Effects of Exenatide (Exendin-4) on Glycemic Control on Patients Taking Sulfonyl

Effects of Exenatide (Exendin-4) on Glycemic Control on Patients Taking Sulfonylurea + Metformin

Results show a weight loss and a drop in A1c of 1 point over 30 weeks. The study evaluated the effects of exenatide, a novel incretin mimetic, in hyperglycemic patients with type 2 diabetes unable to achieve glycemic control with metformin-sulfonylurea combination therapy.

A 30-week, double-blind, placebo-controlled study was performed in 733 subjects (aged 55 ± 10 years, BMI 33.6 ± 5.7 kg/m2, A1C 8.5 ± 1.0%; means ± SD) randomized to 5 µg subcutaneous exenatide b.i.d. (arms A and B) or placebo for 4 weeks. Thereafter, arm A remained at 5 µg b.i.d. and arm B escalated to 10 µg b.i.d. Subjects continued taking their dose of metformin and were randomized to either maximally effective (MAX) or minimum recommended (MIN) doses of sulfonylurea.
The results showed that at week 30 A1C changes from baseline (±SE) were –0.8 ± 0.1% (10 µg), –0.6 ± 0.1% (5 µg), and +0.2 ± 0.1% (placebo; adjusted P < 0.0001 vs. placebo), yielding placebo-adjusted reductions of –1.0% (10 µg) and –0.8% (5 µg). In the evaluable population, exenatide-treated subjects were more likely to achieve A1C 7% than placebo-treated subjects (34% [10 µg], 27% [5 µg], and 9% [placebo]; P < 0.0001). Both exenatide arms demonstrated significant weight loss (–1.6 ± 0.2 kg from baseline each exenatide arm, –0.9 ± 0.2 kg placebo; P 0.01 vs. placebo). Mild or moderate nausea was the most frequent adverse event. The incidence of mild/moderate hypoglycemia was 28% (10 µg), 19% (5 µg), and 13% (placebo) and appeared lower with MIN than with MAX sulfonylurea treatment. From the results it was concluded that Exenatide significantly reduced A1C in patients with type 2 diabetes unable to achieve adequate glycemic control with maximally effective doses of combined metformin-sulfonylurea therapy. This improvement in glycemic control was associated with no weight gain and was generally well tolerated.
Diabetes Care 28:1083-1091, 2005

Dr. Austin G. Stack, of Letterkenny General Hospital, Ireland, and colleagues examined the potential benefits of regular physical activity on mortality in 2386 ESRD patients in the Dialysis Morbidity and Mortality Wave 2 study.

Overall, 56% of subjects exercised less than once a week, 18% exercised 2-to 3-times per week, 6% exercised 4- to 5-times per week and 20% exercised daily. Severe limitations in vigorous physical activities were reported by 75% of patients, while 42% of subjects reported severe limitations in moderate physical activities.

After a mean follow-up of 3.6 years, there were 1366 deaths (57.3%) and 487 transplantations (20.4%).

“Multivariate modeling with adjustment for known mortality predictors confirmed the survival advantage of a 2- to 3-times per week or a 4- to 5-times per week exercise pattern (relative risks 0.74 and 0.70, respectively), whereas no such benefit was seen for those reporting daily exercise (adjusted RR, 1.06),” Dr. Stack’s team writes.

Patients with severe limitations in either moderate or vigorous physical activities had the greatest mortality risk. Subjects who exercised 2- to 3-times per week had a significantly lower RR for cardiovascular death (adjusted RR, 0.80).

Severe limitations in either moderate or vigorous physical activities were associated with significantly increased cardiovascular mortality.
Am J Kidney Dis 2005;45:690-701.

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