Macitentan and Morbidity and Mortality in Pulmonary Arterial Hypertension
In an event-driven trial, macitentan (an endothelin-receptor antagonist) at a dose of 3 or 10 mg was compared with placebo in patients with symptomatic pulmonary arterial hypertension. At a median of 115 weeks, both macitentan doses were associated with reduced morbidity and mortality. Pulmonary art...
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| Published in | The New England journal of medicine Vol. 369; no. 9; pp. 809 - 818 |
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| Main Authors | , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Waltham, MA
Massachusetts Medical Society
29.08.2013
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| Subjects | |
| Online Access | Get full text |
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| Abstract | In an event-driven trial, macitentan (an endothelin-receptor antagonist) at a dose of 3 or 10 mg was compared with placebo in patients with symptomatic pulmonary arterial hypertension. At a median of 115 weeks, both macitentan doses were associated with reduced morbidity and mortality.
Pulmonary arterial hypertension, a severe disease characterized by a sustained elevation of pulmonary vascular resistance, ultimately leads to right heart failure and death.
1
Disease progression occurs despite the availability of drugs that are specific for the disorder.
2
Endothelin-receptor antagonists, phosphodiesterase type 5 inhibitors, and prostacyclin and its analogues have been approved for the treatment of pulmonary arterial hypertension and adopted clinically on the basis of short-term trials (12 to 16 weeks) that have shown improvements in exercise capacity as measured by the distance walked in 6 minutes.
3
–
10
However, current guidelines suggest that the primary end point in phase 3 . . . |
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| AbstractList | 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.BACKGROUNDCurrent 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.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.METHODSWe 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.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.RESULTSA 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.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.).CONCLUSIONSMacitentan 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.). In an event-driven trial, macitentan (an endothelin-receptor antagonist) at a dose of 3 or 10 mg was compared with placebo in patients with symptomatic pulmonary arterial hypertension. At a median of 115 weeks, both macitentan doses were associated with reduced morbidity and mortality. Pulmonary arterial hypertension, a severe disease characterized by a sustained elevation of pulmonary vascular resistance, ultimately leads to right heart failure and death. 1 Disease progression occurs despite the availability of drugs that are specific for the disorder. 2 Endothelin-receptor antagonists, phosphodiesterase type 5 inhibitors, and prostacyclin and its analogues have been approved for the treatment of pulmonary arterial hypertension and adopted clinically on the basis of short-term trials (12 to 16 weeks) that have shown improvements in exercise capacity as measured by the distance walked in 6 minutes. 3 – 10 However, current guidelines suggest that the primary end point in phase 3 . . . 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. 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. 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. 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.). BackgroundCurrent 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.MethodsWe 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.ResultsA 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.ConclusionsMacitentan 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.) |
| Author | Sastry, B.K.S Sitbon, Olivier Souza, Rogério Perchenet, Loïc Jansa, Pavel Jing, Zhi-Cheng Torbicki, Adam Ghofrani, Hossein-Ardeschir Delcroix, Marion Mittelholzer, Camilla M Mehta, Sanjay Zeng, Xiaofeng Adzerikho, Igor Rubin, Lewis J Channick, Richard N Galiè, Nazzareno Simonneau, Gérald Pulido, Tomás Le Brun, Franck-Olivier |
| Author_xml | – sequence: 1 givenname: Tomás surname: Pulido fullname: Pulido, Tomás organization: The authors' affiliations are listed in the Appendix – sequence: 2 givenname: Igor surname: Adzerikho fullname: Adzerikho, Igor organization: The authors' affiliations are listed in the Appendix – sequence: 3 givenname: Richard N surname: Channick fullname: Channick, Richard N organization: The authors' affiliations are listed in the Appendix – sequence: 4 givenname: Marion surname: Delcroix fullname: Delcroix, Marion organization: The authors' affiliations are listed in the Appendix – sequence: 5 givenname: Nazzareno surname: Galiè fullname: Galiè, Nazzareno organization: The authors' affiliations are listed in the Appendix – sequence: 6 givenname: Hossein-Ardeschir surname: Ghofrani fullname: Ghofrani, Hossein-Ardeschir organization: The authors' affiliations are listed in the Appendix – sequence: 7 givenname: Pavel surname: Jansa fullname: Jansa, Pavel organization: The authors' affiliations are listed in the Appendix – sequence: 8 givenname: Zhi-Cheng surname: Jing fullname: Jing, Zhi-Cheng organization: The authors' affiliations are listed in the Appendix – sequence: 9 givenname: Franck-Olivier surname: Le Brun fullname: Le Brun, Franck-Olivier organization: The authors' affiliations are listed in the Appendix – sequence: 10 givenname: Sanjay surname: Mehta fullname: Mehta, Sanjay organization: The authors' affiliations are listed in the Appendix – sequence: 11 givenname: Camilla M surname: Mittelholzer fullname: Mittelholzer, Camilla M organization: The authors' affiliations are listed in the Appendix – sequence: 12 givenname: Loïc surname: Perchenet fullname: Perchenet, Loïc organization: The authors' affiliations are listed in the Appendix – sequence: 13 givenname: B.K.S surname: Sastry fullname: Sastry, B.K.S organization: The authors' affiliations are listed in the Appendix – sequence: 14 givenname: Olivier surname: Sitbon fullname: Sitbon, Olivier organization: The authors' affiliations are listed in the Appendix – sequence: 15 givenname: Rogério surname: Souza fullname: Souza, Rogério organization: The authors' affiliations are listed in the Appendix – sequence: 16 givenname: Adam surname: Torbicki fullname: Torbicki, Adam organization: The authors' affiliations are listed in the Appendix – sequence: 17 givenname: Xiaofeng surname: Zeng fullname: Zeng, Xiaofeng organization: The authors' affiliations are listed in the Appendix – sequence: 18 givenname: Lewis J surname: Rubin fullname: Rubin, Lewis J organization: The authors' affiliations are listed in the Appendix – sequence: 19 givenname: Gérald surname: Simonneau fullname: Simonneau, Gérald organization: The authors' affiliations are listed in the Appendix |
| BackLink | http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=27615028$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/23984728$$D View this record in MEDLINE/PubMed |
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| Contributor | Udwadia, Z F Sharma, K Abrahamovych, O Podolec, P Šimková, I Essop, M R Coghlan, G Forster, T Sánchez, M A Gómez Sathe, S Zeng, X Barbarash, O L Ershova, O Behr, J Kramer, M San Juan, M V Hidalgo Adir, Y Bruch, L Mitić-Milikić, M Pimanov, S Tomulic, V Chuchalin, A Hsu, H-H Ekmehag, B Louthrenoo, W Poloński, L Delcroix, M Sitbon, O Wang, H Wang, G Durongpisitkul, K Snijder, R J Sliwa-Hahnie, K Barberá, J A Wirtz, H Bogdan, M A Youssef, P Middlemost, S Ewert, R Karlócai, K Zhang, W Broto, A Roman Shen, J Williams, T Klose, H Shostak, N Williams, P Abelson, M Tyagi, S Nanagara, R Neurohr, C Wilkens, H Simor, T Chew, D Jovanović, I Kerkar, P G Tam, L S Putniković, B Lang, I Chazova, I Adzerikho, I Lim, S T Arkhipov, M Keogh, A Zhou, D Evtushenko, A Tzonzarova, M Doubell, A Ghofrani, A Ginghina, C Sastry, B K S Vizza, C D Bourdin, A Nash, P Yao, H Nielsen-Kudsk, J E Dzyak, G Yip, J Rosenkranz, S Wikström, G Varabei, A Lenskaya, L Grünig, E Höffken, G Lee, S W-L Raghuraman, B Rådegran, G Tanomsup, S Torbicki, A Pfeifer, M Moiseeva, O Küçükoglu, S Chen, S L Goncalvesová, E Temesvári, |
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| Snippet | In an event-driven trial, macitentan (an endothelin-receptor antagonist) at a dose of 3 or 10 mg was compared with placebo in patients with symptomatic... 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... BackgroundCurrent therapies for pulmonary arterial hypertension have been adopted on the basis of short-term trials with exercise capacity as the primary end... |
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| SubjectTerms | Adult Biological and medical sciences Clinical outcomes Clinical trials Double-Blind Method Drug dosages Endothelin A Receptor Antagonists Endothelin B Receptor Antagonists Endothelins Epidemiology Exercise Tolerance Familial Primary Pulmonary Hypertension Female General aspects Headache Heart failure Hospitalization - statistics & numerical data Humans Hypertension Hypertension, Pulmonary - complications Hypertension, Pulmonary - drug therapy Hypertension, Pulmonary - mortality Intravenous administration Intubation Kaplan-Meier Estimate Laboratories Lung transplantation Male Medical sciences Middle Aged Morbidity Mortality Patients Pharmaceuticals Pneumology Prostaglandins Public health. Hygiene Public health. Hygiene-occupational medicine Pulmonary hypertension Pulmonary hypertension. Acute cor pulmonale. Pulmonary embolism. Pulmonary vascular diseases Pyrimidines - adverse effects Pyrimidines - therapeutic use Rhinopharyngitis Substance abuse treatment Sulfonamides - adverse effects Sulfonamides - therapeutic use |
| Title | Macitentan and Morbidity and Mortality in Pulmonary Arterial Hypertension |
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