Macitentan for the treatment of inoperable chronic thromboembolic pulmonary hypertension (MERIT-1): results from the multicentre, phase 2, randomised, double-blind, placebo-controlled study.
University of Giessen1, Imperial College London2, University of Paris-Sud3, French Institute of Health and Medical Research4, University of Pavia5, University of California, San Diego6, Imperial College Healthcare7, National Institutes of Health8, Papworth Hospital9, Peking Union Medical College10, Actelion11
TL;DR: In MERIT-1, macitentan significantly improved PVR in patients with inoperable CTEPH and was well tolerated, and resting PVR at week 16, expressed as percentage of PVR measured at baseline.
About: This article is published in The Lancet Respiratory Medicine.The article was published on 2017-10-01. It has received 189 citations till now. The article focuses on the topics: Macitentan & Placebo-controlled study.
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University of Mainz1, Paris Descartes University2, University of Perugia3, Carlos III Health Institute4, Utrecht University5, Helsinki University Central Hospital6, Leiden University7, French Institute of Health and Medical Research8, Imperial College London9, University of Alcalá10, University Hospital of Lausanne11, Medical University of Vienna12, University of Göttingen13, Maastricht University14, University of Franche-Comté15, University College Dublin16, Medical University of Warsaw17, University of Geneva18
TL;DR: Guidelines summarize and evaluate available evidence with the aim of assisting health professionals in proposing the best management strategies for an individual patient with a given condition.
Abstract: Guidelines summarize and evaluate available evidence with the aim of assisting health professionals in proposing the best management strategies for an individual patient with a given condition. Guidelines and their recommendations should facilitate decision making of health professionals in their daily practice. However, the final decisions concerning an individual patient must be made by the responsible health professional(s) in consultation with the patient and caregiver as appropriate.
2,079 citations
TL;DR: New ESCardio Guidelines for the Diagnosis and Management of Acute PulmonaryEmbolism developed in collaboration with EuroRespSoc are available.
Abstract: New @ESCardio Guidelines for the Diagnosis and Management of Acute #PulmonaryEmbolism developed in collaboration with @EuroRespSoc now available: #cardiotwitter @erspublicationshttp://bit.ly/2HnrJaj
1,334 citations
512 citations
TL;DR: The ESC/ERS pulmonary hypertension guidelines as mentioned in this paper incorporate changes and adaptations focusing on clinical management, which are made in consultation with the patient and caregiver as appropriate, based on what they consider to be the most appropriate in the circumstances.
Abstract: Guidelines summarize and evaluate available evidence, with the aim of assisting health professionals in proposing the best management strategies for an individual patient with a given condition. Guidelines and their recommendations should facilitate decision-making of health professionals in their daily practice. However, guidelines are not a substitute for the patient's relationship with their practitioner. The final decisions concerning an individual patient must be made by the responsible health professional(s), based on what they consider to be the most appropriate in the circumstances. These decisions are made in consultation with the patient and caregiver as appropriate. 2022 ESC/ERS pulmonary hypertension guidelines incorporate changes and adaptations focusing on clinical management https://bit.ly/3QtUvb4
216 citations
Katholieke Universiteit Leuven1, Imperial College London2, Université Paris-Saclay3, Leiden University Medical Center4, Medical University of Vienna5, University of Cambridge6, University of California, San Diego7, VU University Amsterdam8, South University9, University of Giessen10, Hannover Medical School11, First Faculty of Medicine, Charles University in Prague12, University Hospital Heidelberg13, University of Pavia14, University of Bologna15
TL;DR: A review of the literature and current practice concerning diagnosis and management of chronic thromboembolic pulmonary hypertension (CTEPH) is presented in this article, which is a rare complication of acute pulmonary embolism, either symptomatic or not.
Abstract: Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare complication of acute pulmonary embolism, either symptomatic or not. The occlusion of proximal pulmonary arteries by fibrotic intravascular material, in combination with a secondary microvasculopathy of vessels less than 500 µm, leads to increased pulmonary vascular resistance and progressive right heart failure. The mechanism responsible for the transformation of red clots into fibrotic material remnants has not yet been elucidated. In patients with pulmonary hypertension, the diagnosis is suspected when a ventilation/perfusion lung scan shows mismatched perfusion defects and confirmed by right heart catheterisation and vascular imaging. Today, in addition to lifelong anticoagulation, treatment modalities include surgery, angioplasty and medical treatment according to the localisation and characteristics of the lesions. This Statement outlines a review of the literature and current practice concerning diagnosis and management of CTEPH. It covers the definitions, diagnosis, epidemiology, follow up after acute pulmonary embolism, pathophysiology, treatment by pulmonary endarterectomy, balloon pulmonary angioplasty, drugs and their combination, rehabilitation and new lines of research in CTEPH. It represents the first collaboration of the European Respiratory Society (ERS), the International CTEPH Association (ICA) and the European Reference Network (ERN)-Lung in the pulmonary hypertension domain. The Statement summarises current knowledge but does not make formal recommendations for clinical practice.
203 citations
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TL;DR: In this paper, the authors defined the following terms: ALAT, alanine aminotransferase, ASAT, aspartate AMINOTE, and APAH, associated pulmonary arterial hypertension.
Abstract: ALAT
: alanine aminotransferase
ASAT
: aspartate aminotransferase
APAH
: associated pulmonary arterial hypertension
BAS
: balloon atrial septostomy
BMPR2
: bone morphogenetic protein receptor 2
BNP
: brain natriuretic peptide
BPA
: balloon pulmonary angioplasty
BREATHE
: Bosentan
5,224 citations
TL;DR: This article is being published concurrently in the European Heart Journal and the European Respiratory Journal and is identical except for minor stylistic and spelling differences in keeping with each journal’s style.
Abstract: Published on behalf of the European Society of Cardiology. All rights reserved. & 2015 European Society of Cardiology & European Respiratory Society. This article is being published concurrently in the European Heart Journal (10.1093/eurheartj/ehv317) and the European Respiratory Journal (10.1183/13993003.01032-2015). The articles are identical except for minor stylistic and spelling differences in keeping with each journal’s style. Either citation can be used when citing this article. * Corresponding authors: Nazzareno Galiè, Department of Experimental, Diagnostic and Specialty Medicine–DIMES, University of Bologna, Via Massarenti 9, 40138 Bologna, Italy, Tel: +39 051 349 858, Fax: +39 051 344 859, Email: nazzareno.galie@unibo.it.
2,510 citations
TL;DR: Inhaled Iloprost is an effective therapy for patients with severe pulmonary hypertension and hemodynamic values were significantly improved at 12 weeks when measured after iloprost inhalation, and were significantly worse in the placebo group.
Abstract: Background Uncontrolled studies suggested that aerosolized iloprost, a stable analogue of prostacyclin, causes selective pulmonary vasodilatation and improves hemodynamics and exercise capacity in patients with pulmonary hypertension. Methods We compared repeated daily inhalations of 2.5 or 5.0 μg of iloprost (six or nine times per day; median inhaled dose, 30 μg per day) with inhalation of placebo. A total of 203 patients with selected forms of severe pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension (New York Heart Association [NYHA] functional class III or IV) were included. The primary end point was met if, after week 12, the NYHA class and distance walked in six minutes were improved by at least one class and at least 10 percent, respectively, in the absence of clinical deterioration according to predefined criteria and death. Results The combined clinical end point was met by 16.8 percent of the patients receiving iloprost, as compared with 4.9 percent of the patients...
1,613 citations
TL;DR: Macitentan significantly reduced morbidity and mortality among patients with pulmonary arterial hypertension in this event-driven study.
Abstract: curred 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 hyper tension at baseline. Adverse events more frequently associated with macitentan than with placebo were headache, nasopharyngitis, and anemia.
1,121 citations
TL;DR: Riociguat significantly improved exercise capacity and pulmonary vascular resistance in patients with chronic thromboembolic pulmonary hypertension.
Abstract: BACKGROUND Riociguat, a member of a new class of compounds (soluble guanylate cyclase stim ulators), has been shown in previous clinical studies to be beneficial in the treat ment of chronic thromboembolic pulmonary hypertension. METHODS In this phase 3, multicenter, randomized, double-blind, placebo-controlled study, we randomly assigned 261 patients with inoperable chronic thromboembolic pul monary hypertension or persistent or recurrent pulmonary hypertension after pul monary endarterectomy to receive placebo or riociguat. The primary end point was the change from baseline to the end of week 16 in the distance walked in 6 minutes. Secondary end points included changes from baseline in pulmonary vascular resis tance, N-terminal pro–brain natriuretic peptide (NT-proBNP) level, World Health Organization (WHO) functional class, time to clinical worsening, Borg dyspnea score, quality-of-life variables, and safety. RESULTS By week 16, the 6-minute walk distance had increased by a mean of 39 m in the riociguat group, as compared with a mean decrease of 6 m in the placebo group (least-squares mean difference, 46 m; 95% confidence interval [CI], 25 to 67; P<0.001). Pulmonary vascular resistance decreased by 226 dyn · sec · cm –5 in the riociguat group and increased by 23 dyn · sec · cm –5 in the placebo group (least-squares mean difference, –246 dyn · sec · cm –5 ; 95% CI, –303 to –190; P<0.001). Riociguat was also associated with significant improvements in the NT-proBNP level (P<0.001) and WHO functional class (P = 0.003). The most common serious adverse events were right ventricular failure (in 3% of patients in each group) and syncope (in 2% of the riociguat group and in 3% of the placebo group). CONCLUSIONS Riociguat significantly improved exercise capacity and pulmonary vascular re sistance in patients with chronic thromboembolic pulmonary hypertension. (Funded by Bayer HealthCare; CHEST-1 and CHEST-2 ClinicalTrials.gov numbers, NCT00855465 and NCT00910429, respectively.)
1,065 citations