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NEWS: Jeanne Lenzer Inhaled insulin is approved in Europe and United States BMJ 2006; 332: 321 [Full text]

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Inhaled insulin is approved in Europe and United States

Bruce Charlesworth   (14 March 2006)

Inhaled insulin is approved in Europe and United States 14 March 2006
Bruce Charlesworth, Head of RMRS and Medical Affairs. Pfizer Ltd, Walton Oaks, Dorking Road, Walton-on-the-Hill, Tadworth, Surrey KT20 7NS Send response to journal: Re: Inhaled insulin is approved in Europe and United States	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 control(1,2,3). 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 to Exubera. Yours etc. Dr Bruce Charlesworth, Head of RMRS and Medical Affairs, Pfizer Limited References 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. Competing interests: I work for Pfizer Ltd.