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GLG News by Pulmonologists (US)

Robert Aris, MD, Associate Professor of Medicine
Robert Aris, MD, Associate Professor of Medicine
University of North Carolina Chapel Hill - CC
Analysis of: Ambrisentan for the Treatment of Pulmonary Arterial Hypertension (circ.ahajournals.org)
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...
Mark Vandewalker, MD, Allergy Specialist and Partner
Allergy & Asthma Consultants Of The Ozarks Ltd
Analysis of: Investigational Anti-IgE Antibody Promising as Extracorporeal Allergy Therapy (www.medscape.com)
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...
Analysis of: Metabolic Syndrome Not Useful in Predicting Cardiovascular Risk (www.medpagetoday.com)
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...
Analysis of: New data show Tekturna HCT® is twice as effective at reducing blood pressure than the diuretic HCT alone (www.novartis.com)
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...
Analysis of: New data show Tekturna HCT® is twice as effective at reducing blood pressure than the diuretic HCT alone (www.novartis.com)
 Study will be ridiculed.   1) Comparator drug is not appropriate. 2) Not an outcomes study. 3) Time frame too short to be clinically significant. 4) Drug too expensive for first line use. 5) Long term safety not established.
Analysis of: Warning over drug trial’s effects on testing (www.ft.com)
IMS, a publically traded healthcare consutancy has concerns about the CATT study, funded by the National Eye Institute. Given their award winning reputation, one might worry that IMS has uncovered a real problem. Think again. 1. Among IMS' main customers are those who seek pharmaceutical intelligence...
Analysis of: FDA investigates suicide with Merck drug (www.physorg.com)
The FDA is investigating Merck's Singulair for a possible link to suicidal thought and action.  With over 28 million prescriptions last year and a 12 year record of safety in children and adults, the evidence must be evaluated closely before coming to any conclusion. Of note antihistamines, including...
David Engler, MD, Physician
David Engler, MD, Physician
The Allergy Clinic
Analysis of: New antihistamine gets FDA green light.(RX CARE)(Levocetirizine (Xyzal) by UCB Inc. and Sanofi-Aventis ) (www.therapeuticsdaily.com)
 A bottle of 30 Generic Zyrtec can be purchased for $15.  No one is going to get Xyzal that inexpensively. There are no head to head studies showing Xyzal to be better than Zyrtec.  Even though Xyzal claims a 6% sedation rate compared to Zyrtec's 14% rate, it's not apples to apples. ...
David Engler, MD, Physician
David Engler, MD, Physician
The Allergy Clinic
Analysis of: FDA Approves ASMANEX (R) TWISTHALER(R) (Mometasone Furoate Inhalation Powder) for the Once Daily Maintenance Treatment of Asthma in Children Ages 4-11 (www.pipelinereview.com)
Use of Asmanex will continue to increase with this approval down to age 4. Its dose counter tells you exactly how many doses are left in the device.  Pulmicort uses a system that counts down 120---90---60---30---0. A lot of patients on Pulmicort complain to me about this "approximate" dose...
David Engler, MD, Physician
David Engler, MD, Physician
The Allergy Clinic
Analysis of: FDA Investigating Possible Link Between Singulair and Suicide (www.foxnews.com)
It is difficult to imagine why taking Singulair would increase the risk that someone would complete suicide.  After all, what does a leukotriene receptor antagonist have to do with mental health?  I don't know. But doctors, ask yourself, have you ever had a Singulair patient stop taking it...

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