The Pharmaceutical Journal
Vol 277 No 7412 p155
5 August 2006

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Doctors want warning on long-acting beta₂ agonists

Two doctors are calling on the European Medicines Agency (EMEA) to issue a warning about the potential dangers of long-acting beta₂ agonists — salmeterol and formoterol — for the treatment of asthma.

In an editorial published in the Journal of the Royal Society of Medicine (2006;99:382), Vassilis Vassiliou of the University of Cambridge and department of medicine, Addenbrooke’s Hospital, Cambridge, and Christos Zipitis, of the department of paediatrics, Burnley General Hospital, Burnley, argue that the current role of long-acting beta₂ agonists should be reviewed. The US Food and Drug Administration called for strengthened warnings for these drugs last year after results from the salmeterol multicentre asthma research trial (SMART) became known.

SMART compared the addition of salmeterol or placebo to existing asthma therapy in 26,355 patients and was stopped early after results revealed that there were more respiratory-related deaths (24 versus 11) and asthma-related deaths (13 versus three) in the salmeterol group than in the placebo group.

Shortly after the FDA warning, the Medicines and Healthcare products Regulatory Agency issued a reminder that patients treated with salmeterol or formoterol should always be prescribed an inhaled corticosteroid, along with other prescribing advice (PJ, 26 November 2005, p654).

The doctors say that in their personal experience there is a worrying increase in the number of asthma patients referred to clinics on long-acting beta₂ agonist monotherapy — a practice which, they say, needs to be abandoned.

The doctors also believe that provisions in the British Thoracic Society guidelines for long-acting beta₂ agonists to be discontinued if no benefit is seen after a trial period should be reinforced. In addition, they say that step 3 of the BTS guidelines should be revised so that long-acting beta₂ agonists are only tried after other therapy has failed.

Anna Murphy, consultant respiratory pharmacist at Glenfield Hospital in Leicester, told The Journal: “The report of adverse effects with long-acting beta₂ agonists is not a new concept. A post-marketing surveillance study showed that the incidence of respiratory and asthma-related death was numerically, though not significantly, greater in patients treated with salmeterol versus salbutamol when added to usual asthma therapy. However, the SMART study is important in reminding prescribers that patients given salmeterol or formoterol should always be prescribed an inhaled corticosteroid, as per the joint BTS/Scottish Intercollegiate Guidelines Network guidelines.”

She added that patients with acutely deteriorating asthma should not be initiated on long-acting beta₂ agonists and that any patient should be monitored closely during the first three months of treatment.

“Pharmacists involved in the management of patients with asthma should ensure that these prescribing points are followed. They also need to be aware of this study since patients may ask questions about their asthma treatments.

“UK patients can be reassured that the SMART study does not mirror UK practice; it was designed in the 1990s in America where it was not common practice to prescribe an inhaled corticosteroid. Most patients in the UK are prescribed a steroid inhaler for their asthma,” Ms Murphy said.