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Done by: Khalid Al-Rashdi R3

Budesonide/formoterol as effective as prednisolone plus formoterol in acute exacerbations of COPD A double-blind, randomised, non-inferiority, parallel-group, multicentre study. Done by: Khalid Al-Rashdi R3.

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Done by: Khalid Al-Rashdi R3

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  1. Budesonide/formoterol as effective as prednisolone plus formoterolin acute exacerbations of COPD A double-blind, randomised,non-inferiority, parallel-group, multicentre study Done by: Khalid Al-Rashdi R3

  2. Non-inferiority is a kind of similarity within a limit. The limit is the degree of tolerable inferiority of the new drug compared with the standard treatment . if the non-inferiority limit is set at 7·5%, an increase in the incidence of serious events or deaths—say 7% instead of the 5% currently established for the comparator—is not seen as large enough to mark a difference between the new and the control drug. The new drug will therefore be considered non-inferior to the old drug.

  3. Introduction: - Chronic obstructive pulmonary disease (COPD) is a major health problem and cause of death and disability. - up to 90% of all COPD patients with exacerbations can be treated at primary health care centres and thereafter return home with intensified therapy. - oral corticosteroids represent standard treatment for COPD exacerbations.

  4. - 2-week course of inhale budesonide/formoterol would be equally effective for treatment of acute COPD exacerbations as standard therapy in patients judged by the investigator not to require hospitalisation. • - the initial 2-week treatment would influence the rate of exacerbations during a subsequent 12-week open-label treatment period with the fixed combination of budesonide and formoterol at a standard dose of 320/9 μg bid.

  5. -Department of Public Health and Caring Sciences, Family Medicine and Clinical Epidemiology, Uppsala University, Sweden. • -done in one hospital and 29 health centers. Published: 19 February 2009 Respiratory Research 2009, 10:11 doi:10.1186/1465-9921-10-11 This article is available from: http://respiratory-research.com/content/10/1/11

  6. Methods: • -double-blind, randomised, non-inferiority, parallel-group, multicentre study comparing two treatment strategies. • -two weeks' treatment with inhaled budesonide/formoterol (320/9 μg, qid) was compared with prednisolone (30 mg once daily) plus inhaled formoterol (9 μg bid) in patients with acute exacerbations of COPD attending a primary health care centres.

  7. Inclusion criteria: - ≥ 10 pack years,aged ≥ 40 years, with moderate COPD corresponding to GOLD stage IIa or IIb ,COPD for ≥ 6 months prior to study entry. -dyspnoea for less than one week -FEV1 30–60% of predicted normal after acute treatment with a single dose of oral corticosteroid plus nebulised salbutamol/ipratropium bromide -no requirement for subsequent immediate hospitalisation. • -subsequent open-label budesonide/formoterol (320/9 μg bid) for another 12 week.

  8. Exclusion criteria: - diagnosis of asthma. - a previous COPD exacerbation within 30 days prior to the study. - oxygen saturation < 92% after the initial acute treatment. - Requirement for oxygen therapy. - a need for immediate hospitalisation as judged by the investigator. - treatment with any inhaled corticosteroid in doses > 1000 μg/day at study entry. - use of or need for treatment with a non-selective β-receptor.

  9. Assessments: • - end of weeks one and two, and at the end of the • open follow-up period. • - The primary efficacy variable → change in FEV1 from baseline to treatment. • - Other efficacy variables were treatment failures,FEV1 measured twice daily at home with a Piko-1® electronic peak flow meter, the number of patients with an • exacerbation and the time to first exacerbation during the follow-up period.

  10. -A self administered Clinical COPD Questionnaire (CCQ)was completed at the start of the study, after one week and at the end of the double-blind period. -At all visits serum C-reactive protein (CRP) concentrations. -Safety was monitored by reporting of adverse events, serious adverse events and discontinuations due to adverse events.

  11. Results:

  12. -treatment failure: • 2 cases in first group • -Use of reliever medication • patients in the budesonide/formoterol and prednisolone plus formoterol groups used 1.8 and 2.1 inhalations per day of reliever medication, respectively.

  13. Critical appraizal: • Were the Pts in the two groups similar at the start of the trial with respect to prognostic factors? • Were Pts analysed in the groups to which they were randomized

  14. Blinding : • Were Pts aware of group allocation? • Were clinicians aware of group allocation? • Were outcome assessors aware of group allocation? • Were statisticians aware of group allocation?

  15. Were the follow up of Pts sufficiently long & complete?

  16. Absolute Risk Reduction (ARR): The absolute arithmetic difference in events rate . ARR= EER – CER after 1 week =6.84 % -2.5% = 4.34% after 2 week =8.55 % -7.5% = 1.05%

  17. Relative Risk Reduction (RRR): Proportional reduction in rates of bad events between experimental & control group in trial . RRR =(EER-CER)/CER first week=(6.84 % -2.5 % ) /2.5% =173% second =(8.55% -7.50)/7.50 =14%

  18. Number Need to Treat ( NNT ): The number of Pts who need to be treated to achieve one additional favourable outcome. NNT = 1/ ARR =1/4.34% = 23.04 =1/1.05%=95.24

  19. Will the results help me in caring for my Pts? • Were the study Pts similar to Pts in my care? • Were all clinically important outcomes considered? • Are the likely benefits worth the potential harms & costs?

  20. discussion: • - The risk of systemic side effects when using oral prednisolone – even short courses – has been well recognised and the total steroid burden may be heavy in patients with frequent exacerbations. • - Short-term increases in the doses of inhaled budesonide have been found safe and well tolerated

  21. Limitation: - lack of a placebo. - this study included only patients who had a deterioration of their clinical status during the last week prior to entry. - all treatment effects were due to the initial single dose of oral steroid plus the nebulisation of bronchodilators. -duration of the prednisolone course (2 weeks) -3-month follow-up period to be sufficient to evaluate the incidence of further exacerbations. -coast effective.

  22. Conclusion: - High dose budesonide/formoterol was as effective as prednisolone plus formoterol for the ambulatory treatment of acute exacerbations in non-hospitalized COPD patients. - An early increase in budesonide/formoterol dose may therefore be tried before oral corticosteroids are used.

  23. END

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