Safety of riociguat for the treatment of pulmonary hypertension: Data from the EXPERT registry

Background: Riociguat is approved for the treatment of patients with pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). Aims: The EXPosurE Registry RiociguaT (EXPERT: NCT02092818) aims to obtain long-term safety data on the use of riociguat in clinical practice. Methods: EXPERT is an international, multicenter, prospective, non-interventional study. The study is currently ongoing and the primary endpoints are adverse event (AE) and serious AE (SAE) incidence, and all-cause mortality. The secondary endpoints include clinical effects and resource utilization. Data from the July 2017 interim analysis will be presented. Results: Baseline data were available for 713 patients (79% of the planned cohort) at the time of the July 10, 2016 analysis. Of these patients, 169 had PAH, 511 had CTEPH, and 33 had other forms of PH. At study entry, 54% of patients with PAH and CTEPH were pretreated (receiving riociguat for ≥3 months), while 46% were newly treated (receiving riociguat for Conclusions: The AEs and SAEs reported in EXPERT are consistent with the known safety profile of riociguat, with no new safety signals identified. Newly treated patients were more likely to experience an AE than pretreated patients.