1. Real-life effectiveness of different treatment modalities of asthma or COPD in patients with significant co-morbidities Leif Bjermer 10:00–10.20

2. Real-life effectiveness of different treatment modalities of asthma or COPD in patients with significant comorbidities

3. Weight Loss (Cachexia) Cardiovascular Disease Anaemia Osteoporosis Depression Muscle Weakness & Wasting Agustí A. PATS 2006 COPD

4. Vanfleteren et al. AJRCCM 2013 97.7% of all 213 patients had ≥1 comorbidities and 53.5% had ≥4 comorbidities

5. Comorbidity in COPD Stage IIStage IIIStage IVp-value Heart trouble 26%25% 0.992 Heart attack 10%8% 0.457 Stroke 4%3% 0.327 Heart failure 7%6%9%0.287 Arrhythmia 12% 10%0.721 Osteoporosis 13%14%12%0.785 Diabetes 11%9%11%0.118 Inflamm. Bowel Dis. 6%3%6%0.045 Peptic ulcer 11% 8%0.206 Reflux/heartburn 31%23%21%<0.001 Depression requring tx. 16%17%15%0.516 Agusti A et al, Respir Res 2010

6. Co-morbidity and prognosis Mannino et al, ERJ 2008 Time to first hospitalisation within 5 years None One Two Three No co-morbidities Death within 5 years

7. Chest 2006;129;285-291

8. Questions What is the best treatment option for COPD and CVD? – LAMA vs ICS/LABA Bonus effects on Co-morbid conditions? – Statins – Roflimulast

9. P P Rho A MLCK MLCP ROCK (Rho kinase) P P P P P P P P P P P P P P P P F-actin Stress fibre Actin polimerization Statins

10. Lm(µm) Am J Physiol Lung Cell Mol Physiol 294: L882–L890, 2008

11. E.V. Ponte et al Allergy 2008;63:564 * *** Excluded

12. BUD 400x2 BUD Double dose add Montelukast C linical O utcome of M ontelukast as P artner A gent to C orticosteroid T herapy Price D et al. Thorax 2003;58:211–216

13. Cigarette Smoking Impairs the Therapeutic response to Oral Corticosterods in Asthma. Chauduri et al. AJRCCM 2003;168:1308-11

14. Questions What is the best treatment option for Asthma and Rhinitis? Optimal management of smoking asthmatics?

15. REG Priorities (I) Results from clinical trials should always be accomplished by comments on feasibility /generalizability to the target population. These data will be provided by the company seeking for registration.

16. REG Priorities (II) In order to get a drug reimbursed, the company must commit itself to provide reasonably priced placebo to competitive or independent researchers. This in order to facilitate company independent clinical trials.

17. REG Priorities (III) Add-on value of a treatment should be taken into consideration when a drug is launched for a specific treatment. Example 1 A drug can have a small effect on lung function (FEV), but a fair effect on physical performance. Moreover, It has a good effect on a pathophysiological relevant biomarker. Example 2 A drug have a minor effect on lung function (FEV) and on nasal symptoms and in obese asthmatics, weight is often reduced.