Navigation Links
GlaxoSmithKline Responds to JAMA Article on the ICES Thiazolidinediones and Cardiovascular Outcomes in Older Patients with Diabetes
Date:12/11/2007

ater than 70 years of age, and demonstrated the safety profile of rosiglitazone to be consistent with the control medicine (sulfonylurea).

Importantly, the results of this study do not reproduce what is already known about the risk of CHF in TZD users. TZDs can cause fluid retention which can lead to or exacerbate heart failure. TZDs also have a similar increased risk of CHF. Yet, in this analysis, pioglitazone is not associated with an increased risk of CHF (Adjusted RR of 0.91 (95% CI = 0.52-1.59) whereas rosiglitazone is associated with 2 fold-increased risk of CHF (Adjusted RR = 1.98 and 95% CI=1.44-2.72) compared to oral anti-diabetic combination therapy. This is inconsistent with the product labeling.

Moreover, the authors of this retrospective analysis fail to acknowledge the findings of large epidemiological studies, encompassing over 1.3 million patients with type 2 diabetes, as well as other similar studies presented during the recent FDA Advisory Committee meeting. These studies have investigated whether use of rosiglitazone in the real world setting is associated with an increase in myocardial infarction or coronary revascularization. The majority of these studies show that rosiglitazone is not associated with an increased risk of myocardial infarction compared to other anti-diabetic agents.

GSK cites the following as examples of the limitations of this retrospective analysis:

-- As the authors state, patients on TZDs in their analysis may represent

an older, select group of patients with advanced diabetes and therefore

higher baseline risk for cardiovascular disease.

-- The ODB database is composed of a select group of patients.

Rosiglitazone is only prescribed for those patients who fail

treatment on metformin and sulfonylurea, or for whom sulfonylurea or

metformin are contraindicated. The rosiglitazone patients are

therefore ones with higher
'/>"/>

SOURCE GlaxoSmithKline
Copyright©2007 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4 5

Related biology technology :

1. GlaxoSmithKline Recognizes University of Michigans Dr. Daniel F. Hayes as the First Recipient of the Gianni Bonadonna Breast Cancer Award
2. AUDIO from Medialink and GlaxoSmithKline: Fiber Key in Managing Irritable Bowel Syndrome (IBS) Symptoms
3. Exelixis Submits XL880 Diligence Report to GlaxoSmithKline
4. GlaxoSmithKline Awarded U.S. Department of Defense Contract to Pursue Novel Antibacterial Research Program
5. GlaxoSmithKline and Anacor Pharmaceuticals Form Alliance to Develop Systemic Antivirals and Antibiotics Based on Boron Chemistry
6. BioWa Announces Licensing of BioWas POTELLIGENT(R) Technology by GlaxoSmithkline for Use in Antibody Research and Development
7. GlaxoSmithKline Consumer Healthcare Recommends Maintaining FDAS Current Two-Class Drug System
8. ImmuneRegen Responds to Defense Threat Reduction Agency Request for Information
9. Updated Drug Development Scrip Report Responds to the Pharma Industrys Major Changes
10. Michigan Catholic Conference Responds to Formation of Embryonic Stem Cell Research Ballot Committee
11. Anesiva Grants Specific-Use License of Its Needle-Free Drug Delivery Technology to Particle Therapeutics for Diabetes Drug
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/20/2013)... May 20, 2013 Cempra, Inc. (Nasdaq: ... differentiated antibiotics to meet critical medical needs in ... it presented data at the American Thoracic Society ... demonstrating the antibacterial and enhanced immunomodulatory ... Phase 2 clinical trial in outpatients with community ...
(Date:5/20/2013)... May 20, 2013 Researchers from the ... connection between lower back pain, and the acne causing P.acnes ... the system the bacteria seek out oxygen deprived location to ... the spinal column, P.acnes has the ability to live in ... Fernando Perez, a spokesman for “ The best acne treatment ...
(Date:5/20/2013)... May 20, 2013 In Early 2013, ... field of biotoxin related illnesses , announced his vision ... able to advance his protocol for treating Chronic Inflammatory ... the third physician to achieve certification in the Shoemaker ... able to practice the Shoemaker Protocol in other parts ...
(Date:5/17/2013)... Topricin Pain Relief and Healing Cream, ... among nationally recommended over-the-counter (OTC) health products 2012 ... News" Health in collaboration with "Pharmacy Times." ... Pharmacists Recommended designation” in the “Topical Analgesics” category, ... is the only homeopathic formula to earn that ...
Breaking Biology Technology:Cempra Presents Post-Phase 2 Analysis of Solithromycin's Efficacy and Safety Results from Patients with Community Acquired Bacterial Pneumonia (CABP) 2Adult Acne Treatment, Probiotic Action Shares New Insight How Treating Acne May Help Reduce Body Pain 2Dr. Ritchie Shoemaker Certifies Third Physician in His Treatment Protocol for Chronic Inflammatory Response Syndrome (CIRS) 2Pharmacists' Picks: Topical BioMedics' Topricin Listed on Top Recommended OTC Health Products 2
... 11 Schering-Plough,Corporation (NYSE: SGP ) today announced ... of a New Drug Application (NDA) for ZEGERID(R),(omeprazole/sodium bicarbonate) ... a branded over-the-counter (OTC) product to treat frequent,heartburn., ... license agreement with,Santarus, Inc. of San Diego, Calif., which ...
... analysis affordable and accessible to all researchers, ... today that Harvard Medical School and the University ... Program. Each University,purchased access to whole genome human ... Consortium and distributed by Open Biosystems., (Logo: ...
... China,Bionanometer Industries Corporation (Pink Sheets: CBIU), a ... signed an agreement to,establish long-term strategic cooperative ... Guangzhou LGLY Advertising LTD is China,s top ... and is well-known for its core senior ...
Cached Biology Technology:Schering-Plough Announces Filing of U.S. Application for OTC ZEGERID(R) 2Schering-Plough Announces Filing of U.S. Application for OTC ZEGERID(R) 3Open Biosystems' Open Access RNAi Program Adopted by Harvard Medical School and University of North Carolina 2CBIU Signs Agreement with LGLY Advertising LTD 2
(Date:5/17/2013)... the white noise of the South, but the night belongs ... air hangs heavy from the humidity and the sounds of ... species of frogs, toads and salamanders, is the center of ... swamps are the auditorium for their symphonic choruses, the scientists ... or ARMI, have front-row seats. , Amphibians, which ...
(Date:5/17/2013)... The iCargo project (Intelligent Cargo in Efficient and Sustainable ... thanks to an improvement in the efficiency of intermodal ... assist decision making. It comprises 29 European organisations with ... management. It has a budget totalling 17,000,000 and a ... is working to specify and develop the semantic components ...
(Date:5/16/2013)... Access to Research Careers) Program has announced the ... 95th Annual Meeting in San Francisco, CA from ... promote the entry of students, postdoctorates and scientists ... basic science community and to encourage the participation ... Meeting. , Awards are given to poster/platform presenters ...
Breaking Biology News(10 mins):Front-row seats to climate change 2Front-row seats to climate change 3Front-row seats to climate change 4New logistics services that will cut energy consumption and CO2 emissions 2
... An interactive web tool has been developed to improve the ... information. The new ,Geo-Wiki, uses Google Earth and information ... ,data gaps, and to verify existing land cover information. Developers ... of the tool and to encourage community involvement in environmental ...
... Neuro Kinetics, Inc. (NKI) ( www.neuro-kinetics.com ), manufacturers ... for neurophysiologic/ neurotologic testing, said today that it is ... Sessions in Washington D.C. on February 28, 2012. ... program funded by the NIH in cooperation with the ...
... Researchers studying why arteries stiffen in postmenopausal women ... vascular function. Kerrie Moreau, Ph.D., Associate Professor ... Medicine, discovered that BH4 or tetrahydrobiopterin plays a key ... a critical cofactor of the enzyme endothelial nitric oxide ...
Cached Biology News:New web tool to improve accuracy of global land cover maps 2New web tool to improve accuracy of global land cover maps 3New web tool to improve accuracy of global land cover maps 4Neuro Kinetics Invited to Present at NIH Forum for Investors and Strategic Partners 2Critical element that improves vascular function in postmenopausal women found 2
Mouse monoclonal [IA-C6] to MHC Class II I Ab + Ad (FITC) ( Abpromise for all tested applications). Antigen: Tissue / cell preparation of Purified Mouse lymph node B cells...
BD BioCoat Vented Caps for 175 cm2 Flasks...
BD BioCoat Poly-D-Lysine 60 mm Culture Dishes, tissue-culture treated polystyrene with a uniform application of poly-D-lysine....
BD Falcon Center-well 60 mm In Vitro Fertilization (IVF) Dish, nonembryotoxic, noncytotoxic, tissue-culture treated polystyrene. (20/sp, 500/ca) Packaging: 20 / sleeve, 500 / case ...
Biology Products: