乌鸦传媒

SAN FRANCISCO -- The Endocrine Society has joined its voice to the recent call for incretin drugmakers to release all patient-level data on their products, the group announced at its annual meeting.

In a statement, the organization said it supports the call by the American Diabetes Association (ADA) for data and that it urges "all manufacturers of incretin-based therapy to make the data from these studies on rates of pancreatitis and pancreatic cancer transparent and available to an independent group of scientists for analysis."

The group said that currently available data on risks and safety of incretin therapies, which include GLP-1 agonists and DPP-4 inhibitors, have significant limitations and aren't of the caliber typically used to validate adverse events.

It also "believes that more research is needed ... before any conclusion can be reached about safety with regard to pancreatitis and pancreatic cancer."

The current state of the literature on risks of incretins was the subject of a panel discussion at the meeting. Panelist Steven Kahn, MB, ChB, who has written a critical editorial about some of the existing data -- notably that by Peter Butler, MD, of the University of California Los Angeles -- said endocrinologists are expecting data from several large trials to become available in the near future to make better decisions about the drug class.

Kahn, a professor of medicine and member of the Diabetes Research Group at the University of Washington, told 乌鸦传媒 that researchers will be looking to two types of studies for clarification on the risks of the drugs. Of particular interest will be cardiovascular safety studies that will be large enough to detect other events including pancreatitis and pancreatic cancer.

Experts are also awaiting analyses from European health regulators, who have sanctioned the Safety Evaluation of Adverse Reactions in Diabetes (SAFEGUARD) study to assess incretin risks.

Kahn said there will be several aspects to the SAFEGUARD study that will be conducted by a multidisciplinary team of researchers. One piece includes analysis of data from the FDA, the European Medicines Agency (EMA), and the World Health Organization (WHO) databases for risk assessment; another will involve pooling data from major healthcare organizations.

The project will also include several mechanistic studies to gauge whether the drugs have effects on pancreatic histology, Kahn said.

"I think [these] will throw a lot of new light onto this issue, and at the end of the day help us better understand the problems and better treat our patients and safely treat our patients," he said. "At the end of the day, we have to do what's best for our patients, and understanding if there is truly a risk of pancreatitis that outweighs the benefits -- we must remember that no drug is free of side effects and risk -- or more importantly if there is pancreatic cancer, we need to know."

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