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OPSUMIT (macitentan), endothelin receptor antagonist
CARDIOLOGY - Focus
Opinions on drugs -
Posted on
Apr 04 2016
Reason for request
Re-assessment of the improvement in actual benefit
OPSUMIT (macitentan), endothelin receptor antagonist
No clinical benefit demonstrated in patients with class II or III functional status of pulmonary arterial hypertension by comparison with the comparators.
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OPSUMIT has Marketing Authorisation, in monotherapy or in combination, for the long-term treatment of adults with class II or III functional status of pulmonary arterial hypertension (PAH). Its efficacy has been demonstrated in patients with idiopathic and heritable PAH or PAH associated with connective tissue disorders or corrected simple congenital heart disease.
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A study against placebo has shown a reduction in the worsening of PAH, but no reduction in mortality.
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There are no studies versus the other active comparators: endothelin receptor antagonists or phosphodiesterase type 5 inhibitors.
Clinical Benefit
| Moderate |
Le service médical rendu par OPSUMIT en monothérapie ou en association thérapeutique, dans le traitement au long cours des patients adultes atteints d’hypertension artérielle pulmonaire en classe fonctionnelle OMS II ou III reste modéré. |
Clinical Added Value
| no clinical added value |
OPSUMIT (macitentan), 3ème représentant de la classe des antagonistes des récepteurs de l’endothéline, n’apporte pas d’amélioration du service médical rendu (ASMR V) dans la stratégie thérapeutique de prise en charge des patients avec hypertension artérielle pulmonaire en classe fonctionnelle OMS II ou III. |
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