A Multicenter, Double-Blind, Placebo-Controlled, Randomized Clinical Trial of Oral Anticoagulation in Systemic Sclerosis-Related Pulmonary Arterial Hypertension-Results From the SPHInX Study - PubMed
3 hours ago
- #pulmonary arterial hypertension
- #clinical trial
- #systemic sclerosis
- The SPHInX study was the first randomized controlled trial to evaluate oral anticoagulation as adjunct therapy for systemic sclerosis-related pulmonary arterial hypertension (SSc-PAH).
- In this double-blind Phase III trial, patients received either apixaban (2.5 mg twice daily) or placebo for up to 3 years, with the primary endpoint being time to clinical worsening or death.
- No significant benefit was observed with apixaban compared to placebo; the hazard ratio was 0.92 with a p-value of 0.88, indicating no improvement in outcomes.
- There were also no differences between groups in event-free survival, all-cause mortality, or other exploratory endpoints like physical function and quality of life.
- A high incidence of new iron deficiency anemia was reported in the apixaban group (81.8%) compared to controls (28.6%), suggesting potential risks with anticoagulation therapy in SSc-PAH.