Study Group: Pulmonologists (US)

GLG News^SM Analyses by this Study Group's Leading Experts(?)

FDA Poised to Damage Asthma Pharmacotherapy Advances

December 10, 2008

Analysis by:Mark Vandewalker, Allergy Specialist and Partner,

Analysis of:FDA: Long-Acting Asthma Drugs Increase Asthma Risks | online.wsj.com

The use of long-acting beta-agonists (LABAs) in the treatment of persistent asthma has become one of the most controversial issues of respiratory disease management during this decade. Both salmeterol and formoterol have been shown in numerous clinical trials of asthma to dramatically improve pulmonary function, symptoms scores, and need for rescue medication. However, some long-term safety studies have demonstrated increased risk of severe asthma exacerbations when these LABAs are used as monotherapy without concomitant inhaled steroid therapy. Based on this data, the FDA is considering the withdrawal of LABAs from the US market. I anticipate the FDA will come to their senses and appreciate the significant benefit that combination LABA/ICS therapy has in the vast majority of moderate and severe asthmatics for whom they are appropriately prescribed. In my opinion, cessation of LABA therapy for asthma would return us to asthma mortality rates not seen since the 1990s.     

Oral Treprostinil: An effective medicine hiding in a study with a challenging design?

November 18, 2008

Analysis by:Robert Aris, Associate Professor of Medicine,

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 oral dosing. While in hindsight, this may have not been ideal, the trial holds a lot of promise that treprostinil will be effective since there was a nice dose-response curve and the higher doses clearly appeared to be effective. Oral Treprostinil is probably very similar to subcutaneous and intravenous prostanoids (remodulin and flolan) that require a slow uptitration of dose to allow the patient to become tolerant to the side effects. Thus having smaller doses for titration, which were available later in the trial, probably would have allowed for greater success had these doses been available earlier in the study.

Mild PAH improved by early treatment with bosentan

July 18, 2008

Analysis by:Robert Aris, Associate Professor of Medicine,

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 limitation in physical activity. Understanding "slight" is not so easy in clinical practice and there has been some reservation in treating "slightly" ill patients with very expensive drugs without better outcome studies in this target group. Thus the results of the EARLY study (Lancet June 2008) are welcome news to the PAH community.  Analyses were done with 168 patients and showed significant improvements in pulmonary vascular resistance and a strong trend (p = 0.075) toward improvement in 6 minute walk distance in bosentan-treated patients.  These results will certainly compell clinicians to treat patients with "slight" PAH more aggressively.

They'll fix this before the end of the month

July 2, 2008

Analysis by:David Engler, Physician,

Analysis of:Medicare fees to doctors fall Tuesday | news.yahoo.com

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.    

This may have a market after all

July 2, 2008

Analysis by:David Engler, Physician,

Analysis of:Taro Receives Final FDA Approval For RX Cetirizine Hydrochloride Syrup ANDA | www.medicalnewstoday.com

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    

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