HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Skyler, J. S. Search for Related Content PubMed PubMed Citation Articles by Skyler, J. S. Social Bookmarking                What's this?

Two-Year Safety and Efficacy of Inhaled Human Insulin (Exubera) in Adult Patients With Type 1 Diabetes

¹ Division of Endocrinology, Diabetes, and Metabolism, University of Miami, Miami, Florida
² Sansum Diabetes Research Institute, Santa Barbara, California
³ Pfizer Global Research and Development, New London, Connecticut

Address correspondence and reprint requests to Jay S. Skyler, MD, University of Miami, 1450 N.W. 10th Ave., Suite 3054, Miami, FL 33136. E-mail: jskyler{at}miami.edu

OBJECTIVE—The purpose of this study was to evaluate the long-term (2-year) safety and efficacy of inhaled human insulin (Exubera [insulin human (rDNA origin)] inhalation powder) (EXU) in adult patients with type 1 diabetes.

RESEARCH DESIGN AND METHODS—Patients were randomly assigned to receive EXU (n = 290) or subcutaneous (SC) insulin (n = 290), plus basal (intermediate- or long-acting) insulin. The primary end point was the annual rate of decline in pulmonary function (forced expiratory volume in 1 s [FEV₁] and carbon monoxide diffusing capacity [DL_CO]).

RESULTS—The mean ± SEM annual rates of change between months 0 and 24 were –0.051 ± 0.005 l/year with EXU and –0.034 ± 0.005 l/year with SC insulin (significant mean difference –0.017 ± 0.007 l/year [90% CI –0.028 to –0.005]) for FEV₁ and –0.437 ± 0.073 ml · min^–1 · mmHg^–1 · year^–1 with EXU and –0.287 ± 0.065 ml · min^–1 · mmHg^–1 · year^–1with SC insulin (nonsignificant mean difference –0.150 ml · min^–1 · mmHg^–1 · year^–1 [–0.310 to 0.011]) for DL_CO. The mean annual rates of change in FEV₁ between months 3 and 24 were –0.041 ± 0.005 and –0.031 ± 0.006 l/year in the EXU and SC insulin groups, respectively (nonsignificant mean difference –0.011 l/year [–0.023 to 0.002]), indicating that the significant difference between the treatment groups in FEV₁ developed during the first 3 months and was not progressive thereafter. Adverse event profiles were similar except for a higher incidence of cough (usually mild and unproductive) in patients receiving EXU (37.6 vs. 13.1%) that decreased to 1.3% by month 24. Glycemic control was sustained in both groups (adjusted mean treatment difference in change from baseline A1C at month 24 0.25 ± 0.07% [0.13–0.37]). Although the overall hypoglycemic events were comparable between groups (4.0 vs. 3.8 events/subject-month), the incidence of severe hypoglycemic events was lower with EXU than with SC insulin (2.8 vs. 4.1 events/100 subject-months, risk ratio 0.67 [0.57–0.79]). Body weight increased to a significantly lesser extent with EXU (adjusted mean treatment difference –1.25 ± 0.36 kg [–1.85 to –0.66]).

CONCLUSIONS—Treatment group differences in lung function between EXU and SC insulin in adult patients with type 1 diabetes are small, develop early, and are nonprogressive for up to 2 years of therapy.

Abbreviations: DL_CO, carbon monoxide diffusing capacity • EXU, Exubera • FEV₁, forced expiratory volume in 1 s • FPG, fasting plasma glucose • LOCF, last observation carried forward • SC, subcutaneous • TLC, total lung capacity

CiteULike    Del.icio.us    Digg    Reddit    Technorati    What's this?

This article has been cited by other articles:

				M. C. Liu, R. J. Riese, K. Van Gundy, P. Norwood, B. E. Sullivan, P. F. Schwartz, and J. G. Teeter Effects of inhaled human insulin on airway lining fluid composition in adults with diabetes Eur. Respir. J., July 1, 2008; 32(1): 180 - 188. [Abstract] [Full Text] [PDF]

				L. Kuitert The lung in diabetes - yet another target organ? Chronic Respiratory Disease, May 1, 2008; 5(2): 67 - 68. [PDF]

				C. J Bailey and A. H Barnett Why is Exubera being withdrawn? BMJ, December 1, 2007; 335(7630): 1156 - 1156. [Full Text] [PDF]

				P. A. Hollander, A. Krasner, S. Klioze, P. Schwartz, and W. Duggan Body Weight Changes Associated With Insulin Therapy: A retrospective pooled analysis of inhaled human insulin (Exubera) versus subcutaneous insulin in five controlled Phase III trials Diabetes Care, October 1, 2007; 30(10): 2508 - 2510. [Full Text] [PDF]

				J. R. Holman Inhaled Insulin Shows Short-term Safety DOC News, September 1, 2007; 4(9): 1 - 13. [Full Text]

				Endocrinology & Metabolism News, April 2007 J. Clin. Endocrinol. Metab., April 1, 2007; 92(4): 17a - 17a. [Full Text] [PDF]

				Changes in Lung Function with Inhaled Insulin Journal Watch (General), March 29, 2007; 2007(329): 3 - 3. [Full Text]