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Efficacy and safety of selexipag in patients with inoperable or persistent/recurrent CTEPH (SELECT randomised trial)
Nick H Kim1, Richard Channick2, Marion Delcroix3
1Pulmonary Vascular Medicine, University of California San Diego, La Jolla, CA, USA h33kim@health.ucsd.edu.
Insights
The SELECT trial for chronic thromboembolic pulmonary hypertension was stopped early due to futility. Selexipag did not show a significant benefit over placebo in reducing pulmonary vascular resistance.
Area of Science:
- Cardiology
- Pulmonology
- Clinical Trials
Background:
- The SELECT trial was the first global randomized controlled trial evaluating selexipag in patients with chronic thromboembolic pulmonary hypertension (CTEPH).
- It aimed to assess the efficacy and safety of selexipag as a treatment for inoperable or persistent/recurrent CTEPH.
Purpose of the Study:
- To evaluate the efficacy of selexipag in reducing pulmonary vascular resistance (PVR) in patients with CTEPH.
- To assess the safety and tolerability of selexipag in this patient population.
Main Methods:
- A multicenter, randomized, double-blind, placebo-controlled, phase 3 study (NCT03689244).
- Adults with CTEPH (WHO FC I-IV, 6-min walk distance 100-450m) received selexipag or placebo plus standard of care.
- The primary endpoint was the percent change in PVR from baseline at week 20.
Main Results:
- The study was discontinued for futility by the data monitoring committee.
- No statistically significant difference in PVR was observed between the selexipag and placebo groups (PVR ratio: 0.95, p=0.412).
- Adverse events were reported in 98.4% of selexipag patients and 82.8% of placebo patients, consistent with known selexipag safety.
Conclusions:
- The SELECT trial demonstrated no treatment effect of selexipag on PVR in patients with CTEPH.
- The study's discontinuation for futility highlights the challenges in treating this condition.
- Selexipag's safety profile in the trial was consistent with previous findings, with no new safety concerns.
Background:
SELECT was the first global randomised controlled trial of selexipag with standard of care in patients with inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension.
Methods:
SELECT was a multicentre, randomised, double-blind, placebo-controlled, parallel-group, group-sequential, phase 3 study (ClinicalTrials.gov: NCT03689244). Adults aged ≤85 years in World Health Organization Functional Class I-IV, with a 6-min walk distance of 100-450 m, were randomised (1:1) to receive selexipag (200-1600 µg twice daily titration until individual maximum tolerated dose)+standard of care or placebo+standard of care. Patients were recruited into the haemodynamic set (first 91 randomised patients to undergo right heart catheterisation (RHC); week 20) or non-haemodynamic cohort (remaining patients, no RHC required). The primary end-point was percent of baseline pulmonary vascular resistance (PVR; week 20). Safety was also assessed.
Results:
Of 321 patients screened, 128 were randomised (haemodynamic set n=91 (selexipag n=47; placebo n=44)). In the haemodynamic set, 29 (31.9%) patients had previous pulmonary endarterectomy (PEA), 20 (22.0%) balloon pulmonary angioplasty (BPA), and 14 (15.4%) both PEA and BPA; 28 (30.8%) were inoperable. The independent data monitoring committee recommended to stop the study for futility as no statistically significant difference was observed for the primary end-point (between-treatment geometric least squares mean ratio of PVR: 0.95, 95% CI 0.84-1.07; p=0.412). Adverse events were reported in 63 (98.4%) and 53 (82.8%) patients for selexipag and placebo, respectively.
Conclusions:
SELECT was discontinued for futility, as no treatment effect on the primary end-point (PVR) was observed. Safety data were consistent with the established safety profile of selexipag, with no new safety signals identified.
