NPC Archive Item: Observational data adds to concerns regarding inhaled steroids and pneumonia risk in patients with COPD

NOTE – This is an archive post from the NPC and has not been updated since first publication. Therefore, some hyperlinks may no longer be working.
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A study published in the American Journal of Respiratory Critical Care provides further information about the risks associated with using inhaled corticosteroids in chronic obstructive pulmonary disease (COPD)

What does this study claim?
This observational study in elderly people with chronic obstructive pulmonary disease (COPD) patients in Quebec found that current users of inhaled steroids were 70% more likely to be admitted with pneumonia than matched controls, and 53% more likely to die from pneumonia. The higher the steroid dose the greater the risk.

How does this relate to other studies?
The TORCH study (Calverley PMA et al. NEJM 2007; 356: 775-89) was a randomised controlled trial (RCT) comparing the combination of inhaled salmeterol plus fluticasone with placebo or salmeterol or fluticasone alone in patients with COPD. Over three years, the number needed to treat for harm (NNH) for pneumonia with the combination versus salmeterol alone was 16 (relative risk or risk ratio (RR) 1.47, P<0.001). There was no increase in death from any cause, the study’s primary outcome.

So what?
Ernst’s observational study has certain methodolological limitations and the finding in the TORCH study was not the study’s primary outcome. These factors limit the conclusions that can be drawn. Nevertheless, clinicians should:

  • Note that none of the inhalers containing an inhaled corticosteroid alone is currently licensed for use in COPD and the responsibility for such unlicensed use lies with the prescriber
  • Follow NICE guidance on use of inhaled steroids in COPD
  • Discuss with patients the possible increased risk of pneumonia, and other risks such as osteoporosis, etc.
    Be cautious about abruptly withdrawing inhaled steroids in patients with COPD: the COPE study (van der Valk et al, Am J Respir Crit Care Med 2002; 166: 1358-1363) suggested this may be associated with increased risk of rapid recurrent exacerbation