Merck & Co. Inc. and Pfizer Inc.'s medicine Steglatro was shown to be safe in terms of major heart issues but failed to reduce certain heart and kidney risks among patients with type 2 diabetes and heart conditions in a late-stage study.
Steglatro, or ertugliflozin, was approved in the U.S. in December 2017 to treat type 2 diabetes.
The phase 3 trial for the drug, named Vertis CV, was conducted to satisfy the U.S. Food and Drug Administration's guidance on showing cardiovascular safety for novel anti-hyperglycemic drugs in the pre-approval and post-approval time periods.
Vertis CV, which enrolled 8,246 adults with type 2 diabetes and atherosclerotic cardiovascular disease, evaluated Steglatro against placebo, added to standard of care. Arteriosclerosis is a hardening of the arteries which can restrict blood flow to the organs and tissues.
Data from the study showed that 11.9% of patients on both the diabetes drug and placebo experienced a non-fatal heart attack, stroke or cardiovascular death, according to a June 16 news release.
Steglatro, however, failed to perform better than placebo in the secondary goals of the study, which included prolonging the time to cardiovascular death or hospitalization for heart failure, delaying death due to kidney complications and dialysis/transplant.
Merck and Pfizer said in the news release that Steglatro showed a 30% reduction in the risk of hospitalization for heart failure versus placebo, but noted that this measure was not part of the study's hierarchical testing sequence.
The safety profile of Steglatro was consistent with that reported in previous studies.
Steglatro belongs to a class of drugs known as SGLT-2 inhibitors, which include Johnson & Johnson's Invokana and AstraZeneca PLC's Farxiga.
Invokana is approved in the U.S. for reducing the risk of end-stage kidney disease and cardiovascular risk in certain patients with diabetes. Farxiga is also approved for reducing the risk of heart failure.