An Assessment of Eligibility for Inhaled Insulin (Exubera)

Abstract

The product information (1) for human insulin inhalation powder (Exubera; Pfizer) recommends spirometry at baseline, 6 months postinitiation, and at least annually thereafter. Patients with a forced expiratory volume in the first second (FEV1) <70% of that predicted for age, sex, and height should not start Exubera. In those exhibiting ≥20% decline in FEV1 during follow-up, Exubera should be discontinued. Exubera is contraindicated for patients with unstable or poorly controlled lung disease, and its efficacy and safety have not been established for patients with asthma or chronic obstructive pulmonary disease. To determine the proportions and characteristics of patients predicted to fall into these categories, we analyzed spirometric and other data from the representative community-based Fremantle Diabetes Study (FDS) (2). The FDS was a longitudinal observational study involving 127 type 1 and 1,294 type 2 diabetic patients from a population of 120,097 in the state of Western Australia (2). Between May 1993 and September 1994, we performed spirometry on 70 type 1 and 647 type 2 diabetic patients (55 and 50% of all type 1 and type 2 diabetic FDS subjects, respectively). We had additional data from 107 nonsmoking Europid type 2 diabetic patients with no history of chronic respiratory disease who were restudied a mean ± SD 7.0 ± 0.5 years later. Aspects of the data from the type 2 patients …