Inhaled corticosteroids: pneumonia
Physicians should remain vigilant for pneumonia and other infections of the lower respiratory tract (ie, bronchitis) in patients with chronic obstructive pulmonary disease who are treated with inhaled products that contain steroids
Article date: October 2007
Long-acting beta2 agonists (salmeterol or formoterol) and combination products that contain salmeterol with fluticasone (Seretide Accuhaler) or formoterol with budesonide (Symbicort Turbohaler) are indicated for the management of chronic obstructive pulmonary disease (COPD). Although inhaled corticosteroids are not indicated for monotherapy in COPD, treatment guidelines (including those issued by the Global initiative on Obstructive Lung Disease, GOLD)[footnote 1]recommend that inhaled steroids may be added to ongoing bronchodilator therapy in COPD management.
皇冠体育app TORCH study
TOwards a Revolution in COPD Health (TORCH)[footnote 2] compared Seretide Accuhaler (50 碌g salmeterol/500 碌g fluticasone twice a day), 50 碌g salmeterol twice a day, and 500 碌g fluticasone twice a day with placebo over a 3-year period. 皇冠体育app primary endpoint was all-cause mortality within 3 years. 皇冠体育app absolute risk for all-cause mortality was reduced by 2路6% for Seretide compared with placebo, and was increased by 0路8% for fluticasone compared with placebo (both nonsignificant).
皇冠体育app table summarises the absolute and relative risks of pneumonia for groups in the TORCH study:
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| Placebo (n=1544) | Salmeterol (n=1542) | Fluticasone (n=1552) | Seretide (n=1546) | |||||
|---|---|---|---|---|---|---|---|---|
| Number of events | 听 | 139 (9%) | 听 | 162 (11%) | 听 | 224 (14%) | 听 | 248 (16%) |
| Events per 1000 treatment-years | 听 | 51路9 | 听 | 51路5 | 听 | 84路4 | 听 | 87路6 |
| Probability of event by 3 years* (95% CI) | 听 | 12路3% (10路4鈥�14路3) | 听 | 13路3% (11路4鈥�15路2) | 听 | 18路3% (16路1鈥�20路4) | 听 | 19路6% (17路4鈥�21路9) |
| Active treatment vs placebo | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 |
| Hazard ratio (95% CI) | 听 | 听 | 听 | 1路09 (0路87鈥�1路37) | 听 | 1路53鈥� (1路24鈥�1路89) | 听 | 1路64鈥� (1路33鈥�2路02) |
| Seretide vs components | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 |
| Hazard ratio (95%CI) | 听 | 听 | 听 | 1路51鈥� (1路24鈥�1路84) | 听 | 1路07 (0路89鈥�1路28) | 听 | 听 |
Note: Log-Rank test stratified by smoking status. *Kaplan-Meier estimate. 鈥爌<0路001
In TORCH, older patients, patients with a lower body mass index (ie, <25 kg/m2), and patients with very severe disease (FEV1<30% predicted) were at highest risk of pneumonia, irrespective of treatment.
Other data
A recent case-control study[footnote 3] of 175 906 elderly patients with COPD suggested that current use of inhaled corticosteroids was associated with a significant increase of 70% in the frequency of hospitalisation for pneumonia compared with non-use in the last year. For patients with pneumonia who died within 30 days of hospitalisation, current use of inhaled corticosteroids significantly increased the frequency by 53%. 皇冠体育app risks of hospitalisations for pneumonia and for subsequent death within 30 days were dose-dependent.
Advice for healthcare professionals:
- Physicians should remain vigilant for the development of pneumonia and other infections of the lower respiratory tract (ie, bronchitis) in patients with COPD who are treated with inhaled drugs that contain steroids because the clinical features of such infections and exacerbations frequently overlap
- Any patient with severe COPD who has had pneumonia during treatment with inhaled drugs that contain steroids should have their treatment reconsidered
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Article citation: Drug Safety Update October 2007; Vol 1, Issue 3: 5.