In this phase 2 proof-of-concept study we examined the safety and efficacy of selexipag, an orally available, selective prostacyclin receptor (IP receptor) agonist, as a treatment for pulmonary arterial hypertension (PAH). 43 adult patients with symptomatic PAH (receiving stable endothelin receptor antagonist and/or a phosphodiesterase type-5 inhibitor therapy) were randomised three to one to receive either selexipag or placebo. Dosage was up-titrated in 200-μg increments from 200 μg twice daily on day 1 to the maximum tolerated dose by day 35 (maximum allowed dose of 800 μg twice daily). Change in pulmonary vascular resistance at week 17 expressed as a percentage of the baseline value was the primary efficacy end-point, and was analysed in the per protocol set first and then in the all-treated set to assess robustness of results. A statistically significant 30.3% reduction in geometric mean pulmonary vascular resistance was observed after 17 weeks' treatment with selexipag compared with placebo (95% confidence limits -44.7- -12.2; p=0.0045, Wilcoxon rank sum test). This was supported by a similar result from the all-treated set. Selexipag was well tolerated with a safety profile in line with the expected pharmacological effect. Our results encourage the further investigation of selexipag for the treatment of PAH.
In this phase 2 proof - of - concept study we examined the safety and efficacy of selexipag , an orally available , selective prostacyclin receptor ( IP receptor ) agonist , as a treatment for pulmonary arterial hypertension ( PAH ) . 43 adult patients with symptomatic PAH ( receiving stable endothelin receptor antagonist and/or a phosphodiesterase type-5 inhibitor therapy ) were randomised three to one to receive either selexipag or placebo . Dosage was up - titrated in 200-μg increments from 200 μg twice daily on day 1 to the maximum tolerated dose by day 35 ( maximum allowed dose of 800 μg twice daily ) . Change in pulmonary vascular resistance at week 17 expressed as a percentage of the baseline value was the primary efficacy end - point , and was analysed in the per protocol set first and then in the all - treated set to assess robustness of results . A statistically significant 30.3 % reduction in geometric mean pulmonary vascular resistance was observed after 17 weeks ' treatment with selexipag compared with placebo ( 95 % confidence limits -44.7- -12.2 ; p=0.0045 , Wilcoxon rank sum test ) . This was supported by a similar result from the all - treated set . Selexipag was well tolerated with a safety profile in line with the expected pharmacological effect . Our results encourage the further investigation of selexipag for the treatment of PAH .
Selexipag is used for which disease?
Selexipag is used for which disease ?
pulmonary arterial hypertension
pulmonary arterial hypertension