Janu-"Meh": pancreatitis study fails to cause uproar

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A JAMA Internal Medicine report linking diabetes medications Januvia and Byetta with an increased link in hospitalizations for pancreatitis—an inflammation that may lead to scarring and organ damage—appears to have had an immediately underwhelming impact.

The report did prompt a joint statement by the American Diabetes Association and the American Association of Endocrinologists which said they stand by the GLP-1 inhibitors, and that the study, which analyzed a database of patients from 2005 through 2008, “does not provide the basis for changing treatment in people with diabetes.” The organizations also noted that the hospitalization rate amounted to "a small excess risk of hospitalization" and the same patient group was at a greater risk for a pancreatitis-linked hospital visit if they used tobacco, "consumed alcohol or were obese."

Patients also seem unconcerned so far. Although Merck wouldn't comment on patient reaction, the American Diabetes Association said it has yet to receive a single patient inquiry regarding the study.

Leerink Swann analyst Seamus Fernandez dismissed the study in a February 27 research note, saying “we are skeptical that this study alone will have any meaningful impact on use of these therapies.” He pointed out that the study focused on hospitalizations resulting from pancreatitis among GLP-1/DPP4 patients as opposed to pancreatitis incidents as a whole.

The drugs, made by Merck and Bristol-Myers Squibb for adults with type 2 diabetes, are blockbusters and have come under scrutiny in the past. In 2009 the FDA had Merck revise labels for Januvia and Janumet (sitagliptin) to address reports of acute pancreatitis among patients. The 2009 notice said that there had been 88 “post-marketing cases of acute pancreatitis, including two cases of hemorrhagic or necrotizing pancreatitis” among patients using the drug between 2006 and 2009.

The regulator also revised Byetta's label in 2008 for the very same reason, noting that six cases of hemorrhagic or necrotizing pancreatitis were reported the year before.

Merck said the company's products are reviewed by regulators worldwide and that “in our extensive evaluation of the drug, we see no compelling evidence of a causal relationship between the use of sitagliptin and pancreatitis."

Ken Dominski of Bristol-Myers Squibb emailed MM&M a similar remark, saying that BMS and collaborator AstraZeneca “are confident in the positive risk-benefit profile of Byetta.”

The ADA and AACE said there are nine studies currently reviewing this same issue among 65,000 patients which they expect will address safety concerns.

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