Contact Information:

Media Contact

Dr. Anna-Sabine Ernst
presse@iqwig.de
49-022-135-6850

http://www.iqwig.de/




Kredyty mieszkaniowe Kredyty mieszkaniowe

Sprawdź aktualny ranking najlepszych kredytów mieszkaniowych w Polsce - atrakcyjne kredytowanie nieruchomości.

PRESS-NEWS.org - Press Release Distribution
FREE PRESS RELEASES DISTRIBUTION
RSS - Press News Release
Add Press Release

Safinamide in Parkinson disease: No hint of added benefit

Relevant study data were not considered / analyses in the dossier were incomplete regarding serious side effects in the comparator therapy, long-term data and other aspects


2015-08-19
(Press-News.org) Safinamide (trade name: Xadago) has been available since February 2015 as add-on therapy for the treatment of mid- to late-stage Parkinson disease in adults. In combination with levodopa alone or together with other Parkinson disease medicinal products, this monoamine oxidase (MAO-B) inhibitor is used to help restore dopamine levels in the brain. The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment whether this drug offers an added benefit over the appropriate comparator therapy.

Such an added benefit cannot be derived from the dossier, however, because relevant study data were not considered and the analyses were therefore incomplete.

Indirect comparison with limited study pool

Due to a lack of studies of direct comparisons, the drug manufacturer conducted an adjusted indirect comparison with studies that tested either safinamide or the COMT inhibitor entacapone as appropriate comparator therapy against placebo. All six studies included provided data on a 24-week treatment: Two studies provided data on safinamide and four studies on entacapone.

One of the safinamide studies (016) was followed by an extension phase (018), in which the patients were treated for another 78 weeks (total duration 016/018: 102 weeks). The manufacturer did not include this extension phase in the benefit assessment because it did not identify an entacapone study with the same duration. It had limited study selection to the exact duration (24 and 102 weeks). The additionally relevant and more current entacapone study BIA-91067-301 with a treatment duration of 52 weeks was therefore not included in the study pool.

Analyses incomplete because relevant study data were lacking

The limitation of the study pool is methodologically inadequate and resulted in an important loss of information. The analyses in the dossier are therefore incomplete and cannot be used for the assessment of the added benefit: It would be possible to conduct a comparison with the long-term data from the safinamide study 016/018 in connection with the missing entacapone study.

Furthermore, only the BIA-91067-301 study provided information on serious side effects (SAEs) on the entacapone side of the indirect comparison. Moreover, treatment of adults with Parkinson disease has probably changed in the last 5 to 15 years so that the missing study results may be more similar to the safinamide studies from about the same period of time than the four entacapone studies included, all of which were approximately ten years older.

G-BA decides on the extent of added benefit

This dossier assessment is part of the early benefit assessment according to the Act on the Reform of the Market for Medicinal Products (AMNOG) supervised by the Federal Joint Committee (G-BA). After publication of the dossier assessment, the G-BA conducts a commenting procedure and makes a final decision on the extent of the added benefit.

INFORMATION:

An overview of the results of IQWiG's benefit assessment is given by a German-language executive summary. In addition, the website » http://www.gesundheitsinformation.de, published by IQWiG, provides easily understandable German-language information.

More English-language information will be available soon (Sections 2.1 to 2.6 of the dossier assessment as well as subsequently published health information on » http://www.informedhealthonline.org). If you would like to be informed when these documents are available, please send an e-mail to » info@iqwig.de.


ELSE PRESS RELEASES FROM THIS DATE:

Tall, masculine men aged around 35 years old perceived to be most dominant

2015-08-19
The study, by scientists at the University of St Andrews, shows that simple increases in a man's height and age automatically makes them appear more dominant. The research, published today (Wednesday 19 August 2015) by the SAGE journal 'Perception', sheds light on why Hollywood directors might choose certain actors to play leading roles. The study was carried out by Carlota Batres, Daniel Re, and Professor David Perrett of the Perception Lab at the University's School of Psychology & Neuroscience. Carlota and her team used computer graphic manipulations to make subtle ...

Research reveals link between age and opinions about video games

2015-08-19
The older the clinician, the more likely they are to think playing video games leads to violent behavior, according to new research published in Computers in Human Behavior. Psychology professor Dr. Christopher Ferguson, author of the study from Stetson University, US, says his findings go some way to explaining why people have different opinions about the effect of video games and suggests many of the reasons come down to generational issues. For parents, one way to close this gap is speaking to children and testing out the games themselves. As long as video games ...

New report offers first nationwide look at the impact of the ACA on medically underserved

2015-08-19
WASHINGTON and NEW YORK (August 19, 2015)--A new report examining newly-released data from the 2014 Uniform Data System (UDS), which collects patient and health care information from the nation's community health centers, shows how the Affordable Care Act (ACA) is changing insurance coverage and health care in the nation's most medically underserved urban and rural communities. Examining data collected from nearly 1,300 federally funded health centers operating in over 9,000 locations, the report shows that between 2013 and 2014, the number of health center patients with ...

Instant oatmeal for breakfast may help curb your appetite at lunch

2015-08-19
CHICAGO, IL, August 19, 2015 - A new study revealed that your cereal choice at breakfast might have an impact on how much you eat for lunch. Newly published research in the Journal of the American College of Nutrition showed that a hearty bowl of instant oatmeal helped curb food intake at lunch better than a leading oat-based, cold cereal -- even when each bowl provided the same number of calories. The statistically significant results of the randomized, controlled crossover study (n=47) showed that a 250-calorie instant oatmeal serving (with an additional 113 calories ...

Study finds racial disparity between what black and white borrowers pay for home mortgages

2015-08-19
Racial disparity in mortgage rates is widespread between black and white borrowers, according to a newly published study which found more financially vulnerable black women suffer the most. The study, led by Ping Cheng, Ph.D., professor of finance in Florida Atlantic University's College of Business, used data from three waves of U.S. Survey of Consumer Finance and found that black borrowers on average pay about 29 basis points more than comparable white borrowers, or .29 percent more. Their article was published in the July 2015 issue of The Journal of Real Estate Finance ...

Trade liberalization reduces countries' defense spending

2015-08-19
Reducing trade barriers between countries reduces the likelihood of armed conflict and leads to a reduction in defence spending. In turn, this promotes a domino effect in relation to other countries, which has a positive effect on the situation in the world as a whole. This is the conclusion reached by Roman Zakharenko, Assistant Professor of the HSE International College of Economics and Finance, and his colleagues regarding the relationship between trade and defence spending. In today's word, armed conflicts are not as frequent as they used to be, but defence spending ...

Warning to DIY enthusiasts & construction workers as dangerous dust emissions

2015-08-19
Scientists at the University of Surrey found peak concentrations of potentially harmful ultrafine particles reach up to 4000 times local background levels when undertaking building activities such as drilling. Breathing of these particles is linked with serious cardiovascular and respiratory system related diseases, with ultrafine particles penetrating deeper into the lungs. The researchers also found that the greatest ultrafine particle emissions occurred during wall chasing (cutting grooves into a wall using an electrical tool, for example to lay electrical cables). ...

Better-tasting grocery store tomatoes could soon be on their way

2015-08-19
BOSTON, Aug. 19, 2015 -- Tomato lovers rejoice: Adding or rearranging a few simple steps in commercial processing could dramatically improve the flavor of this popular fruit sold in the grocery store, according to researchers. The scientists will present new research on flavor-saving methods at the 250th National Meeting & Exposition of the American Chemical Society (ACS), the world's largest scientific society. The meeting features more than 9,000 reports on new advances in science and other topics. It is being held here through Thursday. "Ideally, tomatoes should ...

Change in process of disinfecting spinach, salad greens could reduce illness outbreaks

2015-08-19
BOSTON, Aug.19, 2015 -- Cross contamination in commercial processing facilities that prepare spinach and other leafy greens for the market can make people sick. But researchers are reporting a new, easy-to-implement method that could eliminate or reduce such incidences. The scientists will present their work at the 250th National Meeting & Exposition of the American Chemical Society (ACS), the world's largest scientific society. The meeting features more than 9,000 reports on new advances in science and other topics. It is being held here through Thursday. Each year ...

New compounds could reduce alcoholics' impulse to drink

2015-08-19
BOSTON, Aug. 19, 2015 -- Alcoholism inflicts a heavy physical, emotional and financial toll on individuals and society. Now new discoveries and promising animal studies are offering a glimmer of hope that a new class of drugs could treat the disease without many of the unwanted side effects caused by current therapies. Researchers are presenting the results of their work today at the 250th National Meeting & Exposition of the American Chemical Society (ACS), the world's largest scientific society. The meeting features more than 9,000 presentations on a wide range of science ...

LAST 30 PRESS RELEASES:

How your brain decides blame and punishment -- and how it can be changed

Uniquely human brain region enables punishment decisions

Pinpointing punishment

Chapman University publishes research on attractiveness and mating

E-cigarettes: Special issue from Nicotine & Tobacco Research

Placental problems in early pregnancy associated with 5-fold increased risk of OB & fetal disorders

UT study: Invasive brood parasites a threat to native bird species

Criminals acquire guns through social connections

Restoring ocean health

Report: Cancer remains leading cause of death in US Hispanics

Twin study suggests genetic factors contribute to insomnia in adults

To be fragrant or not: Why do some male hairstreak butterflies lack scent organs?

International team discovers natural defense against HIV

Bolivian biodiversity observatory takes its first steps

Choice of college major influences lifetime earnings more than simply getting a degree

Dominant strain of drug-resistant MRSA decreases in hospitals, but persists in community

Synthetic biology needs robust safety mechanisms before real world application

US defense agencies increase investment in federal synthetic biology research

Robots help to map England's only deep-water Marine Conservation Zone

Mayo researchers identify protein -- may predict who will respond to PD-1 immunotherapy for melanoma

How much water do US fracking operations really use?

New approach to mammograms could improve reliability

The influence of citizen science grows despite some resistance

Unlocking secrets of how fossils form

What happens on the molecular level when smog gets into the lungs?

Using ultrasound to clean medical instruments

Platinum and iron oxide working together get the job done

Tiny silica particles could be used to repair damaged teeth, research shows

A quantum lab for everyone

No way? Charity's logo may influence perception of food in package

[Press-News.org] Safinamide in Parkinson disease: No hint of added benefit
Relevant study data were not considered / analyses in the dossier were incomplete regarding serious side effects in the comparator therapy, long-term data and other aspects
Press-News.org is a service of DragonFly Company. All Rights Reserved.
Issuers of news releases are solely responsible for the accuracy of their content.