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ARTICLE | Clinical News

Glucagon-like peptide-1 endocrine/metabolic data

September 19, 2011 7:00 AM UTC

Researchers at the university reported data showing that the use of GLP-1-related therapies Januvia sitagliptin and Byetta exenatide showing was associated with a significant sixfold increased rate of reported pancreatitis vs. 4 other marketed Type II diabetes control therapies (p<2x10-16 for both). Additionally, both drugs were associated with a significantly higher rate of reported pancreatic cancer vs. control therapies (p<0.008 and p<0.00009, respectively), while only Byetta led to a significantly higher rate of thyroid cancer vs. controls (p<0.004). There was no significant difference between either Januvia or Byetta compared to control therapies in the rate of all cancers (p=0.2 and p=0.47, respectively). The researchers analyzed adverse events associated with Januvia or Byetta that were reported to FDA's Adverse Event Reporting System (AERS) between 2004-09. Control therapies included Avandia rosiglitazone from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK, London, U.K.); Starlix nateglinide from Novartis AG (NYSE:NVS; SIX:NOVN; Basel, Switzerland); Prandin repaglinide from Novo Nordisk A/S (CSE:NVO; NYSE:NVO; Bagsvaerd, Denmark); and glipizide. Data were published in Gastroenterology.

The researchers said the GLP-1 class of drugs could have serious unintended and unpredicted side effects. Victoza liraglutide is a long-acting analog of GLP-1 that is marketed by Novo Nordisk; however, it wasn't included in the analysis. Merck & Co. Inc. (NYSE:MRK; Whitehouse Station, N.J.) markets Januvia, a dipeptidyl peptidase-4 (DPP-4) inhibitor, while Amylin Pharmaceuticals Inc. (NASDAQ:AMLN; San Diego, Calif.) and Eli Lilly and Co. (NYSE:LLY; Indianapolis, Ind.) market Byetta, a synthetic exendin-4. ...