Document Detail

Safety and efficacy of exenatide in combination with insulin in patients with type 2 diabetes mellitus.
MedLine Citation:
PMID:  18463034     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To evaluate the 1-year efficacy and safety of treatment with exenatide in combination with insulin (a use not approved by the US Food and Drug Administration). METHODS: Electronic medical records of 3 private-practice endocrinologists were reviewed to identify patients with type 2 diabetes mellitus (T2DM) receiving insulin who subsequently began exenatide therapy. Patients' baseline hemoglobin A1c (A1C) levels, weights, lipid profiles, blood pressures, and medication utilization were compared with corresponding data obtained after a minimal duration of 12 months. RESULTS: We identified 134 patients with T2DM initiating exenatide therapy in combination with insulin between April 2005 and April 2006. One-year follow-up information was available for 124 patients. Exenatide use resulted in a significant 0.87% reduction in A1C (P<.001), despite a 45% discontinuation of premeal insulin use (P<.001), a 9-U reduction in mean premeal insulin doses (P = .0066), a reduction in the median number of daily insulin injections from 2 to 1 (P = .0053), and a 59% discontinuation rate of sulfonylurea use (P = .0088). Exenatide use was associated with a mean weight loss of 5.2 kg (P<.001), with 72% of evaluable patients losing weight. Forty-eight patients (36%) discontinued exenatide therapy during the first year, primarily attributable to gastrointestinal intolerance. Fourteen patients (10%) experienced hypoglycemia, most of which was mild. CONCLUSION: Exenatide in combination with insulin in patients with T2DM was associated with significant reductions in A1C and weight after 1 year of therapy. This was offset, however, by an exenatide discontinuation rate of 36%, primarily due to adverse gastrointestinal effects.
Catherine A Sheffield; Michael P Kane; Robert S Busch; Gary Bakst; Jill M Abelseth; Robert A Hamilton
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists     Volume:  14     ISSN:  1934-2403     ISO Abbreviation:  Endocr Pract     Publication Date:  2008 Apr 
Date Detail:
Created Date:  2008-05-08     Completed Date:  2008-08-11     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9607439     Medline TA:  Endocr Pract     Country:  United States    
Other Details:
Languages:  eng     Pagination:  285-92     Citation Subset:  IM    
Department of Pharmacy Practice, Albany College of Pharmacy The Endocrine Group, Albany, New York 12208, USA.
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MeSH Terms
Abdominal Pain / chemically induced
Diabetes Mellitus, Type 2 / blood,  drug therapy*
Dose-Response Relationship, Drug
Drug Therapy, Combination
Hemoglobin A, Glycosylated / metabolism
Hypoglycemic Agents / adverse effects,  therapeutic use*
Insulin / adverse effects,  therapeutic use*
Middle Aged
Nausea / chemically induced
Peptides / adverse effects,  therapeutic use*
Retrospective Studies
Treatment Outcome
Venoms / adverse effects,  therapeutic use*
Vomiting / chemically induced
Reg. No./Substance:
0/Hemoglobin A, Glycosylated; 0/Hypoglycemic Agents; 0/Peptides; 0/Venoms; 11061-68-0/Insulin; 141732-76-5/exenatide

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