PMID- 18463034 OWN - NLM STAT- MEDLINE DCOM- 20080811 LR - 20221207 IS - 1934-2403 (Electronic) IS - 1530-891X (Linking) VI - 14 IP - 3 DP - 2008 Apr TI - Safety and efficacy of exenatide in combination with insulin in patients with type 2 diabetes mellitus. PG - 285-92 AB - 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. FAU - Sheffield, Catherine A AU - Sheffield CA AD - Department of Pharmacy Practice, Albany College of Pharmacy The Endocrine Group, Albany, New York 12208, USA. FAU - Kane, Michael P AU - Kane MP FAU - Busch, Robert S AU - Busch RS FAU - Bakst, Gary AU - Bakst G FAU - Abelseth, Jill M AU - Abelseth JM FAU - Hamilton, Robert A AU - Hamilton RA LA - eng PT - Journal Article PL - United States TA - Endocr Pract JT - Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists JID - 9607439 RN - 0 (Glycated Hemoglobin A) RN - 0 (Hypoglycemic Agents) RN - 0 (Insulin) RN - 0 (Peptides) RN - 0 (Venoms) RN - 9P1872D4OL (Exenatide) SB - IM MH - Abdominal Pain/chemically induced MH - Aged MH - Diabetes Mellitus, Type 2/blood/*drug therapy MH - Dose-Response Relationship, Drug MH - Drug Therapy, Combination MH - Exenatide MH - Female MH - Glycated Hemoglobin/metabolism MH - Humans MH - Hypoglycemic Agents/adverse effects/*therapeutic use MH - Insulin/adverse effects/*therapeutic use MH - Male MH - Middle Aged MH - Nausea/chemically induced MH - Peptides/adverse effects/*therapeutic use MH - Retrospective Studies MH - Treatment Outcome MH - Venoms/adverse effects/*therapeutic use MH - Vomiting/chemically induced EDAT- 2008/05/09 09:00 MHDA- 2008/08/12 09:00 CRDT- 2008/05/09 09:00 PHST- 2008/05/09 09:00 [pubmed] PHST- 2008/08/12 09:00 [medline] PHST- 2008/05/09 09:00 [entrez] AID - S1530-891X(20)43576-1 [pii] AID - 10.4158/EP.14.3.285 [doi] PST - ppublish SO - Endocr Pract. 2008 Apr;14(3):285-92. doi: 10.4158/EP.14.3.285.