Real-life effectiveness of different treatment modalities of asthma or COPD in patients with significant co-morbidities Leif Bjermer10:00–10.20

Real-life effectiveness of different treatment modalities of

asthma or COPD in patients with significant comorbidities

Weight Loss (Cachexia)

CardiovascularDisease

Anaemia

Osteoporosis

Depression

Muscle Weakness &

Wasting

Agustí A. PATS 2006

COPD

Vanfleteren et al. AJRCCM 2013

97.7% of all 213 patients had ≥1 comorbidities and 53.5% had ≥4 comorbidities97.7% of all 213 patients had ≥1 comorbidities and 53.5% had ≥4 comorbidities

Co-morbidity and prognosis

Mannino et al, ERJ 2008

Time to first hospitalisation within 5 years

NoneOneTwoThree

No co-morbidities

Death within 5 years

Chest 2006;129;285-291

Questions

• What is the best treatment option for COPD and CVD?– LAMA vs ICS/LABA

• Bonus effects on Co-morbid conditions?– Statins– Roflimulast

P P

Rho A

MLCK

MLCP

ROCK (Rho kinase)

PPP P

PPP P

PPP P

PPP P

F-actin

Stress fibre

Actinpolimerization

Statins

Lm(µ

m)

Am J Physiol Lung Cell Mol Physiol 294: L882–L890, 2008

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

*

***

***

Excluded

Excluded

BUD 400x2BUD Double dose

add Montelukast

Clinical Outcome of Montelukast as Partner Agent to Corticosteroid Therapy

Price D et al. Thorax 2003;58:211–216

Smokers Ex-smokers Never-smokers

-300

-200

-100

0

100

200

300

400

500

600p=0.605 p=0.386 p=0.019

F

EV

(m

l)

Smokers Ex-smokers Never-smokers

-2

-1

0

1p=0.865 p=0.108 p=0.004

A

sth

ma

sco

re

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

Questions

• What is the best treatment option for Asthma and Rhinitis?

• Optimal management of smoking asthmatics?

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.

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.

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.