Inhaled human insulin (Exubera): clinical profile and patient considerations

Abstract

Inhaled human insulin (Exubera) is a rapid-acting regular human insulin administered by oral inhalation before meals. It provides a non-invasive alternative to multiple subcutaneous injections for the treatment of hyperglycemia in adult patients with type 1 and type 2 diabetes. Compared with subcutaneous rapid-acting insulin analogs, Exubera provides equivalent HbA1c control. As a monotherapy or in combination with oral agents, Exubera also provides greater glycemic control than oral agents alone, at least in patients with high levels of HbA1c. Exubera demonstrates improved patient satisfaction compared with subcutaneous insulin or oral agents alone. When offered as a treatment option together with standard treatments in uncontrolled patients naive to insulin, Exubera increases acceptance of insulin therapy three-fold compared with patients offered standard regimens only. Exubera is well tolerated in comparison to subcutaneous insulin, with a similar incidence of mild to moderate hypoglycemia. Although cough is a common adverse effect early in therapy, this leads to treatment discontinuations in less than 1% of patients. Despite an increased incidence of insulin antibodies compared with subcutaneous administration, and a consistent but minor impact on pulmonary function, long-term safety data of up to 4 years continue to support the safety profile of Exubera.

Figure 1

Conservative versus proactive management of type 2 diabetes: (A) traditional stepwise approach to long-term glycemic control and (B) early combination approach. Reproduced with permission from Campbell IW. 2000. Need for intensive early glycaemic control in patients with type 2 diabetes. Br J Cardiol, 7:625–31. Abbreviations: HbA1c, glycosylated hemoglobin; OAD, oral antidiabetic drug.

Figure 2

In the UK Prospective Diabetes Study (UKPDS), each 1% reduction in HbA1c was projected to produce significant reductions in the risk of diabetesrelated complications (Stratton et al 2000).

Figure 3

Proportion of patients choosing indicated treatment based on theoretical availability of standard therapy only or inhaled insulin in addition to standard therapy. Patients with type 2 diabetes currently managed by dietary measures and/or oral antidiabetic drugs were randomized to receive educational information about the potential risks and benefits of standard therapy alone (oral antidiabetic drugs and/or subcutaneous insulin, n=388) or inhaled insulin in addition to standard therapy (n=391). In the group offered inhaled insulin as an option, 43.2% of patients opted for a treatment that included insulin during a patient-physician consultation compared with 15.5% of patients who were offered standard therapy only (odds ratio 4.16 [95% CI, 2.93–5.95], p<0.0001). Reprinted with permission from Freemantle N, et al. 2005. Availability of inhaled insulin promotes greater perceived acceptance of insulin therapy in patients with type 2 diabetes. Diabetes Care, 28:427–8. Copyright © American Diabetes Association.