Macitentan Triple combination therapy in Pulmonary Arterial Hypertension: Real World evidence from Opus Registry

Triple combination therapy, either initial or sequential is part of the recommendation in the ESC/ERS guidelines for the treatment of Pulmonary Arterial Hypertension (PAH). OPUS is a prospective, multicenter, observational drug registry of PAH patients newly initiated on macitentan. Recently, analysis was done on treatment patterns, outcomes, and safety for PAH patients receiving triple combination therapy comprising of macitentan plus a phosphodiesterase type 5 inhibitor (PDE5i) plus a prostacyclin pathway agent (any route) in OPUS from April 2014 to 2020. In the study triple therapy was either initial (i.e. with no PAH therapy for over 60 days before the start of triple therapy) or sequential (i.e. with ≥1 PAH therapy for over 60 days from the start of triple therapy). In the registry 51 (12.6%) patients were on initial triple therapy and 353 (87.4%) patients were in sequential therapy. Change in clinical characteristics was seen better in the initial triple therapy group with improvement in 6min walking distance, Functional Class, NT pro-BNP, and BNP compared to sequential therapy group. From a safety point of view, no change in the Hepatic adverse event was seen among the triple therapies with Macitentan, but drug discontinuation (Prostacyclin) was seen more with initial triple therapy than with sequential. Kaplan-Meier (KM) estimates (95% CI) patients in Macitentan initiation showed that 69% (for mono), 62% (double) and 61% (triple) therapy were free from hospitalization at 12 months. Survival after 1 year was seen in 91% (sequential), 78% (initial) triple therapy patients. Thus to conclude, there is a steady increase in triple therapy for patients with PAH, and a large improvement in clinical status was seen. The observed safety profile indicates that the majority of patients tolerate this triple regimen with Macitentan. Disclaimer: Lupin makes no representation or warranty of any kind, expressed or implied, regarding the accuracy, adequacy, validity, reliability, availability or completeness of any scientific information shared by the HCP on the ­­­STAR UPDATE podcast. You should not allow the contents of this to substitute for your own medical judgment, which you should exercise in evaluating the information on this website.