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Selexipag: an oral, selective prostacyclin receptor agonist for the treatment of pulmonary arterial hypertension

Gérald Simonneau, Adam Torbicki, Marius M. Hoeper, Marion Delcroix, Kristóf Karlócai, Nazzareno Galiè, Bruno Degano, Diana Bonderman, Marcin Kurzyna, Michela Efficace, Ruben Giorgino, Irene M. Lang
European Respiratory Journal 2012 40: 874-880; DOI: 10.1183/09031936.00137511
Gérald Simonneau
*AP-HP Hôpital Antoine Béclère, Dept of Pneumology, Clamart, France
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  • For correspondence: gerald.simonneau@abc.aphp.fr
Adam Torbicki
#Dept of Pulmonary Circulation and Thromboembolic Diseases, Postgraduate Medical School, ECZ-Otwock, Warsaw, Poland
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Marius M. Hoeper
¶Hannover Medical School, Hannover, Germany
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Marion Delcroix
+University Hospitals (UZ) Leuven, Leuven, Belgium
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Kristóf Karlócai
§Semmelweis University, Budapest, Hungary
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Nazzareno Galiè
fUniversity of Bologna, Institute of Cardiology, Bologna, Italy
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Bruno Degano
*AP-HP Hôpital Antoine Béclère, Dept of Pneumology, Clamart, France
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Diana Bonderman
**Medical University of Vienna, Dept of Internal Medicine II, Division of Cardiology, Vienna, Austria
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Marcin Kurzyna
#Dept of Pulmonary Circulation and Thromboembolic Diseases, Postgraduate Medical School, ECZ-Otwock, Warsaw, Poland
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Michela Efficace
##Actelion Pharmaceuticals Ltd, Allschwil, Switzerland
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Ruben Giorgino
##Actelion Pharmaceuticals Ltd, Allschwil, Switzerland
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Irene M. Lang
**Medical University of Vienna, Dept of Internal Medicine II, Division of Cardiology, Vienna, Austria
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  • Article
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  • Figure 1–
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    Figure 1–

    Change in pulmonary vascular resistance (PVR) from baseline to week 17. a) Per protocol set and b) all-treated set. Data are presented as means and error bars represent 95% confidence limits (CL). Baseline PVR values (mean±sd) for per protocol population for selexipag were 951.9±434.5 dyn·s·cm−5 and for placebo were 826.8±195.8 dyn·s·cm−5. Baseline PVR values (mean± sd) for the all-treated population for selexipag were 948.6±428.0 dyn·s·cm−5 and for placebo were 867.2±379.38 dyn·s·cm−5. TE: treatment effect.

  • Figure 2–
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    Figure 2–

    Change in 6-min walk distance (6MWD) from baseline to week 17 (all-treated population). Baseline values (mean±sd) for selexipag were 394.7±72.0 m and for placebo were 350.3±123.5 m. Week 17 values (mean±sd) for selexipag were 419.3±106.3 m and for placebo were 350.7±139.6 m. TE: treatment effect; CL: confidence limits.

Tables

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  • Table 1– Demographics and aetiology of pulmonary arterial hypertension (PAH) (all-treated set)
    PlaceboSelexipag
    Subjects n1033
    Demographics
     Male/female2/8 (20.0/80.0)6/27 (18.2/81.8)
     Age yrs53.8±16.354.8±16.8
     Weight kg70.6±13.968.7±12.4
     Caucasian/other9/1 (90.0/10.0)29/4 (88.0/12.0)
    Aetiology of PAH
     Idiopathic PAH7 (70.0)24 (72.7)
     Hereditary PAH1 (10.0)1 (3.0)
     Anorexigen-induced PAH2 (6.1)
     PAH-CTD2 (20.0)4 (12.1)
     PAH associated with congenial heart disease2 (6.1)
    • Data are presented as n (%) or mean±sd, unless otherwise stated. CTD: connective tissue disease.

  • Table 2– Disease characteristics and pulmonary arterial hypertension (PAH) background therapy (all-treated set)
    PlaceboSelexipag
    Subjects n1033
    Time from diagnosis yrs4.0±3.15.5±6.1
    PVR dyn·s·cm−5867.2±379.3928.6±436.6
    6-min walk distance m350.3±123.5396.2±71.4
    WHO FC
     I
     II2 (20.0)15 (45.5)
     III8 (80.0)18 (54.5)
     IV
    Borg dyspnoea score4.1±2.63.3±2.1+
    NT-proBNP pg·mL−1#2400.9±1269.8¶1601.4±2443.0§
    Background PAH therapy
     ERA monotherapy4 (40.0)12 (36.4)
     Sildenafil monotherapy3 (30.0)9 (27.2)
     ERA plus sildenafil3 (30.0)12 (36.4)
    • Data are presented as mean±sd or n (%), unless otherwise stated. PVR: pulmonary vascular resistance; WHO FC: World Health Organization functional class; NT-proBNP: N-terminal pro-brain natriuretic peptide; ERA: endothelin receptor antagonist. #: Upper reference values are 100 pg·mL−1 and 172 pg·mL−1 for males aged 45–59 and ≥60 yrs, respectively, and 164 pg·mL−1 and 225 pg·mL−1 for females aged 45–59 and ≥60 yrs, respectively [18]; ¶: n=8; +: n=32; §: n=27.

  • Table 3– Baseline, week 17 and change from baseline to week 17 in secondary haemodynamic parameters (all-treated set)
    RHC parameterBaselineWeek 17Change from baseline to week 17Treatment effect (95% CL)Wilcoxon p-value
    PlaceboSelexipagPlaceboSelexipagPlaceboSelexipag
    Subjects n103310331033
    PVR dyn·s·cm−5867.2±379.3948.6±428.0#1090.8±421.3818.8±416.9#223.6±355.4-129.8±309.7#-33.0%ƒ (-47.0– -15.2)0.0022
    Cardiac index L·min·m−22.5±0.52.4±0.6#2.3±0.42.7±0.6#-0.2±0.20.3±0.5#0.5 (0.13–0.83)0.01
    Mean pulmonary arterial pressure mmHg54.6±13.854.5±15.3#60.3±20.252.8±19.1#5.7±13.3-1.7±11.0#-7.4 (-15.9–1.1)0.1
    Right atrial pressure mmHg11.2±5.76.9±3.6¶8.3±4.97.2±3.6¶-2.9±2.80.3±3.5¶3.2 (0.8–5.7)0.02
    Pulmonary capillary wedge pressure mmHg10.3±2.58.5±3.1+8.7±1.79.1±2.7+-1.6±2.70.6±3.4+2.2 (-0.2–4.6)0.07
    SVR dyn·s·cm−51399.2±475.11572.8±544.7¶1687.1±429.21452.8±433.6¶287.9±227.8-119.9±498.8¶-407.8 (-740.2– -75.5)0.01
    Mixed venous oxygen saturation %60.6±8.461.0±12.3§58.4±9.362.9±10.0§-2.1±4.11.9±10.64.1 (-3.8–11.9)0.3
    • Data are shown as mean±sd, unless otherwise stated. RHC: right heart catheterisation; CL: confidence limits; PVR: pulmonary vascular resistance; SVR: systemic vascular resistance. #: n=32; ¶: n=30; +: n=31; §: n=26; ƒ: treatment effect calculated at week 17 as the change in the geometric mean expressed as a percentage of the baseline value. Although p-values were calculated for secondary end-points, they are only exploratory in nature as there was no formal statistical hypothesis for secondary end-points.

  • Table 4– Baseline and end of study period values, and change from baseline to end of study period in vital sign parameters (safety set)
    Vital signs parameter#BaselineEnd of study periodChange from baseline to end of study period
    PlaceboSelexipagPlaceboSelexipagPlaceboSelexipag
    Subjects n103310331033
    Systolic blood pressure mmHg116.2±11.7117.3±18.5112.7±17.3114.0±15.8−3.5±17.1−3.6±17.3
    Diastolic blood pressure mmHg66.8±10.465.9±10.970.0±9.871.8±9.13.2±12.85.4±11.2
    Heart rate beats·min−174.8±13.275.3±15.877.9±10.575.2±12.13.1±6.0−0.1±7.7
    • Data are presented as mean±sd. #: Treatment effect was not calculated for these safety parameters.

  • Table 5– Treatment-emergent adverse events during the study (safety set)
    Adverse eventsPlaceboSelexipag
    Subjects1033
    Patients with ≥1 adverse event1031
    Adverse events >10% on selexipag
     Headache222
     Jaw pain12
     Pain in an extremity10
     Nausea9
     Nasopharyngitis28
     Diarrhoea16
     Flushing6
     Dizziness5
     Cough4
     Myalgia4
    • Data are presented as n.

Additional Files

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    Please note: supplementary material is not edited by the Editorial Office, and is put online as it has been supplied by the author.

    Files in this Data Supplement:

    • Supplementary tables - Tables 1-3
    • Supplemental figure 1 - Study flow chart
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Selexipag: an oral, selective prostacyclin receptor agonist for the treatment of pulmonary arterial hypertension
Gérald Simonneau, Adam Torbicki, Marius M. Hoeper, Marion Delcroix, Kristóf Karlócai, Nazzareno Galiè, Bruno Degano, Diana Bonderman, Marcin Kurzyna, Michela Efficace, Ruben Giorgino, Irene M. Lang
European Respiratory Journal Oct 2012, 40 (4) 874-880; DOI: 10.1183/09031936.00137511

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Selexipag: an oral, selective prostacyclin receptor agonist for the treatment of pulmonary arterial hypertension
Gérald Simonneau, Adam Torbicki, Marius M. Hoeper, Marion Delcroix, Kristóf Karlócai, Nazzareno Galiè, Bruno Degano, Diana Bonderman, Marcin Kurzyna, Michela Efficace, Ruben Giorgino, Irene M. Lang
European Respiratory Journal Oct 2012, 40 (4) 874-880; DOI: 10.1183/09031936.00137511
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