Navigation Links
Added benefit of aclidinium bromide is not proven
Date:1/30/2013

The drug aclidinium bromide (trade names Eklira, Bretaris) has been approved since October 2012 for widening the narrowed airways of adults with chronic-obstructive pulmonary disease (COPD). The German Institute for Quality and Efficiency in Health Care (IQWiG) has now examined the added benefit of the drug pursuant to the "Act on the Reform of the Market for Medicinal Products" (AMNOG). No proof of an added benefit of aclidinium bromide compared with the appropriate comparator therapy (ACT) can be inferred from the data in the drug manufacturer's dossier.

No robust results were submitted by the manufacturer in its dossier: for the direct comparison, there were no studies of an adequate duration. The data for the indirect comparison were incomprehensible for several reasons. Therefore the added benefit is not proven.

Tiotropium bromide as the appropriate comparator therapy

In COPD the lungs are permanently damaged and the airways are constantly narrowed. This makes breathing difficult. Aclidinium bromide (aclidinium for short) is a "bronchodilator" approved for long-term therapy. It inhibits the body's own substance acetylcholine which causes the bronchial muscles to tense up in COPD. The drug aclidinium, in the form of a powder, is breathed in using a special inhaler (Genuiar).

The ACT specified by the Federal Joint Committee (G-BA) takes account of the graded treatment scheme of the current National Care Guidelines for COPD: from Stage II of the disease, long-acting beta-2 sympathomimetics (formoterol, salmeterol) and/or long-acting anticholinergics (tiotropium bromide) are to be used; from Stage III/IV, if there are more than 2 severe attacks (exacerbations) per year, inhaled corticosteroids (ICS) are recommended in addition. The manufacturer followed these requirements and chose tiotropium bromide (tiotropium for short) as ACT.

Study duration too short for direct comparison

Since aclidinium is a long-term treatment, a reliable benefit assessment requires studies that last for at least 6 months. However, for the direct comparison of aclidinium with tiotropium, the manufacturer submitted 2 studies that only lasted for 2 and 6 weeks respectively. The dossier thus contained no studies relevant for the direct comparison.

Placebo studies for indirect comparison

For the indirect comparison, the manufacturer used studies that compared aclidinium and tiotropium with a dummy drug (placebo) in each case. But of a total of 24 studies (3 on aclidinium, 21 on tiotropium) only 14 were suitable for the assessment, because the others had lasted for less than 6 months.

Results for indirect comparison incomprehensible

When comparing the submitted results on the placebo studies with the original sources, IQWiG found substantial differences: on the one hand, some of the manufacturer's information did not match the corresponding original data. On the other hand, it was often unclear whether data emanated from the manufacturer or from another source and how they had been calculated. Much of the information in the manufacturer's dossier (especially about patient numbers and confidence intervals) could not be traced in the original sources.

Due to these deficiencies, it was impossible to check and therefore also to interpret the results presented in the dossier for almost all outcomes regarding benefit. In addition, the manufacturer repeatedly did not consider study results on relevant outcomes (exacerbations, mortality, quality of life), although they were to be found in the original sources. Because of these deficiencies, an added benefit of aclidinium on the basis of the manufacturer's dossier is not proven.

G-BA decides on the extent of added benefit

The dossier assessment is part of the overall procedure for early benefit assessments supervised by the G-BA. After publication of the manufacturer's dossier and IQWiG's assessment, the G-BA conducts a commenting procedure, which may provide further information and result in a change to the benefit assessment. The G-BA then decides on the extent of the added benefit, thus completing the early benefit assessment.


'/>"/>

Contact: Anna-Sabine Ernst
presse@iqwig.de
49-221-356-850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

Related medicine news :

1. Linagliptin: Once again, no proof of added benefit
2. New Wall Clocks Added to the Balvi Range at Contemporary Heaven
3. Email W-2 and 1099 Tax Forms - EzW2 Software Added New PDF Printing Feature For 2013 Tax Season
4. Payroll Tax Solution: EzPaycheck 2013 Added New Features For Small Firms And Non-profits
5. New Model [ZT-F1012-31221A] T10 Tube has been Added to Zhongtian Lighting’s Production Line
6. Indication of considerable added benefit of vemurafenib in advanced melanoma
7. Marketing Xocolate International Corporation (MXI-Corp) Introduces Xe Healthy Energy Drink, A Rich And Delicious Antioxidant Beverage, Now Added to Xoçai™ Product Line
8. Capsiplex Plus Reviews for Improved Weight Loss Supplement Added to BestAppetiteSuppressantPills.com
9. UV-Aid Cold and Flu Prevention Added to List of Biomimicry Strategies on AskNature.Org
10. Healthy Chocolate Omega Squares, a Decedent Dark Chocolate Added to Marketing Xocolate International Corporation (MXI Corp) Product Lines
11. Rilpivirine for HIV: Added benefit for single agent proven
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/12/2017)... Wis. (PRWEB) , ... October 12, 2017 , ... ... standard products to meet the demand of today’s consumer and regulatory authorities worldwide. ... of probiotic experts and tested to meet the highest standard. , These ...
(Date:10/12/2017)... MD (PRWEB) , ... October 12, 2017 , ... The ... of Excellence to Carol Friedman, PhD, FACMI, during the Opening Session of AMIA’s Annual ... – 8. , In honor of Morris F. Collen, a pioneer in the field ...
(Date:10/12/2017)... ... October 12, 2017 , ... Information about the ... to develop to enable prevention of a major side effect of chemotherapy in ... in pediatric patients. For cisplatin, hearing loss is FDA listed on-label as a ...
(Date:10/12/2017)... ... October 12, 2017 , ... HMP , a leader in healthcare events ... Magazine Eddie Digital Award for ‘Best B-to-B Healthcare Website.’ Winners were announced during the ... The annual award competition recognizes editorial and design excellence across a range of sectors. ...
(Date:10/12/2017)... ... 12, 2017 , ... On Saturday, October 21, the Health & Wellness Center ... to raise money for the American Heart Association Heart Walk. Teams of up to ... together to keep their treadmills moving for 5 hours. Treadmills will start at 7:00 ...
Breaking Medicine News(10 mins):
(Date:10/4/2017)... Mass. , Oct. 4, 2017  According to the Centers for ... the end of October . PhysicianOne Urgent Care is helping communities across ... Westchester, NY , by offering no-cost* flu shots through the ... as mandated by certain health insurance regulations. ... The best time to get a flu shot is by the ...
(Date:10/2/2017)... , Oct. 2, 2017 Halo Labs announces the ... analysis system called the HORIZON at MIBio 2017 in ... subvisible and visible particulate matter in biopharmaceutical samples with unprecedented speed ... of the novel technique Backgrounded Membrane Imaging. ... The HORIZON subvisible particle analysis system ...
(Date:9/27/2017)... and NEW YORK , Sept. 27, 2017 /PRNewswire/ ... health and big data solutions, today announced that its MyDario product is ... your local TV listings for when The Dr. Oz Show airs in ... The nine-time ... month. ...
Breaking Medicine Technology: