Takeda Pharmaceutical said a post hoc study on alogliptin showed no increase in the composite rate of cardiovascular mortality and among high-risk patients with diabetes. The results were published in The Lancet.
The study was the first DPP-4i to report out results on cardiovascular safety outcomes in high-risk Type 2 diabetes patients and comes as the company looks ahead from Actos, which accounts for half of the Japanese company's U.S. revenues and 18% of its worldwide sales.
The company saw Nesina approved a few weeks into 2013 along with two combos dubbed Kazano and Oseni just 6 months after Actos generics spurred a serious sales dive.
"Patients with diabetes are at significantly higher risk of having heart disease or suffering a stroke, and it is critical that diabetes treatments adequately manage glucose levels without adversely affecting cardiovascular outcomes, such as hospitalized heart failure and cardiac death," said Faiez Zannad, a medical doctor and professor of therapeutics and cardiology at the Institut Lorrain du Coeur et des Vaisseaux, Centre d'Investigation Clinique Inserm, in France.
"The publication of these post hoc analyses of data from EXAMINE is an opportunity to share findings that alogliptin compared with placebo did not increase the composite rate of cardiovascular mortality and hospitalized heart failure in this high-risk population of patients with diabetes."
The data in the study specifically showed that in patients with Type 2 diabetes and recent acute coronary syndrome (ACS), dipeptidyl peptidase 4 inhibitor (DPP-4i) alogliptin compared to placebo did not increase the risk of heart failure outcomes.
The clinical work examined a randomized 5,380 patients in 49 countries with Type 2 diabetes with an ACS within the previous 15-90 days, meeting the primary end endpoint of noninferiority compared to placebo in addition to standard of care.
- here's the release
- and the Lancet abstract
Special Report: New drug approvals 2013 - Nesina: Takeda trio enters a crowded diabetes field in Actos' wake