EMBARGOED UNTIL 00:01 HRS GMT THURSDAY 27 JULY 2006
Doctors warn on asthma drugs
Doctors are calling on the European Medicines Agency to warn against a class of leading asthma drugs following the emergence of new evidence which shows they have the potential to increase severe asthma episodes and deaths.
Writing in the Journal of the Royal Society of Medicine, Drs Vassiliou1 and Zipitis2 argue that the current role of long acting beta-agonist drugs, which are known as LABA3 and include salmeterol and formoterol, should be reviewed. In addition they argue that LABA should not be used on their own.
Salmeterol and formoterol are commonly prescribed in the treatment of asthma.
"We are seeing an increasingly worrying trend where chronic asthma suffers, mainly children, are being treated solely by LABA drugs” said Dr Vassilis Vassiliou.
"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 [BTS]."
In the UK, asthma affects more than 5 million people, leads to around 70,000 hospital admissions and causes 1,400 deaths each year. Usually prescribed for sufferers with severe forms of the disease, salmeterol is appealing because its effects are long-lasting and allows for twice daily administration.
Drs Vassiliou and Christos Zipitis examined the results of the Salmeterol Multicenter Asthma Research Trial (SMART) undertaken by GlaxoSmithKline which compared the addition of salmeterol or placebo to existing asthma medication amongst 26, 355 patients.
SMART was halted in 2003 following interim analysis that showed there were more overall respiratory-related deaths (24 versus 11) and asthma-related deaths (13 versus 3) amongst patients on salmeterol.
"The US Food and Drug Administration warned in July last year that salmeterol may be associated with rare serious asthma episodes or asthma-related deaths and it is crucial the European Medicines Agency follow," said Dr Vassilis Vassiliou.
"While there is provision in the BTS 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," he said.
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Long-acting broncho-dilators:time for a re-think [PDF 46k]
'Long-acting bronchodilators: time for a re-think' is published in the August 2006 (Vol. 99) of the Journal of the Royal Society of Medicine>.
JRSM is the flagship journal of the Royal Society of Medicine. It has been published continuously since 1809. Its Editor is Dr Kamran Abbasi. www.jrsm.org.
1 University of Cambridge and Department of Medicine, Addenbrooke’s Hospital, Cambridge
2 Department of Paediatrics, Burley General Hospital, Burley
3 Long-acting beta-adrenoceptor agonists
