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ADEMPAS (riociguat), antihypertensive for pulmonary arterial hypertension

CARDIOLOGY - New medicinal product
Opinions on drugs - Posted on Jan 21 2015

Reason for request

Inclusion

No clinical benefit demonstrated in functional class II or III pulmonary arterial hypertension when compared with available therapies.

Minor improvement in the treatment of class II or III chronic thromboembolic pulmonary hypertension that is inoperable or persistent/recurrent following surgical treatment.

 

  • ADEMPAS has Marketing Authorisation in the treatment of:

- WHO functional class II or III pulmonary arterial hypertension (PAH), as monotherapy or in combination with an endothelin receptor antagonist

- WHO functional class II or III chronic thromboembolic pulmonary hypertension that is inoperable or persistent/recurrent following surgical treatment.

  • In both indications, its efficacy has been demonstrated relative to placebo by a moderate improvement in the walking distance, but there are no data relating to its efficacy in relation to morbidity and mortality.
  • It cannot be used in combination with phosphodiesterase type 5 inhibitors.
  • The risk of respiratory tract bleeding is increased by riociguat among patients who are frequently taking anticoagulants in the presence of risk factors such as recent episodes of serious haemoptysis.

Clinical Benefit

Moderate

Moderate in pulmonary arterial hypertension in functional class II to III in adult patients, as monotherapy or in combination with endothelin receptor antagonists, to improve exercise capacity.

- Moderate in chronic thromboembolic pulmonary hypertension in functional class II to III which is inoperable, or persistent or recurrent after surgical treatment, to improve exercise capacity.


Clinical Added Value

minor

Chronic thromboembolic pulmonary hypertension
The ADEMPAS proprietary medicinal products provide a minor improvement in actual benefit (level IV) in the management of chronic thromboembolic pulmonary hypertension in functional class II to III which is inoperable, or persistent or recurrent after surgical treatment, in the absence of any alternative treatment.

no clinical added value

Pulmonary arterial hypertension
The ADEMPAS proprietary medicinal products do not provide an improvement in actual benefit (level V, non-existent) in the management of pulmonary arterial hypertension in functional class II to III, in comparison with available specific treatments for pulmonary arterial hypertension.


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