Lancet: Despite recent FDA warnings, once-weekly Byetta proves effective

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Using a new formulation of the diabetes drug exenatide (Byetta) given once weekly provides better glycemic control and is much more convenient than the current twice-daily regimen, according to a study published online Sept. 8 in the Lancet.

Daniel Drucker, MD, from the Mount Sinai Hospital in New York City and University of Toronto in Ontario, and colleagues presented their findings at the European Association for the Study of Diabetes meeting in Rome.

According to the researchers, exenatide improves blood sugar control and gives progressive weight reductions in patients with type 2 diabetes.

Despite the positive findings, in late August Amylin Pharmaceuticals and Eli Lilly revealed that four new deaths occurred in patients with pancreatitis, who were taking its injectable diabetes drug. The companies said they were aware of the pancreatitis cases referenced in the FDA warning, as well as others, and previously reported the cases to the agency.

In the international, multicenter, six-month randomized trial, 259 patients completed a 30-week course of either a long-acting release formulation of exenatide 2 mg administered once weekly (129 patients), or 10 µg exenatide twice a day (130 patients). The patients had a mean weight of 102 kg and an average diabetes duration of nearly seven years. The extent of their blood sugar control was monitored by the levels of haemoglobin A1c (HbA1c) in their blood, which was at a mean of 8.3 percent before exenatide was administered, according to investigators.

The researchers found that patients given exenatide once weekly saw their HbA1c levels fall to a mean of 6.4 percent, while those given the drug twice daily only fell to 6.8 percent. More patients given the once weekly formulation (77 percent) achieved the target HbA1c of 7 percent or less compared with the twice daily regimen (61 percent); the proportions achieving HbA1c of 6.5 percent or less or 6 percent or less were similar in both groups.

The authors concluded that “exenatide once weekly resulted in significantly greater improvements in glycemic control than exetanide given twice a day, with no increased risk of hypoglycemia and similar reductions in bodyweight.”

In an accompanying commentary, André Scheen, MD, from the University of Liège in Belgium said that compared “with the twice-a-day exenatide regimen, the once-a-week formulation, besides obvious improved ease of use, provided the remarkable advantage of both improved efficacy on glucose control and good gastrointestinal tolerability."

Scheen further suggested that management of type 2 diabetes could change substantially as after confirmation and extension of these findings.