Joslin Diabetes Center Affiliate to Participate in International Diabetes and Heart Disease Clinical Trial

November 2, 2009

The number of people with diabetes is growing at an alarming rate. And soon, the Floyd Memorial Joslin Diabetes Center Affiliate will begin working on an international clinical trial aimed at determining the safety of a new diabetes medication for patients with existing cardiac disease. “Some diabetes medicines have been found to increase the risk of cardiac events,” explained Cardiologist Steven Filardo, MD. “Patients with type 2 diabetes are already at high risk for cardiac events, and we want to make sure the diabetes medicine doesn’t increase that risk any further. We will be working with Joslin Center Endocrinologist Vasti Broadstone, MD, throughout the trial to monitor the results.”

spanova“Diabetes is becoming more prevalent in our society. There is a growing need for new medications. This study will play a key role in making sure a promising new medication does not increase the risk of a serious cardiac event in people who have already had acute coronary syndrome.”

Adriana Spanova, MD, FP
Floyd Memorial Clinical Researcher

According to Adriana Spanova, MD, FP, Floyd Memorial clinical researcher, “The study will evaluate the  cardiovascular safety of this investigational drug in comparison with a placebo in patients being treated for type 2 diabetes. This will be a randomized, international study. Half of the participants will receive the new medication, and half the placebo. We will monitor participants for heart attack, stroke or other major acute cardiac events to determine whether the occurrence is higher among the group taking the new medication.”

The duration of the study will be up to four-and-a-half years, and there will be very strict guidelines. “Participants must have been previously diagnosed with type 2 diabetes, using insulin or other anti-diabetic medication, and have been recently admitted to the hospital with an acute coronary event,” said Dr. Spanova. “If qualified, they will be  randomized 15-60 days after their discharge from the hospital.”

Even Mildly Elevated Blood Sugar Increases Risk for Heart Disease

When Dr. Filardo sees a patient, it is nearly always because the patient has heart disease. But according to him, it is extremely common for his younger heart patients to learn that they also have slightly elevated blood sugar. Dr. Filardo is finding that a mildly elevated blood sugar level often indicates a metabolic abnormality that increases the risk of heart disease – even before the onset or diagnosis of diabetes.

“Even if the patient’s blood sugars are only elevated by a few points, the patient is at risk.” said Dr. Filardo. “I am very aggressive about sending patients to Joslin when they have heart disease and mildly elevated sugars. They need to know that a metabolic disorder is part of their makeup. Elevated blood sugars create the risk for heart disease well before the condition progresses to diabetes. Many times, if they get their weight down and exercise, it can decrease their blood sugars.”

filardo“When a young person has a heart attack, I look at the big picture. If their blood sugars are a little elevated, it makes arteries more prone to blockage. It helps to take a comprehensive approach and get an endocrinologist from the Joslin Center involved to help them deal with the problem. We are very fortunate to have the resources of the Joslin Diabetes Center Affiliate right here on our campus.”

Steven Filardo, FACC, MD, MPH
Board Certified Interventional Cardiologist
Preferred Cardiology of Kentuckiana, LLC