
Dr. William White, professor of medicine and chief of the Calhoun Cardiology Center Division of Hypertension and Clinical Pharmacology at UConn Health, analyzed data from a global clinical trial called EXAMINE. Regulatory agencies require a comprehensive evaluation of the cardiovascular safety profile of new diabetic therapies.
“This new analysis shows that Alogliptin was safe in patients with Type 2 diabetes who we considered at high cardiovascular risk because they had had an acute coronary syndrome before entering the trial,” says White.
Even in patients who had a history of heart failure – 28 percent of participants – there was no increase in hospitalization.
The information is significant because of the prevalence of heart disease morbidity and mortality in patients with Type 2 diabetes. According to the World Health Organization, heart disease is responsible for between 50 percent and 80 percent of deaths among diabetics.
Also, the findings contradict a previous clinical trial of another diabetes medication in the same drug class that showed a modest increase in heart failure risk, leading to a closer scrutiny of Alogliptin – an orally administered anti-diabetic drug in the DPP-4 inhibitor class – in the medical community.
EXAMINE is an acronym for “Examination of Cardiovascular Outcomes: Alogliptin vs. Standard of Care in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome.” The study included nearly 5,400 diabetics in 49 countries, all of whom were within 90 days of hospitalization for either a heart attack or chest pain related to coronary heart disease. The trial was funded by Japanese pharmaceutical company Takeda, which makes Alogliptin.
Source: University of Connecticut
Filed Under: Drug Discovery