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 HbA1c 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
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FDA.