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FORMULARY FORUM

Insulin Glulisine: An Evaluation of Its Pharmacodynamic Properties and Clinical Application

Assistant Clinical Professor, Harrison School of Pharmacy, Auburn University, Auburn, AL

Kristi W Kelley, PharmD BCPS CDE

Associate Clinical Professor, Harrison School of Pharmacy, Auburn University

Reprints: Dr. Helms, 1327B Walker Building, Harrison School of Pharmacy, Auburn University, Auburn, AL 36849, fax 334/844-4410, helmskl{at}auburn.edu

OBJECTIVE: To evaluate the pharmacodynamic properties, efficacy, safety, and clinical application of insulin glulisine, a rapid-acting insulin analog, in the treatment of diabetes mellitus in ambulatory and hospitalized patients.

DATA SOURCES: Searches were performed with the headings glulisine, insulin analog, [LysB3, GluB29] insulin, insulin glulisine, rDNA insulin, rapid-acting insulin, SoloStar, safety, efficacy, pharmacodynamics, and cost analysis within MEDLINE and PubMed, American Diabetes Association (ADA), the Food and Drug Administration (FDA), and Sanofi-aventis Pharmaceuticals (1990-August 2008).

STUDY SELECTION AND DATA EXTRACTION: Phase 1, Phase 2, Phase 3, and postmarketing trials examining the efficacy and safety of glulisine in type 1 or type 2 diabetes were reviewed. Studies published as abstracts and the manufacturer's product information supplemented data absent from clinical trials.

DATA SYNTHESIS: Insulin glulisine is a rapid-acting insulin with relative equivalence in efficacy and safety to other short- and rapid-acting insulins. Glulisine's onset of action of 20 minutes and 4-hour duration of action allow for bolus administration 15-20 minutes prior to or up to 20 minutes after meals. Clinical trials have demonstrated the safety and efficacy in adults with type 1 or type 2 diabetes. Several studies indicated a statistically significant decrease of hemoglobin A_1C (A1C) with glulisine compared with regular insulin (0.10 decrease); however, no difference in A1C control was found compared with insulin aspart or lispro. Significant adverse effects appear to be limited to localized and systemic allergic reactions and hypoglycemia.

CONCLUSIONS: Insulin glulisine is a safe and effective rapid-acting insulin analog for the treatment of adults with diabetes. Clinical benefit over other short- and rapid-acting insulin products is not established. Addition of insulin glulisine to a formulary should be based on institution-specific availability and cost differences between glulisine, lispro, and aspart in the absence of superiority of clinical efficacy or safety and data beyond 26 weeks.

Key Words: diabetes mellitus, insulin analog, insulin glulisine

Published Online, March 31, 2009. www.theannals.com, DOI 10.1345/aph.1E662

THIS ARTICLE IS APPROVED FOR CONTINUING EDUCATION CREDIT
ACPE UNIVERSAL PROGRAM NUMBER: 407-000-09-006-H01-P