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GLG News by Physicians who Treat Asthma (US)

December 17, 2008
LABA and the FDA
Analysis of: FDA: Long-Acting Asthma Drugs Increase Asthma Risks (online.wsj.com)
The FDA is considering removing single drug long acting Beta Agonist from the market. They believe they have the potential to cause harm. They are considering removing component therapy drugs that contain long acting Beta agonist like Symbicort and Advair also. This would lead to a major problem for...
December 16, 2008
Remember the frying pan?
Analysis of: Scientists back brain drugs for healthy people (www.washingtonpost.com)
This is an abuse of medication - what we don't need
December 15, 2008
Asthma - will this help??
Analysis of: FDA: Long-Acting Asthma Drugs Increase Asthma Risks (online.wsj.com)
Ruling not unreasonable, but may cause confusion to patients.
December 11, 2008
LABA daba done?
Analysis of: FDA: Long-Acting Asthma Drugs Increase Asthma Risks (online.wsj.com)
Some information of note, the current FDA briefing document (http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4398b1-00-index.htm) is a publication entirely created by GSK,  Novartis, and AstraZeneca and not an independently created FDA review.  It merely is a summary of trials data already...
Mark Vandewalker, MD, Allergy Specialist and Partner
Allergy & Asthma Consultants Of The Ozarks Ltd
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...
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...
Analysis of: COPD Medicines: Risky or Safe? (www.webmd.com)
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...
August 27, 2008
A rough in the diamond
Analysis of: FDA Alert: Hemorrhagic or Necrotizing Pancreatitis in Patients Taking Byetta (www.fda.gov)
If truly an association, this will alter the use of this drug.
Analysis of: AstraZeneca and Bristol-Myers Squibb Submit New Drug Application in the United States and Marketing Authorisation Application in Europe for ONGLYZA™ (Saxagliptin) for the Treatment of Type 2 Diabetes (www.astrazeneca.com)
DDP4 inhibitor class fairly new.  Another arrow in the theraputic quiver

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