Use of concomitant glucose-lowering therapies and associated treatment results
observed in clinical trials of twice-daily exenatide.
Author(s): Pencek R, Brunell SC, Li Y, Hoogwerf BJ, Malone J.
Affiliation(s): Amylin Pharmaceuticals, Inc., San Diego, California 92121, USA.
Richard.Pencek@amylin.com
Publication date & source: 2012, Endocr Pract. , 18(2):227-37
OBJECTIVE: To explore, by post hoc analyses of pooled data, the efficacy and
safety of the use of exenatide twice daily (BID) in patients stratified by
baseline glucose-lowering therapies.
METHODS: Patients with type 2 diabetes from long-term randomized controlled
trials who were treated with exenatide BID were classified into concomitant
medication groups on the basis of background treatment (diet and exercise only,
metformin only, sulfonylurea only, thiazolidinedione only, metformin +
sulfonylurea, metformin + thiazolidinedione, or insulin with or without other
oral antihyperglycemic medications). Seventeen studies were included in the
analyses (N = 2,096).
RESULTS: In these analyses of patients treated with exenatide BID for 12 to 30
weeks, there were significant decreases from baseline in hemoglobin A(1c) (A1C)
and fasting glucose levels in all groups and significant decreases from baseline
in body weight in all groups except the thiazolidinedione-only group. The
decrease in A1C appeared to be greater in the insulin group than in the other
groups, likely because the insulin dose was titrated whereas doses of concomitant
antihyperglycemic medications were generally not titrated. Overall, changes in
blood pressure and lipids were small. Across all groups, the most common adverse
effects were gastrointestinal events. Hypoglycemia was more common in the
sulfonylurea-only, metformin + sulfonylurea, and insulin groups than it was in
the other concomitant medication groups.
CONCLUSION: The use of exenatide BID across a wide range of background therapies
was associated with reductions in A1C, fasting glucose, and body weight.
Gastrointestinal adverse events were common.
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