The study involved a trial in which the medication alogliptin (brand name Nesina), which is used to lower blood sugar, was tested against a placebo, or fake medicine.
The researchers found that alogliptin was not linked to an increase in heart attacks, stroke or death from heart problems in people with type 2 diabetes and cardiovascular health issues.
William White, MD, of the University of Connecticut School of Medicine, led this study to see if alogliptin, a new medication for type 2 diabetes, would have an effect on cardiovascular health.
Type 2 diabetes is a disease in which the body has become desensitized to insulin, a substance that helps regulate blood sugar.
Often, individuals who have type 2 diabetes must take medication to bring blood sugar levels back to normal. One of those medications is alogliptin.
Previous studies have shown that alogliptin was effective in lowering blood sugar. However, because many patients with type 2 diabetes also have heart problems, the researchers wanted to test the medication's effect on cardiovascular health.
This study tested the effect of alogliptin on people with type 2 diabetes and an existing heart problem, like a previous heart attack or unstable angina (a condition in which the heart does not get enough oxygen or blood).
A total of 5,380 people with type 2 diabetes and either a previous heart attack or unstable angina participated in this trial. Each participant was assigned to take either alogliptin or a placebo.
The participants came in for a follow-up visit during the first, third, sixth, ninth and twelfth month of treatment, then every fourth month after that, up to 40 months after they started treatment.
The median time that participants took alogliptin was 533 days.
The researchers looked for patients who experienced heart problems while taking the medicine, including death from cardiovascular issues, nonfatal heart attack or nonfatal stroke. They also monitored death rates overall and other health issues.
They found that 11.3 percent of the patients who had been taking alogliptin had either died from heart problems, had a heart attack or had a stroke, compared with 11.8 percent of the placebo group.
The researchers concluded that alogliptin did not create an additional heart health risk among individuals with type 2 diabetes and existing cardiovascular problems.
"It's long been known that diabetics have a high incidence of coronary disease, so the thought has always been that aggressively treating diabetes would also help with cardiovascular events. Unfortunately, several medications for the treatment of diabetes have shown either no benefit or even worse cardiac outcomes. The data on alogliptin is encouraging, but it will remain to be seen if it will help improve the overall health of the diabetic patient," Jeffrey Schussler, MD, an interventional cardiologist on the medical staff at Baylor Heart and Vascular Hospital and Baylor University Medical Center at Dallas.
This study was published in October 3 in The New England Journal of Medicine.
The research was supported by grants, and several researchers disclosed financial activities with pharmaceutical companies.