Approval of inhaled insulin in Europe and United States

doi:10.1136/bmj.332.7543.730-b

BMJ 2006;332:730 (25 March), doi:10.1136/bmj.332.7543.730-b

Letter

Approval of inhaled insulin in Europe and United States

The first 150 words of the full text of this article appear below.

EDITOR—We wish to respond to several points in the newsitem by Lenzer on the approval of inhaled insulin.¹

Firstly, the article states that critics say that Exubera failsto control postprandial glucose presentations as well as subcutaneousinsulin. In fact, in clinical trials Exubera is comparable orsuperior to subcutaneous human insulin in terms of postprandialglucose control.^2-4

Secondly, the article raises concerns about the pulmonary effectsof Exubera. Pfizer has already collected and is committed tothe ongoing collection of extensive safety data on pulmonaryfunction. Having examined the data, both the EMEA and FDA haveapproved Exubera for use in adults. Although small, clinicallyinsignificant, reductions in FEV₁ were noted in clinical trials,the changes occurred early, the rate of change compared withcomparator groups did not change after the first three to sixmonths, and resolution was seen in patients with both type 1. . . [Full text of this article]