Level Of Concern About These Incretin Therapies For Diabetes Was Raised By Gastroenterology Medical Journal Article
In September 2011, at the 47th European Association for the Study of Diabetes (EASD) Annual Meeting, Diabetes Medical Congress, in Lisbon, Portugal, there was a debate about whether there is an increased risk of pancreatitis, pancreatic cancer, and thyroid cancer for patients who use Januvia (sitagliptin) or Byetta (exenatide), which are incretin therapies for diabetes.
On one side was Peter Butler, MD, of the University of California Los Angeles (UCLA), who found higher rates of pancreatitis and pancreatic cancer in patients. Those findings are the subject of a paper by Dr. Butler and his colleagues, "Byetta and Januvia: Pancreatitis, Pancreatic, and Thyroid Cancer With Glucagon-Like Peptide-1–Based Therapies" which was published by the medical journal Gastroenterology-- initially online back in February 2011 and later in the July 2011 print edition.
On the other side of this drug safety debate was Michael Nauck, MD, of the Diabetes Center Bad Lauterberg in Harz, Germany. Dr. Nauck pointed out that those findings set forth in the Gastroenterology article were based on an analysis of data from the FDA's Adverse Event Reporting System (AERS).
A September 18, 2011 MedPage Today article, "EASD: Debate Brings Incretin Risks to Forefront", did a good job of presenting the main points made by Dr. Butler and Dr. Nauck:
(1) In their paper, Butler and colleagues reviewed AERS data between 2004 and 2009, and found a six-fold increased likelihood of reported pancreatitis with [Byetta] or [Januvia] compared with control reports.
They also found a significant threefold greater likelihood of reported pancreatic cancer with either drug, as well as a four-fold greater likelihood of reported thyroid cancer with [Byetta].
(2) "There will be a lot of reporting bias," Nauck said during an interview with MedPage Today. "If there is public awareness for certain things, then physicians and others will feel more inclined to report such events to the database."...
But given the limitations of the FDA data set, researchers said data from other sources still need to be analyzed before drawing any conclusions about the potential side effects of the drug class.
Nauck said randomized controlled trials would be a near-impossibility because the number of patients needed in each arm would have to be exceedingly large in order to have the power to detect true risk, since pancreatitis and pancreatic cancers are so rare.
Instead, researchers will need to assess large databases, potentially individual registries or combined ones, Nauck said.
(3) Butler echoed those sentiments. "It is important from these studies that we look carefully at the possibility," of the link between the incretin therapies and these side effects.
"This does not establish that pancreatitis is caused by GLP-1's," he said. "It simply raises the level of concern, and appropriate prospective studies are needed."
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Back in June 2010 a different observational study of medical claims data done by the pharmacy benefit manager Medco Health Solutions in association with the University of Texas Southwestern Medical School found that Januvia and Byetta did not increase the risk of developing pancreatitis compared with other diabetes drugs.
From a June 27, 2010 Reuters report by Lewis Krauskopf about that earlier study, "No pancreatitis risk seen in Byetta, Januvia drugs-study":
Dr. Merri Pendergrass, who conducted the study, acknowledged that it was an observational study of data, as opposed to the gold standard of a randomized clinical trial.
But the results were reassuring about use of Byetta and Januvia, said Pendergrass, national practice leader of Medco’s therapeutic resource center for diabetes.
“There does not seem to be a signal of increased risk,” Pendergrass said from Orlando, Florida, where the study was being presented at the American Diabetes Association scientific sessions in Orlando. “There’s no smoke here, so that’s reassuring.”...
For the group taking various diabetic medicines, there were 5.72 cases of acute pancreatitis for every 1,000 patient years. It was 5.69 for Byetta, and 5.54 for Januvia.
Furthermore, according to this June 2010 Reuters report:
The study also found that diabetics generally are at increased risk of acute pancreatitis, compared with non-diabetics, which the study’s author said confirmed previous research, although the risk remains very low.
In the end, one thing that can be said with certainty is that the safety profiles of Byetta and Januvia remain a subject deserving of more medical research. We will continue to monitor the situation and report significant developments here.
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