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VOLIBRIS (ambrisentan), antihypertensive
CARDIOLOGY - New indication
Opinions on drugs -
Posted on
Aug 28 2017
Reason for request
Extension of indication
No clinical benefit demonstrated in patients with functional class II or III pulmonary arterial hypertension by comparison with the available treatments, in combination with tadalafil, as a first-line treatment.
- VOLIBRIS has marketing authorisation,in combination, in the treatment of pulmonary arterial hypertension (PAH) in adults in functional class II and III (WHO classification).
- The efficacy of the ambrisentan/tadalafil combination was demonstrated in patients not previously treated compared to ambrisentan and tadalafil as a monotherapy, on the reduction of the time until occurrence of the first cardiovascular event, especially hospitalisation for worsened PAH.
- No difference was found in terms of improvement of functional class or mortality compared to ambrisentan and tadalafil as a monotherapy.
- The use of the ambrisentan/tadalafil combination from the outset in functional class II or III should be discussed in regard to the increase of adverse events associated with this combination.
Clinical Benefit
| Moderate |
- |
Clinical Added Value
| no clinical added value |
- |
English version
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