ROGERIO DE SOUZA
Projetos de Pesquisa
Unidades Organizacionais
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
Instituto do Coração, Hospital das Clínicas, Faculdade de Medicina - Médico
LIM/09 - Laboratório de Pneumologia, Hospital das Clínicas, Faculdade de Medicina - Líder
12 resultados
Resultados de Busca
Agora exibindo 1 - 10 de 12
- Clinical, demographic and functional evaluation of patients with hypersensitivity pneumonitis and their comparison based on current diagnostic criteria(2023) BRIDI, Guilherme Das Posses; SILVA, Bianca Freire Da; CUNHA, Marieta Cabral Amaral Da; QUEIROZ, Douglas Silva; ALVES- JR., Jose Leonidas; SALGE, Joao Marcos; CARVALHO, Celso R. F. De; KAIRALLA, Ronaldo Adib; SOUZA, Rogerio De; BALDI, Bruno Guedes
- Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension(2023) HOEPER, Marius M.; BADESCH, David B.; GHOFRANI, H. Ardeschir; GIBBS, J. Simon R.; GOMBERG-MAITLAND, Mardi; MCLAUGHLIN, Vallerie V.; PRESTON, Ioana R.; SOUZA, Rogerio; WAXMAN, Aaron B.; GRUENIG, Ekkehard; KOPEC, Grzegorz; MEYER, Gisela; OLSSON, Karen M.; ROSENKRANZ, Stephan; XU, Yayun; MILLER, Barry; FOWLER, Marcie; BUTLER, John; KOGLIN, Joerg; PENA, Janethe de Oliveira; HUMBERT, MarcBACKGROUNDPulmonary arterial hypertension is a progressive disease involving proliferative remodeling of the pulmonary vessels. Despite therapeutic advances, the disease-associated morbidity and mortality remain high. Sotatercept is a fusion protein that traps activins and growth differentiation factors involved in pulmonary arterial hypertension.METHODSWe conducted a multicenter, double-blind, phase 3 trial in which adults with pulmonary arterial hypertension (World Health Organization [WHO] functional class II or III) who were receiving stable background therapy were randomly assigned in a 1:1 ratio to receive subcutaneous sotatercept (starting dose, 0.3 mg per kilogram of body weight; target dose, 0.7 mg per kilogram) or placebo every 3 weeks. The primary end point was the change from baseline at week 24 in the 6-minute walk distance. Nine secondary end points, tested hierarchically in the following order, were multicomponent improvement, change in pulmonary vascular resistance, change in N-terminal pro-B-type natriuretic peptide level, improvement in WHO functional class, time to death or clinical worsening, French risk score, and changes in the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Physical Impacts, Cardiopulmonary Symptoms, and Cognitive-Emotional Impacts domain scores; all were assessed at week 24 except time to death or clinical worsening, which was assessed when the last patient completed the week 24 visit.RESULTSA total of 163 patients were assigned to receive sotatercept and 160 to receive placebo. The median change from baseline at week 24 in the 6-minute walk distance was 34.4 m (95% confidence interval [CI], 33.0 to 35.5) in the sotatercept group and 1.0 m (95% CI, -0.3 to 3.5) in the placebo group. The Hodges-Lehmann estimate of the difference between the sotatercept and placebo groups in the change from baseline at week 24 in the 6-minute walk distance was 40.8 m (95% CI, 27.5 to 54.1; P < 0.001). The first eight secondary end points were significantly improved with sotatercept as compared with placebo, whereas the PAH-SYMPACT Cognitive-Emotional Impacts domain score was not. Adverse events that occurred more frequently with sotatercept than with placebo included epistaxis, dizziness, telangiectasia, increased hemoglobin levels, thrombocytopenia, and increased blood pressure.CONCLUSIONSIn patients with pulmonary arterial hypertension who were receiving stable background therapy, sotatercept resulted in a greater improvement in exercise capacity (as assessed by the 6-minute walk test) than placebo. (Funded by Acceleron Pharma, a subsidiary of MSD; STELLAR ClinicalTrials.gov number, .)
- Loss of response to calcium channel blockers after long-term follow-up treatment in patients with idiopathic pulmonary arterial hypertension(2023) PILOTO, Bruna; FERNANDES, Caio Julio Cesar dos Santos; JARDIM, Carlos; CASTRO, Marcela; ALVES- JR., Jose Leonidas; SOUZA, RogerioIdiopathic pulmonary arterial hypertension (PAH) patients with a positive response to acute vasodilator challenge and a clinical response to calcium channel blockers (CCBs) for at least one year are traditionally designated true responders. Nevertheless, little is known about a sustained response to CCBs over longer periods of time. We evaluated the loss of response to CCBs after long-term treatment in a cohort of idiopathic PAH patients previously classified as being true responders. Our data suggest that idiopathic PAH patients can lose clinical response to CCBs even after one year of clinical stability, reinforcing the need for constant multidimensional reevaluation to assess the need for targeted PAH therapies and to classify these patients correctly.
bookPart Hipertensão arterial pulmonar(2023) PARENTE, Yuri de Deus Mont´Alverne; FERNANDES, Caio Julio Cesar; SOUZA, Rogerio- Unusual Forms of Pulmonary Hypertension(2023) PARENTE, Yuri de Deus Montalverne; SILVA, Natalia Fernandes da; SOUZA, Rogerio
- Reply to: ""Mortality and prognostic factors in connective tissue disease-associated pulmonary arterial hypertension patients complicated with right heart failure""(2023) GARCIA, Marcos Vinicius Fernandes; SOUZA, Rogerio; CARUSO, Pedro
- Sotatercept for the treatment of pulmonary arterial hypertension: PULSAR open-label extension(2023) HUMBERT, Marc; MCLAUGHLIN, Vallerie; GIBBS, J. Simon R.; GOMBERG-MAITLAND, Mardi; HOEPER, Marius M.; PRESTON, Ioana R.; SOUZA, Rogerio; WAXMAN, Aaron B.; GHOFRANI, Hossein-Ardeschir; SUBIAS, Pilar Escribano; FELDMAN, Jeremy; MEYER, Gisela; MONTANI, David; OLSSON, Karen M.; MANIMARAN, Solaiappan; PENA, Janethe de Oliveira; BADESCH, David B.Background In participants with pulmonary arterial hypertension, 24 weeks of sotatercept resulted in a significantly greater reduction from baseline in pulmonary vascular resistance than placebo. This report characterises the longer-term safety and efficacy of sotatercept in the PULSAR open-label extension. We report cumulative safety, and efficacy at months 18-24, for all participants treated with sotatercept. Methods PULSAR was a phase 2, randomised, double-blind, placebo-controlled study followed by an open-label extension, which evaluated sotatercept on top of background pulmonary arterial hypertension therapy in adults. Participants originally randomised to placebo were re-randomised 1:1 to sotatercept 0.3 or 0.7 mg center dot kg(-1) ( placebo-crossed group); those initially randomised to sotatercept continued the same sotatercept dose (continued-sotatercept group). Safety was evaluated in all participants who received >= 1 dose of sotatercept. The primary efficacy endpoint was change from baseline to months 18-24 in pulmonary vascular resistance. Secondary endpoints included 6-min walk distance and functional class. Two prespecified analyses, placebo-crossed and delayed-start, evaluated efficacy irrespective of dose. Results Of 106 participants enrolled in the PULSAR study, 97 continued into the extension period. Serious treatment-emergent adverse events were reported in 32 (30.8%) participants; 10 (9.6%) reported treatment-emergent adverse events leading to study discontinuation. Three (2.9%) participants died, none considered related to study drug. The placebo-crossed group demonstrated significant improvement across primary and secondary endpoints and clinical efficacy was maintained in the continued-sotatercept group. Conclusion These results support the longer-term safety and durability of clinical benefit of sotatercept for pulmonary arterial hypertension.
- Long-term survival after acute decompensated pulmonary hypertension: A propensity-score matched study(2023) GARCIA, M. V. F.; SOUZA, R.; CARUSO, P.
- Risk assessment validation in patients with pulmonary arterial hypertension: Data from a Southern Brazil registry (RESPHIRAR study)(2023) SPILIMBERGO, Fernanda Brum; RODRIGUES, Roger Pirath; DIAS-PINTO, Marcelo Credidio; BLANCO, Daniela Cavalet; BARBIERI, Glaucia Maria; ANDRADE-LIMA, Marina; FAGUNDES, Ariovaldo Leal; GAZZANA, Marcelo Basso; RONCATO, Gabriela; MELLO, Marcelo Martins; WATTE, Guilherme; ASSMANN, Tais Silveira; CAURIO, Cassia Ferreira Braz; SOUZA, Rogerio; MEYER, Gisela Martina BohnsPulmonary arterial hypertension (PAH) is a severe and progressive disease characterized by increased pulmonary vascular resistance, ultimately leading to right heart failure and death. Registries are a valuable tool in the research of rare conditions such as PAH. Moreover, the risk assessment strategy has been validated in European and North American registries and has been reported to provide an accurate prediction of mortality and the clinical advantage of reaching low-risk status. However, there is no available data from Brazil. Thus, the aim of the present study was to describe the characteristics of a sample of PAH from Southern Brazil and to retrospectively validate the risk assessment at our population. The RESPHIRAR is a retrospective and multicentric registry on pulmonary hypertension. With a join collaboration from nine centers in Southern Brazil, demographics, clinical presentation, and hemodynamics data of PAH were collected between 2007 and 2017. Moreover, the REVEAL 2.0 and REVEAL 2.0 Lite risk assessments were validated in our population. Overall, 370 PAH patients were included in the present study. Patients were predominantly female (78.5%) and had a mean age of 41.8 +/- 18.8 years. Most patients (33.4%) had idiopathic PAH, 30.2% had PAH associated with congenital heart disease, and 23.5% had PAH associated with connective tissue disease. The low-risk group showed significantly lower mortality than the intermediated- or high-risk group at diagnosis (p < 0.05). In conclusion, our data suggest that REVEAL 2.0 and REVEAL 2.0 Lite risk assessments can predict mortality risk in PAH patients in Southern Brazil.
- Effects of sotatercept on haemodynamics and right heart function: analysis of the STELLAR trial(2023) SOUZA, Rogerio; BADESCH, David B.; GHOFRANI, H. Ardeschir; GIBBS, J. Simon R.; GOMBERG-MAITLAND, Mardi; MCLAUGHLIN, Vallerie V.; PRESTON, Ioana R.; WAXMAN, Aaron B.; GRUENIG, Ekkehard; KOPE, Grzegorz; MEYER, Gisela; OLSSON, Karen M.; ROSENKRANZ, Stephan; LIN, Jianxin; JOHNSON-LEVONAS, Amy O.; PENA, Janethe de Oliveira; HUMBERT, Marc; HOEPER, Marius M.Background In the phase 3 STELLAR trial, sotatercept, an investigational first-in-class activin signalling inhibitor, demonstrated beneficial effects on 6-min walk distance and additional efficacy endpoints in pretreated participants with pulmonary arterial hypertension (PAH).Methods This post hoc analysis evaluated data from right heart catheterisation (RHC) and echocardiography (ECHO) obtained from the STELLAR trial. Changes from baseline in RHC and ECHO parameters were assessed at 24 weeks. An analysis of covariance (ANCOVA) model was used to estimate differences in least squares means with treatment and randomisation stratification (mono/double versus triple therapy; World Health Organization functional class II versus III) as fixed factors, and baseline value as covariate.Results Relative to placebo, treatment with sotatercept led to significant (all p<0.0001 except where noted) improvements from baseline in mean pulmonary artery (PA) pressure (-13.9 mmHg), pulmonary vascular resistance (-254.8 dynscm(-5)), mean right atrial pressure (-2.7 mmHg), mixed venous oxygen saturation (3.84%), PA elastance (-0.42 mmHgmL(-1)beat(-1)), PA compliance (0.58 mLmmHg(-1)), cardiac efficiency (0.48 mLbeat(-1)mmHg(-1)), right ventricular (RV) work (-0.85 gm) and RV power (-32.70 mmHgLmin(-1)). ECHO showed improvements in tricuspid annular plane systolic excursion (TAPSE) to systolic pulmonary artery pressure ratio (0.12 mmmmHg(-1)), end-systolic and end-diastolic RV areas (-4.39 cm(2) and -5.31 cm(2), respectively), tricuspid regurgitation and RV fractional area change (2.04% p<0.050). No significant between-group changes from baseline were seen for TAPSE, heart rate, cardiac output, stroke volume or their indices.Conclusion In pre-treated patients with PAH, sotatercept demonstrated substantial improvements in PA pressures, PA compliance, PA-RV coupling and right heart function.