The new guidance, which is effective immediately, recommends that Phase 2 and Phase 3 clinical trials demonstrate that new antidiabetic therapies do not increase cardiovascular risk in comparison with existing therapies, especially when they are used by older patients or by those with advanced diabetes or renal impairment. This means that companies will have to enroll more patients in clinical trials than in the past, especially older patients who are already at risk for heart disease.

 

Moreover, trials assessing for cardiovascular risk will have to last for at least a year so scientists can figure out risks for heart disease appropriately.

 

More than 23 million people in the US suffer from type 2 diabetes or diabetes mellitus, a chronic metabolic disorder in which the quantity of sugar in the blood is higher than normal. These people need to take antidiabetic drugs for the rest of their lives and thus they need to know more about whether these drugs increase risk of heart attack and stroke.

 

It is also a known fact that diabetes leads to heart disease, kidney failure and blindness so the need of drugs preventing these conditions is urgent. And drug makers should develop more efficient drugs as the number of the people suffering from diabetes is on the rise given the rise in obesity, a condition known to lead to type 2 diabetes. The American Diabetes Association estimates there will be nearly 50 million people with the disease by 2025. Poor diet and lack of physical activity are also two important factors in developing diabetes.

 

The new guidance posted under the title “Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes” is posted on FDA’s Web site and will be published in the Federal Register on December 19, 2008. It affects future antidiabetic therapies as well as pending approval applications, including one from Bristol-Myers Squibb Co. and AstraZeneca PLC for saxagliptin and one from Eli Lilly & Co. and Amylin Pharmaceutical Inc. for Byetta as a stand-alone treatment.

 

Mary Parks, FDA’s director of metabolism and endocrinology products office, said the agency sent out more than 100 letters to companies with type 2 diabetes drugs in development informing them of the new guidelines.

 

“The guidance document will help industry evaluate the cardiovascular risk associated with new therapies under development to treat type 2 diabetes,” she added.

 

The new guidance reflects the decision of the FDA’s Endocrinologic and Metabolic drugs Advisory Committee, which in July called for studies of the cardiovascular risks of new diabetic drugs.