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EASD: Once-Weekly Exenatide Benefit Sustained over 52 Weeks

Posted: Sunday, October 03, 2010

Once-Weekly Exenatide maintains a drop in A1c of 2 points for more than 52 weeks.

John Buse, M.D., of the University of North Carolina, who reported the 52-week data found that patients who switched from standard exenatide injections at 10 µg bid to the 2 mg extended-release formulation achieved improved glycemic control from an average reduction of 1.5% to 2%.

And exenatide reduced both hemoglobin A1c and fasting plasma glucose without increasing the risk of hypoglycemia, Dr. Buse said, noting that over 52 weeks the only reports of hypoglycemia occurred in patients on background sulfonylurea, and there were no major hypoglycemia incidents regardless of background therapy.

He added that there were no adverse events related to switching patients from twice-a-day injections to once-weekly injections. "Initially there was a slight loss of glycemic control, but that was very quickly overcome," he said.

The data reported by Dr. Buse were obtained from an extension of a 30-week, open-label, non-inferiority trial that compared the once-weekly formulation with standard exenatide twice-daily injections. The results of the 30-week trial were reported at the American Diabetes Association meeting in June and published online by The Lancet on Sept. 8.

The 52-week trial recruited 295 patients evenly randomized to a once-weekly injection of long-acting exenatide and twice-daily injections. At baseline the mean HbA1c was 8.3%, mean fasting plasma glucose was 9 mmol/L and average weight was 102 kg. Patients had diabetes for an average of seven years.

After 30 weeks, 120 patients originally randomized to once-weekly exenatide were continued on therapy and 121 of the 10-µg bid patients were switched over to once-weekly 2-mg exenatide for 22 weeks, Dr. Buse said.

Among the findings of the 52-week analysis:

    * In both groups 75% of patients achieved HbA1c levels of 7% or less and more than half had levels of 6.5% or less.
    * Patients in both groups lost an average of 4 kg by week 52.
    * Patients in the 52-week long-acting exenatide arm had an average reduction in systolic blood pressure of 5.7 mm Hg, and patients switched to once-weekly reduced systolic pressure by an average of 4 mm Hg.
    * Lipid profiles in both groups improved over 52 weeks, but patients assigned to once-weekly therapy for 52 weeks had a greater improvement.

Dr. Buse said the once-weekly treatment was well tolerated in both groups, although about 26% of the once-weekly group reported at least one episode of nausea, as did 35% of the standard-exenatide group. During the 22-week extension, about 7% of patients reported nausea.

There were no cases of pancreatitis after 30 weeks of treatment reported in either arm of the published trial, and Dr. Buse reported no cases in the 52-week data.

Source: http://www.diabetesincontrol.com/index.php?option=com_content&view=article&id=9868&catid=53&Itemid=8, Buse J, et al "Exenatide once weekly elicits sustained glycemic control and weight loss over 52 weeks" EASD 2008; Abstract 146.