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Bosentan and Pulmonary Hypertension Caused by COVID-19: A Pilot Randomized Double-blind Clinical Study
Fahime Shokrollahi1, Ali Pazoki1, Abbas Allami1
1Clinical Research Development Unit, BouAlisina Hospital, Qazvin University of Medical Sciences, Qazvin, Iran.
Insights
Bosentan reduced in-hospital mortality and improved echocardiographic measures in COVID-19 patients with pulmonary hypertension (PH). However, it was linked to increased long-term mortality and oxygen needs, requiring further research.
Area of Science:
- Cardiology
- Pulmonology
- Infectious Diseases
Background:
- COVID-19 can cause severe complications like pulmonary hypertension (PH).
- Endothelin-1 (ET-1) receptor antagonists, such as bosentan, may treat elevated ET-1 levels associated with PH.
- Investigating bosentan's efficacy in COVID-19-induced PH is crucial.
Purpose of the Study:
- To evaluate the therapeutic effects of bosentan in patients with COVID-19-induced PH.
- To assess bosentan's impact on mortality and echocardiographic parameters in this patient group.
Main Methods:
- A randomized, double-blind, single-centre study with 72 participants (36 bosentan, 36 placebo).
- Echocardiography was used to measure pulmonary arterial pressure, tricuspid valve pressure gradient, and right atrial pressure.
- Cox proportional hazards regression analyzed mortality over a 6-month follow-up.
Main Results:
- In-hospital mortality was significantly lower in the bosentan group (13%) versus placebo (33.3%) (P=0.003).
- Bosentan improved systolic pulmonary artery pressure and tricuspid regurgitation gradient (P=0.011, P=0.003).
- Bosentan use predicted higher long-term mortality (age-adjusted hazard ratio of 5.24).
Conclusions:
- Bosentan shows a mixed effect in COVID-19-related PH, reducing in-hospital mortality and improving echocardiographic measures.
- However, bosentan therapy was associated with increased supplemental oxygen requirements and long-term mortality.
- Further large-scale studies are needed to clarify bosentan's role in managing PH post-COVID-19.
Introduction/Objective:
Coronavirus disease 2019 (COVID-19) has been the biggest pandemic in history, with severe complications, such as acute respiratory distress syndrome and pulmonary hypertension (PH). An endothelin-1 (ET-1) receptor antagonist, such as bosentan, may be beneficial in treating elevated ET-1 levels. Hence, our study aimed to evaluate the therapeutic effects of bosentan in patients with COVID-19-induced PH.
Methods:
A single-centre, randomized, double-blind study involving 72 participants was carried out; 36 received bosentan and the other 36 received a placebo. Pulmonary arterial pressure, tricuspid valve pressure gradient, and right atrial pressure were measured using echocardiography. The Cox proportional hazards regression model was used to investigate the impact of bosentan and patients' age on mortality during a 6-month follow-up period.
Results:
In-hospital mortality was significantly lower in the case group (13%) compared with the control group (33.3%) (P=0.003). Additionally, bosentan improved echocardiographic parameters, such as systolic pulmonary artery pressure and tricuspid regurgitation gradient (P=0.011 and P=0.003, respectively). Bosentan use was a significant predictor of long-term mortality rates for 600 days [age-adjusted hazard ratio of 5.24 (95% CI 1.34 to 20.46)].
Conclusion:
This study provided a mixed perspective on the use of bosentan therapy in patients with COVID-19-related PH. Bosentan effectively reduced in-hospital mortality and improved echocardiographic measures. However, the treatment group showed an increased requirement for supplemental oxygen therapy and long-term mortality. Further studies with larger sample sizes are necessary to elucidate the effects of bosentan in PH following COVID-19.
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