Efficacy, safety and tolerability of bosentan in Chinese patients with pulmonary arterial hypertension
BACKGROUND: Bosentan has an established role in the management of pulmonary arterial hypertension (PAH). This clinical trial assessed the benefits of bosentan in the Chinese population.
METHODS: We investigated the efficacy and safety of bosentan in 92 Chinese citizens (mean +/- standard deviation age, 29.0 +/- 3.8 years) with PAH for a minimum of 12 weeks. All received bosentan (62.5 mg twice daily) for 4 weeks; then, patients who weighed <40 kg received 62.5 mg bosentan twice daily and patients who weighed >40 kg received 125 mg twice daily. All patients were eligible to continue bosentan beyond 12 weeks. The primary end point was a change in exercise capacity from baseline to 12 and 24 weeks. Secondary end points included a change in World Health Organization (WHO) functional class and changes in cardiopulmonary hemodynamics.
RESULTS: At baseline, 66 patients (72%) were in WHO functional class III; presentation was 37 (40%) with idiopathic PAH (iPAH), 34 (37%) with PAH related to congenital heart disease (CHD), and 21 (23%) with PAH related to connective tissue disease (CTD). Exercise capacity increased to 67.8 m after 12 weeks and 92.6 m after 24 weeks (p < 0.001). After 24 weeks, WHO functional class decreased (-0.8 +/- 0.6; p < 0.001), mean pulmonary artery pressure and pulmonary vascular resistance decreased (p < 0.01), and cardiac output increased (p < 0.001). Twelve patients (13%) experienced at least 1 adverse event.
CONCLUSIONS: Bosentan improved exercise capacity, functional class, and cardiopulmonary hemodynamics in this patient cohort and was well tolerated.
| Errataetall: |
CommentIn: J Heart Lung Transplant. 2010 Feb;29(2):157-8. - PMID 20113908 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2010 |
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| Erschienen: |
2010 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:29 |
|---|---|
| Enthalten in: |
The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation - 29(2010), 2 vom: 30. Feb., Seite 150-6 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Jing, Zhi-Cheng [VerfasserIn] |
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| Links: |
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| Themen: |
Antihypertensive Agents |
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| Anmerkungen: |
Date Completed 27.05.2010 Date Revised 01.12.2018 published: Print CommentIn: J Heart Lung Transplant. 2010 Feb;29(2):157-8. - PMID 20113908 Citation Status MEDLINE |
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| doi: |
10.1016/j.healun.2009.09.020 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM194722120 |
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| 100 | 1 | |a Jing, Zhi-Cheng |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Efficacy, safety and tolerability of bosentan in Chinese patients with pulmonary arterial hypertension |
| 264 | 1 | |c 2010 | |
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| 500 | |a Date Completed 27.05.2010 | ||
| 500 | |a Date Revised 01.12.2018 | ||
| 500 | |a published: Print | ||
| 500 | |a CommentIn: J Heart Lung Transplant. 2010 Feb;29(2):157-8. - PMID 20113908 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a BACKGROUND: Bosentan has an established role in the management of pulmonary arterial hypertension (PAH). This clinical trial assessed the benefits of bosentan in the Chinese population | ||
| 520 | |a METHODS: We investigated the efficacy and safety of bosentan in 92 Chinese citizens (mean +/- standard deviation age, 29.0 +/- 3.8 years) with PAH for a minimum of 12 weeks. All received bosentan (62.5 mg twice daily) for 4 weeks; then, patients who weighed <40 kg received 62.5 mg bosentan twice daily and patients who weighed >40 kg received 125 mg twice daily. All patients were eligible to continue bosentan beyond 12 weeks. The primary end point was a change in exercise capacity from baseline to 12 and 24 weeks. Secondary end points included a change in World Health Organization (WHO) functional class and changes in cardiopulmonary hemodynamics | ||
| 520 | |a RESULTS: At baseline, 66 patients (72%) were in WHO functional class III; presentation was 37 (40%) with idiopathic PAH (iPAH), 34 (37%) with PAH related to congenital heart disease (CHD), and 21 (23%) with PAH related to connective tissue disease (CTD). Exercise capacity increased to 67.8 m after 12 weeks and 92.6 m after 24 weeks (p < 0.001). After 24 weeks, WHO functional class decreased (-0.8 +/- 0.6; p < 0.001), mean pulmonary artery pressure and pulmonary vascular resistance decreased (p < 0.01), and cardiac output increased (p < 0.001). Twelve patients (13%) experienced at least 1 adverse event | ||
| 520 | |a CONCLUSIONS: Bosentan improved exercise capacity, functional class, and cardiopulmonary hemodynamics in this patient cohort and was well tolerated | ||
| 650 | 4 | |a Clinical Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
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| 650 | 7 | |a Sulfonamides |2 NLM | |
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| 700 | 1 | |a Strange, Geoff |e verfasserin |4 aut | |
| 700 | 1 | |a Zhu, Xian-Yang |e verfasserin |4 aut | |
| 700 | 1 | |a Zhou, Da-Xin |e verfasserin |4 aut | |
| 700 | 1 | |a Shen, Jie-Yan |e verfasserin |4 aut | |
| 700 | 1 | |a Gu, Hong |e verfasserin |4 aut | |
| 700 | 1 | |a Yang, Zhen-Kun |e verfasserin |4 aut | |
| 700 | 1 | |a Pan, Xin |e verfasserin |4 aut | |
| 700 | 1 | |a Xiang, Mei-Xiang |e verfasserin |4 aut | |
| 700 | 1 | |a Yao, Hua |e verfasserin |4 aut | |
| 700 | 1 | |a Zhao, Dong-Bao |e verfasserin |4 aut | |
| 700 | 1 | |a Dalton, Brad S |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Zhuo-Li |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Yong |e verfasserin |4 aut | |
| 700 | 1 | |a Cheng, Xian-Sheng |e verfasserin |4 aut | |
| 700 | 1 | |a Yang, Yue-Jin |e verfasserin |4 aut | |
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