[e-farmacos] Se detiene un estudio sobre asma

[e-farmacos@usa.healthnet.org]

E-farmacos: Se detiene un estudio sobre asma
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[Esta nota de prensa de la FDA ha sido remitida a la
lista de discusion 'e-drugs'. Refiere al anuncio hecho
por la FDA sobre los datos de un analisis intermedio
de un ensayo clinico con xinafoato de salmeterol, que
revelan su posible asociacion con muerte por episodios
de asma. La incluimos en 'e-farmacos' por si es de
vuestro interes, AF]

FDA Press Release January 23, 2003

The Food and Drug Administration (FDA) today announced
that an interim analysis of a large safety study of
the approved asthma drug Serevent (salmeterol
xinafoate) Inhalation Aerosol suggests that the drug
may be associated with an increased risk of
life-threatening asthma episodes or asthma-related
deaths, particularly in some patients.

The interim analysis did not show a statistically
significant result for the primary endpoint - a
combination of respiratory-related deaths or
intubations (or ventilatory failure). There was a
trend, however, towards increases in asthma deaths and
serious asthma episodes when all patients in the study
were considered, though again this did not reach
statistical significance. A further analysis of the
data from the study suggested that the risk might be
greater in African-American patients. Also, further
analyses showed that patients not taking inhaled
corticosteroids at study entry appeared to have
greater risk for serious outcomes than those who were
taking inhaled corticosteroids.

This study was designed to further investigate the
safety of Serevent, particularly whether it might
rarely cause serious asthma-related adverse events. It
was begun in 1996, after FDA received post-marketing
reports of several asthma deaths associated with the
use of Serevent Inhalation Aerosol and following
publication of studies raising concern about the
regular use of short-acting and long-acting beta
agonists, including Serevent. Because asthma patients
can sometimes suffer sudden, serious life-threatening 
episodes of bronchospasm as a consequence of their
disease, the deaths and serious adverse events
reported for Serevent could neither be clearly
attributed to use of this product, nor could it be 
excluded as a cause. This study was undertaken to try
to help provide better information on the safety of
this product.

Today, the manufacturer of Serevent Inhalation
Aerosol, GlaxoSmithKline (GSK), notified investigators
that it is stopping this study, mostly due to
difficulties in enrollment and the likelihood the
study would not give a clear result, even if fully 
enrolled. The Glaxo Data Safety Monitoring Board
overseeing this trial conducted the interim data
analyses that led to today's action. Approximately
26,000 subjects, representing more than 4.3 million 
patient-days of exposure to the drug, had participated
in the study. The study was intended to enroll 60,000
patients. FDA routinely monitors adverse event reports
as part of its continuing efforts to reduce adverse
events. Drug safety and risk management are among FDA
Commissioner Dr. Mark B. McClellan's top priorities.

FDA approved Serevent Inhalation Aerosol in 1994 to
treat asthma, and later this approval was extended to
use for treatment of chronic obstructive pulmonary
disease (COPD). The drug belongs to the class 
of asthma medications known as beta2-receptor agonists
(commonly called beta agonists). The active drug in
Serevent, salmeterol, is also contained in the asthma
drugs Serevent Diskus and Advair Diskus, also
manufactured by Glaxo.

FDA plans to meet with Glaxo shortly to obtain more
details about the data from the interim analyses of
the study and to determine what steps are warranted to
address this important new risk information. FDA is
particularly interested in further evaluating the
question of whether certain patients may be at a
greater risk for rare, but potentially serious adverse
events due to Serevent use and use of other related
drugs.

FDA emphasizes that based on available data, the
benefits of Serevent for the asthma population
continue to outweigh the risks and that the serious
adverse events reported in the trial were rare. FDA
strongly advises patients that they should NOT stop
taking Serevent, or any other medication, for asthma
or COPD, without first talking to their physicians.
Abruptly stopping drugs for the treatment of asthma
and COPD can result in serious exacerbations of these
diseases that could be life-threatening. FDA further
emphasizes that all asthma drugs, including Serevent,
should be a given as a part of a comprehensive 
treatment plan that takes into account the patient's
asthma severity and fully educates the patient in the
disease and its proper treatment.

An estimated 16 million patients in the U.S. now have
asthma, and the number of asthmatics has increased
significantly in the recent decades. In addition to
the beta2-receptor family of medications, other drugs
approved for asthma include leukotriene blockers,
inhaled corticosteroids and theophylline.



[NOTA: Mensaje sin acentos ni caracteres especiales.]
























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