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Once-Weekly Diabetes Drug Boosts Blood Sugar Control
Date:9/7/2008

But Byetta has also been linked recently to patient deaths

SUNDAY, Sept. 7 (HealthDay News) -- A new once-a-week formulation of the injectable diabetes drug Byetta controls blood sugar even better than the older twice-a-day formulation, researchers report.

"Besides obvious improved ease of use, [the new formulation] provided the remarkable advantage of both improved efficacy on glucose control and good gastrointestinal tolerability," said Dr. Andre Scheen of the University of Liege in Belgium, in a commentary accompanying the study's publication online Sunday in The Lancet.

The study, led by Dr. Daniel Drucker of Mount Sinai Hospital and the University of Toronto, Canada, is also slated for presentation Sunday at The European Association for the Study of Diabetes meeting, in Rome.

The findings, while encouraging, come on the heels of less-heartening news about Byetta (exenatide). On Aug. 26, the drug's makers, Eli Lilly and Amylin Pharmaceuticals Inc., reported the pancreatitis-linked deaths of four people who'd been taking the medication. That news came a week after the U.S. Food and Drug Administration said that two Byetta users had died of acute pancreatitis, a condition that can cause nausea, vomiting and abdominal pain.

While Byetta use has not been confirmed as a causative factor in these deaths, the FDA has noted an association between Byetta use and pancreatitis, and on Aug. 18 announced it was working on stronger labeling for the injected drug, which has been used by more than 700,000 people since being approved in June 2005.

The new study involved 259 patients with type 2 diabetes who received 30-week courses of either 2 milligrams of long-acting release Byetta given once weekly, or 10 microgram doses given twice a day. Researchers monitored blood sugar control via levels of hemoglobin A1C in the blood (HbA1C), which averaged 8.3 percent at the start of the study.

According to the researchers, HbA1C levels fell to a mean of 6.4 percent among the Byetta once-weekly group, versus 6.8 percent for those on the twice-daily regimen. More patients on the weekly dose achieved a target Hb1AC level of 7 percent (77 percent) than those on the twice-a-day regimen (61 percent).

Overall, the once-a-week formulation provided patients with better blood sugar control than the twice-daily regimen, the authors wrote, "with no increased risk of hypoglycaemia and similar reductions in body weight."

The findings echo those from a similar study reported June 10 at the American Diabetes Association meeting in San Francisco. In their year-long study of 295 type 2 diabetics, researchers at the University of North Carolina School of Medicine, Chapel Hill, found that 74 percent of all participants achieved an HbAIC level of 7 percent or less -- regardless of whether they received Byetta once a week or twice daily.

More information

To learn more, visit the FDA.



-- E.J. Mundell



SOURCE: The Lancet, news release, Sept. 7, 2008


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