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GLG News by Pulmonologists (US)

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Robert ArisNovember 18, 2008
Oral Treprostinil: An effective medicine hiding in a study with a challenging design?
Analysis of: Freedom-C Trial of Oral Treprostinil in Pulmonary Arterial Hypertension Fails to Meet Primary Endpoint | ir.unither.com
Author: Robert Aris, Associate Professor of Medicine, University of North Carolina Chapel Hill - CC
This phase III study was done without the benefit of conventional drug development with Phase I and Phase II studies (which would have provided more information about the effective dose) preceding it because pharmacokinetic date from IV and SC dosing studies were used to extrapolate for the...
October 2, 2008
COPD Drugs - Some safer than others
Analysis of: COPD Medicines: Risky or Safe? | www.webmd.com
Author: GLG Expert Contributor
In a recent article it is noted that for users of Ipatropium bromide there was an increase in all death and cardiac death in the group studied.  Theoretically at doses normally used there is not much of a corresponding mechanistic risk.  Therefore at this time additional study must be done...
Robert ArisJuly 18, 2008
Mild PAH improved by early treatment with bosentan
Analysis of: Treatment of patients with mildly symptomatic pulmonary arterial hypertension with bosentan (EARLY study): a double-blind, randomised controlled trial. | www.sciencedirect.com
Author: Robert Aris, Associate Professor of Medicine, University of North Carolina Chapel Hill - CC
While functional class II (FC II) PAH patients have been included in previous clinical trials, the EARLY trial is the first study to concentrate (ie recruit exclusively) FC II PAH patients.  This is important because the definition of functional class II is that a patient has a sight...
David EnglerJuly 2, 2008
They'll fix this before the end of the month
Analysis of: Medicare fees to doctors fall Tuesday | news.yahoo.com
Author: David Engler, Physician, The Allergy Clinic
If this isn't fixed, it won't be long before cognitive specialties, like internal medicine and neurology, start capping their practices and not allowing new Medicare patients.    
David EnglerJuly 2, 2008
This may have a market after all
Analysis of: Taro Receives Final FDA Approval For RX Cetirizine Hydrochloride Syrup ANDA | www.medicalnewstoday.com
Author: David Engler, Physician, The Allergy Clinic
Here comes a prescription version of generic Zyrtec syrup.  At first glance, we wonder how it will compete with over the counter Zyrtec.  But wait...there may be a market for this drug    
David EnglerJune 18, 2008
Next-Generation Xolair (omalizumab) sounds pretty good
Analysis of: Investigational Anti-IgE Antibody Promising as Extracorporeal Allergy Therapy | www.medscape.com
Author: David Engler, Physician, The Allergy Clinic
This drug seems much more effective at reducing free-IgE levels than is Xolair.  Overall, Xolair has given many patients a tremendous improvement in their quality of life, but it hasn't fulfilled many of its promises. Frankly, some of Xolair's benefits are disappointing, particularly in the 40...
Robert ArisJune 10, 2008
Peer reviewed literature on Ambrisentan, a selective ETRA for PAH
Analysis of: Ambrisentan for the Treatment of Pulmonary Arterial Hypertension | circ.ahajournals.org
Author: Robert Aris, Associate Professor of Medicine, University of North Carolina Chapel Hill - CC
This Circulation paper is the first peer reviewed data on the 2 pivotal Phase III trials on ambrisentan that lead the FDA to approving it for the treatment of PAH in July 2007. This paper is critically important since all new research needs to withstand the rigor of peer-review for...
June 10, 2008
Will Xolair Become Obsolete in the Treatment of Allergies?
Analysis of: Investigational Anti-IgE Antibody Promising as Extracorporeal Allergy Therapy | www.medscape.com
Author: Mark Vandewalker, Allergy Specialist and Partner, Allergy & Asthma Consultants Of The Ozarks Ltd
This recent report characterizes a newly discovered anti-IgE monoclonal antibody (mAb12) which appears dramatically more potent than omalizumab (Xolair) in its ability to reduce systemic IgE levels. If further studies confirm this enhanced reduction of IgE and IgE-bearing cells, mAb12 has significant...
May 30, 2008
Data is Not Information
Analysis of: Metabolic Syndrome Not Useful in Predicting Cardiovascular Risk | www.medpagetoday.com
Author: GLG Expert Contributor
The PROSPER Trial is important because it is not.There are many ways to diagnose the Metabolic Syndrome offered by "Expert Consensus", and that is the red flag to make the disticntion between data and information. Information is actionable, data is just that- data, and must be interpreted. Researchers...
May 19, 2008
A Diamond in the Rough
Analysis of: New data show Tekturna HCT® is twice as effective at reducing blood pressure than the diuretic HCT alone | www.novartis.com
Author: GLG Expert Contributor
Since its launch those involved in the treatment of hypertension have been hoping for more data on the effectiveness of Tekturna. Results of this study add evidence that the product is just beginning to solidly position itself in the antihyptertensive armamentarium, and is therefore encouraging. But...

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