ADEMPAS (riociguat), antihypertensive for pulmonary arterial hypertension

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.