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:6/25/2016)... ... ... Austin residents seeking Mohs surgery services, can now turn to Dr. Jessica ... Peckham for medical and surgical dermatology. , Dr. Dorsey brings specialization to include Mohs ... Mohs Micrographic Surgery completed by Dr. Dorsey was under the direction of Glenn Goldstein, ...
(Date:6/25/2016)... Oklahoma (PRWEB) , ... June 25, 2016 , ... ... both athletes and non-athletes recover from injury. Recently, he has implemented orthobiologic procedures ... Oklahoma City area —Johnson is one of the first doctors to perform the ...
(Date:6/24/2016)... ... June 24, 2016 , ... June 19, 2016 is World Sickle ... chronic pain and the benefits of holistic treatments, Serenity Recovery Center of ... Sickle Cell Disease. , Sickle Cell Disease (SCD) is a disorder of the red ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San Diego, CA ... the Road To Recovery® program to drive cancer patients to and from their cancer ... ensure the highest quality of life and ongoing independence. Getting to and from ...
(Date:6/24/2016)... ... June 24, 2016 , ... Puradigm® ... Group (TGIG), has initiated cultivation and processing operations at its production facility, and ... Nevada. , Puradigm is the manufacturer of a complete system of proactive air ...
Breaking Medicine News(10 mins):
(Date:6/26/2016)... -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ ) ... Improvements Act of 1976, as amended ("HSR"), with respect ... Nasdaq: CPXX ) expired effective June 24, ... As previously announced on May 31, 2016, Jazz Pharmaceuticals ... which Jazz Pharmaceuticals has commenced a tender offer for ...
(Date:6/24/2016)... SAN FRANCISCO, Calif. , June 24, 2016 ... GBT ), a biopharmaceutical company developing novel therapeutics ... significant unmet needs, today announced the closing of ... shares of common stock, at the public offering ... shares in the offering were offered by GBT. ...
(Date:6/24/2016)... June 24, 2016 Dehaier Medical Systems Ltd. ... which develops, markets and sells medical devices and wearable ... signed a strategic cooperation agreement with Hongyuan Supply Chain ... Chain") on June 20, 2016, to develop Dehaier,s new ... cooperation agreement, Dehaier will leverage Hongyuan Supply Chain,s sales ...
Breaking Medicine Technology: