Drug updated on 10/9/2024
| Dosage Form | Tablet (oral; macitentan/tadalafil 10 mg/20 mg, 10 mg/40 mg) |
| Drug Class | endothelin receptor antagonists and phosphodiesterase 5 inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for chronic treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adult patients of WHO functional class (FC) II-III. Individually, macitentan reduces the risk of clinical worsening events and hospitalization, and tadalafil improves exercise ability.
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Summary
- This summary is based on the review of one randomized controlled trial(s).
- Fixed-dose combination of macitentan and tadalafil (M/T FDC) demonstrated a 29% greater reduction in pulmonary vascular resistance (The primary endpoint was change in pulmonary vascular resistance (PVR)) compared to macitentan monotherapy (geometric mean ratio 0.71; 95% CL: 0.61-0.82; P < 0.0001) and a 28% greater reduction compared to tadalafil monotherapy (geometric mean ratio 0.72; 95% CL: 0.64-0.80; P < 0.0001). [1]
- The study included risk pulmonary arterial hypertension (PAH) patients classified as WHO functional class II-III, covering treatment-naïve patients and those previously treated with BACKGROUND Endothelin receptor antagonist (ERA) or PDE5i monotherapy, although specific outcomes for these subgroups were not provided in the study.
- Adverse events, serious adverse events, and adverse events leading to discontinuation were more frequent in the M/T FDC group compared to the monotherapy groups, with anemia, hypotension, and edema being more commonly observed.
- Three deaths occurred in the M/T FDC arm, but these were determined to be unrelated to the treatment.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Opsynvi (macitentan and tadalafil) Prescribing Information. | 2024 | Janssen Pharmaceutical Company, Titusville, NJ |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Randomized Trial of Macitentan/Tadalafil Single-Tablet Combination Therapy for Pulmonary Arterial Hypertension. | 186Subjects F: 78% M: 22% | 2024 | Journal of the American College of Cardiology |
Document Title
Sex Distribution:
F:78%
M:22%
186Subjects
Year:
2024
Source:Journal of the American College of Cardiology