Table 1Summary of Results

OutcomeGRIPHON Study
Selexipag
N =574		Placebo
N = 582
Median Exposure to Study Treatment (Range), Weeks70.7 (0.3 to 217)63.7 (0.7 to 192)
Primary Composite Outcome, n (%)140 (24.4)212 (36.4)HR 0.61;
99% CI, 0.46 to 0.81;
P < 0.0001
Death — all cause to EOT + 7 days, n (%)a25 (4.4)16 (2.7)
Hospitalization for PAH worsening, n (%)71 (12.4)95 (16.5)
PAH worsening resulting in need for lung transplant or balloon atrial septostomy1 (0.2)2 (0.3)
Parenteral prostanoid therapy or chronic oxygen therapy11 (1.9)14 (2.4)
Disease progression32 (5.6)84 (14.4)
6MWD
Mean baseline 6MWD, m359 (76)348 (83)–
Mean change from baseline (SD) at week 26, m–52 (150)–66 (148)–
Median change from baseline (range) at week 26, m4 (–448 to 260)–9 (–438 to 262)Between-group difference of change: 12.0; 99% CI, 1 to 24
WHO FC Changes
Absence of worsening from baseline of WHO FC at week 26 compared with baseline, n/N (%)444/571 (78)430/574 (75)OR 1.16;
99% CI, 0.81 to 1.66;–P = 0.19
Improvement in WHO FC at week 26 compared with baseline, n/N (%)77/571 (13)50/574 (9)
Deaths
All deaths up to EOT + 7 days46 (8.0)37 (6.4)HR 1.17; 99% CI 0.66 to 2.076
All deaths up to EOT + 30 days▬▬
All deaths up to study closure100 (17.4)105 (18.0)HR 0.97; 99% CI, 0.68 to 1.39
SAE, n (%)252 (44)272 (47)
Stopped treatment due to adverse events, n (%)182 (32)214 (37)

6MWD = six-minute walking distance; CI = confidence interval; EOT= end of treatment (last dose of study drug); FC = functional class; HR = hazard ratio; OR = odds ratio; PAH = pulmonary arterial hypertension; SAE = serious adverse event; SD = standard deviation; WHO = World Health Organization.

Note: Populations in this table are from the full analysis set unless otherwise stated. WHO FC analysis imputed missing data as worsening, and FC IV was excluded for the worsening analysis, because those patients could not worsen to another class.7

a

Counting of deaths as a primary outcome event only included deaths if they occurred as a first event.

Source: Clinical Study Report,8 Sitbon et al.,9 with additional information from the manufacturer.6

From: Executive Summary

Cover of Clinical Review Report: Slexipag (Uptravi)
Clinical Review Report: Slexipag (Uptravi) [Internet].
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