Researchers Face Off Over Incretin Risk

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Researchers Face Off Over Incretin Risk
By Kristina Fiore, Staff Writer, MedPage Today
Published: May 17, 2013

As concerns escalate over glucagon-like peptide-1 (GLP-1)-based therapies
and their potential risk of pancreatitis, pancreatic cancer, and thyroid
cancer, the journal Diabetes Care hosted a point-counterpoint debate between
the researchers who have been the leading voices on each side of the issue.

Michael Nauck, MD, of the Diabetes Center in Bad Lauterbern, Germany,
claimed the benefits outweigh the risks.

Nauck reported relationships with Berlin-Chemie AG/Menarini, Eli Lilly,
Merck Sharp & Dohme, Novartis, AstraZeneca, Boehringer Ingelheim,
GlaxoSmithKline, MetaCure, Roche, Grenzach-Whylen, Novo Nordisk, Tolerx,
Bristol-Myers Squibb, Rueil-Malmaison, Diartis Pharmaceuticals, Hoffman-La
Roche, Intarcia Therapeutics, MannKind, Sanofi, Takeda, Versartis, and
Wyeth.

Peter Butler, MD, of the University of California Los Angeles, and
colleagues argued the need to reconsider use of GLP-1 therapy.

Bulter is supported by the NIDDK, the Larry L. Hillblom Foundation, and the
Peter and Valerie Kompaniez Foundation.

Butler first raised eyebrows over GLP-1 drug risk in a study published in
Gastroenterology that found higher rates of pancreatitis and pancreatic
cancer in patients taking either sitagliptin (Januvia) or exenatide (Byetta)
when looking at data from the FDA's Adverse Event Reporting System (AERS).

Butler and colleagues said the case of GLP-1 drugs is similar to that of
other classes of diabetes medications.

"The story is familiar. A new class of anti-diabetic agents is rushed to
market and widely promoted in the absence of any evidence of long-term
beneficial outcomes," they wrote. "Evidence of harm accumulates but is
vigorously discounted. The regulators allow years to pass before they act.
The manufacturers are expected -- quite unrealistically -- to monitor the
safety of their own product."

They said the case closely parallels that of the thiazolidinediones,
including rosiglitazone (Avandia), which had fallen from grace after
researchers found significant cardiovascular risks.

Butler added that the concerns expressed by regulatory authorities over
potential risks for pancreatitis and related conditions are "largely
discounted by the manufacturers and those representing their views to
physicians, who typically maintain that the risk of pancreatic inflammation
is illusory."



A critical analysis of the clinical use of incretin-based therapies: The
benefits far outweigh the potential risks"

Diabetes Care 2013
Nauck M

DOI: 10.2337/dc12-2504.