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S27 The effects of statin therapy on inflammatory markers in patients with copd: a double blind randomised controlled trial
  1. M John1,
  2. AJ Knox1,
  3. TM McKeever2,
  4. G Meakin1,
  5. H Bailey1,
  6. JR Cockcroft3,
  7. DJ Shale3,
  8. TW Harrison1,
  9. CE Bolton1
  1. 1Nottingham Respiratory Research Unit, Nottingham, UK
  2. 2School of Community Health Sciences, Nottingham, UK
  3. 3Wales Heart Research Institute, Cardiff, UK

Abstract

Background Systemic and airway inflammation are recognised in COPDand reducing inflammation has been postulated to alter disease course1. Statins have pleiotropic effects including anti-inflammatory properties2. A study in asthma showed that statins reduced sputum macrophage levels3. We hypothesised that statins would reduce systemic (hs-CRP) and airway (exhaled nitric oxide: FeNO, sputum neutrophils and macrophages) inflammation in patients with COPD.

Methods Clinically stable patients with confirmed COPD were recruited and randomised to either simvastatin 20mg od (active) or placebo for 6 weeks in a double blinded parallel group randomised controlled trial. Circulating hs-CRP and fasting lipids were measured in all subjects’ pre- and post- treatment. 5-flow FeNO and induced sputum were performed in consenting patients where possible pre- and post-treatment. Primary analysis compared the six week change in each inflammatory marker between active and placebo groups.

Results Patients were matched for age, sex, smoking and lung function; active: n = 33, placebo: n = 37. Compliance was good and the active group achieved total cholesterol reduction: between arms mean (95% CI): -1.1 (-1.3, -0.8)mmol/L, p < 0.001. Baseline median (IQR) hs-CRP was 3.09 (1.3–7.4)mg/l but there was no significant change after treatment between active and placebo: between arms mean (95% CI) 0.5(-3.2, 4.1)mg/l. Baseline sputum samples were obtained in n = 27 and 22/27 had neutrophilic sputum. Paired samples were obtained in 20 patients: active n = 8 and placebo n = 12 with no significant difference in change between treatment arms for sputum neutrophils or macrophages. FeNO was measured in 36 patients: active n = 17, placebo n = 19 with no significant difference in change between arms.

Conclusions In this pilot RCT, despite significant lipid lowering, there was no demonstrable systemic or airway anti-inflammatory effect over 6 weeks with simvastatin 20mg od in patients with COPD. Baseline results showed a majority had neutrophilic sputum however only a small proportion had airway inflammation evaluation.

Trial reference: NCT01151306

Supported by NIHR RfPB grant

References

  1. Sin, DD, et al. AJRCCM 2004;170:760–765

  2. Walsh, G. M Expert Review of Respiratory Medicine 2008;2(3):329–335

  3. Hothersall, EJ, et al., Thorax 2008;63(12):1070–5

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