Navigation Links
Added benefit of the fixed combination of dapagliflozin and metformin is not proven
Date:5/15/2014

mmissioned IQWiG to also assess not only studies on glibenclamide and glimepiride, but also on glipizide in each case combined with metformin in the first research question.

Drugs were not used in compliance with their approval

The drug manufacturer presented results of a study that directly compared the fixed combination with glipizide plus metformin. In this study, however, which had already been the basis for its dossier on the monotherapy, the drugs were not used according to the specifications in the approval both in the intervention and in the control arm. It remained unclear whether the same effects would have been observed if the drugs had been administered in compliance with the Summary of Product Characteristics. At any rate, the study results cannot be interpreted with regard to the approval-compliant use.

Insulin therapy could not be optimized

For the second research question, in which the fixed combination was to be complemented with insulin, the manufacturer used three studies, which it had also already cited in the dossier on the monotherapy. However, their results could also not be used for assessing the added benefit. The main reason for this is that the insulin therapy could not be tailored sufficiently to the individual patient: Even though their current insulin therapy was insufficient, patients were neither supposed to change the insulin nor to adapt the dose. But to be able to draw conclusions about the added benefit, the fixed combination would have to be compared with other strategies for optimizing treatment, for example optimizing insulin use.

Not tailoring treatment to the individual patient does not meet the current standard of diabetological practice anyway. Instead, insulin therapy is optimized for the individual patient so that hyperglycaemia and hypoglycaemia do not occur in the first place. So in the study, insulin was not used in a way that would be necessary and appropr
'/>"/>

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

Page: 1 2 3

Related medicine news :

1. No Added Cancer Risk From Hip Replacement Materials: Study
2. Tafamidis: Approval denotes proven added benefit
3. Nurse Alert Provides Added Level of Senior Alert Care With New Nurse Triage Feature
4. Abiraterone: Indication of considerable added benefit in certain patients
5. Collagenase for Dupuytrens contracture: Added benefit not proven
6. Added benefit of linagliptin is not proven
7. Added benefit of eribulin in breast cancer is not proven
8. Added benefit of fampridine is not proven
9. Belimumab for lupus erythematosus: Added benefit not proven
10. Keeping Up a Healthy Lifestyle Pays Off in Added Years: Study
11. Telaprevir: Added benefit in certain patients with hepatitis C
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/29/2015)... ... July 29, 2015 , ... The NCCA re-accredited ... period, expiring November 30, 2019, during its recent meeting. , The Commission received ... the program’s compliance with the NCCA’s Standards for the Accreditation of Certification Programs. ...
(Date:7/29/2015)... ... July 29, 2015 , ... On July 26th the ... FDA for nicotine laced liquid products. Their report says cigarette use has decreased ... are particularly troublesome to addiction professionals as many of the candy flavors available ...
(Date:7/29/2015)... ... July 29, 2015 , ... ... has once again teamed up with Stillwaters Cancer Support Services and announced a ... Stillwaters provides individual and family counseling, support groups, workshops and educational programs at ...
(Date:7/29/2015)... FL (PRWEB) , ... July 29, 2015 , ... For ... excited to be featured in the list of the 50 fastest growing companies in ... revolves around the business community. On July 16th, a team of Vast Bridges staffers ...
(Date:7/29/2015)... Los Angeles, CA (PRWEB) , ... July 29, 2015 , ... We are privileged to ... at Keck Medicine of USC as the ninth best ophthalmology hospital in the nation for ... the top 10 American hospitals for ophthalmology. , “It is an honor to be ...
Breaking Medicine News(10 mins):Health News:Commission for Case Manager Certification Receives Re-Accreditation of its CCM® credential from the National Commission for Certifying Agencies (NCCA) 2Health News:Commission for Case Manager Certification Receives Re-Accreditation of its CCM® credential from the National Commission for Certifying Agencies (NCCA) 3Health News:Harbor Village Urges South Florida Residents to Abstain from the Use of E Cigarettes 2Health News:Harbor Village Urges South Florida Residents to Abstain from the Use of E Cigarettes 3Health News:Scott Campbell Agency and Nonprofit Stillwaters Cancer Support Services Initiate New Charity Campaign in Waukesha, WI to Provide Help for People Touched by Cancer 2Health News:Scott Campbell Agency and Nonprofit Stillwaters Cancer Support Services Initiate New Charity Campaign in Waukesha, WI to Provide Help for People Touched by Cancer 3Health News:Vast Bridges Continues Its Swift Growth 2Health News:21 Years & Counting: The USC Eye Institute Ranks in the Top 10 Ophthalmology Hospitals in America 2Health News:21 Years & Counting: The USC Eye Institute Ranks in the Top 10 Ophthalmology Hospitals in America 3
... -- Ernest Moore, an audiologist and cell biologist at Northwestern ... in his ears -- twenty years ago after serving in ... damaged by the crack of too many M16 rifles and ... opossum with rifles as a kid on his grandmother,s farm ...
... Saved and Healed by Registered Organ and Tissue ... of,organ and tissue donors joined organ transplant recipients ... thank lawmakers, the Department of Motor,Vehicles (DMV) and ... save,and heal lives by signing up on the ...
... M.D., editor-in-chief of the peer-reviewed medical journal, AIDS,Patient ... journal,s,publisher, Mary Ann Liebert, are calling upon Senator ... AIDS virus, which his pastor, Jeremiah Wright,said was ... wipe out people of,color. "It is not enough ...
... Perot Systems,Corporation (NYSE: PER ) ... received the #1 ranking in the KLAS ... implementation services(1). Known throughout,the Healthcare industry for ... informed technology decisions by independently,monitoring vendor performance ...
... basis may lower womens risk of a particular type ... Centrals open access journal Breast Cancer Research. In this ... reduction in estrogen receptor-positive breast cancers. However, unlike in ... found to reduce the total risk of breast cancer. ...
... kinds of cardiac cells , , WEDNESDAY, April 30 (HealthDay ... mouse skin cells reprogrammed to have the same unlimited ... the University of California, Los Angeles. , This ... stem (iPS) cells, which don,t involve the use of ...
Cached Medicine News:Health News:Zebrafish may help solve ringing in vets' ears 2Health News:Three Million Californians Say 'Yes!' to Organ and Tissue Donation 2Health News:Three Million Californians Say 'Yes!' to Organ and Tissue Donation 3Health News:OPEN LETTER: Medical Journal Calls Upon Barack Obama to Set the Record Straight on AIDS Virus 2Health News:Perot Systems Ranked #1 for Clinical Implementation Services By KLAS 2Health News:Perot Systems Ranked #1 for Clinical Implementation Services By KLAS 3Health News:Daily aspirin may reduce risk of common type of breast cancer 2Health News:Mouse Skin Cells Reprogrammed to Act Like Embryonic Stem Cells 2
(Date:7/29/2015)... DIEGO , July 29, 2015  ViaCyte, Inc., a privately-held ... for the treatment of diabetes in clinical trials, today announced the ... STEP ONE, or S afety, T olerability, and ... One Diabetes.  The new site, which is the first in ... Alberta Hospitals in Edmonton , Alberta.  ...
(Date:7/29/2015)... , July 29, 2015 ... Market Research " Active Pharmaceutical Ingredients (API) Market - ... 2014 - 2020 " the global active pharmaceutical ingredients ... and is anticipated to reach USD 185.9 billion by ... forecast period from 2014 to 2020. Full ...
(Date:7/29/2015)... 29, 2015   Decision Resources Group finds ... Europe will continue to be hindered in ... Eurozone. On a longer timeline, however, the outlook is ... active will increase the prevalence of osteoarthritic damage and ... orthopedic soft tissue solutions. Coupled with continuing economic recovery ...
Breaking Medicine Technology:ViaCyte Announces Second Clinical Trial Site at University of Alberta 2ViaCyte Announces Second Clinical Trial Site at University of Alberta 3ViaCyte Announces Second Clinical Trial Site at University of Alberta 4Active Pharmaceutical Ingredients Market Expected to Reach USD 185.9 Billion Globally in 2020: Transparency Market Research 2Active Pharmaceutical Ingredients Market Expected to Reach USD 185.9 Billion Globally in 2020: Transparency Market Research 3Active Pharmaceutical Ingredients Market Expected to Reach USD 185.9 Billion Globally in 2020: Transparency Market Research 4Active Pharmaceutical Ingredients Market Expected to Reach USD 185.9 Billion Globally in 2020: Transparency Market Research 5The Long-Term Outlook for European Sports Medicine Device Markets Remains Positive, with Economic Recovery and Expanding Patient Populations Supporting Growth Through 2023 2The Long-Term Outlook for European Sports Medicine Device Markets Remains Positive, with Economic Recovery and Expanding Patient Populations Supporting Growth Through 2023 3
... Jan. 3, 2011 Accuray Incorporated (Nasdaq: ... radiosurgery, announced today that it has been named to the ... companies. The NASDAQ Global Select Market is designated for public ... with measures including market value, liquidity and earnings. ...
... Dec. 31, 2010 On January 1, 2011, ... durable medical equipment and supplies in nine metropolitan ... Miami, Orlando, Pittsburgh, and Riverside, California.  This program ... the following equipment and related services and supplies: ...
Cached Medicine Technology:Accuray Elevated to NASDAQ Global Select Market 2Accuray Elevated to NASDAQ Global Select Market 3Complaints and Concerns about Medicare Competitive Bidding for Home Medical Equipment Can Be Reported Via a Toll-Free Number and Website 2Complaints and Concerns about Medicare Competitive Bidding for Home Medical Equipment Can Be Reported Via a Toll-Free Number and Website 3
Gynecomastia Vest...
Male Compression Vest Binder...
Ideal for breast compression and contouring breast cups....
Ideal for breast compression, adjustable hook and eye front closure with adjustable shoulder straps....
Medicine Products: