Samer El Rayess, M.D. Internal Medicine, PGY3 29 January 2016

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1 Samer El Rayess, M.D. Internal Medicine, PGY3 29 January 2016

2 Case Scenario Mr. X., a 50 year old man heavy smoker 80 pack / year known to have -COPD on spiriva at home last exacerbation 9 months ago -Hypertension on Amlor 5 mg daily -BPH on omnic presented to the hospital with dyspnea and sputum production of 3 days duration. Diagnosed as having COPD exacerbation for which he was started on IV steroids + short acting bronchodilators +Antibiotics. Patient was labeled as having grade C COPD and was discharged on seretide 500/50 (fluticasone+salmeterol ) Pulmonary function testing done 1 month after his exacerbation revealed obstructive pattern suggestive of COPD with FEV1= 40%

3 COPD Background Chronic obstructive pulmonary disease, a common preventable and treatable disease, is characterized by progressive airflow limitation due to chronic inflammatory response in the airways and the lung to noxious particles or gases. Exacerbations and comorbidities contribute to the overall severity in individual patients

4 COPD Background Exacerbations of chronic obstructive pulmonary disease (COPD) lead to an accelerated decline in lung function and health status. Once COPD is diagnosed, treatment will aim to reduce symptoms, disease progression and future exacerbations

5 GOLD recommendations

6 Prevention of COPD LABA LAMA ICS LABA+ICS LABA+LAMA+ICS Roflumilast Macrolides exacerbation Background

7 GOLD recommendations

8 Prevention of COPD exacerbation In COPD patients with GOLD C or D, the benefit of inhaled glucocorticoids in a regimen that includes LAMA+LABA has not yet been determined in an adequately powered study.

9 Prevention of COPD exacerbation Most clinical trials involving patients with COPD have established the benefit of treatment by comparing a new therapy with placebo or a relevant active control. Few trials have considered the question of whether such therapy should be continued after clinical stability has been achieved

10 Clinical Question In patients with severe or very severe COPD who were receiving a combination of a LAMA (tiotropium) and a LABA (salmeterol), does a stepwise withdrawal of ICS changes the risk of exacerbation compared with continued use of ICS?

11 PICO Question P I C O Patient with severe or very severe COPD no Inhaled corticosteroids inhaled corticosteroids moderate or severe exacerbation

12 PubMed Mesh terms Searching for Evidence COPD exacerbation, inhaled corticosteroid discontinuation, inhaled corticosteroid withdrawal 5 articles retrieved

13

14

15 Searching for Evidence

16 Paper Summary Span and Location The study was conducted at 200 centers in 23 countries between February 2009 and July 2013

17 Paper Summary Patients Characteristics 2485 patients, at least 40 years of age who met the eligibility criteria were enrolled in the study severe or very severe COPD(FEV1 less than 50%) current smokers ( 10 pack-years) or former smokers at least one documented exacerbation in the 12 months before screening

18 Paper Summary Randomization Eligible patients were randomly assigned study group : Salmeterol 50 mcg BID + Tiotropium 18 mcg daily with a stepwise reduction in the fluticasone dose every 6 weeks, from a total daily dose of 1000 μg to 500 μg, then to 200 μg, and finally to 0 μg daily Control group : Salmeterol 50 mcg BID + tiotropium 18 mcg daily + fluticasone 500 mcg for 52 weeks

19 Paper Summary Surveillance Physical examinations were performed at the time of screening and at week 52 vital signs were measured and recorded at baseline and at weeks 6, 12, 18, and 52. Chest radiography was requested when pneumonia was suspected during the trial. Adverse events and serious adverse events were also recorded throughout the study, and results are reported descriptively

20 Primary endpoint Paper Summary Outcomes time to the first moderate or severe COPD exacerbation

21 Paper Summary Outcomes Secondary and Tertiary Outcomes Time to the first severe COPD exacerbation Number of moderate or severe COPD exacerbations, Change from baseline in lung function (FEV 1, forced vital capacity, and peak expiratory flow rate), Health status ( through St. George's Respiratory Questionnaire ) Dyspnea ( through modified Medical Research Council scale )

22 Paper Summary

23 Are the Results Valid? Were the patients randomized? YES Withdrawal of inhaled corticosteroids in COPD patients receiving dual bronchodilation: WISDOM study a randomized double blind active-controlled trial

24 Were patients analyzed in the groups to which they were randomized? YES Are the Results Valid? Were patients in the study groups similar with respect to known prognostic factors? YES

25 Are the results valid? Baseline Characteristics

26 Are the Results Valid? Were patients or clinicians aware of group allocation? NO Were outcome assessors aware of group allocation? NO

27 Are the Results Valid? Was the follow up complete? Almost 231 patients of 1244 in the glucocorticoid withdrawal group and 227 patients of 1244 in the glucocorticoid continuation group discontinued the study Around 18% of recruited patients were lost to follow-up or withdrew from the study in each of the treatment and placebo group

28 What are the Results? How large was the treatment effect? As compared with continued glucocorticoid use, glucocorticoid was no inferior with respect to the first moderate or severe COPD exacerbation (hazard ratio, 1.06; 95% CI, 0.94 to 1.19).

29 What are the Results? At week 18, the adjusted mean reduction from baseline in the FEV1 was 38 ml greater in the glucocorticoid-withdrawal group than in the glucocorticoid-continuation group (P=0.001) No change in dyspnea and minor changes in health status occurred in the glucocorticoidwithdrawal group. The change from baseline in the mmrc score did not differ significantly between two groups at week 18 (P=0.36) or at week 52 (0.035 and points, respectively; P=0.06). The changes from baseline in the total SGRQ scores were an increase of 1.15 and a decrease of 0.07, respectively, at week 52 (P=0.047).

30 What are the Results? How precise was the estimate of the treatment effect? Withdrawal of glucocorticoid resulted in a significant non inferiority in the primary end point (P=0.005)

31 What are the Results?

32 What are the Results?

33 What are the Results? Adverse Effects

34 Summary of Results In the withdrawal group as compared with the placebo group NO significant increase in the rate of moderate or severe exacerbations No significant difference in time to first severe exacerbation ( non sustained ) No significant between-group differences in hazard ratios in any of the subgroup analyses

35 Summary of Results In the withdrawal group as compared with the placebo group Greater reduction of FEV1 in the glucocorticoid-withdrawal group than in the glucocorticoid- continuation group No significant difference in dyspnea score but health status score : total SGRQ score -- unclear finding (between-group difference was smaller than the frequently used minimum clinically important difference)

36 Summary of Results In the withdrawal group as compared with the continuation group No significant between-group difference in the safety profile, including the number of cases of pneumonia

37 Limitations 9 months of observation of patients who were not receiving glucocorticoids Smaller enrollment of women in our study due to disease prevalence in study countries (no significant difference in outcome on the basis of sex was observed )

38 Apply Results to Patient Care? Were the study participants similar to my patient? YES Were all patient-important outcomes considered? YES Are the likely treatment benefits worth the potential harms and costs? YES

39 Back to My Patient In a patient with moderate or severe COPD, would the discontinuation of ICS results in increase of the rate of exacerbations?

40 Back to My Patient In a patient with moderate or severe COPD, would the discontinuation of ICS results in increase of the rate of exacerbations? No, BUT..

41 Thank you

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