“Up until now, no real-world studies have looked at a head-to-head comparison of agents in the class on heart failure or amputation,” Buse said. Researchers used propensity score adjustment to reduce confounding. other agents in the class, in both the overall population and among a subgroup with established CVD. non-SGLT2 therapies and for canagliflozin vs. The researchers compared risk for both hospitalization for HF and below-the-knee amputation for canagliflozin vs. Data included 142,000 new users of canagliflozin, 110,000 users of other SGLT2 inhibitors ( dapagliflozin and empagliflozin ) and 460,000 users of non-SGLT2 antihyperglycemic agents, excluding metformin. administrative claims databases: Truven MarketScan Commercial Claims and Encounters, Multi-state Medicaid, Medicare Supplemental Beneficiaries and OptumInsight’s Clinformatics Datamart. In OBSERVE-4D, Buse and colleagues analyzed patient-level data from four U.S. On the other hand, only about 5 to 10% of patients in the United States with type 2 diabetes have availed themselves of the potential benefits of SGLT2 inhibitors.” “Probably 60% to 70% of patients with type 2 diabetes will die of either cardiovascular disease, heart failure or kidney failure, and this class of drugs has been shown to reduce those outcomes substantially. “The SGLT2 inhibitor class is exceptionally promising,” Buse said. The benefits of the agent outweigh any risks for most patients, Buse said. The findings from OBSERVE-4D, a retrospective, real-world, observational study, suggest the amputation risk previously observed with canagliflozin is similar to risk with other SGLT2 inhibitors and other classes of antidiabetes medications.
In 2017, the FDA required the addition of a Boxed Warning to the canagliflozin label describing the increased amputation risk. However, researchers also noted that participants assigned canagliflozin were twice as likely to experience an amputation, primarily at the toe or metatarsal, compared with placebo treatment.
Qbserve 1.82 trial#
In a real-world analysis of more than 700,000 patients with type 2 diabetes, researchers also observed a substantial reduction in risk for hospitalization for heart failure - including patients with established CVD - a benefit noted in other SGLT2 inhibitor trials that suggests a possible class effect.ĭata that suggested a possible increased risk for below-the-knee amputation with canagliflozin (Invokana, Janssen), first revealed in the CANVAS trial presented the 2017 American Diabetes Association Scientific Sessions, have been the “fly in the ointment in an otherwise very attractive set of results,” John Buse, MD, PhD, director of the Diabetes Center, director of the North Carolina Translational and Clinical Sciences Institute and executive associate dean for clinical research at the University of North Carolina School of Medicine in Chapel Hill, said during a press conference.Īs Endocrine Today previously reported, findings from the integrated CANVAS program demonstrated that patients with type 2 diabetes at high risk for CVD assigned canagliflozin had a 33% reduction in risk for hospitalization for HF and were 40% less likely to experience renal decline vs. Adults with type 2 diabetes with and without established cardiovascular disease treated with the SGLT2 inhibitor canagliflozin did not have an increased risk for below-the-knee amputation compared with patients assigned similar SGLT2 inhibitors or other antidiabetes therapies, according to findings from the OBSERVE-4D study.
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