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Clinical Summary

Pulmonary arterial hypertension: oral treprostinil reduces risk of clinical worsening

Takeaway

  • Oral treprostinil reduces risk of clinical worsening, including death, by 26% in patients with pulmonary arterial hypertension (PAH), according to the FREEDOM-EV trial.

Why this matters

  • This is the first trial to assess the clinical outcomes of oral treprostinil therapy for PAH.
  • A previous trial found improvement in exercise capacity.

Study design

  • Multicentre, randomised, double-blind, placebo-controlled trial (n=690).
  • Participants were eligible if using approved oral monotherapy for >30 days prior to randomisation and had a 6-minute walk distance ≥150 m.
  • Primary outcome: time to clinical worsening (defined by death, hospitalisation due to worsening PAH, initiation of inhaled or parenteral prostacyclin therapy, disease progression, or unsatisfactory long-term clinical response).
  • Funding: United Therapeutics Corporation.

Key results

  • The treprostinil group had 26% less clinical worsening (26% vs 36% of placebo group; HR, 0.74; P=.028).
  • The treprostinil group had better measures of disease status (including functional class, Borg dyspnoea score, and N-terminal-pro-brain natriuretic peptide) at week ≥24.
  • The treprostinil group attained a lower mortality risk profile (at weeks 12-60) despite higher mortality risk at baseline, according to noninvasive risk stratification analysis.
  • The most common adverse events were:
    • Headache: 69.9% vs 29.7%.
    • Diarrhoea: 65.6% vs 19.8%.
    • Flushing: 43.6% vs 7.6%.
    • Nausea: 37.0% vs 16.9%.
    • Vomiting: 32.1% vs 7.6%.

Limitations

  • High discontinuation rate, 18.8%.

References


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