Exubera inhaled insulin in patients with type 1 and type 2 diabetes: the first 12 months.

BACKGROUND

Following National Institute for Clinical Excellence approval of inhaled insulin Exubera (Pfizer, New York, NY) in 2006, we established a dedicated clinic in January 2007 to monitor the efficacy and safety of Exubera. Between January and October 2007, eight patients started Exubera: six because of needle phobia (DSM-IV criteria) and two with injection site problems.

METHODS

Data were collected at the clinic over a 12-month period from February 2007 at 3-, 6-, 9-, and 12-month intervals. The clinic is jointly led by a consultant diabetologist and a diabetes specialist nurse within the secondary care setting.

RESULTS

Inhaled insulin was well tolerated in all eight patients who had previously experienced significant problems with initiation or intensification of subcutaneous insulin injections. Mean hemoglobin A1c was 10.7% (range, 8.1-14.2%) at initiation, 8.3% (7.2-9.4%) at 3 months, 7.7% (6.9-9.0%) at 6 months, 7.4% (6.7-8.4%) at 9 months, and 7.5% (6.5-8.7%) at 12 months. At 6 months, six patients had a reduction in forced expiratory volume in the first second (FEV1) by 4-12%, whereas five patients had a reduction of 2-12% at 12 months. One developed dyspnea, with a 29% fall in FEV1, which was transient and secondary to an upper respiratory tract infection. Two patients with the highest starting and most improved hemoglobin A1c developed significant retinopathy.

CONCLUSIONS

Our 12-month audit data demonstrate that the initiation of inhaled insulin in this difficult-to-treat group of patients resulted in a significant improvement in glycemic control. The subsequent withdrawal of an alternative and acceptable form of insulin treatment now presents a renewed challenge for our patients and healthcare professionals.