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GLG News by Critical Care Physicians (US)

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August 4, 2008
Cure is a strong word
Analysis of: Amgen Told to Reword Drug Label | www.nytimes.com
Author: GLG Expert Contributor
It is important to remember that there are many more "treatable" cancers diagnosed than curable cancers. The initiation of chemotherapy after surgical removal of a neoplasm is a signal that there may be undetectable metastatic disease.  You are therefore hoping for a cure but accepting the reality....
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...
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...
April 2, 2008
Singulair suicide story won't kill Merck
Analysis of: FDA Investigating Possible Link Between Singulair and Suicide | www.foxnews.com
Author: Michael Wechsler, Associate Physician in Pulmonary and Critical Care, BRIGHAM AND WOMEN'S HOSPITAL
Singulair helps millions of people suffering from asthma. While there are a few sporadic cases of suicide and depression among the millions of patients taking singulair, no causal link has been established and there is no clear mechanism of how singulair might even cause such effects.  In fact,...
October 8, 2007
Use of injectable zileuton may not be a panacea for asthma
Analysis of: Critical Therapeutics Initiates Phase II Clinical Trial for Zileuton Injection | www.pipelinereview.com
Author: GLG Expert Contributor
Several questions arise about injectable Zileuton.  Inhaled steroids still remain the mainstay of theray for asthma.  Will patients accept the use of an injectable drug for asthma - if it results in infrequent dosing, it may be an acceptable option for patients.  Liver function tests...
October 8, 2007
IV ZYFLO- GREAT POTENTIAL IN ER, BUT WILL THEY MARKET IT WELL?
Analysis of: Critical Therapeutics Initiates Phase II Clinical Trial for Zileuton Injection | www.pipelinereview.com
Author: Michael Wechsler, Associate Physician in Pulmonary and Critical Care, BRIGHAM AND WOMEN'S HOSPITAL
Zyflo is a great drug in its oral fornmaulation with goiod efficacy but has failed because one has to take it multiple times a day and because one has to monitor liver function. This new IV formulation should be as effective in the ER setting, but hurdles include poor drug marketing by Critical Therapeuitcs...
September 7, 2007
Erythropoietin Fails to Reduce Transfusion Needs in Critically Ill Patients
Analysis of: J&J Ends Plan to Seek Wider Procrit Use | online.wsj.com
Author: GLG Expert Contributor
This study, published this week in The New England Journal of Medicine, randomized 1,460 critically ill patients to receive erythropoietin (Epo) or placebo.  Although patients receiving Epo did achieve a statistically greater rise in hemoglobin at the end of the study period, but surprisingly...
September 5, 2007
The Vast Potential for High Energy Ultrasound
Analysis of: Star Trek Medical Device Uses Ultrasound To Seal Punctured Lungs | www.medicalnewstoday.com
Author: GLG Expert Contributor
This article suggests a novel therapeutic use for ultrasonography, which may have implications for both acute and chronic disease management.  The study showed that high-energy ultrasound may be used to effectively seal an injured and leaking lung, similar to previous demonstrations of its...
September 3, 2007
Asthmatics respond
Analysis of: Oral Allergy Syndrome Made Worse By Ragweed, Fruits And Vegetables | www.medicalnewstoday.com
Author: GLG Expert Contributor
Ragweed, august september asthma worsen allergies worsen
August 28, 2007
FDA Review of Proton Pump Inhibitors (PPI's)
Analysis of: Survey: Did the FDA Jump the Gun on PPIs? | www.medpagetoday.com
Author: GLG Expert Contributor
The frequency of proton pump inhibitors (PPI) prescriptions make FDA review an important step in the long-term assessments of their risk-benefit profile.  It is important to recognize that the FDA did not change the prescribing indications or even issue a warning to physicians about the use of...

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