Navigation Links
Linagliptin: Once again, no proof of added benefit
Date:1/30/2013

Linagliptin (trade name Trajenta) has been approved since August 2011 to improve blood glucose control in adults with type 2 diabetes. The assessment of the new dossier according to the German Act on the Reform of the Market for Medicinal Products (AMNOG) again showed that no added benefit of the drug over the appropriate comparator therapy (ACT) can be determined, because the pharmaceutical company has not submitted any relevant studies. This is the conclusion of the report by the German Institute for Quality and Efficiency in Health Care (IQWiG) published on 3rd December 2012.

First assessment negative because the comparator therapy deviated from the one specified

In its first early benefit assessment dated January 2012, IQWiG was unable to determine any added benefit because the pharmaceutical company (Boehringer Ingelheim) had chosen sitagliptin as comparator therapy in its first dossier instead of the ACT (a sulfonylurea) specified by the Federal Joint Committee (G-BA). A decision based on the IQWiG report was made by the G-BA on 29th March 2012.

Company can submit a new dossier in the transitional period

On the basis of an exemption clause since enshrined in the German Social Code Book V (35a Paragraph 5b), during a transitional period up to the end of 2012, companies are allowed to apply for a new assessment at any time if the added benefit is considered unproven due to incomplete evidence. The G-BA decided to allow a corresponding application for linagliptin and commissioned IQWiG to assess the new dossier submitted by the company. Linagliptin is the first drug to be re-assessed according to this rule.

Approval status distinguishes between three treatment situations

The ACT (the sulfonylureas glibenclamide and glimepiride) specified by the G-BA differs according to which of three treatment situations applies: firstly, where linagliptin is given alone (monotherapy) as a substitut
'/>"/>

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. To make old skin cells act young again, boost their surroundings, U-M scientists show
2. No Proof Drugs Ease Kids Migraines: Study
3. Corporate Whistle Blower Center Now Urges Physicians Medical Device and Drug Industry Insiders To Step Up-If They Have Proof Of Serious Wrongdoing or Overbilling
4. Pesticides and Parkinsons: UCLA researchers uncover further proof of a link
5. Corporate Whistle Blower Center Now Urges Physicians to Become a Whistleblower if They Have Proof a Medical Device or a Drug Product was Defective-and it was Sold Anyway
6. Corporate Whistle Blower Center Now Urges Physicians, Medical Device or Drug Insiders With Proof A Company Knowingly Sold A Bad Product to Become a Whistleblower
7. No Proof That Doping With EPO Gives Athletes an Edge: Review
8. Vandetanib in thyroid cancer: No proof of added benefit
9. No proof that patients lose weight after joint replacement surgery
10. More Proof Cranberry Juice Thwarts Infection
11. More Proof That Healthy Habits Fight Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/11/2014)... (PRWEB) July 11, 2014 ... least $50 billion in fuel costs now ... The current GHG standards are ... taken it upon themselves to install new ... , 1.    Idle reduction technologies , 2.    Efficient driveline ...
(Date:7/11/2014)... U.S. health officials have concluded that it,s highly unlikely ... a safety mishap last month. But, the U.S. ... a moratorium on the transfer of any dangerous germs ... report issued Friday, the CDC outlined several measures the ... doesn,t occur again. Last month, as many as 75 ...
(Date:7/11/2014)... 11, 2014 Alliance for Cancer ... non-profit dedicated exclusively to cell and gene therapies ... has joined the organization as Senior Development Officer. ... deep experience securing gifts and addressing influential donors. ... Giving Director for NewYork Presbyterian Hospital/Columbia University Medical ...
(Date:7/11/2014)... Biostimulants are widely applied in turf and ... These also help turf and ornamentals in absorption of ... ornamentals, and flowers appear healthy and strong as a ... from the last few years. The most dominating region ... with around 40% share in 2013, and is estimated ...
(Date:7/11/2014)... Miriam Hospital have found that people with mobility ... of smoking than those without mobility impairments. Additionally, ... attempt quitting than those without mobility impairments, and ... this population. The study and its findings are ... American Journal of Public Health . ...
Breaking Medicine News(10 mins):Health News:LeaseQ Agrees the Latest Round of Greenhouse Gas Rules Could Increase the Cost of Truck Acquisition and Maintenance 2Health News:LeaseQ Agrees the Latest Round of Greenhouse Gas Rules Could Increase the Cost of Truck Acquisition and Maintenance 3Health News:CDC Issues Tough Report on Anthrax Scare 2Health News:Alliance for Cancer Gene Therapy (ACGT) Welcomes Joshua Corday as Senior Development Officer 2Health News:Alliance for Cancer Gene Therapy (ACGT) Welcomes Joshua Corday as Senior Development Officer 3Health News:Biostimulants Market in Turf and Ornamentals is Expected to Reach $ 3.8 Billion by 2018 - New Report by MicroMarket Monitor 2Health News:Biostimulants Market in Turf and Ornamentals is Expected to Reach $ 3.8 Billion by 2018 - New Report by MicroMarket Monitor 3Health News:Miriam Hospital study examines smoking prevalence 2
... Steven Reinberg HealthDay Reporter , THURSDAY, June ... preschool program that sees them through elementary school have ... were not in preschool do, University of Minnesota researchers ... incomes, higher education levels, a higher socioeconomic status and ...
... 9, 2011From body builders to baby boomers, more Americans ... and maintenance in later life, satiety, weight loss and ... abreast of advancing research on the health benefits of ... Dairy Council of California and National Dairy Council are ...
... brain mechanism that could be targeted for new medications designed ... funded by the National Institute on Drug Abuse (NIDA), part ... subclass of brain nicotinic receptor is involved in nicotine,s ability ... the average weight gain after smoking is less than 10 ...
... , THURSDAY, June 9 (HealthDay News) -- With record-breaking ... States -- and with little relief in sight -- health ... posed by oppressive temperatures and humidity. "The elderly, young ... who are taking certain medications, especially antidepressants, are most ...
... June 9 (HealthDay News) -- Children are among those most ... toxocariasis (OT), which can lead to permanent vision loss, according ... occur when a person ingests dirt that,s contaminated with microscopic ... or cat. Larvae that emerge from the eggs migrate throughout ...
... treatments for Parkinson,s disease (PD) restore function for extended ... inaugural issue issue of the Journal of Parkinson,s ... platelet-derived growth factor-BB (PDGF-BB) restored function in rodents and ... of PD. Parkinson,s disease is the second most ...
Cached Medicine News:Health News:Preschool's Benefits Linger Into Adulthood, Study Finds 2Health News:Preschool's Benefits Linger Into Adulthood, Study Finds 3Health News:From body builders to baby boomers: IFT session explores protein recommendations beyond muscle 2Health News:Potential new target for smoking cessation without weight gain 2Health News:Record Temperatures Posing Health Risks in U.S. 2Health News:Record Temperatures Posing Health Risks in U.S. 3Health News:Tainted Soil May Put Kids at Risk for Vision Loss 2Health News:New animal study shows promise for development of Parkinson's disease drug 2
(Date:1/15/2014)... DALLAS , Jan. 15, 2014 /PRNewswire-iReach/ -- ChinaMarketResearchReports.com ... to its store . (Photo: ... consumption upgrade and policy support, China,s ... the years, with total market size rising from 3.28 ...
(Date:1/15/2014)... , Jan. 15, 2014  Research and Markets ( http://www.researchandmarkets.com/research/6k27gw/dental ... Consumables Market - Global Industry Analysis, Size, Share, Growth, ... their offering. (Logo: http://photos.prnewswire.com/prnh/20130307/600769 ... are used on patients in order to treat dental ...
(Date:1/15/2014)... Foundation today announced it has established a relief fund ... weather that has gripped much of the nation. AARP and ... to support these emergency relief efforts AARP and AARP Foundation ... up to $500,000 in aid. The matching program will be ...
Breaking Medicine Technology:Orthopedic Instrument Industry in China Markets Forecast to 2015 2Orthopedic Instrument Industry in China Markets Forecast to 2015 3Dental Consumables Market - Global Industry Analysis, Size, Share, Growth, Trends And Forecast, 2013 - 2018 2Dental Consumables Market - Global Industry Analysis, Size, Share, Growth, Trends And Forecast, 2013 - 2018 3AARP Foundation Establishes Winter Relief Fund for Older Adults Suffering from the Severe Cold Weather 2AARP Foundation Establishes Winter Relief Fund for Older Adults Suffering from the Severe Cold Weather 3
... Hill Studios, in partnership with the UCSF School of ... therapy games that have been specifically designed to help ... disease. Sue Lifschiz, a woman with Parkinson,s, will demonstrate ... levels to meet the needs of a variety of ...
... May 16, 2011 New Jersey Center for Prostate ... the nation to treat advanced prostate cancer patients with ... known as autologous cellular immunotherapies.  PROVENGE was approved by ... treatment of men with asymptomatic or minimally symptomatic metastatic ...
Cached Medicine Technology:Red Hill Studios/UCSF Partnership to Showcase 'Gaming Therapy' for People With Parkinson's Disease at Games for Health Conference 2Red Hill Studios/UCSF Partnership to Showcase 'Gaming Therapy' for People With Parkinson's Disease at Games for Health Conference 3New Jersey Center for Prostate Cancer & Urology Among First in Nation to Treat Advanced Prostate Cancer Patients with PROVENGE 2
Alpha prime immunoassay system features unsurpassed quality of results, full automation of EIA tests for microplate applications, complete walk-away, up to 18 different assays per run, photometric an...
... is a flexible system that ... environments small hospitals, backup ... satellite locations. The Vitros 250 ... can be automated or placed ...
AxSYM Plus provides cutting-edge ergonomics and smart new features that mean increased ease-of-use and enhanced reliability. Also, advanced software means less operator intervention and high-integrit...
The ADx system uses fluorescence polarization immunoassay technology for the detection of abused drugs and toxicology assays....
Medicine Products: