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General Health : Drug News Last Updated: Apr 20, 2011 - 9:38:09 AM


Which is better for diabetes, Byetta or Januvia?
By Sue Mueller
Sep 9, 2008 - 5:58:48 PM

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credit:ltdhd.ky.gov
TUESDAY Sep. 9, 2008 (foodconsumer.org) -- Amylin Pharmaceuticals today released a new study at the European Association for the Study of Diabetes in Rome to demonstrate that its anti-diabetes drug Byetta is better than Januvia, a diabetes drug made by Merck, news media reported.

 

Amylin and Eli Lilly confirmed that Byetta is indeed more potent than Januvia.  But Merck Co. Inc. said comparing Byetta to Januvia is like comparing apples to oranges.

 

Januvia, used once a day, is indicated for patients who experience the earlier signs of type 2 diabetes while Byetta, injected twice a day is prescribed for patients with advanced type 2 diabetes who need additional benefits such as weight loss and suppressed appetite, according to Forbes.com.

 

Dr. Barry Goldstein, Merck's vice president of clinical research, told Forbes.com that the Amylin study did not compare the side effects of the two drugs.  In fact, the Merck diabetes drug Januvia has less severe adverse effects.

 

One severe adverse effect associated with both drugs is increased risk of pancreatitis.  Yaron Werber of Citi Investment Research was cited as saying in a client note that patients on Byetta are four times as likely to develop pancreatitis as those on Januvia.

 

Werber said of every 100,000 patients on Byetta, 6.5 are expected to develop acute pancreatitis compared to 1.6 for every 100,000 patients taking Januvia.

 

(Editor's note: the severity of diabetes in the two groups may be different and the data may not mean that the higher incidence of pancreatitis in patients on Byetta is due to the drug itself. In any case, a causal relationship has not bee established.)

 

There is more bad news for Byetta.    The Food and Drug Administration announced last month that six patients who had been taking Byetta developed severe pancreatitis of whom two had died.

 

Pancretistis, which can release toxins contaminating the bloodstream, can develop in patients with diabetes.   It is obviously unknown whether the increased risk was due to the effect of the drug or the patients’ condition.

 

"The study is really looking at the peak of when Byetta is in the body after it is injected; on the other hand, Januvia works for a 24-hour period and has a steady effect," Goldstein was quoted as saying. "It's a mismatch in comparing the two in the way that the study is done."

 

Byetta being taken by an estimated 700,000 Americans was expected to be considered for approval in early 2009, according to Werber, cited by forbes.com.

 

The following is the message issued by the FDA regarding the safety of Byetta.

 

Byetta (exenatide)

Audience: Endocrinologists, other healthcare professionals, consumers
[UPDATED 08/18/2008] Since issuing Information for Healthcare Professionals in October 2007, FDA has received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta. Byetta is a medicine given by subcutaneous injection to help treat adults with type 2 diabetes. Of the 6 cases of hemorrhagic or necrotizing pancreatitis, all patients required hospitalization, two patients died and four patients were recovering at time of reporting. Byetta was discontinued in all 6 cases. Byetta and other potentially suspect drugs should be promptly discontinued if pancreatitis is suspected. There are no signs or symptoms that distinguish acute hemorrhagic or necrotizing pancreatitis associated with Byetta from the less severe form of pancreatitis. If pancreatitis is confirmed, initiate appropriate treatment and carefully monitor the patient until recovery. Byetta should not be restarted. Consider antidiabetic therapies other than Byetta in patients with a history of pancreatitis.

[UPDATED 02/27/2008] Dear Healthcare Professional letter posted.

[Posted 10/16/2007] FDA has reviewed 30 postmarketing reports of acute pancreatitis in patients taking Byetta (exenatide), a drug used to treat adults with type 2 diabetes. An association between Byetta and acute pancreatitis is suspected in some of these cases. Amylin Pharmaceuticals, Inc. has agreed to include information about acute pancreatitis in the PRECAUTIONS section of the product label.

Healthcare professionals should be alert to the signs and symptoms of acute pancreatitis and instruct patients taking Byetta to seek prompt medical care if they experience unexplained, persistent, severe abdominal pain which may or may not be accompanied by vomiting. If pancreatitis is suspected, Byetta should be discontinued. If pancreatitis is confirmed, Byetta should not be restarted unless an alternative etiology is identified.


---


Update 8/18/2008:  Since issuing Information for Healthcare Professionals in October 2007, FDA has received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta. Byetta is a medicine given by subcutaneous injection to help treat adults with type 2 diabetes. Of the 6 cases of hemorrhagic or necrotizing pancreatitis, all patients required hospitalization, two patients died and four patients were recovering at time of reporting.  Byetta was discontinued in all 6 cases.   

Byetta and other potentially suspect drugs should be promptly discontinued if pancreatitis is suspected.  There are no known patient characteristics which determine when pancreatitis associated with Byetta will be complicated by the hemorrhagic or necrotizing forms of this condition.   If pancreatitis is confirmed, initiate appropriate treatment and carefully monitor the patient until recovery.  Byetta should not be restarted.  Consider antidiabetic therapies other than Byetta in patients with a history of pancreatitis.

FDA is working with the maker of Byetta, Amylin Pharmaceuticals, Inc., to add stronger and more prominent warnings in the product label about the risk of acute hemorrhagic or necrotizing pancreatitis.

This information reflects FDA’s current analysis of data available to FDA concerning this drug. FDA is not advising practitioners to discontinue prescribing the product. FDA intends to update this sheet when additional information or analyses become available.


To report any unexpected adverse or serious events associated with the use of this drug, please contact the FDA MedWatch program and complete a form on line at http://www.fda.gov/medwatch/report/hcp.htm or report by fax to 1-800-FDA-0178, by mail using the postage-paid address form provided on line, or by telephone to 1-800-FDA-1088.  






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