Treatment of patients with mildly symptomatic pulmonary arterial hypertension with bosentan (EARLY study): a double-blind, randomised controlled trial

Galiè, Nazzareno; Rubin, Leona J.; Hoeper, Marius M.; Jansa, Pavel; Al‐Hiti, Hikmet; Meyer, Gmb; Chiossi, Eleonora; Kusic‐Pajic, Andjela; Simonneau, Gérald

doi:10.1016/s0140-6736(08)60919-8

Cited by 850 publications

(667 citation statements)

References 31 publications

Supporting

Mentioning

600

Contrasting

Unclassified

Order By: Relevance

“…In the subgroup of patients enrolled in the EARLY study [141] (bosentan in WHO-FC II PAH patients) who were already on treatment with sildenafil, the haemodynamic effect of the addition of bosentan was comparable with that achieved in patients without background sildenafil treatment. A pharmacokinetic interaction has been described between bosentan and sildenafil, which act as inducers or inhibitors of cytochrome P450 CYP3A4, respectively.…”

Section: Combination Therapymentioning

confidence: 88%

Guidelines for the diagnosis and treatment of pulmonary hypertension

Galiè¹,

Hoeper²,

Humbert³

et al. 2012

Revista Portuguesa de Cardiologia (English Edition)

419

738

View full text Add to dashboard Cite

Section: Combination Therapymentioning

confidence: 88%

Guidelines for the diagnosis and treatment of pulmonary hypertension

Galiè¹,

Hoeper²,

Humbert³

et al. 2012

Revista Portuguesa de Cardiologia (English Edition)

419

738

View full text Add to dashboard Cite

“…This hypothesis was based on the observed effects of bosentan monotherapy on time to clinical worsening in earlier short-term trials [10][11][12], open-label uncontrolled reports [13] and preliminary data [14] that suggested a clinical benefit when bosentan was combined with sildenafil in patients with PAH.…”

Section: Discussionmentioning

confidence: 99%

Bosentan added to sildenafil therapy in patients with pulmonary arterial hypertension

et al. 2015

View full text Add to dashboard Cite

The safety and efficacy of adding bosentan to sildenafil in pulmonary arterial hypertension (PAH) patients was investigated.In this prospective, double-blind, event-driven trial, symptomatic PAH patients receiving stable sildenafil (⩾20 mg three times daily) for ⩾3 months were randomised (1:1) to placebo or bosentan (125 mg twice daily). The composite primary end-point was the time to the first morbidity/mortality event, defined as all-cause death, hospitalisation for PAH worsening or intravenous prostanoid initiation, atrial septostomy, lung transplant, or PAH worsening. Secondary/exploratory end-points included change in 6-min walk distance and World Health Organization functional class at 16 weeks, change in N-terminal pro-brain natriuretic peptide (NT-proBNP) over time, and all-cause death.Overall, 334 PAH patients were randomised to placebo (n=175) or bosentan (n=159). A primary endpoint event occurred in 51.4% of patients randomised to placebo and 42.8% to bosentan (hazard ratio 0.83, 97.31% CI 0.58-1.19; p=0.2508). The mean between-treatment difference in 6-min walk distance at 16 weeks was +21.8 m (95% CI +5.9-37.8 m; p=0.0106). Except for NT-proBNP, no difference was observed for any other end-point. The safety profile of bosentan added to sildenafil was consistent with the known bosentan safety profile.In COMPASS-2, adding bosentan to stable sildenafil therapy was not superior to sildenafil monotherapy in delaying the time to the first morbidity/mortality event. @ERSpublications COMPASS-2: adding bosentan was not superior to sildenafil alone in delaying time to first morbidity/mortality event http://ow.ly/NiM65

show abstract

“…62 Bosentan has also been used in mildly symptomatic adult patients with PAH in the EARLY trial. 63 Although a significant fall was seen in PVR, there was no significant change in 6MWT distance. Currently, this drug is perhaps best reserved for patients with WHO or NYHA functional class III or more.…”

Section: Bosentanmentioning

confidence: 88%

“…There is genetic anticipation in familial PAH, i.e. the onset of disease occurs at an Indian Heart Journal 6401 (2012) [60][61][62][63][64][65][66][67][68][69][70][71][72][73] earlier age in successive generations. 8,9 Group 1 of Dana Point classification also includes drugs and toxins associated with development of PAH; the most notorious of these include the appetite suppressants fenfluramine and dexfenfluramine.…”

Section: Epidemiologymentioning

confidence: 99%

Pulmonary hypertension—“state of the art” management in 2012

Saxena

2012

Indian Heart Journal

View full text Add to dashboard Cite

A B S T R A C TPulmonary artery hypertension (PAH) is a pathological condition of small pulmonary arteries, characterised by vascular proliferation and remodelling. The pulmonary artery pressure and pulmonary vascular resistance progressively rise, leading to right heart failure and death. Pulmonary artery hypertension may be secondary to various conditions, or it may be idiopathic where no underlying cause is identifiable. Earlier, only symptomatic treatment was available for such patients which did not change the natural history of the disease. However, over the years, improvement in understanding the pathogenesis has resulted in the development of targeted approaches to the treatment of PAH. Survival advantage has also been shown with some of the pharmacologic agents. This review article discusses the current management strategy for PAH with special emphasis on an idiopathic variety, in an Indian context.

show abstract

Treatment of patients with mildly symptomatic pulmonary arterial hypertension with bosentan (EARLY study): a double-blind, randomised controlled trial

Cited by 850 publications

References 31 publications

Guidelines for the diagnosis and treatment of pulmonary hypertension

Guidelines for the diagnosis and treatment of pulmonary hypertension

Bosentan added to sildenafil therapy in patients with pulmonary arterial hypertension

Pulmonary hypertension—“state of the art” management in 2012

Contact Info

Product

Resources

About