Navigation Links
Added benefit of linagliptin is not proven
Date:1/6/2012

Linagliptin (trade name: Trajenta) has been approved since August 2011 to improve blood glucose control ("glycaemic control") in adults with type 2 diabetes mellitus whose elevated blood glucose levels are inadequately controlled by diet and exercise. It is an option for patients who do not tolerate or should not take the usual treatment with the drug metformin. Moreover, linagliptin can be added if treatment with metformin alone is not sufficient.

In an early benefit assessment pursuant to the "Act on the Reform of the Market for Medicinal Products" (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether linagliptin offers an added benefit versus the appropriate comparator therapy specified by the Federal Joint Committee (G-BA). No such added benefit can be inferred from the dossier, as the drug manufacturer deviated from the G-BA's specifications and chose a different comparator therapy.

Approval status distinguishes between three treatment situations

The appropriate comparator therapy specified by the G-BA distinguishes between three treatment situations:

* Administration of linagliptin alone (monotherapy) as a substitute for metformin if this drug is not tolerated by patients or should not be taken because of impaired kidney function. To assess the added benefit, linagliptin monotherapy should be compared with a drug from the sulfonylurea class (glibenclamide or glimepiride).

* Dual therapy combines linagliptin and metformin and is indicated if treatment with metformin alone is insufficient to control blood glucose levels. To assess the added benefit, dual therapy with linagliptin should be compared with a combination of metformin and a sulfonylurea (glibenclamide or glimepiride).

* Triple therapy combines linagliptin, metformin and a sulfonylurea and is used if dual therapy with metformin and a sulfonylurea is no longer a sufficient treatment option. To assess the added benefit, triple therapy should be compared with a combination of insulin and metformin.

Drug manufacturer chose a gliptin as comparator therapy

In its dossier, the manufacturer compared linagliptin with a different drug from the gliptin class (sitagliptin) in all three treatment situations and thereby deviated from the specifications of the G-BA. However, in IQWiG's opinion, the manufacturer insufficiently justified this deviation. For the dossier assessment IQWiG therefore uses the appropriate comparator therapy specified by the G-BA.

In the dossier, the manufacturer makes no statements on the extent and probability of an added benefit of linagliptin versus the appropriate comparator therapy specified by the G-BA. Studies that would have been relevant for this purpose were explicitly excluded from the assessment. The manufacturer's dossier therefore provides no proof of an added benefit of linagliptin versus the G-BA's appropriate comparator therapy. This applies to all three treatment situations mentioned above, that is, monotherapy, dual and triple combination therapy.

In the dossier the manufacturer did not determine an added benefit of linagliptin versus the comparator therapy they had chosen themselves (sitagliptin).

G-BA decides on the extent of added benefit

The procedure for inferring the overall conclusion on the extent of added benefit is a proposal from IQWiG. The G-BA, which has opened a formal commenting procedure, will decide on the extent of added benefit.


'/>"/>
Contact: Anna-Sabine Ernst
presse@iqwig.de
49-022-135-6850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

Related medicine news :

1. Repeated Weight-Loss Surgery Carries Added Risks
2. Added Drug Aids MS Treatment
3. Breast cancer screening: No added value through mammography
4. Employee Donations for Haiti Relief Matched by Capital BlueCross, Added to Corporate Contribution
5. Licorice Flavonoid Oil with Glavonoid™ Added to the Swanson Health Products' Swanson Best Weight-Control Formulas
6. Microwize Technology is Recognized as the Best Support Value Added Reseller (VAR) for Lytec Medical Billing Software
7. Added Sugars in Diet Threaten Heart Health
8. LifeLinks Revolutionizes Video Interpreting, Shows Spanish Interpreting in Added Dimension-VIDEO!
9. Genetic data added to archaeology and linguistics to get picture of African population history
10. FileHold Document Management Software welcomes Click2ScanLtd. as a Value Added Re-sellers in the UK
11. More Natural Fat Burning Foods & Ready-Made Meal Plans Added to the Newly Revised Version of The Diet Solution Program
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/19/2017)... ... , ... Curl Keeper® is excited to announce that the H2O Water Bottle ... for the second year in a row. The H2O Bottle, a refillable ultra-fine spray ... Moisturizer for Type 2 Wavies and Best Refresher for Type 2 Wavies in 2017. ...
(Date:8/19/2017)... , ... August 19, 2017 , ... ... is a diverse community of over 1,000 passionate employees, caregivers, volunteers, thought leaders, ... Parker at Stonegate changed ownership, it was time to refresh the carpeting with ...
(Date:8/18/2017)... ... August 19, 2017 , ... ... Thailand presided over the Amazing Thailand Health and Wellness Tourism Showcase 2017 yesterday, ... Noppadon Pakprot, Deputy Governor for Tourism Products and Business at TAT said, “Thailand ...
(Date:8/18/2017)... , ... August 18, 2017 ... ... Quick International, LLC (“Quick”), a highly specialized asset-light logistics provider of complex ... into a definitive agreement to purchase Unitrans International Corporation, a division of ...
(Date:8/18/2017)... ... August 18, 2017 , ... Mediaplanet today announces the launch ... lifestyles and highlighting the importance of proactive eye and ear health. The campaign ... latest innovations in hearing aid technology. , In this issue, the American ...
Breaking Medicine News(10 mins):
(Date:8/15/2017)... 2017 AccuGenomics, Inc., a diagnostic company based ... that the company has provided an AccuKit to the ... at Chapel Hill and to Qura Therapeutics for evaluation ... quantify HIV reservoir and viral expression in human CD4+ ... Cure Center is a joint initiative between the University ...
(Date:8/14/2017)... PETACH TIKVAH, Israel , Aug. 15, ... leading developer of adult stem cell technologies for neurodegenerative ... June 30, 2017. ... our pivotal Phase 3 trial to investigate NurOwn ® ... and Chief Executive Officer of BrainStorm. "We have agreements ...
(Date:8/10/2017)... Colo. , Aug. 10, 2017  Physical Rehabilitation Network ... located in Lakewood, Colorado . The reputable ... Jeff Lipkin , PT, DPT with his staff of four ... University of Pittsburgh and brings over 10 years of experience ... Belmar PT marks the 10th PRN clinic in ...
Breaking Medicine Technology: