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SPIOLTO RESPIMAT (tiotropium/olodaterol), long-acting anticholinergic/beta-2-adrenergic agonist
RESPIRATORY MEDICINE - New medicinal product
Opinions on drugs -
Posted on
Oct 14 2016
Reason for request
Inclusion
No clinical benefit demonstrated relative to comparators in the treatment of symptoms of chronic obstructive pulmonary disease
- SPIOLTO RESPIMAT has a Marketing Authorisation as a maintenance bronchodilator treatment to relieve symptoms of chronic obstructive pulmonary disease (COPD) in adult patients.
- Its clinical benefit is low in the absence of a clear demonstration of efficacy on trough FEV1, dyspnoea, reduction of exacerbations and quality of life compared to a long-acting beta-2-adrenergic agonist or anticholinergic taken alone.
- It is a second-line medicinal product in patients with moderate to very severe COPD stage in case of insufficient response to a long-acting bronchodilator used as a monotherapy.
Clinical Benefit
| Moderate |
- |
Clinical Added Value
| no clinical added value |
- |
Therapeutic use
|
- |
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