome trial on 7,020 adults (mean age, 63.1 years; 71% men) with type 2 diabetes randomly assigned to empagliflozin 10 mg, empagliflozin 25 mg or placebo. Researchers sought to determine the risk for lower-limb amputations among the different treatment groups. Participants were observed for a median 3.1 years.
Overall, lower-limb amputations were reported in 131 participants: 1.9% in the empagliflozin groups and 1.8% in the placebo groups, for an incidence rate of 6.5 per 1,000 patient-years in both groups. The time to the first event was similar between both groups. The risks for lower-limb amputations were also similar between the empagliflozin 10 mg and empagliflozin 25 mg groups.
“A dedicated case report form was not used in the EMPA-REG Outcome trial as there was no concern regarding an increased risk of amputation with empagliflozin before or during the trial,” the researchers wrote. “We are confident that the reporting and systematic retrieval processes employed were thorough.” – by Amber Cox
Disclosures: Inzucchi reports he has consulted for AstraZeneca, Boehringer Ingelheim, Intarcia Therapeutics, Janssen, Lexicon Pharmaceuticals, Merck & Co., Novo Nordisk, Sanofi and vTv Therapeutics. Please see the study for all other authors’ relevant financial disclosures.