ROGERIO DE SOUZA

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Departamento de Cardio-Pneumologia, Faculdade de Medicina - Docente
Instituto do Coração, Hospital das Clínicas, Faculdade de Medicina - Médico
LIM/09 - Laboratório de Pneumologia, Hospital das Clínicas, Faculdade de Medicina - Líder

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Colaboração internacional: Alemanha × Assunto: Respiratory System ×

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Agora exibindo 1 - 10 de 22
  • article 180 Citação(ões) na Scopus
    Bosentan added to sildenafil therapy in patients with pulmonary arterial hypertension
    (2015) MCLAUGHLIN, Vallerie; CHANNICK, Richard N.; GHOFRANI, Hossein-Ardeschir; LEMARIE, Jean-Christophe; NAEIJE, Robert; PACKER, Milton; SOUZA, Rogerio; TAPSON, Victor F.; TOLSON, Jonathan; HITI, Hikmet Al; MEYER, Gisela; HOEPER, Marius M.
    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 end-point 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.
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    Impact of macitentan on the health-related quality of life (HRQoL) in pulmonary arterial hypertension (PAH): Results from a long-term randomised controlled trial
    (2013) JANSA, Pavel; CHANNICK, Richard; DELCROIX, Marion; GALIE, Nazzareno; GHOFRANI, Hossein-Ardeschir; HUNCHE, Elke; MEHTA, Sanjay; MITTELHOLZER, Camilla; PULIDO, Tomas; SASTRY, B. K. S.; SITBON, Olivier; SOUZA, Rogerio; TORBICKI, Adam; SIMONNEAU, Gerald; RUBIN, Lewis
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    PULSAR open-label extension: interim results from a phase 2 study of the efficacy and safety of sotatercept when added to standard of care for the treatment of pulmonary arterial hypertension (PAH)
    (2021) BADESCH, David; GIBBS, Simon; GOMBERG-MAITLAND, Mardi; HOEPER, Marius; MCLAUGHLIN, Vallerie; PRESTON, Ioana; SOUZA, Rogerio; WAXMAN, Aaron; MANIMARAN, Solaiappan; BARNES, Jennifer; PENA, Janethe De Oliveira; HUMBERT, Marc; HOEPER, Marius M.
  • article 551 Citação(ões) na Scopus
    A global view of pulmonary hypertension
    (2016) HOEPER, Marius M.; HUMBERT, Marc; SOUZA, Rogerio; IDREES, Majdy; KAWUT, Steven M.; SLIWA-HAHNLE, Karen; JING, Zhi-Cheng; GIBBS, J. Simon R.
    Pulmonary hypertension is a substantial global health issue. All age groups are affected with rapidly growing importance in elderly people, particularly in countries with ageing populations. Present estimates suggest a pulmonary hypertension prevalence of about 1% of the global population, which increases up to 10% in individuals aged more than 65 years. In almost all parts of the world, left-sided heart and lung diseases have become the most frequent causes of pulmonary hypertension. About 80% of affected patients live in developing countries, where pulmonary hypertension is frequently associated with congenital heart disease and various infectious disorders, including schistosomiasis, HIV, and rheumatic heart disease. These forms of pulmonary hypertension occur predominantly in those younger than 65 years. Independently of the underlying disease, the development of pulmonary hypertension is associated with clinical deterioration and a substantially increased mortality risk. Global research efforts are needed to establish preventive strategies and treatments for the various types of pulmonary hypertension.
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    Is 6-minute walk distance (6MWD) associated with long-term outcomes in pulmonary arterial hypertension (PAH)? Results from SERAPHIN
    (2013) DELCROIX, Marion; CHANNICK, Richard; GALIE, Nazzareno; GHOFRANI, Hossein-Ardeschir; JANSA, Pavel; BRUN, Franck-Olivier Le; MEHTA, Sanjay; PERCHENET, Loic; PULIDO, Tomas; SASTRY, B. K. S.; SITBON, Olivier; SOUZA, Rogerio; TORBICKI, Adam; SIMONNEAU, Gerald; RUBIN, Lewis
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    PULSAR Study Open-Label Extension: Interim Results from a Phase 2 Study of the Efficacy and Safety of Sotatercept When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH)
    (2021) BADESCH, D. B.; GIBBS, S.; GOMBERG-MAITLAND, M.; HOEPER, M. M.; MCLAUGHLIN, V. V.; PRESTON, I; SOUZA, R.; WAXMAN, A. B.; MANIMARAN, S.; BARNES, J.; PENA, J. de Oliveira; HUMBERT, M.
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    Effect of macitentan on haemodynamics in SERAPHIN, a randomised controlled trial in pulmonary arterial hypertension (PAH)
    (2013) SITBON, Olivier; CHANNICK, Richard; DELCROIX, Marion; GALIE, Nazzareno; GHOFRANI, Hossein-Ardeschir; JANSA, Pavel; BRUN, Franck-Olivier Le; MEHTA, Sanjay; PERCHENET, Loic; PULIDO, Tomas; SASTRY, B. K. S.; SOUZA, Rogerio; TORBICKI, Adam; RUBIN, Lewis; SIMONNEAU, Gerald
  • article 48 Citação(ões) na Scopus
    Macitentan Improves Health- Related Quality of Life for Patients With Pulmonary Arterial Hypertension
    (2017) MEHTA, Sanjay; SASTRY, Bhagavatula Kutumba Srinivasa; SOUZA, Rogerio; TORBICKI, Adam; GHOFRANI, Hossein-Ardeschir; CHANNICK, Richard N.; DELCROIX, Marion; PULIDO, Tomas; SIMONNEAU, Gerald; WLODARCZYK, John; RUBIN, Lewis J.; JANSA, Pavel; HUNSCHE, Elke; GALIE, Nazzareno; PERCHENET, Loic; SITBON, Olivier
    BACKGROUND: Pulmonary arterial hypertension (PAH) leads to reduced health-related quality of life (HRQoL). The objectives of this analysis were to evaluate the effect of macitentan on HRQoL in patients with PAH in the Study with an Endothelin Receptor Antagonist in Pulmonary Arterial Hypertension to Improve Clinical Outcome (SERAPHIN) study. The association between baseline HRQoL and long-term outcomes was also investigated. METHODS: Patients were randomized to placebo, macitentan 3 mg, or macitentan 10 mg once daily. Patients aged 14 years or older completed the 36-Item Short Form Survey (SF-36) at baseline, at month 6 and month 12, and at the end of treatment (EOT). The absolute change from baseline to month 6 in SF-36 scores was calculated. The time to a clinically meaningful deterioration in the SF-36 physical component summary and mental component summary (PCS and MCS) scores and associations between baseline PCS/MCS scores and time to morbidity/mortality events were also assessed. RESULTS: At month 6, macitentan 10 mg significantly improved seven of eight SF-36 domains and the PCS and MCS scores vs placebo. Macitentan 10 mg significantly reduced the risk of a three-point or greater deterioration in PCS (hazard ratio [HR], 0.60; 95% CI, 0.47- 0.76; P <.0001) and MCS scores (HR, 0.76; 95% CI, 0.61- 0.95; P = .0173) until EOT vs placebo. Patients with a baseline PCS score greater than the median baseline value had a significantly reduced risk of morbidity/mortality compared with patients with a PCS score less than the median; a similar result was observed for the MCS score. CONCLUSIONS: Macitentan significantly improved HRQoL in patients with PAH compared with placebo and significantly reduced the risk of a clinically meaningful HRQoL deterioration. An association between better baseline HRQoL and improved long-term outcomes was shown.
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    Baseline characteristics of patients included into the ERS Clinical Research Collaboration: ""Pulmonary Hemodynamics during Exercise - Research Network"" (PEX-NET) registry
    (2022) KOVACS, G.; HUMBERT, M.; HERVE, P.; AVIAN, A.; GALIE, N.; LEWIS, G.; SOUZA, R.; ULRICH, S.; NOORDEGRAAF, A. Vonk; ANDERSEN, M.; BARBERA, J. A.; BLANCO, I; CONDLIFFE, R.; D'ALTO, M.; EGENLAUF, B.; EWERT, R.; GRUENIG, E.; HEINE, A.; HERKENRATH, S.; HSU, S.; KASPEROWICZ, K.; MAK, S.; MARON, B.; MCCABE, C.; OLIVEIRA, R.; ROSENKRANZ, S.; SAVALE, L.; SAXER, S.; SYSTROM, D.; TEDFORD, R.; TORBICKI, A.; OLSCHEWSKI, H.
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    Effect of macitentan on morbidity and mortality in pulmonary arterial hypertension: A randomised controlled trial (SERAPHIN)
    (2013) GHOFRANI, Hossein-Ardeschir; CHANNICK, Richard; DELCROIX, Marion; GALIE, Nazzareno; JANSA, Pavel; BRUN, Franck-Olivier Le; MEHTA, Sanjay; MITTELHOLZER, Camilla; PULIDO, Tomas; SASTRY, B. K. S.; SITBON, Olivier; SOUZA, Rogerio; TORBICKI, Adam; RUBIN, Lewis; SIMONNEAU, Gerald