番茄社区

The watchdog group Public Citizen has conducted and concluded that the type 2 diabetes drug liraglutide (Victoza) likely causes pancreatitis, the group said.

, of Public Citizen, and colleagues found that out of 278 cases of acute pancreatitis that were reported within the first 2 years of the drug coming on the market, 51 cases were "probably" caused by liraglutide, the group reported.

And in 12 of those cases, the GLP-1 receptor agonist was the "highly probable" cause, the researchers said.

The study was not published in a journal. The researchers relied on Naranjo criteria to determine the likelihood of a causal relationship between the drug and an adverse event.

They assessed data from the Adverse Event Reporting System (AERS) between February 2010 and December 2011. Pancreatitis occurred relatively soon after starting drug therapy, with 30% developing the condition within 1 month and 72% within 4 months.

The majority (60%) of patients needed hospitalization, and two patients died from complications of acute pancreatitis. In most cases, the condition resolved when the medications were stopped.

The debate over whether incretin mimetics -- including GLP-1 agonists and DPP-4 inhibitors -- cause pancreatitis and pancreatic cancer continues to rage. , of the University of California Los Angeles, has been one of the loudest voices on the subject, publishing several studies that show an association with pancreatitis.

But , long a critic of Butler's, has been critical of that work and has specifically pointed out the inadequacies of studies based on AERS data.

When asked to comment on the most recent study, Nauck told 番茄社区 that he does not "consider this a valid analysis, because it does not present any reference (e.g. per patient year of treatment) or comparison."

"The mere number is difficult to judge, although it seems high," Nauck added. "The mortality is not representative of acute pancreatitis in general, so the rigor with which the diagnosis has been made has to be questioned."

, of the Grunberger Diabetes Institute in Bloomfield Hills, Mich., and president elect of the American Association of Clinical Endocrinologists (AACE), said it's unlikely all patients should be taken off GLP-1 agonists.

"There is a reason physicians prescribe these drugs and patients continue taking them," Grunberger said. "ADA [the American Diabetes Association], EASD [the European Association for the Study of Diabetes] and AACE placed them as second-line drugs after metformin, and their recommendations have not changed."

"If you check the FDA's own website it specifically states that AERS information should NOT be used for the purposes Public Citizen is using [it]," he added.

In March, the FDA denied a citizen's petition from Public Citizen asking the agency to remove liraglutide from the market.

The agency has previously issued drug safety communications for other incretin drugs, including exenatide (Byetta) in 2007 and sitagliptin (Januvia) in 2009, and has slapped warnings about acute pancreatitis on the labels of all incretin drugs on the market.

Public Citizen cited several other studies that have found risks of pancreatitis with incretin drugs. An analysis of French data revealed that pancreatitis is an exclusive side effect of incretin drugs and does not occur with any other diabetes medications.

And data from Novo Nordisk's SCALE study of liraglutide in obesity -- an indication that will come before an FDA advisory committee in September -- showed a daily dose of 3 mg of the drug tripled the risk of acute pancreatitis (the dose, however, is far higher than that used to treat type 2 diabetes).

Sidney Wolfe, MD, founder and senior adviser to Public Citizen, the "potential expansion of liraglutide to include treatment of obesity, at a dose 1.7 times higher than that for diabetes, is extremely worrying."

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