Newswise — An advisory panel to the Food & Drug Administration voted 14-2 on Wednesday that new diabetes medications should be subjected to tougher standards. This recommendation means longer studies should be conducted to properly evaluate the cardiovascular risks of diabetes medication before they go to market.
AACE member Farhad Zangeneh, MD, FACP, FACE, the medical director of the Endocrine, Diabetes & Osteoporosis Clinic (EDOC) in Sterling, Virginia, and the assistant clinical professor of medicine at the George Washington School of Medicine, testified before the panel on behalf of the Association.
"Diabetes is a multifaceted, multisystem and progressive disease. Type 2 Diabetes Mellitus is an increasingly prevalent chronic disorder that carries with it a formidable portfolio of associated metabolic derangements," Dr. Zangeneh said. "The Centers for Disease Control recently reported that there are over 24 million people with diabetes in the US, roughly eight percent of the population. Microvascular complications of diabetes remain the leading causes of blindness and renal failure in the developed world and are much more closely associated with hyperglycemia than with macrovascular complications."
"We need to commence strategies for diabetes prevention," Dr. Zangeneh said. "AACE will hold a consensus conference to review the Diagnosis and Management of Pre-Diabetes in the Continuum of Hyperglycemia - When do the Risks of Diabetes Begin?"
Recent trials have been disappointing. Despite uncoupling of A1c reduction and CV risk reduction, the lower-than-anticipated rate of cardiovascular events seen in the intensive treatment group and the standard-treatment group in these studies is an affirmation of the success of modern therapeutics, even when incompletely implemented.
"Short trials may only detect adverse events, lack of effect or disease complication and not the benefit of intensive diabetes therapy," he said. "Trials need to be long enough (perhaps greater than the duration of diabetes and pre-diabetes) with better adaptive designs to recognize on and off target events."
"Ear-marking the approval process of developing oral anti-diabetes agents (OAD's) with cardiovascular outcomes/endpoints in pre-marketing clinical trials would delay drug delivery, impact innovation and likely not improve the safety profiles of OAD's," Dr. Zangeneh said.
"Strict and transparent post-marketing surveillance of new medications is needed. Such an approach would complement the existing use of surrogate markers used to evaluate safety and efficacy of novel approved drugs for the management of chronic illnesses evaluated by the FDA."
AACE President Daniel S. Duick, MD, FACP, FACE, commenting on the events of the FDA two-day meeting and Dr. Zageneh's testimony said; "Dr. Zangeneh's remarks are congruous with AACE's guidelines and AACE's concerns regarding diabetes as being a disease with many untoward and disastrous outcomes. The problem with adding cardiovascular endpoints to pivotal diabetes drug trials, rather than post-approval, Phase IV expanded surveillance studies, is the glaring fact that this will impede the development and release in a timely fashion of diabetes drugs necessary for the management of this disease."
About AACEAACE is a professional medical organization with as many as 6,000 members in the United States and 84 other countries. Founded in 1991, AACE is dedicated to the optimal care of patients with endocrine problems. AACE initiatives inform the public about endocrine disorders. AACE also conducts continuing education programs for clinical endocrinologists, physicians whose advanced, specialized training enables them to be experts in the care of endocrine disease, such as diabetes, thyroid disorders, growth hormone deficiency, osteoporosis, cholesterol disorders, hypertension and obesity. For more information, visit http://www.aace.com.
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