Bronchodilators in COPD

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1 TSANZSRS Gold Coast 2015 Can average outcomes in COPD clinical trials guide treatment strategies? Long live the FEV1? Christine McDonald Dept of Respiratory and Sleep Medicine Austin Health Institute for Breathing & Sleep University of Melbourne Bronchodilators in COPD Pharmacology= how they work Physiology= why they work Clinical trials=do they work? How does this translate into effectiveness in clinical practice? 1

2 Average outcomes 1. Mean outcomes cf subgroups or individuals 2. Average patient in trials cf real world 3. Trials outcomes FEV1 cf patient reported outcomes (PROs) 2

3 Bronchodilators History Traditional Chinese medicine Ma Huang ( from plant Ephedra equisitena) used to treat resp ailments for over 3000 yrs Turn of 20 th C epinephrine s/c for treatment of acute asthma 1940 s inh isoprenaline for asthma:non β2 selective Later development of β2 selective agonist salbutamol and subsequently longer acting agents Muscarinic acetylcholine receptor antagonists Smoking of anticholinergic plant alkaloids atropa belladonna and dature stramonium recommended in literature of Ayurvedic medicine from 17 th C Introduced to Britain early 19 th C belladonna and stramonium cigs/cigars/burning powders Later development of non selective short acting machr antagonist and subsequently longer acting agents 3

4 Goals of COPD therapy Relieve symptoms Improve exercise tolerance Improve health status Reduce symptoms Prevent and treat exacerbations Prevent disease progression Reduce mortality Reduce risk GOLD COPD

5 Lung Health Study Randomised trial of smoking cessation and inhaled ipratropium bromide in smokers aged with mild asymptomatic COPD 10 clinical centres US & Canada Usual care v smoking intervention ± ipratropium bromide for 5 yrs Followed up to 14.5 yrs» Anthonisen et al Ann Intern Med 2005;142:233 All-cause 14.5-year survival Smoking cessation reduced decline in lung function; no change lung function decline with bronchodilator Anthonisen, N. R. et. al. Ann Intern Med 2005;142:

6 Annual Rates of Decline in FEV 1 and FVC before and after bronchodilatation no different over 4 years NS UPLIFT study Tashkin DP et al. N Engl J Med 2008 Annual Rates of Decline in FEV 1 and FVC before and after bronchodilatation no different over 4 years No safety concerns NS UPLIFT study Tashkin DP et al. N Engl J Med

7 Goals of COPD therapy Relieve symptoms Improve exercise tolerance Improve health status Reduce symptoms Prevent and treat exacerbations Prevent disease progression X Reduce mortality X Reduce risk GOLD COPD 2015 Stepwise COPD X The aim of pharmacological treatment...to treat symptoms or to prevent deterioration (either by decreasing exacerbations or by reducing decline in quality of life) or both. A stepwise approach is recommended, irrespective of disease severity, until adequate control has been achieved Use short acting medications Then LAMA and/or LABA for symptom relief and to prevent exacerbations 7

8 COPD X Stepwise management GOLD COPD 2015 (Short acting) bronchodilators are given on either regular or PRN basis to prevent or reduce symptoms References refer only to bronchodilatation and do not focus on symptoms Few studies of short acting agents examined patient reported outcomes such as relief of breathlessness, cough, fatigue, exercise capacity, quality of life 8

9 Clinical trials in COPD Historically, FEV1 used as a global marker for pathophysiological changes and by regulators Correlates with mortality but poorly with patient reported outcomes (PROs) Studies of newer drugs are more likely to Include PROs as endpoints Consider responders versus non responders ( responder analyses ) rather than just mean improvements Report results in terms of clinically important improvements (MCID)...so, do these bronchodilators bronchodilate? 9

10 Short acting beta2 agonists for stable chronic obstructive pulmonary disease: post BD FEV1; for SABA v placebo Yes they do bronchodilate Ram et al Cochrane Database of Systematic Reviews 22 JUL 2002 DOI: / CD Small mean differences :overall 140mls? clinically significant Minimum clinically important difference Is a measure of change in a given variable that is required to produce a clinically perceivable effect and distinguishes clinical efficacy from statistical difference MCIDs are average estimates obtained in a patient population An individual patient may have a meaningful perceived benefit from a result that is below the MCID threshold Jones P AJRCCM

11 MCID for COPD outcomes Lung function: FEV1 MCID suggested to be roughly mls 1 but remains poorly defined (within subject variability estimated at 160ml 2 ); ATS/GOLD state FEV1 inc of >12 % and 200mls to be the threshold of clinical significance Health status: SGRQ: 4 units CRQ 0.5 units per domain 1. Cazzola M et al ERJ Tweedale PN et al Thorax 1997 Dyspnoea MCID Transitional Dyspnoea Index : 1 unit UCSD dyspnoea questionnaire: 5 7 units VAS:10 20 units Borg: 2units Exercise capacity 6MWD: 25 33m 1 ISWT: 47.5 m ESWT: m Constant load cycle sec 1.Holland AE et al ERJ

12 Inspiratory capacity and other measures of hyperinflation? Conclusion: short acting Short acting bronchodilators significant bronchodilator effects Limited data on PROs such as dyspnoea, quality of life 12

13 New Bronchodilator Therapies Do long acting bronchodilators relieve symptoms? GOLD Long acting bronchodilators are convenient and more effective at producing maintained symptom relief than short acting Combining bronchodilators of different pharmacological classes may improve efficacy and decrease risk of side effects compared to increasing dose of a single bronchodilator 13

14 Probability of Treatment Discontinuation, Mean FEV 1 and FVC before and after Bronchodilation, and Scores for Health-Related Quality of Life. Tashkin DP et al. N Engl J Med 2008;359: UPLIFT Long term efficacy and safety of Indacaterol N = 412 FEV1 = 1.5 L DB,R, PC. 26 weeks Two doses versus placebo No important adverse side effects Decreased exacerbations by 14% USA FDA approved 75 mcg Chapman K et al CHEST 2011;140:68 14

15 Indacaterol versus Tiotropium n = 1600 FEV1 = 1.5 l 12 weeks Indacaterol 150 mcg Tiotropium 18 mcg Outcomes spirometry SGRQ TDI Buhl et al Eur Respir J 2011: 28:797 LAMA + LABA (tiotropium + olodaterol) 4 week, crossover studies (n=232) Olodaterol 5 μg Olodaterol10 μg FEV 1 (L) at 4 weeks Tiotropium 5 μg* +Tiotropium 2.5 μg* +Tiotropium 1.25 μg* Olodaterol 5 μg Tiotropium 5 μg* +Tiotropium 2.5 μg* +Tiotropium 1.25 μg* Olodaterol 10 μg ~0.34 L ~0.36 L mean baseline mean baseline Time Time Addition of tiotropium to olodaterol significantly improved FEV 1 versus olodaterol alone * via Respimat SMI Aalbers et al. Eur Resp J 2012;40(Suppl 56): 525s (P2882). 15

16 Long acting beta2 agonist in addition to tiotropium versus either tiotropium or long acting beta2 agonist alone for chronic obstructive pulmonary disease HRQOL Change from baseline of -6.1 units with combination treatment v -4.5 with tio alone Karner et al Cochrane Database of Systematic Reviews 18 APR 2012 DOI: / CD pub2 Conclusion Bronchodilators do bronchodilate. The Ultra LABA and LAMA increase FEV1 between 120 and 200 ml They improve Qol and dyspnoea Decrease exacerbations. All better than placebo Combinations may provide additional benefit 16

17 Personalised medicine Is this bronchodilator ( or combination) likely to benefit my patient? How do I choose which of the new bronchodilators or combinations to use? How shall I monitor treatment response? When( if ever?) do I stop therapy ie is there a concept of back titration or cessation in COPD? Adherence to bronchodilator over time Patterns of Long-acting Bronchodilators in Routine COPD Care: The OUTPUL Study COPD Aug

18 Non adherence to treatment may account for many observed differences between efficacy and effectiveness of drug treatment Average adherence rates in COPD clinical trials 70 90% Much lower in real world Reasons for lack of adherence Poor device technique (up to 90% don t use devices properly) not getting response True lack of response: responder analyses in COPD trials suggest significant proportions of patients do not have clinically important benefits in outcomes important for patients Even if achieve MCID may not be relevant for this patient 18

19 Thoughts and questions Each patient is n of 1 trial Uncertainties exist: Which BD to trial first device will impact Is my patient a responder? How long is treatment trial to ensure not just placebo effect? Does my patient meet inclusion criteria for trial ( cardiac, renal exclusions, QT interval, comorbidities) Why am I treating? symptoms alone ( non exacerbator) symptoms plus exacerbations( longer trial? how long) does my patient have ACOS add ICS Cease one BD then trial another or add on? 19

20 Conclusions Population mean changes not easily translatable outside a clinical trial. Responders v non responders: useful concept in addition to NNT COPD clinical trials moving from FEV1 to PROs Regulatory bodies also looking for PROs not just lung function Consider clinical rather than just statistically significant benefits (caveats) Clinical gestalt still trumps 20

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