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Upfront triple combination therapy in pulmonary arterial hypertension: a pilot study

Olivier Sitbon, Xavier Jaïs, Laurent Savale, Vincent Cottin, Emmanuel Bergot, Elise Artaud Macari, Hélène Bouvaist, Claire Dauphin, François Picard, Sophie Bulifon, David Montani, Marc Humbert, Gérald Simonneau
European Respiratory Journal 2014 43: 1691-1697; DOI: 10.1183/09031936.00116313
Olivier Sitbon
1Univ. Paris-Sud, Faculté de Médecine, Le Kremlin-Bicêtre
2APHP, Centre de Référence de l'Hypertension Pulmonaire Sévère, Service de Pneumologie et Soins Intensifs, DHU Thorax Innovation, Hôpital de Bicêtre, Le Kremlin-Bicêtre
3INSERM U999, LabEx LERMIT, Centre Chirurgical Marie-Lannelongue, Le Plessis-Robinson
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  • For correspondence: olivier.sitbon@bct.aphp.fr
Xavier Jaïs
1Univ. Paris-Sud, Faculté de Médecine, Le Kremlin-Bicêtre
2APHP, Centre de Référence de l'Hypertension Pulmonaire Sévère, Service de Pneumologie et Soins Intensifs, DHU Thorax Innovation, Hôpital de Bicêtre, Le Kremlin-Bicêtre
3INSERM U999, LabEx LERMIT, Centre Chirurgical Marie-Lannelongue, Le Plessis-Robinson
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Laurent Savale
1Univ. Paris-Sud, Faculté de Médecine, Le Kremlin-Bicêtre
2APHP, Centre de Référence de l'Hypertension Pulmonaire Sévère, Service de Pneumologie et Soins Intensifs, DHU Thorax Innovation, Hôpital de Bicêtre, Le Kremlin-Bicêtre
3INSERM U999, LabEx LERMIT, Centre Chirurgical Marie-Lannelongue, Le Plessis-Robinson
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Vincent Cottin
4Univ. Lyon-1, Hospices Civils de Lyon, Centre de Référence des maladies pulmonaires rares, Centre de Compétences de l'Hypertension Pulmonaire, Hôpital Louis Pradel, Lyon
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Emmanuel Bergot
5Service de Pneumologie et d'oncologie thoracique, Hôpital Universitaire de Caen, Caen
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Elise Artaud Macari
1Univ. Paris-Sud, Faculté de Médecine, Le Kremlin-Bicêtre
2APHP, Centre de Référence de l'Hypertension Pulmonaire Sévère, Service de Pneumologie et Soins Intensifs, DHU Thorax Innovation, Hôpital de Bicêtre, Le Kremlin-Bicêtre
3INSERM U999, LabEx LERMIT, Centre Chirurgical Marie-Lannelongue, Le Plessis-Robinson
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Hélène Bouvaist
6Service de Cardiologie, CHU, Grenoble
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Claire Dauphin
7Service de Cardiologie, CHU Gabriel-Montpied, Clermont-Ferrand
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François Picard
8Service de Cardiologie, Hôpital Haut-Lévêque, Pessac, France
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Sophie Bulifon
1Univ. Paris-Sud, Faculté de Médecine, Le Kremlin-Bicêtre
2APHP, Centre de Référence de l'Hypertension Pulmonaire Sévère, Service de Pneumologie et Soins Intensifs, DHU Thorax Innovation, Hôpital de Bicêtre, Le Kremlin-Bicêtre
3INSERM U999, LabEx LERMIT, Centre Chirurgical Marie-Lannelongue, Le Plessis-Robinson
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David Montani
1Univ. Paris-Sud, Faculté de Médecine, Le Kremlin-Bicêtre
2APHP, Centre de Référence de l'Hypertension Pulmonaire Sévère, Service de Pneumologie et Soins Intensifs, DHU Thorax Innovation, Hôpital de Bicêtre, Le Kremlin-Bicêtre
3INSERM U999, LabEx LERMIT, Centre Chirurgical Marie-Lannelongue, Le Plessis-Robinson
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Marc Humbert
1Univ. Paris-Sud, Faculté de Médecine, Le Kremlin-Bicêtre
2APHP, Centre de Référence de l'Hypertension Pulmonaire Sévère, Service de Pneumologie et Soins Intensifs, DHU Thorax Innovation, Hôpital de Bicêtre, Le Kremlin-Bicêtre
3INSERM U999, LabEx LERMIT, Centre Chirurgical Marie-Lannelongue, Le Plessis-Robinson
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Gérald Simonneau
1Univ. Paris-Sud, Faculté de Médecine, Le Kremlin-Bicêtre
2APHP, Centre de Référence de l'Hypertension Pulmonaire Sévère, Service de Pneumologie et Soins Intensifs, DHU Thorax Innovation, Hôpital de Bicêtre, Le Kremlin-Bicêtre
3INSERM U999, LabEx LERMIT, Centre Chirurgical Marie-Lannelongue, Le Plessis-Robinson
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    Figure 1–

    Box and whisker plots of a) 6-min walk distance, b) mean pulmonary arterial pressure (PAP), c) cardiac index and d) pulmonary vascular resistance (PVR) at baseline, month 4 and the final follow-up visit (mean±sd follow-up time 32±19 months) after initiation of upfront epoprostenol, bosentan and sildenafil combination therapy (n=18). Squares represents the mean, boxes and diamonds represent the standard deviation, and whiskers represent the range.

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  • Table 1– Patients’ baseline characteristics
    Subjects19
    Age years (range)39.4±14.2 (18.1–63.1)
    Females17 (89)
    Idiopathic/heritable/anorexigen-associated PAH9/10/0
    BMPR2 mutation carrier n/n tested (%)10/13 (77)
    NYHA functional class III/IV8 (42)/11 (58)
    6-min walk distance m215±174
    Haemodynamics
     Right atrial pressure mmHg12.2±5.2
     Mean pulmonary arterial pressure mmHg67.7±15.8
     Pulmonary capillary wedge pressure mmHg8.3±3.4
     Cardiac output L·min−12.83±0.77
     Cardiac index L·min−1·m−21.64±0.34
     Pulmonary vascular resistance dyn·s·cm−51807±722
     Mean blood pressure mmHg91.7±12.2
     Heart rate beats per min92.3±10.7
     Mixed venous oxygen saturation %50.1±9.0
    • Data are presented as n, mean±sd or n (%), unless otherwise stated. PAH: pulmonary arterial hypertension; BMPR2: bone morphogenetic protein receptor type II; NYHA: New York Heart Association.

  • Table 2– Functional class, 6-min walk distance (6MWD) and haemodynamics at the baseline, month 4 and final follow-up visits
    BaselineMonth 4 visitFinal follow-up visit#
    NYHA FC I/II/III/IV n0/0/8/101/16/1/0**4/14/0/0**
    6MWD m227±171463±94**514±105**,¶
    Haemodynamics
     RAP mmHg11.9±5.24.9±4.9**5.2±3.5**
     mPAP mmHg65.8±13.745.7±14.0**44.4±13.4**
     PCWP mmHg8.4±3.56.7±3.27.9±2.8
     Cardiac index L·min−1·m−21.66±0.353.49±0.69**3.64±0.65**
     PVR dyn·s·cm−51718±627564±260**492±209**
     Mean BP mmHg92.1±12.580.1±11.7**84.9±19.4
     HR beats per min92.3±10.783.9±9.8**79.9±13.4**
     SvO2 %51.0±8.569.7±5.2**72.2±4.0**
    Dose of epoprostenol achieved ng·kg−1·min−1015.9±1.919.6±6.0
    • Data are presented as mean±sd unless otherwise stated. n=18. NYHA: New York Heart Association; FC: functional class; 6MWD: 6-minute walk distance; RAP: right atrial pressure; mPAP: mean pulmonary arterial pressure; PCWP: pulmonary capillary wedge pressure; PVR: pulmonary vascular resistance; BP: blood pressure; HR: heart rate; SvO2: mixed venous oxygen saturation. #: follow-up time 32±19 months. **: p<0.01 versus baseline; ¶: p<0.01 versus month 4 visit.

Additional Files

  • Figures
  • Tables
  • Disclosures

    Files in this Data Supplement:

    • H. Bouvaist
    • V. Cottin
    • M. Humbert
    • X. Jaïs
    • D. Montani
    • F. Picard
    • L. Savale
    • G. Simonneau
    • O. Sitbon
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Upfront triple combination therapy in pulmonary arterial hypertension: a pilot study
Olivier Sitbon, Xavier Jaïs, Laurent Savale, Vincent Cottin, Emmanuel Bergot, Elise Artaud Macari, Hélène Bouvaist, Claire Dauphin, François Picard, Sophie Bulifon, David Montani, Marc Humbert, Gérald Simonneau
European Respiratory Journal Jun 2014, 43 (6) 1691-1697; DOI: 10.1183/09031936.00116313

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Upfront triple combination therapy in pulmonary arterial hypertension: a pilot study
Olivier Sitbon, Xavier Jaïs, Laurent Savale, Vincent Cottin, Emmanuel Bergot, Elise Artaud Macari, Hélène Bouvaist, Claire Dauphin, François Picard, Sophie Bulifon, David Montani, Marc Humbert, Gérald Simonneau
European Respiratory Journal Jun 2014, 43 (6) 1691-1697; DOI: 10.1183/09031936.00116313
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