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GLG News by Physicians who Treat Cystic Fibrosis (US)

Analysis of: The Minimal Impact of a Big Hypertension Study (www.nytimes.com)
I agree with the premise of the article -- that diuretics may be underutilized as a cheap way to get the benefits of antihypertensives. However, more than 40% of my HTN patients are on diuretics, and I think the data presented in the NY Times article may be flawed. Here's why:
Robert Aris, MD, Associate Professor of Medicine
Robert Aris, MD, Associate Professor of Medicine
University of North Carolina Chapel Hill - CC
Analysis of: Freedom-C Trial of Oral Treprostinil in Pulmonary Arterial Hypertension Fails to Meet Primary Endpoint (ir.unither.com)
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...
Robert Aris, MD, Associate Professor of Medicine
Robert Aris, MD, Associate Professor of Medicine
University of North Carolina Chapel Hill - CC
Analysis of: Treatment of patients with mildly symptomatic pulmonary arterial hypertension with bosentan (EARLY study): a double-blind, randomised controlled trial. (www.sciencedirect.com)
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 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...
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.
January 18, 2008
I couldn't agree more
Analysis of: WellPoint patients to review doctors online (www.healthcarefinancenews.com)
Insurance company data is primitive and flawed. Any entity that can manage this data well in the future will be extremely profitable.
Analysis of: Critical Therapeutics Initiates Phase II Clinical Trial for Zileuton Injection (www.pipelinereview.com)
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...
Warren Botnick, MD, President
PSS Clinical Research
Analysis of: Newly Discovered Fatty Acids May Lead To Novel Treatments For COPD And Asthma (www.medicalnewstoday.com)
Eicosanoids appear promising in the treatment of such airways diseases as COPD and asthma, which affect millions worldwide.  Any alternative to current anti-inflammatory therapy, which consists almost entirely of forms of corticosteroids, would almost certainly be welcomed and adopted in widespread...
Warren Botnick, MD, President
PSS Clinical Research
Analysis of: Basilea Announces Positive Top-line Data from Phase III Study of Ceftobiprole in Community-acquired Pneumonia Requiring Hospitalization (www.pipelinereview.com)
Cephalosporins have been standard therapy for pneumonia for many years, but to date this class of drug has been ineffective against MRSA.  Ceftobiprole appears to represent a breakthrough in this regard.  I would expect the drug to be well tolerated and, for the most part, to cause few major...
Warren Botnick, MD, President
PSS Clinical Research
Analysis of: GlaxoSmithKline and Sepracor Inc. announce international alliance for commercilisation of Lunivia (www.pipelinereview.com)
Though the potential international market for eszopiclone is large, interest in the product among sleep specialists in the US has leveled off.  Its success internationally may well depend more on distancing the product from other agents such as the Ambien "family," a decidedly difficult task, and...

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