No difference seen in the risk of acute pancreatitis in patients on Byetta and Januvia compared with those on other diabetes treatments
FRANKLIN LAKES, N.J., June 28 /PRNewswire-FirstCall/ -- Two popular diabetes drugs do not increase the risk of acute pancreatitis, according to a study presented today at the American Diabetes Association's (ADA's) 70th Scientific Sessions.
The study conducted by Medco Health Solutions, Inc. (NYSE: MHS) – in association with the Medco Research Institute™ and the University of Texas Southwestern Medical School – examined the relationship between Byetta® and Januvia® and the risk of acute pancreatitis. The study revealed that patients initiating treatment with either of these two medications were no more likely to develop acute pancreatitis than patients initiating treatment with other antidiabetic drugs.
Byetta and Januvia are FDA-approved medications used to treat adults with type 2 diabetes. These drugs are valuable treatment options because they have been shown to lower a patient's blood sugar without hypoglycemia or an increase in body weight, common side effects of other antidiabetics. Due to the reported cases of acute pancreatitis, the FDA added warnings to the drugs' labels to alert physicians and patients of this potential risk.
"While cases of acute pancreatitis have been reported in patients using Byetta and Januvia, diabetic patients who are not taking these drugs also have been reported to have an increased risk for pancreatitis; the major question has been are these medications causing the pancreatitis or are they innocent bystanders?" said Merri Pendergrass, MD, PhD, national practice leader of the Medco Therapeutic Resource Center® for diabetes, who conducted the study. "Our findings are reassuring in that they did not reveal any increased risk of acute pancreatitis with Byetta and Januvia."
The study did find that risk of acute pancreatitis was substantially higher among diabetic patients than a nondiabetic control group.
The study analyzed Medco's pharmacy and medical claims data for more than 786,000 adult patients between January 2007 and June 2009. The diabetic patients were divided into three groups based on the antidiabetic drug they had recently begun taking – Byetta, Januvia or other oral antidiabetic agents. A nondiabetic control group was also identified. While the risk for acute pancreatitis was essentially the same among the three diabetic groups, the average risk for all the diabetic groups was 91 percent higher than that for the nondiabetic control group.
This study shows that, although rare, acute pancreatitis is a potential complication in type 2 diabetes patients regardless of the treatment therapy.
Exenatide Not Associated with Increased Risk of Renal Failure
Another study presented by Medco at the ADA's Scientific Sessions found that, despite FDA warnings, Byetta is not associated with an increased risk of acute renal failure in type 2 diabetes patients. The methodology and study parameters were comparable to those of the pancreatitis study. This Medco analysis indicated that while there is an increased risk of acute renal failure in diabetic patients, the antidiabetic medication the patient is taking does not appear to impact that risk.
For more information on these studies, visit www.medcoresearch.com.
About Medco Research Institute
Medco Research Institute™ is an evidence-based research organization focused solely on novel research, analytics and new discoveries that close the gap between scientific discovery and medical practice for improved patient outcomes and lower overall healthcare costs. More information about the Medco Research Institute's peer-reviewed research can be found at www.medcoresearch.com.
Medco Health Solutions, Inc. (NYSE: MHS) is pioneering the world's most advanced pharmacy® and its clinical research and innovations are part of Medco making medicine smarter™ for approximately 65 million members.
With more than 20,000 employees dedicated to improving patient health and reducing costs for a wide range of public and private sector clients, and 2009 revenues of nearly $60 billion, Medco ranks 35th on the Fortune 500 list and is named among the world's most innovative, most admired and most trustworthy companies.
For more information, go to http://www.medcohealth.com.
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that may cause results to differ materially from those set forth in the statements. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the risks and uncertainties that affect our business, particularly those mentioned in the Risk Factors section of the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission.
SOURCE Medco Health Solutions, Inc.