Safety of Riociguat in the Treatment of Thromboembolic Pulmonary Hypertension in Common Practice
In March 2021, the final safety results of riociguat in the treatment of thromboembolic pulmonary arterial hypertension in real-world practice were published from the international EXPERT registry, which also included Czech patients. The safety profile of the therapy was consistent with the findings of previous clinical studies.
Riociguat in the Treatment of CTEPH
Riociguat is the first representative of soluble guanylate cyclase stimulators recommended by the European Respiratory Society and the European Society of Cardiology for the treatment of patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or CTEPH that is persistent/recurrent after surgery. Its efficacy and safety have been confirmed in phase III clinical studies. Other therapeutic options for pulmonary arterial hypertension are prostacyclin analogs, endothelin receptor antagonists, and type 5 phosphodiesterase inhibitors. However, except for treprostinil, these drugs are not approved for CTEPH. Another therapeutic alternative is pulmonary artery balloon angioplasty.
EXPERT Registry
The prospective non-interventional EXPERT registry (EXPosurE Registry RiociguaT) was designed to monitor the long-term safety of riociguat in routine clinical practice. Physicians from 28 countries participated. In addition to patient and disease data, they recorded the occurrence of adverse events and serious adverse events at patient entry into the study and then at regular clinical follow-ups every 3–6 months. Patients were monitored for at least 1 year and up to 4 years during treatment or until day 30 after discontinuation of riociguat. Of the 969 enrolled individuals, 86% completed the study.
Data from 956 patients were analyzed, of whom 56.2% had been using riociguat for at least 3 months before, while it was newly initiated in the others. Their average age was 66.3 ± 13.7 years, and 59.6% were women. The median follow-up duration was 504 days, and the median treatment duration with riociguat was 493.5 days.
Safety of Riociguat in Routine Practice
During follow-up, adverse events occurred in 615 (64.3%) patients, with 148 (15.5%) attributed to the treatment by the investigator. Serious adverse events were reported in 365 (38.2%) patients, with 34 (3.6%) related to the treatment.
The most common adverse events included peripheral edema/edema, dyspnea, right ventricular/right heart failure, dizziness, and pneumonia. Among serious adverse events, right ventricular/right heart failure, pneumonia, dyspnea, and syncope were most frequently reported.
Treatment was discontinued due to adverse effects in 55 (5.8%) patients and due to serious adverse effects in 38 (4.0%). Bleeding, most frequently in the form of epistaxis or hemoptysis, was reported in 110 (11.5%) patients, and serious bleeding occurred in 57 (6.0%). According to the investigators, the treatment was related to bleeding in only 0.9% to 0.4% of registry participants.
Conclusion
The registry facilitated data collection on a large cohort of CTEPH patients who were monitored long enough to detect even less common adverse effects with an incidence of < 0.5%. Data analysis showed that the long-term safety of riociguat in CTEPH patients aligns with clinical trial results. No new safety signals were detected in routine practice.
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Source: Ghofrani H. A., Gomez Sanchez M. A., Humbert M. et al. Riociguat treatment in patients with chronic thromboembolic pulmonary hypertension: final safety data from the EXPERT registry. Respir Med 2021 Mar; 178: 106220, doi: 10.1016/j.rmed.2020.106220.
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