Pulmonary Disease Treatment concerning COPD

1. Pulmonary Disease Treatment concerning COPD By Melissa Jakubowski

2. Agenda • Introduce the journal article • Review of preliminary background • Discuss the details of the study • Evaluation of the study • Discuss how the implications of the study translate into practice • Questions

3. Journal Article • Efficacy of corticosteroid therapy in patients with an acute exacerbation of chronic obstructive pulmonary disease receiving ventilatory support

4. This study assessed: • The effect ofsystemic corticosteroids on ICU patients who were mechanically ventilated (invasive or noninvasive) due to COPD exacerbations

5. Importance • Previous randomized trials assessing the effect of systemic corticosteroid therapy on COPD exacerbations have excluded patients with respiratory failure who required mechanical ventilation or ICU admission • Critically ill patients in the ICU are more prone to develop complications potentially associated with corticosteroid therapy

6. Hospital treatment for COPD • Bronchodilators • Antibiotics • Oxygen • Corticosteroids

7. COPD and Corticosteroid Therapy • COPD: airways damaged interfering with the exchange of oxygen and carbon dioxide in the lungs • Function: reduce lung and bronchial tube inflammation related to tissue damage and improve respiratory function

8. Short-term side effects • Increased appetite • Fluid retention • Weight gain • Increased blood pressure • Hyperglycemia

9. Systemic steroids, corticosteroids • Prednisone • Prednisolone • Methylprednisolone • Betamethasone • Beclamethasone • Dexamethasone • Flurocortisone • Hydrocortisone • Triamcinolone

10. Screening for subjects • Screening: 354 patients from 8 hospitals in 4 countries from July 2005 – July 2009 • Criteria: hospitalization because of exacerbation of COPD requiring ventilatory support in the ICU • Controls: diagnosis of “exacerbation of COPD” was explicitly defined; patients with conditions that would alter integrity of study were excluded

11. Ethics • Approved by the ethics committee at each hospital • Written informed consent obtained from patients or their surrogates

12. Study population

13. Baseline Characteristics

14. Study design • Within 24 hours after ICU admission, patients randomly assigned to either corticosteroid group or placebo group

15. Length of Administration: 10 days Treatment Group Placebo Group Normal saline solution • Methylprednisolone

16. Administration Regimen

17. Outcome Measures • Duration of mechanical ventilation, d • Length of ICU stay, d • Length of hospital stay, d • In-ICU mortality, % • Failure of NIMV, % • Reintubation within 48 hours of planned extubation and received CMV either initially or after failure of NIMV, %

18. Frequency of Adverse Events • Superinfection • Gastrointestinal bleeding • Arterial hypertension • Hyperglycemia • Ventilator-associated pneumonia • Delirium • ICU-acquired paresis

19. Other daily measurements • ABG analysis • C-reactive protein • Maximal blood glucose level • Daily dose of insulin • PEEP (positive end-expiratory pressure): only in patients who were intubated

20. Results: Outcome Measures

21. Reduction in duration of mechanical ventilation

22. Reduction in the Incidence of NIV Failure

23. Frequency of Adverse Events

24. Pros vs. Cons Pros Cons Hyperglycemia • Modest reduction in the duration of mechanical ventilation • Increased success of NIMV • Trend towards shorter ICU stay

25. Evaluation of the study: Pros • 1st study to confirm the benefits of systemic corticosteroid therapy for ICU patients receiving MV for COPD exacerbation • Validates its usage in clinical practice today • Double-blinded experiment • Source of funding

26. Pros (continued) • Funded by University of Vall d’Hebron Hospital, Laboratory of Experimental Cardiology (LEC) • LEC mission statement: “to contribute to lessen the impact of cardiovascular diseases on survival capacity and quality of life of the general population by elucidating the mechanisms of disease and proposing new treatments”

27. Evaluation of the study: Cons • Results will not have an impact on current clinical treatment practice guidelines • Sample size was small (83) • Length of study (5 years) • Does not mention the effect of the drug on eating behavior

28. Resource • Alia I, de la Cal MA, Esteban A, et al. Efficacy of corticosteroid therapy in patients with an acute exacerbation of chronic obstructive pulmonary disease receiving ventilatory support. Arch Intern Med. 2011;171(21):1939-1946. Accessed April 13, 2012.

29. Additional thoughts • What about corticosteroid long-term side-effects? • Optimal dose and length of treatment? • How do the findings translate into practice?

30. Questions