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Selexipag

(Uptravi®)

Selexipag

Drug updated on 9/4/2024

Dosage FormTablet (oral; 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1000 mcg, 1200 mcg, 1400 mcg, 1600 mcg); Injection (Intravenous; 1800 mcg)
Drug ClassProstacyclin receptor agonists
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH.

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Summary
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  • Uptravi (selexipag) is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH.
  • This summary is based on the review of eight systematic review(s)/meta-analysis(es). [1-8]
  • In pediatric patients with pulmonary hypertension, 80% of the add-on therapy group were classified as low risk according to WHO Functional Class (FC I/II), with 76.9% achieving a 6-minute walk distance (6MWD) greater than 350 meters and 95.5% having a pulmonary vascular resistance index (PVRi) under 20 WU/m². Significant improvements were also observed in NT-proBNP and mean pulmonary arterial pressure (mPAP).
  • In patients with connective tissue disease-associated PAH (CTD-PAH), pharmacological interventions, including selexipag, resulted in significant improvements in WHO FC, 6MWD, clinical worsening (CW), PVR, right atrial pressure (RAP), and cardiac index (CI).
  • Selexipag demonstrated significant clinical benefits in various studies, notably improving hospitalization rates, 6MWD, WHO FC, NT-proBNP, and cardiac index (CI). The efficacy of selexipag was consistent across various dosages and treatment durations, with moderate dosages and longer treatment durations (>6 months) showing enhanced outcomes.
  • Common adverse events associated with selexipag in pediatric patients with pulmonary hypertension included headache, nausea, and diarrhea (>70%). Over 80% of patients in the transition therapy group experienced no side effects.
  • Selexipag was associated with increased adverse events such as vasodilation, headache, jaw pain, diarrhea, nausea/vomiting, myalgias, and pain in extremities. Significant discontinuation due to adverse events was noted compared to other prostacyclin mimetics.
  • In pediatric patients with pulmonary hypertension, the add-on therapy group demonstrated higher effectiveness than the transition therapy group.
  • In patients with CTD-PAH, significant clinical and hemodynamic improvements were observed across subgroups with systemic sclerosis, SLE, and other CTDs.
  • Subgroup analysis revealed that moderate dosages and treatment durations longer than 6 months were associated with better outcomes.
  • There is no specific subgroup information provided for the general adult population with PH.