Exenatide once weekly for the treatment of type 2 diabetes mellitus: clinical results in subgroups of patients using different concomitant medications.
OBJECTIVE
In this pooled analysis, the efficacy and tolerability of exenatide once weekly (EQW) in patients categorized by baseline concomitant glucose-lowering therapy were evaluated.


METHODS
This post hoc analysis included data from the intent-to-treat populations of 7 randomized controlled trials in which patients with type 2 diabetes mellitus were treated with EQW for 24 to 30 weeks. Patients were classified into subgroups on the basis of their baseline glucose-lowering therapy: diet and exercise only, metformin (MET) only, MET + sulfonylurea (SU), SU ± other (thiazolidinedione [TZD] only or MET + TZD), or TZD ± MET. Changes from baseline in key efficacy endpoints and tolerability were analyzed by baseline concomitant glucose-lowering therapy group.


RESULTS
A total of 1719 patients were included. Treatment with EQW was associated with significant improvements from baseline in glycated hemoglobin levels, fasting glucose levels, and body weight in all of the groups. There were significant decreases from baseline for both systolic blood pressure and diastolic blood pressure in the MET and MET + SU groups, and a significant decrease in systolic blood pressure in the diet and exercise group. Lipid profiles generally improved in the diet and exercise, MET only, MET + SU, and TZD ± MET groups. Overall, the most frequent adverse events with EQW treatment, other than hypoglycemia, were nausea (14.7%), diarrhea (10.9%), and nasopharyngitis (7.2%). There was a higher incidence of hypoglycemia when EQW was added to regimens that included an SU.


CONCLUSIONS
The addition of EQW for 24 to 30 weeks to regimens that included a wide variety of background glucose-lowering therapies was associated with significant improvements in glycemic control and weight loss. The tolerability profile of EQW appeared to be similar regardless of background therapy, except for a higher incidence of minor hypoglycemia when EQW was added to regimens that included an SU.
Amylin Pharmaceuticals, Inc, San Diego, CA 92121 , USA. richard.pencek@amylin.com
Richard
R
Pencek
Steven C
SC
Brunell
Yan
Y
Li
Byron J
BJ
Hoogwerf
James
J
Malone
D001786:Blood Glucose / Q000032:analysis; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D000077270:Exenatide; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D057194:Intention to Treat Analysis; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D010455:Peptides / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D014688:Venoms / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use
D001786:Blood Glucose; D007004:Hypoglycemic Agents; D008055:Lipids; D010455:Peptides; D014688:Venoms; D000077270:Exenatide