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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  • conferenceObject
    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
  • article 1080 Citação(ões) na Scopus
    Macitentan and Morbidity and Mortality in Pulmonary Arterial Hypertension
    (2013) PULIDO, Tomas; ADZERIKHO, Igor; CHANNICK, Richard N.; DELCROIX, Marion; GALIE, Nazzareno; GHOFRANI, Hossein-Ardeschir; JANSA, Pavel; JING, Zhi-Cheng; BRUN, Franck-Olivier Le; MEHTA, Sanjay; MITTELHOLZER, Camilla M.; PERCHENET, Loic; SASTRY, B. K. S.; SITBON, Olivier; SOUZA, Rogerio; TORBICKI, Adam; ZENG, Xiaofeng; RUBIN, Lewis J.; SIMONNEAU, Gerald
    Background 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. Methods 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. Results 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. Conclusions 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.)
  • article 9 Citação(ões) na Scopus
    Integrating Data From Randomized Controlled Trials and Observational Studies to Assess Survival in Rare Diseases Insights From Pulmonary Arterial Hypertension
    (2019) TORBICKI, Adam; BACCHI, Marisa; DELCROIX, Marion; FARBER, Harrison W.; GHOFRANI, Hossein-Ardeschir; HENNESSY, Brian; JANSA, Pavel; MEHTA, Sanjay; PERCHENET, Loic; PULIDO, Tomas; ROSENBERG, Daniel; RUBIN, Lewis J.; SASTRY, B. K. S.; SIMONNEAU, Gerald; SITBON, Olivier; SOUZA, Rogerio; WEI, Lee-Jen; CHANNICK, Richard; BENZA, Raymond
    BACKGROUND: Conducting randomized controlled trials to investigate survival in a rare disease like pulmonary arterial hypertension has considerable ethical and logistical constraints. In many studies, such as the Study with an Endothelin Receptor Antagonist in Pulmonary Arterial Hypertension to Improve Clinical Outcome (SERAPHIN) randomized controlled trial, evaluating survival is further complicated by bias introduced by allowing active therapy among placebo-treated patients who clinically deteriorate. METHODS AND RESULTS: SERAPHIN enrolled and followed patients in the same time frame as the US Registry to Evaluate Early And Long-term PAH Disease Management, providing an opportunity to compare observed survival for SERAPHIN patients with predicted survival had they received real-world treatment as in the Registry to Evaluate Early And Long-term PAH Disease Management. From the Registry to Evaluate Early And Long-term PAH Disease Management (N= 3515), 734 patients who met SERAPHIN eligibility criteria were selected and their data used to build a prediction model for time to death up to 3 years based on 10 baseline prognostic variables. The model was used to predict a survival curve for each of the 742 SERAPHIN patients via their baseline variables. The average of these predicted survival curves was compared with observed survival of the placebo (n= 250) and macitentan 10 mg (n= 242) groups using a log-rank test and Cox proportional hazard model. Observed mortality risk for patients randomized to placebo, 62% of whom were taking background pulmonary arterial hypertension therapy, tended to be lower than that predicted for all SERAPHIN patients (16% lower; P= 0.259). The observed placebo survival curve closely approximated the predicted survival curve for the first 15 months. Beyond that time, observed risk of mortality decreased compared with predicted mortality, potentially reflecting the impact of crossover of patients in the placebo group to active therapy. Over 3 years, risk of mortality observed with macitentan 10 mg was 35% lower than predicted mortality (P= 0.010). CONCLUSIONS: These analyses show that, in a rare disease, real-world observational data can complement randomized controlled trial data to overcome some challenges associated with assessing survival in the setting of a randomized controlled trial.
  • conferenceObject
    REDUCTION OF PULMONARY ARTERIAL HYPERTENSION (PAH)-RELATED HOSPITALIZATIONS WITH MACITENTAN IN THE RANDOMIZED CONTROLLED TRIAL SERAPHIN
    (2013) CHANNICK, R. N.; DELCROIX, M.; GALIE, N.; GHOFRANI, H. A.; HUNSCHE, E.; JANSA, P.; BRUN, F. O. Le; MEHTA, S.; MITTELHOLZER, C.; PERCHENET, L.; PULIDO, T.; SASTRY, B.; SITBON, O.; SOUZA, R.; TORBICKI, A.; RUBIN, L. J.; SIMONNEAU, G.
  • article 39 Citação(ões) na Scopus
    Incident and prevalent cohorts with pulmonary arterial hypertension: insight from SERAPHIN
    (2015) SIMONNEAU, Gerald; CHANNICK, Richard N.; DELCROIX, Marion; 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; RUBIN, Lewis J.
    In SERAPHIN, a long-term, randomised, controlled trial (NCT00660179) in pulmonary arterial hypertension (PAH), macitentan significantly reduced the risk of morbidity/mortality and PAH-related death/hospitalisation. We evaluated disease progression and the effect of macitentan in treatment-nave incident and prevalent cohorts. Patients allocated to placebo, or macitentan 3 mg or 10 mg were classified by time from diagnosis to enrolment as incident (<= 6 months; n=110) or prevalent (>6 months; n=157). The risk of morbidity/mortality and PAH-related death/hospitalisation was determined using Cox regression. The risk of morbidity/mortality (Kaplan-Meier estimates at month 12: 54.4% versus 26.7%; p=0.006) and PAH-related death/hospitalisation (Kaplan-Meier estimates at month 12: 47.3% versus 19.9%; p=0.006) were significantly higher for incident versus prevalent patients receiving placebo, respectively. There was no significant difference in the risk of all-cause death between incident and prevalent cohorts (p=0.587). Macitentan 10 mg significantly reduced the risk of morbidity/mortality and PAH-related death/hospitalisation versus placebo in incident and prevalent cohorts. Incident patients had a higher risk for PAH progression compared with prevalent patients but not a higher risk of death. Macitentan delayed disease progression in both incident and prevalent PAH patients.
  • article 2 Citação(ões) na Scopus
    Long-Term Safety, Tolerability and Survival in Patients with Pulmonary Arterial Hypertension Treated with Macitentan: Results from the SERAPHIN Open-Label Extension
    (2022) SOUZA, Rogerio; DELCROIX, Marion; GALIE, Nazzareno; JANSA, Pavel; MEHTA, Sanjay; PULIDO, Tomas; RUBIN, Lewis; SASTRY, B. K. S.; SIMONNEAU, Gerald; SITBON, Olivier; TORBICKI, Adam; BOYANOVA, Neli; CHAMITAVA, Liliya; STEIN, Claudia; CHANNICK, Richard N.
    Introduction In SERAPHIN, a long-term, event-driven, double-blind randomised controlled trial in pulmonary arterial hypertension (PAH), macitentan 10 mg significantly reduced the risk of morbidity/mortality compared with placebo. Its open-label extension study (SERAPHIN OL) further assessed long-term safety and tolerability of macitentan 10 mg in PAH patients. Methods Patients in SERAPHIN who completed the double-blind treatment period or experienced a morbidity event during the study could enter SERAPHIN OL. Patients received macitentan 10 mg once daily, and safety and survival were assessed until end of treatment (+ 28 days). Two overlapping sets were analysed for safety: (1) all patients in SERAPHIN OL (OL safety set); (2) patients randomised to macitentan 10 mg in SERAPHIN (long-term safety/survival set). Survival was evaluated as an exploratory endpoint in the latter set. Results Of 742 patients randomised in SERAPHIN, 550 (74.1%) entered SERAPHIN OL (OL safety set); 242 patients were randomised to macitentan 10 mg in SERAPHIN (long-term safety/survival set). Median (min, max) exposure to macitentan 10 mg was 40.1 (0.1, 130.5) months (2074.7 patient-years; OL safety set) and 54.7 (0.1, 141.3) months (1151.0 patient-years; long-term safety/survival set). Safety in both analysis sets was comparable to the known safety profile of macitentan. Kaplan-Meier survival estimates (95% CI) at 1, 5, 7 and 9 years were 95.0% (91.3, 97.1), 73.3% (66.6, 78.9), 62.6% (54.6, 69.6) and 52.7% (43.6, 61.0), respectively (long-term safety/survival set; median follow-up: 5.9 years). Conclusions This analysis provides the longest follow-up for safety and survival published to date for any PAH therapy. The safety profile of macitentan 10 mg over this extensive treatment period was in line with that observed in SERAPHIN. As the majority of patients were receiving other PAH therapy at macitentan initiation, our study provides additional insight into the long-term safety of macitentan, including as part of combination therapy.
  • conferenceObject
    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
  • conferenceObject
    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 77 Citação(ões) na Scopus
    Pulmonary Arterial Hypertension-Related Morbidity Is Prognostic for Mortality
    (2018) MCLAUGHLIN, Vallerie V.; HOEPER, Marius M.; CHANNICK, Richard N.; CHIN, Kelly M.; DELCROIX, Marion; GAINE, Sean; GHOFRANI, Hossein-Ardeschir; JANSA, Pavel; LANG, Irene M.; MEHTA, Sanjay; PULIDO, Tomas; SASTRY, B. K. S.; SIMONNEAU, Gerald; SITBON, Olivier; SOUZA, Rogerio; TORBICKI, Adam; TAPSON, Victor F.; PERCHENET, Loic; PREISS, Ralph; VERWEIJ, Pierre; RUBIN, Lewis J.; GALIE, Nazzareno
    BACKGROUND Registry data suggest that disease progression in pulmonary arterial hypertension (PAH) is indicative of poor prognosis. However, the prognostic relevance of PAH-related morbidity has not been formally evaluated in randomized controlled trials. OBJECTIVES The purpose of these analyses was to assess the impact of morbidity events on the risk of subsequent mortality using the landmark method and data from the SERAPHIN and GRIPHON studies. METHODS For each study, the risk of all-cause death up to the end of the study was assessed from the landmark time point (months 3, 6, and 12) according to whether a patient had experienced a primary endpoint morbidity event before the landmark. Each analysis was conducted using data from all patients who were available for survival follow-up at the landmark. RESULTS In the SERAPHIN study, on the basis of the 3-month landmark time point, patients who experienced a morbidity event before month 3 had an increased risk of death compared with patients who did not (hazard ratio [HR]: 3.39; 95% confidence interval [CI]: 1.94 to 5.92). In the GRIPHON study, on the basis of the 3-month landmark time point, there was also an increased risk with a HR of 4.48; (95% CI: 2.98 to 6.73). Analyses based on 6-month and 12-month landmarks also showed increased risk in patients who experienced morbidity events, albeit with a reduced HR. CONCLUSIONS These results demonstrate the prognostic relevance of PAH-related morbidity as defined in the SERAPHIN and GRIPHON studies, highlighting the importance of preventing disease progression in patients with PAH and supporting the clinical relevance of SERAPHIN and GRIPHON morbidity events. (Study of Macitentan [ACT-064992] on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension [SERAPHIN]; NCT00660179; Selexipag [ACT-293987] in Pulmonary Arterial Hypertension [GRIPHON]; (c) 2018 The Authors.
  • article 2178 Citação(ões) na Scopus
    Updated Clinical Classification of Pulmonary Hypertension
    (2013) SIMONNEAU, Gerald; GATZOULIS, Michael A.; ADATIA, Ian; CELERMAJER, David; DENTON, Chris; GHOFRANI, Ardeschir; SANCHEZ, Miguel Angel Gomez; KUMAR, R. Krishna; LANDZBERG, Michael; MACHADO, Roberto F.; OLSCHEWSKI, Horst; ROBBINS, Ivan M.; SOUZA, Rogiero
    In 1998, a clinical classification of pulmonary hypertension (PH) was established, categorizing PH into groups which share similar pathological and hemodynamic characteristics and therapeutic approaches. During the 5th World Symposium held in Nice, France, in 2013, the consensus was reached to maintain the general scheme of previous clinical classifications. However, modifications and updates especially for Group 1 patients (pulmonary arterial hypertension [PAH]) were proposed. The main change was to withdraw persistent pulmonary hypertension of the newborn (PPHN) from Group 1 because this entity carries more differences than similarities with other PAH subgroups. In the current classification, PPHN is now designated number 1. Pulmonary hypertension associated with chronic hemolytic anemia has been moved from Group 1 PAH to Group 5, unclear/multifactorial mechanism. In addition, it was decided to add specific items related to pediatric pulmonary hypertension in order to create a comprehensive, common classification for both adults and children. Therefore, congenital or acquired left-heart inflow/outflow obstructive lesions and congenital cardiomyopathies have been added to Group 2, and segmental pulmonary hypertension has been added to Group 5. Last, there were no changes for Groups 2, 3, and 4. (C) 2013 by the American College of Cardiology Foundation