This article is more than 5 years old. Information may no longer be current.

Riociguat safe, tolerable in chronic thromboembolic pulmonary hypertension

Patients with chronic thromboembolic pulmonary hypertension tolerated long-term use of riociguat well, according to recent data, and researchers identified two prognostic factors associated with the treatment.

Gérald Simonneau, MD, from the Assistance Publique–Hôpitaux de Paris and Service de Pneumologie in Hôpital Bicêtre, Université Paris-Sud, Laboratoire d’Excellence en Recherche sur le Médicament et Innovation Thérapeutique in Le Kremlin–Bicêtre, France, and colleagues evaluated 237 patients in the CHEST-2 open-label extension study where patients received riociguat for a minimum of 2 years at a maximum dose of 2.5 mg three times per day. The researchers analyzed 6-minute walking distance (6MWD), WHO functional class and N-terminal prohormone of brain natriuretic peptide [NT-proBNP] concentration at baseline and 2-year follow-up, and overall survival and clinical worsening.

They found an overall survival of 93% (95% CI, 89-96) and a clinical worsening-free survival of 82% (95% CI, 77-87) at 2 years. Six-minute walking distance and NT-proBNP concentration at baseline and 2 years all had a significant association with overall survival, as did change from baseline 6-minute walking distance (P = .0047).

The researchers found significant association between baseline WHO functional class and overall survival; however, there was an association between clinical worsening and WHO functional class. There were no significant changes in safety profiles or signals for patients taking riociguat, but 129 patients (54%) experienced adverse events and 14 patients (6%) discontinued therapy due to adverse events.

“A notable result of this study was that change in [6-minute walking distance] over 12 to 16 weeks of riociguat treatment was significantly associated with long-term overall survival and clinical worsening-free survival,” Simonneau and colleagues wrote. “This finding is in contrast to those from some studies of pulmonary arterial hypertension, where change in [6-minute walking distance] was not significantly associated with survival. These findings emphasize that pulmonary arterial hypertension and [chronic thromboembolic pulmonary hypertension] are distinct disease entities that might require different clinical assessments and treatment targets.” – by Jeff Craven

Disclosures: Simonneau has received grants, personal fees, and non-financial support from Actelion, Bayer Pharma AG, GlaxoSmithKline, Eli Lilly, and Pfizer and has received personal fees and non-financial support from Novartis. Please see the full study for a complete list of all other authors’ relevant financial disclosures.