Inhaled insulin is approved in Europe and United StatesBMJ 2006; 332 doi: https://doi.org/10.1136/bmj.332.7537.321 (Published 09 February 2006) Cite this as: BMJ 2006;332:321
All rapid responses
Dear Dr Godlee,
I read with interest your article “Inhaled insulin is approved in
Europe and the United States” on 11th February 2006.
Whilst Exubera (inhaled human insulin) is now licensed it will not be
available for prescription in the UK until approximately May of this year.
As this is a new method of delivering prandial insulin, Pfizer is
committed to undertaking a comprehensive education and information
programme for healthcare professionals. We therefore have an obligation
to respond to any reports about this new treatment which could be
misinterpreted by your readership.
There are a number of points in the above mentioned article to which
we would like to respond.
Firstly, the article states, “Critics say Exubera…fails to control
postprandial glucose presentations as well as subcutaneous insulin”. In
fact, in clinical trials Exubera has been shown to be comparable or
superior to subcutaneous human insulin in terms of postprandial glucose
Secondly the article raises concerns about the pulmonary effects of
Exubera. Pfizer has already collected and is committed to the ongoing
collection of extensive safety data on pulmonary function. Having
examined the data, both the EMEA and FDA have approved Exubera for use in
adults. While small, clinically insignificant, reductions in FEV1 were
noted in clinical trials, the changes occurred early, the rate of change
compared to comparator groups did not change after the first 3-6 months
and resolution was seen in patients with both type 1 and type 2 diabetes
soon after stopping Exubera.
It is also important to distinguish the inhalation of irritant
“dusts” from the inhalation of insulin which has undergone extensive
safety testing. Exubera has been studied in over 3,500 patients in
clinical trials, some for as long as 7 years, and there is no evidence to
date that Exubera causes any “lung diseases”.
The article also states that critics raised concerns about “pulmonary
effects and erratic absorption even in patients who were exposed to
secondary tobacco smoke”. To clarify, there is no evidence of “erratic
absorption” in non-smokers. However Exubera is contraindicated in smokers
or people who have smoked in the last 6 months, in accordance with
recommendations from Diabetes associations, since smoke does interfere
with the absorption of Exubera.
With regard to the comments made about dosing in milligrams and not
units, the education of healthcare professionals on this aspect of
prescribing Exubera will be extensively covered in the training program
referred to above. Clear guidance will be given in the form of both
training and reference materials and a website, www.INHprogramme.co.uk
will soon be live which will facilitate and enhance this training.
Finally, the article states that Exubera is “to be marketed jointly
by Pfizer and Sanofi-Aventis”. On 12 January 2006, Pfizer announced that
is had reached an agreement to acquire the sanofi-aventis worldwide rights
Dr Bruce Charlesworth,
Head of RMRS and Medical Affairs,
1 Quattrin T, et al. Diabetes Care. 2004; 27:2622-2627
2 Skyler JS, et al. Diabetes Care. 2005; 28:1630-1635
3 Hollander PA, et al. Diabetes Care. 2004; 27:2356-2362.
I work for Pfizer Ltd.
Competing interests: No competing interests