Drug updated on 12/11/2024
Dosage Form | Tablet (oral; 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1000 mcg, 1200 mcg, 1400 mcg, 1600 mcg); Injection (Intravenous; 1800 mcg) |
Drug Class | Prostacyclin 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.
Latest News
Summary
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Functional Class and Six-Minute Walk Distance (6MWD) Improvement: Selexipag improved World Health Organization (WHO) functional class (FC) with an odds ratio of 0.564 (95% confidence interval (CI): 0.457-0.697) and significantly increased 6MWD, with a mean difference of 24.20 m (95% CI: 10.74-37.67), particularly after more than 6 months of treatment (mean difference (MD): 40.87 m, 95% CI: 10.97-70.77).
- Clinical Worsening Reduction and Pulmonary Vascular Resistance (PVR): Selexipag reduced the risk of clinical worsening by 39% when compared to placebo and significantly improved PVR in patients.
- Cardiac Index (CI) and N-terminal pro B-type natriuretic peptide (NT-proBNP) Levels: Selexipag led to a mean improvement in CI (MD: 0.47 L/min/m², 95% CI: 0.17-0.77), with notable improvements even at moderate dosages and within 6 months of treatment; it also improved NT-proBNP levels significantly over extended treatment durations (standardized mean difference (SMD): -0.61, 95% CI: -1.17 to -0.05).
- There is no safety information available in the reviewed studies.
- The reviewed studies included patients with connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH), with subgroups of systemic sclerosis (59%), systemic lupus erythematosus (20%), and other connective tissue diseases (21%); maintained doses of selexipag (low, medium, high) showed favorable effects on 6MWD, WHO functional class, NT-proBNP, and cardiac index, particularly with treatment exceeding six months.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Uptravi (selexipag) Prescribing Information. | 2022 | Janssen Biotech, Inc., Titusville, NJ |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Treatment of pulmonary arterial hypertension in patients with connective tissue diseases: a systematic review and meta-analysis | 2024 | Internal and Emergency Medicine |
Comparing the efficacy and safety of low, medium, and high dosages of selexipag for treating pulmonary hypertension: A systematic review and meta-analysis | 2024 | Animal Models and Experimental Medicine |