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

inium 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
'/>"/>

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

Page: 1 2 3

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:8/27/2014)... 27, 2014 Lighthouse Payment Services ... announced that it will exhibit its image-based lockbox services ... 41st annual convention in beautiful Lake Placid, New ... event will be held at the Lake Placid Convention ... and entertainment options in addition to a variety of ...
(Date:8/27/2014)... 2014 Aspirus Wausau Hospital today announced ... with Buzz™ Digital O.R. at Aspirus Wausau Hospital, in ... new operating rooms will be Buzz, a centralized surgical ... system supports planning, navigation, imaging and communications connectivity. ... intuitive software and hardware all controlled from the full ...
(Date:8/27/2014)... Health care workers in poor nations often do not ... being infected with blood-borne viruses such as Ebola and ... was conducted before the current Ebola outbreak began in ... statistics released Monday by the World Health Organization (WHO). ... number of health care workers have lost their lives ...
(Date:8/27/2014)... Stroke patients are 70 per cent more likely to ... if they have a prescription in hand when discharged ... and the Institute for Clinical Evaluative Sciences (ICES). , ... many Ontarians were taking their medications one week, one ... results reveal the importance of simple interventions, such as ...
(Date:8/27/2014)... Chino Hills, CA (PRWEB) August 27, 2014 ... boot camp franchise in the world, the leading fitness ... to Spike TV’s Gym Rescue reality series. One thing he ... personal brand as a subject matter expert in the fitness ... uploaded to YouTube, he lays out a step-by-step instructional guide ...
Breaking Medicine News(10 mins):Health News:Aspirus Wausau Hospital Announces First Large Scale Digital Operating Room Integration Project in the US 2Health News:Aspirus Wausau Hospital Announces First Large Scale Digital Operating Room Integration Project in the US 3Health News:Lack of Protective Gear Leaves Medics at Risk in Ebola Outbreak: Study 2Health News:Lack of Protective Gear Leaves Medics at Risk in Ebola Outbreak: Study 3Health News:A prescription for better stroke care 2Health News:Bedros Keuilian Releases New Fitness Boot Camp Marketing Webinar on Building a Personal Brand 2Health News:Bedros Keuilian Releases New Fitness Boot Camp Marketing Webinar on Building a Personal Brand 3
... , ... Fresh Look at Coping with Multiple Sclerosis through Community , ... (PRWEB) April 13, 2010 -- Motivational Speaker/MS ... guidebook for those newly diagnosed with Multiple Sclerosis. , , ,Published by iUniverse ...
... likely to develop, die from disease , TUESDAY, April 13 ... comes to both developing and dying from lung cancer. , ... grim picture of how environmental factors, biological factors, cultural attitudes ... deadly disease even deadlier among members of this minority group. ...
... ... patients and may be covered by medical insurance will be provided by Khanna institute in ... (Vocus) April ... with countless solutions for eye and sight problems, hereby announces that it is offering its ...
... mutated gene in human cancers is the reitnoblastoma (RB) gene, ... gene disable the vast and intricate RB pathway in virtually ... cellular functions and ultimately provoking cancer. But which of these ... uncertain. "We have now found that a key function ...
... ... general availability of ActiveStrategy iRound™, which enables field-level performance management data to be ... Enterprise software. , ... (PRWEB) April 13, 2010 -- ActiveStrategy, the leading provider of comprehensive ...
... on failure rates could aid surgeons who import donor tissue, ... a corneal transplant will fail is not affected by the ... transplanted cornea was preserved or the method of preservation, according ... study that included 388 people who were followed for up ...
Cached Medicine News:Health News:Author Erin Morrow Still Releases "Fighting MS: Strength in Numbers" 2Health News:Author Erin Morrow Still Releases "Fighting MS: Strength in Numbers" 3Health News:Blacks Hit Hardest by Lung Cancer 2Health News:Blacks Hit Hardest by Lung Cancer 3Health News:Khanna Institute to Provide Intacs Corneal Implants in Beverly Hills 2Health News:Khanna Institute to Provide Intacs Corneal Implants in Beverly Hills 3Health News:CSHL scientists discover how a tumor suppressor induces senescence and staves off cancer 2Health News:ActiveStrategy iRound™ is Launched to Enable Seamless Capture of Field-Level Performance Management Data 2Health News:ActiveStrategy iRound™ is Launched to Enable Seamless Capture of Field-Level Performance Management Data 3Health News:Corneal Transplant Not Hurt by Long Preservation Time 2
(Date:8/27/2014)... 2014 Reportlinker.com announces that a new ... Global Heart Valve Repair and Replacement ... About Heart Valve Repair and Replacement ... which control the flow of blood during the ... diseases such as valvular stenosis, valvular insufficiency or ...
(Date:8/27/2014)... -- Reportlinker.com announces that a new market research report ... Eastern Europe 2014 http://www.reportlinker.com/p02312454/Baby-Food-Eastern-Europe-2014.html ... a new report by ERC that analyzes the Baby ... , key segments, features & developments, future projections ... which are currently affecting the industry. Furthermore, it profiles ...
(Date:8/27/2014)... , Aug. 27, 2014 North American lighting ... prestigious R&D 100 Award for the new OSRAM ITOS ® ... LED-based white light module for microscopy, endoscopy and surgical head ... with significantly higher efficacy and lamp life. "We,re ... one of the most innovative new technologies of the past ...
Breaking Medicine Technology:Global Heart Valve Repair and Replacement Market 2014-2018 2Global Heart Valve Repair and Replacement Market 2014-2018 3Global Heart Valve Repair and Replacement Market 2014-2018 4Baby Food Eastern Europe 2014 2Baby Food Eastern Europe 2014 3Baby Food Eastern Europe 2014 4Baby Food Eastern Europe 2014 5Baby Food Eastern Europe 2014 6Baby Food Eastern Europe 2014 7Baby Food Eastern Europe 2014 8OSRAM ITOS PHASER 3000 Laser and LED Light Module Recognized With Prestigious R&D 100 Award 2OSRAM ITOS PHASER 3000 Laser and LED Light Module Recognized With Prestigious R&D 100 Award 3
... Antibody (IgM) Test is an ... quantitative detection of antibodies to ... is used as an aid ... thrombosis in individuals with systemic ...
The 8500 is an extremely reliable portable pulse oximeter, requiring no periodic maintenance or calibration....
Rad-5v signal extraction pulse oximeter™...
... The 8500 Digital Handheld ... universal tool for patients monitoring ... continuous monitoring. As the first ... as a benchmark for durability ...
Medicine Products: