PMID- 16135134
OWN - NLM
STAT- MEDLINE
DCOM- 20060209
LR  - 20111117
IS  - 1462-8902 (Print)
IS  - 1462-8902 (Linking)
VI  - 7 Suppl 1
DP  - 2005 Nov
TI  - Unlocking the opportunity of tight glycaemic control. Inhaled insulin: safety.
PG  - S14-8
AB  - Clinical studies of inhaled insulins suggest that pulmonary delivery is well 
      tolerated, with a level of safety comparable to that of subcutaneous (SC) 
      insulin. Questions about the safety of Exubera focus primarily on the lungs, 
      which are probably exposed to two to three times more insulin than an SC 
      injection site. Pulmonary function tests (forced expiratory volume in 1 s and 
      carbon monoxide-diffusing capacity) are routinely included as primary endpoints 
      in Exubera clinical trials. Completed phase 2 and 3 studies up to 4 years in 
      duration indicate that the differences over time in pulmonary function changes 
      between patients treated with Exubera and control patients are small, 
      non-progressive, clinically insignificant and reverse after discontinuation of 
      Exubera therapy. However, it would be useful to understand the physiologic 
      mechanisms responsible for these changes, and ongoing studies should continue to 
      monitor the effects of inhaled insulin on pulmonary function and other parameters 
      in patients with diabetes. In clinical trials of patients with type 1 or 2 
      diabetes who were treated with Exubera, the only significant clinical adverse 
      effect was cough. This was generally characterized as mild to moderate in 
      severity, decreased over time and was not associated with declines in lung 
      function. Thus, insulin administration via the lung appears to be generally safe 
      in patients with type 1 or 2 diabetes.
FAU - Brain, Joseph D
AU  - Brain JD
AD  - Department of Environmental Health, Harvard School of Public Health, 665 
      Huntington Avenue, Boston, MA 02115, USA. brain@hsph.harvard.edu
LA  - eng
PT  - Journal Article
PT  - Review
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Exubera)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin)
SB  - IM
MH  - Administration, Inhalation
MH  - Animals
MH  - Cough/chemically induced
MH  - Diabetes Mellitus/*drug therapy
MH  - Humans
MH  - Hypoglycemic Agents/*adverse effects/therapeutic use
MH  - Insulin/*adverse effects/therapeutic use
MH  - Respiratory Mechanics/drug effects
RF  - 27
EDAT- 2005/09/02 09:00
MHDA- 2006/02/10 09:00
CRDT- 2005/09/02 09:00
PHST- 2005/09/02 09:00 [pubmed]
PHST- 2006/02/10 09:00 [medline]
PHST- 2005/09/02 09:00 [entrez]
AID - DOM527 [pii]
AID - 10.1111/j.1463-1326.2005.00527.x [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2005 Nov;7 Suppl 1:S14-8. doi: 
      10.1111/j.1463-1326.2005.00527.x.