Opsumit (ingredient: macitentan), a pulmonary arterial hypertension (PAH) therapy imported and supplied by Handok, has improved the function of the right ventricle (RV) of PAH patients in multinational phase 4 clinical study.
RV dysfunction is a crucial indicator of the progression of PAH. The dysfunction is a significant factor of death in patients with the disorder.
The result is significant as it showed enhancement of RV function in the group administered with Opsumit, Handok said in a news release Wednesday.
|Pulmonary arterial hypertension drug Opsumit has improved right ventricular function in phase 4 clinical study. (Handok)|
It was conducted on 87 PAH patients to confirm the effect of the Opsumit on RV function and hemodynamic characteristics. The study also adopted magnetic resonance imaging for accurate measure.
The content, recently published in the journal Journal of Heart and Lung Transplantation, is an intermediate analysis in the 26th week of the 52-week study.
According to the analysis of 71 patients, 10 milligrams of macitentan was administered singly for 26 weeks, and the treatment increased 12 milliliters of the RV stroke volume (RVSV). In contrast, pulmonary vascular resistance (PVR) decreased by 38 percent.
Also, the Opsumit group showed a significant improvement in RV volume and a six-minute walk test.
The World Health Organization's evaluation of functional classification also revealed that 56.3 percent of the patients improved significantly, and 42.3 percent maintained their initial grades.
Opsumit is the most prescribed endothelin receptor antagonist (ERA) in Korea. The drug acts on endothelin A and B, which are distributed in vascular endothelial and smooth muscle cells, and induces pulmonary artery pressure drop by suppressing vascular contraction, according to the press release.
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