Efficacy and tolerability of exenatide once weekly versus sitagliptin in patients
with type 2 diabetes mellitus: a retrospective analysis of pooled clinical trial
data.
Author(s): Malloy J(1), Meloni A, Han J.
Affiliation(s): Author information:
(1)Amylin Pharmaceuticals, LLC, San Diego, CA 92121, USA. jaret.malloy@amylin.com
Publication date & source: 2013, Postgrad Med. , 125(3):58-67
AIM: Therapies for type 2 diabetes mellitus that leverage the glucagon-like
peptide-1 (GLP-1) receptor signaling pathway have been shown to reduce rates of
hyperglycemia and have beneficial effects on body weight. This post hoc analysis
compared the effects of 2 GLP-1 receptor- based therapies, exenatide once weekly
(EQW), a GLP-1 receptor agonist, and sitagliptin (sita), a dipeptidyl peptidase-4
inhibitor, on glucose control across the range of baseline glycated hemoglobin
(HbA1c) levels specified in the American Association of Clinical Endocrinologists
and American College of Endocrinology treatment algorithm.
MATERIALS AND METHODS: Data from patients treated with either EQW or sita for 26
weeks in 2 randomized, double-blind, comparator-controlled clinical trials were
pooled and analyzed. Glycemic endpoints and cardiovascular risk factors were
evaluated in subgroups and the overall population.
RESULTS: Analysis included 737 patients on background therapies of diet and
exercise and/or metformin. While both agents reduced HbA1c and fasting blood
glucose (FBG) levels from baseline, significantly greater reductions in HbA1c and
FBG levels occurred with EQW compared with sita across all baseline HbA1c level
strata, and significantly more patients in the EQW group achieved goal HbA1c
levels compared with the sita group. Patients treated with EQW also experienced
significantly greater reductions in body weight and cholesterol levels compared
with patients treated with sita. The incidences of the most common adverse events
of nausea and diarrhea were higher in the EQW group compared with the sita group,
and incidences of these adverse events decreased over time. Both groups
experienced a low incidence of minor hypoglycemic events.
CONCLUSION: Significantly greater improvements in HbA1c and FBG levels were
observed in EQW- compared with sita-treated patients across all baseline HbA1c
level strata. Additionally, greater reductions in body weight and some
cardiovascular risk factors were observed with EQW treatment compared with sita
treatment. Both EQW and sita were generally well tolerated; sita-treated patients
experienced fewer adverse events than EQW-treated patients.
TRIAL REGISTRATION: www.ClinicalTrials.gov identifiers: NCT00637273, NCT00676338.
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