Exubera: Pfizer inhaled insulin - So far no evidence of an additional benefit

Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, (IQWiG) published a comparative review of inhaled insulin versus insulin administered subcutaneously. (see Pfizer notes ) In developing Exubera, Pfizer and Aventis have collaborated with Nektar Therapeutics (formerly Inhale Therapeutics), a company that specialises in finding delivery solutions for oral, injectable and pulmonary drug administration. Exubera is a rapid-acting, fine dry-powder insulin which was developed using Nektar Therapeutics proprietary inhalation technology to reduce invasive injected delivery of insulin.

There is currently no evidence available that inhaled insulin (Exubera) in diabetes therapy shows advantages over short-acting human insulin or insulin analogues administered subcutaneously. The available studies do not provide evidence that Exubera would improve the quality of life or treatment satisfaction of diabetes patients in Germany. However, they do provide indications of disadvantages of Exubera therapy, for example, an increase in severe hypoglycaemia rates. This is the result of the first Rapid Report produced by the Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) on 4 May 2006, which was commissioned by the Federal Joint Committee on 17 November 2005.

On the basis of the data available, it cannot be excluded that long-term Exubera therapy may lead to pulmonary damage. On the contrary: inconsistent study results and the Summary of Product Characteristics provided by the European Medicines Agency (EMEA) in fact indicate a risk potential of Exubera. People who smoke or suffer from pulmonary diseases have so far been excluded from participating in studies on Exubera®.

Although it is possible to reduce the number of subcutaneous injections with Exubera, they cannot be totally avoided, if the additional administration of basal insulin is necessary.

Skin prick testing essential

Moreover, regular self-measurement of blood glucose levels by skin prick is still necessary. It cannot be inferred from the studies available that this new way of administering insulin generally improves treatment satisfaction or quality of life in affected patients.

IQWiG does not see its Rapid Report as a conclusive evaluation.