A class of commonly prescribed asthma drugs may
actually cause severe asthma attacks and even
death, doctors have said.
Experts in respiratory care have called on the
Europes drug watchdog, the European Medicines
Agency, to warn patients of the dangers of long-acting
beta-agonist (LABA) drugs, which are used to treat
the more severe forms of asthma.
Writing in an editorial in the Journal of the
Royal Society of Medicine, Vassilis Vassiliou,
of the University of Cambridge, said that the drugs,
which include Serevent, salmeterol and formoterol,
should not be used on their own, and were safe only
when used in conjunction with a steroid inhaler.
However, he said that more and more people were
using them as a single treatment.
Asthma affects more than five million people
in Britain and is responsible for about 70,000
hospital admissions and 1,400 deaths a year.
Dr Vassiliou said: We are seeing an increasingly
worrying trend where chronic asthma sufferers,
mainly children, are being treated solely by LABA
drugs.
LABA on its own is not safe and this monotherapy
is neither supported by current evidence nor encouraged
by the current British Thoracic Society guidelines.
Serevent, which is the GlaxoSmithKline brand
form of salmeterol, is recommended for severe
forms of the disease because its effects are long-
lasting and can be taken twice a day. When inhaled,
both it and formoterol help to relax the muscles
around the airways of the lungs, which when tight
cause wheezing. Neither drug should be used for
sudden asthma attacks.
Dr Vassiliou, who also works at Addenbrookes
Hospital, and Christos Zipitis, of Burnley General
Hospital, studied the results of GlaxoSmithKlines
Salmeterol Multicentre Asthma Research Trial,
which looked at salmeterols effect on more
than 26,000 asthma sufferers.
The trial was halted in 2003 after interim results
showed that there were more respiratory-related
deaths among patients on salmeterol than those
using a placebo.
Last year the US Food and Drug Administration
gave a warning that LABA drugs may be linked with
asthma-related deaths and serious asthma attacks,
and told drug companies to inform doctors and
patients about the possible risks.
It is crucial the European Medicines Agency
follow (this lead), Dr Vassiliou said. While
there is provision in the British Thoracic Society
guidelines for LABA drugs to be discontinued if
they are not deemed useful after a trial period,
this is not being reinforced.
It is critical that current evidence on
asthma drugs is incorporated in clinical practice.
However, other asthma experts disagree, pointing
out that the LABA concerns are based on a single
study and that repeated warnings gave the impression
there was a growing body of evidence against the
drugs.
Martyn Partridge, the chief medical adviser at
Asthma UK, said that the drugs were of benefit
to most people and that any possible risk highlighted
might be because of genetic or racial differences
between users. However, he said that use of salmeterol
on its own without a steroid inhaler such
as Becotide should be avoided.
Such multiple reanalyses of already published
data gives the impression of multiple new studies
all showing the same thing, which is not actually
what is happening but this is certainly
a situation where we must watch this space,
Professor Partridge said.