Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Exubera: So far no evidence available of an additional therapeutic benefit

10.05.2006


IQWiG publishes a comparative review of inhaled insulin versus insulin administered subcutaneously



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.

For this Rapid Report, outcomes were selected which enabled the comparison of Exubera versus insulin administered subcutaneously with regard to patient-relevant endpoints. The endpoints assessed included quality of life, treatment satisfaction, glycaemic control (changes in HbA1c values), hypoglycaemia rates, adverse drug effects, and prevention of late complications.


Possible higher risk of severe hypoglycaemia with Exubera therapy

No studies were identified in which inhaled insulin was compared with insulin administered subcutaneously in patients with type 2 diabetes, within an identical therapeutic regime. In the only comparator study identified, the therapeutic regimes investigated were different (intensified versus conventional insulin therapy). In this study, even though the reductions in blood glucose levels were comparable between treatment groups, a tendency towards a higher incidence of severe hypoglycaemia was shown in patients treated with Exubera.

According to current knowledge, Exubera is not a safe alternative, either, for patients with type 1 diabetes. IQWiG’s comprehensive literature search only identified two studies in which inhaled insulin was compared with insulin administered subcutaneously, within an identical therapeutic regime (intensified insulin therapy). These studies also showed a higher incidence of severe hypoglycaemia in patients treated with Exubera (even though the reductions in blood glucose levels were comparable between treatment groups).

Long-term risks of Exubera therapy unclear

With regard to adverse drug effects, a higher incidence of cough and formation of insulin antibodies was shown with Exubera therapy. 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.

No valid statements on treatment satisfaction and quality of life

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. 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. On the one hand, these aspects were not or were only insufficiently described in the available publications, although the respective parameters were investigated. On the other hand, the relevance of the available data is limited with regard to Germany, as it appears that Exubera was not compared with insulin administered subcutaneously with pen systems (which is a widespread type of administration in Germany). Instead, it appears that Exubera was compared with insulin administered subcutaneously with syringes for self-filling.

IQWiG does not see its Rapid Report as a conclusive evaluation. IQWiG recommends further evaluations of Exubera and the consideration of previously unpublished data from studies in a next step, provided that the manufacturer supplies them. Furthermore, open issues need to be clarified in an adequately designed randomised intervention study before Exubera is widely prescribed in Germany.

Background on Rapid Reports

The assignment to assess the therapeutic benefit of inhaled insulin was conducted in an accelerated manner by means of a Rapid Report. In contrast to the conventional procedure, a preliminary report is not published during the production of a Rapid Report. A preliminary version of the Rapid Report is reviewed by an external expert. A scientific hearing where interested parties can provide comments is however not conducted. Furthermore, as timelines for publication do not need to be adhered to, the whole procedure is less time-consuming. Primarily, a Rapid Report serves to help the Federal Joint Committee and other organisations form an opinion on a topic. The Federal Joint Committee issues directives for health care services (including the prescription of pharmaceuticals) reimbursed by the statutory health insurance (SHI) funds.

Dr. Anna-Sabine Ernst | EurekAlert!
Further information:
http://www.iqwig.de

More articles from Studies and Analyses:

nachricht Real-time feedback helps save energy and water
08.02.2017 | Otto-Friedrich-Universität Bamberg

nachricht The Great Unknown: Risk-Taking Behavior in Adolescents
19.01.2017 | Max-Planck-Institut für Bildungsforschung

All articles from Studies and Analyses >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Breakthrough with a chain of gold atoms

In the field of nanoscience, an international team of physicists with participants from Konstanz has achieved a breakthrough in understanding heat transport

In the field of nanoscience, an international team of physicists with participants from Konstanz has achieved a breakthrough in understanding heat transport

Im Focus: DNA repair: a new letter in the cell alphabet

Results reveal how discoveries may be hidden in scientific “blind spots”

Cells need to repair damaged DNA in our genes to prevent the development of cancer and other diseases. Our cells therefore activate and send “repair-proteins”...

Im Focus: Dresdner scientists print tomorrow’s world

The Fraunhofer IWS Dresden and Technische Universität Dresden inaugurated their jointly operated Center for Additive Manufacturing Dresden (AMCD) with a festive ceremony on February 7, 2017. Scientists from various disciplines perform research on materials, additive manufacturing processes and innovative technologies, which build up components in a layer by layer process. This technology opens up new horizons for component design and combinations of functions. For example during fabrication, electrical conductors and sensors are already able to be additively manufactured into components. They provide information about stress conditions of a product during operation.

The 3D-printing technology, or additive manufacturing as it is often called, has long made the step out of scientific research laboratories into industrial...

Im Focus: Mimicking nature's cellular architectures via 3-D printing

Research offers new level of control over the structure of 3-D printed materials

Nature does amazing things with limited design materials. Grass, for example, can support its own weight, resist strong wind loads, and recover after being...

Im Focus: Three Magnetic States for Each Hole

Nanometer-scale magnetic perforated grids could create new possibilities for computing. Together with international colleagues, scientists from the Helmholtz Zentrum Dresden-Rossendorf (HZDR) have shown how a cobalt grid can be reliably programmed at room temperature. In addition they discovered that for every hole ("antidot") three magnetic states can be configured. The results have been published in the journal "Scientific Reports".

Physicist Dr. Rantej Bali from the HZDR, together with scientists from Singapore and Australia, designed a special grid structure in a thin layer of cobalt in...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Booth and panel discussion – The Lindau Nobel Laureate Meetings at the AAAS 2017 Annual Meeting

13.02.2017 | Event News

Complex Loading versus Hidden Reserves

10.02.2017 | Event News

International Conference on Crystal Growth in Freiburg

09.02.2017 | Event News

 
Latest News

From rocks in Colorado, evidence of a 'chaotic solar system'

23.02.2017 | Physics and Astronomy

'Quartz' crystals at the Earth's core power its magnetic field

23.02.2017 | Earth Sciences

Antimicrobial substances identified in Komodo dragon blood

23.02.2017 | Life Sciences

VideoLinks
B2B-VideoLinks
More VideoLinks >>>