Dissociation of lung function changes with humoral immunity during inhaled human insulin therapy

American Journal of Respiratory and Critical Care Medicine

Volumn 173, Issue 11, 2006, Pages 1194-1200

  Teeter, John G ^a,b   Riese, Richard J ^a  

^a PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United States)

^b PFIZER INC   (United States)

Author keywords

Exubera; Insulin antibodies; Spirometry

Indexed keywords

INSULIN; INSULIN ANTIBODY; INSULIN GLARGINE; INSULIN LISPRO; INSULIN ZINC SUSPENSION; ISOPHANE INSULIN;

ADULT; AGED; ARTICLE; CONTROLLED STUDY; DRUG EFFECT; FEMALE; FORCED EXPIRATORY VOLUME; HUMAN; HUMORAL IMMUNITY; INSULIN DEPENDENT DIABETES MELLITUS; LUNG FUNCTION; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; SPIROMETRY;

ADMINISTRATION, INHALATION; ADULT; AGED; DIABETES MELLITUS, TYPE 1; FEMALE; FORCED EXPIRATORY VOLUME; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIC AGENTS; INJECTIONS, SUBCUTANEOUS; INSULIN; INSULIN ANTIBODIES; MALE; MIDDLE AGED; RESPIRATORY FUNCTION TESTS;

EID: 33744927444     PISSN: 1073449X     EISSN: 1073449X     Source Type: Journal    
DOI: 10.1164/rccm.200512-1861OC     Document Type: Article

References (31)

1. Patton J, Bukar J, Eldon M. Clinical pharmacokinetics and pharmacodynamics of inhaled insulin. Clin Pharmacokinet 2004;43:781-801.
2. Hollander PA, Blonde L, Rowe R, Mehta AE, Milburn JL, Hershon KS, Chiasson JL, Levin SR. Efficacy and safety of inhaled insulin (Exubera) compared with subcutaneous insulin therapy in patients with type 2 diabetes: results of a 6-month, randomized, comparative trial. Diabetes Care 2004;27:2356-2362.
3. Quattrin T, Belanger A, Bohannon NJ, Schwartz SL. Efficacy and safety of inhaled insulin (Exubera) compared with subcutaneous insulin therapy in patients with type 1 diabetes: results of a 6-month, randomized, comparative trial. Diabetes Care 2004;27:2622-2627.
4. Dreyer M; Exubera Phase 3 Study Group. Efficacy and 2-year pulmonary safety data of inhaled insulin as adjunctive therapy with metformin or glibenclamide in type 2 diabetes patients poorly controlled with oral monotherapy. Diabetologia 2004;47:A44.
5. Skyler JS, Weinstock RS, Raskin P, Yale Y-F, Barrett E, Gerich JE, Gerstein HC; Exubera Phase 3 Study Group. Use of inhaled insulin in a basal/bolus insulin regimen in subjects with type 1 diabetes: a 6-month, randomized, comparative trial. Diabetes Care 2005;28:1630-1635.
6. Fineberg SE, Kawabata T, Finco-Kent D, Liu C, Krasner A. Antibody response to inhaled insulin in patients with type 1 or type 2 diabetes. J Clin Endocrinol Metab 2005;90:3287-3294.
7. Heise T, Bott S, Tusek C, Stephan J-A, Kawabata T, Finco-Kent D, Liu C, Krasner A. The effect of insulin antibodies on the metabolic action of inhaled and subcutaneous insulin: a prospective randomized pharmacodynamic study. Diabetes Care 2005;28:2161-2169.
8. Teeter JG, England RD; Exubera Phase 3 Study Group. Chronically inhaled insulin treatment with patients with diabetes is not associated with functional evidence of airway sensitization [Abstract P2029]. Proc Am Thorac Soc 2005;2:A507.
9. Krasner A, England RD, Teeter JG; Exubera Phase 3 Study Group. Time-course of development of insulin antibodies does not correlate with changes in pulmonary function tests observed during inhaled insulin therapy [Abstract P1784]. Proc Am Thorac Soc 2005;2(Suppl):A511.
10. 1: prediction equations from a probability sample of Michigan, a large, industrial state. Bull Eur Physiopathol Respir 1986;22:589-597.
11. Hankinson JL, Odencrantz JR, Fedan KB. Spirometric reference values from a sample of the general US population. Am J Respir Crit Care Med 1999;159:179-187.
12. Pesola GR, Sunmonu Y, Huggins G, Ford JG. Measured diffusion capacity versus prediction equation estimates in blacks without lung disease. Respiration (Herrlisheim) 2004;71:484-492.
13. Dumas R, England RD, Riese RJ, Teeter JG; Exubera Phase 3 Study Group. Exubera is well tolerated and achieves tight glycemic control in patients with type 1 diabetes [Abstract 355-OR]. Diabetes 2005;54(1 Suppl):A87.
14. American Thoracic Society. Single-breath carbon monoxide diffusing capacity (transfer factor): recommendations for a standard technique - 1995 update. Am J Respir Crit Care Med 1995;152:2185-2198.
15. American Thoracic Society. Standardization of spirometry: 1994 update. Am J Respir Crit Care Med 1995;152:1107-1136.
16. Dockery DW, Ware JH, Ferris J, Glicksberg DS, Fay ME, Spiro I, Speizer FE. Distribution of forced expiratory volume in one second and forced vital capacity in healthy, white, adult, never-smokers in six US cities. Am Rev Respir Dis 1985;131:511-520.
17. Ware HH, Weiss S. Statistical issues in longitudinal research on respiratory health. Am J Respir Crit Care Med 1996;154:S212-S216.
18. Ford ES, Mannino DM. Prospective association between lung function and the incidence of diabetes: findings from the National Health and Nutrition Examination Survey Epidemiologic Follow-up Study. Diabetes Care 2004;27:2966-2970.
19. Innocenti F, Fabbri A, Anichini R, Tuci S, Pettina G, Vannucci F, De Giorgio LA, Seghieri G. Indications of reduced pulmonary function in type 1 (insulin-dependent) diabetes mellitus. Diabetes Res Clin Pract 1994;25:161-168.
20. Lawlor DA, Ebrahim S, Smith GD. Associations of measures of lung function with insulin resistance and type 2 diabetes: findings from the British Women's Heart and Health Study. Diabetologia 2004;47:195-203.
21. Davis TM, Knuiman M, Kendall P, Vu H, Davis WA. Reduced pulmonary function and its associations in type 2 diabetes: the Fremantle Diabetes Study. Diabetes Res Clin Pract 2000;50:153-159.
22. Lazarus R, Sparrow D, Weiss ST. Impaired ventilatory function and elevated insulin levels in nondiabetic males: the Normative Aging Study. Eur Respir J 1998;12:635-640.
23. Engstrom G, Janzon L. Risk of developing diabetes is inversely related to lung function: a population-based cohort study. Diabet Med 2002;19:167-170.
24. Davis WA, Knuiman M, Kendall P, Grange V, Davis TM. Glycemic exposure is associated with reduced pulmonary function in type 2 diabetes: the Fremantle Diabetes Study. Diabetes Care 2004;27:752-757.
25. McKeever TM, Weston PJ, Hubbard R, Fogarty A. Lung function and glucose metabolism: an analysis of data from the Third National Health and Nutrition Examination Survey. Am J Epidemiol 2005;161:546-556.
26. Hsia CC, Raskin P. The diabetic lung: relevance of alveolar microangiopathy for the use of inhaled insulin. Am J Med 2005;118:205-211.
27. Coulson FR, Jacoby DB, Fryer AD. Increased function of inhibitory neuronal M2 muscarinic receptors in trachea and ileum of diabetic rats. Br J Pharmacol 2002;135:1355-1362.
28. Gottlieb DJ, Sparrow D, O'Connor GT, Weiss ST. Skin test reactivity to common aeroallergens and decline of lung function: the Normative Aging Study. Am J Respir Crit Care Med 1996;153:561-566.
29. Bousquet J, Chanez P, Lacoste JY, Barneon G, Ghavanian N, Enander I, Venge P, Ahlstedt S, Simony-Lafontaine J, Godard P. Eosinophilic inflammation in asthma. N Engl J Med 1990;323:1033-1039.
30. Cockroft DW, Davis BE, Boulet LP, Deschesnes F, Gauvreau GM, O'Byrne PM, Watson RM. The links between allergen skin test sensitivity, airway responsiveness and airway response to allergen. Allergy 2005;60:56-59.
31. O'Byrne PM. Pharmacologic interventions to reduce the risk of asthma exacerbations. Proc Am Thorac Soc 2004;1:105-108.