Macitentan and morbidity and mortality in pulmonary arterial hypertension

Standard

Macitentan and morbidity and mortality in pulmonary arterial hypertension. / Pulido, Tomás; Adzerikho, Igor; Channick, Richard N; Delcroix, Marion; Galiè, Nazzareno; Ghofrani, Hossein-Ardeschir; Jansa, Pavel; Jing, Zhi-Cheng; Le Brun, Franck-Olivier; Mehta, Sanjay; Mittelholzer, Camilla M; Perchenet, Loïc; Sastry, B K S; Sitbon, Olivier; Souza, Rogério; Torbicki, Adam; Zeng, Xiaofeng; Rubin, Lewis J; Simonneau, Gérald; SERAPHIN Investigators.

In: NEW ENGL J MED, Vol. 369, No. 9, 29.08.2013, p. 809-18.

Research output: SCORING: Contribution to journalSCORING: Journal articleResearchpeer-review

Harvard

Pulido, T, Adzerikho, I, Channick, RN, Delcroix, M, Galiè, N, Ghofrani, H-A, Jansa, P, Jing, Z-C, Le Brun, F-O, Mehta, S, Mittelholzer, CM, Perchenet, L, Sastry, BKS, Sitbon, O, Souza, R, Torbicki, A, Zeng, X, Rubin, LJ, Simonneau, G & SERAPHIN Investigators 2013, 'Macitentan and morbidity and mortality in pulmonary arterial hypertension', NEW ENGL J MED, vol. 369, no. 9, pp. 809-18. https://doi.org/10.1056/NEJMoa1213917

APA

Pulido, T., Adzerikho, I., Channick, R. N., Delcroix, M., Galiè, N., Ghofrani, H-A., Jansa, P., Jing, Z-C., Le Brun, F-O., Mehta, S., Mittelholzer, C. M., Perchenet, L., Sastry, B. K. S., Sitbon, O., Souza, R., Torbicki, A., Zeng, X., Rubin, L. J., Simonneau, G., & SERAPHIN Investigators (2013). Macitentan and morbidity and mortality in pulmonary arterial hypertension. NEW ENGL J MED, 369(9), 809-18. https://doi.org/10.1056/NEJMoa1213917

Vancouver

Pulido T, Adzerikho I, Channick RN, Delcroix M, Galiè N, Ghofrani H-A et al. Macitentan and morbidity and mortality in pulmonary arterial hypertension. NEW ENGL J MED. 2013 Aug 29;369(9):809-18. https://doi.org/10.1056/NEJMoa1213917

Bibtex

@article{703e1b313fe6440ea8304d33d11537f4,
title = "Macitentan and morbidity and mortality in pulmonary arterial hypertension",
abstract = "BACKGROUND: Current therapies for pulmonary arterial hypertension have been adopted on the basis of short-term trials with exercise capacity as the primary end point. We assessed the efficacy of macitentan, a new dual endothelin-receptor antagonist, using a primary end point of morbidity and mortality in a long-term trial.METHODS: We randomly assigned patients with symptomatic pulmonary arterial hypertension to receive placebo once daily, macitentan at a once-daily dose of 3 mg, or macitentan at a once-daily dose of 10 mg. Stable use of oral or inhaled therapy for pulmonary arterial hypertension, other than endothelin-receptor antagonists, was allowed at study entry. The primary end point was the time from the initiation of treatment to the first occurrence of a composite end point of death, atrial septostomy, lung transplantation, initiation of treatment with intravenous or subcutaneous prostanoids, or worsening of pulmonary arterial hypertension.RESULTS: A total of 250 patients were randomly assigned to placebo, 250 to the 3-mg macitentan dose, and 242 to the 10-mg macitentan dose. The primary end point occurred in 46.4%, 38.0%, and 31.4% of the patients in these groups, respectively. The hazard ratio for the 3-mg macitentan dose as compared with placebo was 0.70 (97.5% confidence interval [CI], 0.52 to 0.96; P=0.01), and the hazard ratio for the 10-mg macitentan dose as compared with placebo was 0.55 (97.5% CI, 0.39 to 0.76; P<0.001). Worsening of pulmonary arterial hypertension was the most frequent primary end-point event. The effect of macitentan on this end point was observed regardless of whether the patient was receiving therapy for pulmonary arterial hypertension at baseline. Adverse events more frequently associated with macitentan than with placebo were headache, nasopharyngitis, and anemia.CONCLUSIONS: Macitentan significantly reduced morbidity and mortality among patients with pulmonary arterial hypertension in this event-driven study. (Funded by Actelion Pharmaceuticals; SERAPHIN ClinicalTrials.gov number, NCT00660179.).",
keywords = "Adult, Double-Blind Method, Exercise Tolerance, Female, Hospitalization, Humans, Hypertension, Pulmonary, Kaplan-Meier Estimate, Male, Middle Aged, Pyrimidines, Receptor, Endothelin A, Receptor, Endothelin B, Sulfonamides",
author = "Tom{\'a}s Pulido and Igor Adzerikho and Channick, {Richard N} and Marion Delcroix and Nazzareno Gali{\`e} and Hossein-Ardeschir Ghofrani and Pavel Jansa and Zhi-Cheng Jing and {Le Brun}, Franck-Olivier and Sanjay Mehta and Mittelholzer, {Camilla M} and Lo{\"i}c Perchenet and Sastry, {B K S} and Olivier Sitbon and Rog{\'e}rio Souza and Adam Torbicki and Xiaofeng Zeng and Rubin, {Lewis J} and G{\'e}rald Simonneau and {SERAPHIN Investigators} and Hans Klose",
year = "2013",
month = aug,
day = "29",
doi = "10.1056/NEJMoa1213917",
language = "English",
volume = "369",
pages = "809--18",
journal = "NEW ENGL J MED",
issn = "0028-4793",
publisher = "Massachussetts Medical Society",
number = "9",

}

RIS

TY - JOUR

T1 - Macitentan and morbidity and mortality in pulmonary arterial hypertension

AU - Pulido, Tomás

AU - Adzerikho, Igor

AU - Channick, Richard N

AU - Delcroix, Marion

AU - Galiè, Nazzareno

AU - Ghofrani, Hossein-Ardeschir

AU - Jansa, Pavel

AU - Jing, Zhi-Cheng

AU - Le Brun, Franck-Olivier

AU - Mehta, Sanjay

AU - Mittelholzer, Camilla M

AU - Perchenet, Loïc

AU - Sastry, B K S

AU - Sitbon, Olivier

AU - Souza, Rogério

AU - Torbicki, Adam

AU - Zeng, Xiaofeng

AU - Rubin, Lewis J

AU - Simonneau, Gérald

AU - SERAPHIN Investigators

AU - Klose, Hans

PY - 2013/8/29

Y1 - 2013/8/29

N2 - BACKGROUND: Current therapies for pulmonary arterial hypertension have been adopted on the basis of short-term trials with exercise capacity as the primary end point. We assessed the efficacy of macitentan, a new dual endothelin-receptor antagonist, using a primary end point of morbidity and mortality in a long-term trial.METHODS: We randomly assigned patients with symptomatic pulmonary arterial hypertension to receive placebo once daily, macitentan at a once-daily dose of 3 mg, or macitentan at a once-daily dose of 10 mg. Stable use of oral or inhaled therapy for pulmonary arterial hypertension, other than endothelin-receptor antagonists, was allowed at study entry. The primary end point was the time from the initiation of treatment to the first occurrence of a composite end point of death, atrial septostomy, lung transplantation, initiation of treatment with intravenous or subcutaneous prostanoids, or worsening of pulmonary arterial hypertension.RESULTS: A total of 250 patients were randomly assigned to placebo, 250 to the 3-mg macitentan dose, and 242 to the 10-mg macitentan dose. The primary end point occurred in 46.4%, 38.0%, and 31.4% of the patients in these groups, respectively. The hazard ratio for the 3-mg macitentan dose as compared with placebo was 0.70 (97.5% confidence interval [CI], 0.52 to 0.96; P=0.01), and the hazard ratio for the 10-mg macitentan dose as compared with placebo was 0.55 (97.5% CI, 0.39 to 0.76; P<0.001). Worsening of pulmonary arterial hypertension was the most frequent primary end-point event. The effect of macitentan on this end point was observed regardless of whether the patient was receiving therapy for pulmonary arterial hypertension at baseline. Adverse events more frequently associated with macitentan than with placebo were headache, nasopharyngitis, and anemia.CONCLUSIONS: Macitentan significantly reduced morbidity and mortality among patients with pulmonary arterial hypertension in this event-driven study. (Funded by Actelion Pharmaceuticals; SERAPHIN ClinicalTrials.gov number, NCT00660179.).

AB - BACKGROUND: Current therapies for pulmonary arterial hypertension have been adopted on the basis of short-term trials with exercise capacity as the primary end point. We assessed the efficacy of macitentan, a new dual endothelin-receptor antagonist, using a primary end point of morbidity and mortality in a long-term trial.METHODS: We randomly assigned patients with symptomatic pulmonary arterial hypertension to receive placebo once daily, macitentan at a once-daily dose of 3 mg, or macitentan at a once-daily dose of 10 mg. Stable use of oral or inhaled therapy for pulmonary arterial hypertension, other than endothelin-receptor antagonists, was allowed at study entry. The primary end point was the time from the initiation of treatment to the first occurrence of a composite end point of death, atrial septostomy, lung transplantation, initiation of treatment with intravenous or subcutaneous prostanoids, or worsening of pulmonary arterial hypertension.RESULTS: A total of 250 patients were randomly assigned to placebo, 250 to the 3-mg macitentan dose, and 242 to the 10-mg macitentan dose. The primary end point occurred in 46.4%, 38.0%, and 31.4% of the patients in these groups, respectively. The hazard ratio for the 3-mg macitentan dose as compared with placebo was 0.70 (97.5% confidence interval [CI], 0.52 to 0.96; P=0.01), and the hazard ratio for the 10-mg macitentan dose as compared with placebo was 0.55 (97.5% CI, 0.39 to 0.76; P<0.001). Worsening of pulmonary arterial hypertension was the most frequent primary end-point event. The effect of macitentan on this end point was observed regardless of whether the patient was receiving therapy for pulmonary arterial hypertension at baseline. Adverse events more frequently associated with macitentan than with placebo were headache, nasopharyngitis, and anemia.CONCLUSIONS: Macitentan significantly reduced morbidity and mortality among patients with pulmonary arterial hypertension in this event-driven study. (Funded by Actelion Pharmaceuticals; SERAPHIN ClinicalTrials.gov number, NCT00660179.).

KW - Adult

KW - Double-Blind Method

KW - Exercise Tolerance

KW - Female

KW - Hospitalization

KW - Humans

KW - Hypertension, Pulmonary

KW - Kaplan-Meier Estimate

KW - Male

KW - Middle Aged

KW - Pyrimidines

KW - Receptor, Endothelin A

KW - Receptor, Endothelin B

KW - Sulfonamides

U2 - 10.1056/NEJMoa1213917

DO - 10.1056/NEJMoa1213917

M3 - SCORING: Journal article

C2 - 23984728

VL - 369

SP - 809

EP - 818

JO - NEW ENGL J MED

JF - NEW ENGL J MED

SN - 0028-4793

IS - 9

ER -