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Inhaled steroids 'increase pneumonia risk', major trial suggests

By Nigel Praities

A major new analysis has thrown serious doubt on the routine use of inhaled steroids in patients with COPD after finding little benefit but a jump in the risk of pneumonia.

The study – which included recent data from the large TORCH and INSPIRE trials – comes as a blow to hopes that inhaled steroids might drive down COPD mortality.

The US and Canadian researchers warned that in patients with mild symptoms, steroids could do more harm than good.

Their meta-analysis – published in the latest issue of JAMA - was the first to look at inhaled steroids versus placebo and other comparator therapies, and examined findings from 11 clinical trials covering 14,426 patients.

Steroids had no significant effect on all-cause mortality, but raised the risk of pneumonia by 34%.

Subgroup analysis found the risk of pneumonia was 90% greater in patients with worse lung function than in those illness was less severe. It was also 46% greater in those taking doses of 1,000mcg than in those on lower doses, and 57% greater in those taking both steroid and bronchodilator therapy than in those on monotherapy.

Study leader Dr Bradley Drummond, research fellow at Johns Hopkins University School of Medicine in the US, said the study suggested GPs should think twice before prescribing inhaled steroids in patients with COPD.

‘Physicians should balance the potential risks and benefits in each individual before prescribing inhaled steroids.

‘If a patient is burdened by significant symptoms such as shortness of breath, cough or exercise intolerance, studies have shown these medications are quite effective. But if a patient has relatively few symptoms, or a lung infection would be life threatening to that patient, inhaled steroids may be of more harm than benefit.'

NICE recommends concomitant inhaled steroids in patients on long-acting beta-agonists with an FEV1 less than or equal to 50% predicted who have had two or more exacerbations requiring treatment with antibiotics or oral steroids within 12 months.

Dr Rupert Jones, a GP in Plymouth and head of the respiratory research unit at Peninsula Medical School, said it was ‘a well-conducted and important study' with potential implications for how GPs approached the treatment of patients with COPD.

‘There is no definite guidance on this. While there is the potential to reduce exacerbations, there is also the potential to increase pneumonia. I would be concerned about patients who are immunocompromised or with diabetes.'

A spokesperson from GSK advised GPs to balance the risks of inhaled steroids with data describing the beneficial effects. ‘An increased rate of pneumonia for COPD patients treated with ICS or an ICS containing product is not a new or unique finding and product labelling for inhaled steroid containing products already includes significant information on the risk of pneumonia,' he said.

COPD may increase the risk of pneumonia COPD may increase the risk of pneumonia Two sides of steroids debate

A post-hoc analysis of TORCH found inhaled steroids plus long-acting [beta]-agonists significantly slowed the progression of lung disease in patients with COPD.
NEJM 2007; 356: 775-89
A Cochrane review reported a 33% decrease in mortality with combination treatment compared with LABA alone after scrutinising all data but focusing on TORCH.
Cochrane Database of Systematic Reviews 2008 Issue 3
A nested case-control analysis in July 2007 showed a 70% increase in hospitalizations for pneumonia in elderly patients with COPD.
Am J. Respir Crit Care Med 2007; 176:162-66;
The new meta-analysis will add to unease over the risks of inhaled steroids, showing a 34% increase in risk of pneumonia compared with placebo.
JAMA 2008; 300: 2407-16

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