Summary

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• This summary is based on the review of one randomized controlled trial. ^[1]
• Fixed-Dose Combination of Macitentan and Tadalafil (M/T FDC): The fixed-dose combination (FDC) of macitentan and tadalafil significantly reduced pulmonary vascular resistance (PVR) at week 16 compared to macitentan alone (29% greater reduction; geometric mean ratio: 0.71, 95% confidence limits (CL), 0.61 to 0.82; P < 0.0001) and tadalafil alone (28% greater reduction; geometric mean ratio: 0.72, 95% CL, 0.64 to 0.80; P < 0.0001).
• The study included patients with pulmonary arterial hypertension (PAH), both treatment-naive and those previously treated with ERA or PDE5i monotherapy. However, no specific effectiveness outcomes for these subgroups were provided.
• The fixed-dose combination of macitentan and tadalafil (M/T FDC) led to a higher frequency of adverse events (AEs) resulting in discontinuation, serious AEs, and AEs of special interest (anemia, hypotension, and edema) compared to the individual monotherapies. There were three deaths in the M/T FDC group, but they were deemed unrelated to the treatment.
• There is no population types or subgroups information available in the reviewed studies.