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1. Access to rehabilitation after stroke in Brazil (AReA study): multicenter study protocol

Author

Roberta de Oliveira Cacho, Carla Heloisa Cabral Moro, Rodrigo Bazan, Suzete Nascimento Farias da Guarda, Elen Beatriz Pinto, Suellen Mary Marinho dos Santos Andrade, Lenise Valler, Kelson James Almeida, Tatiana Souza Ribeiro, Renata Viana Brígido de Moura Jucá, Cesar Minelli, Maria Elisa Pimentel Piemonte, Eric Homero Albuquerque Paschoal, Marco Túlio Araújo Pedatella, Octávio Marques Pontes-Neto, Ana Paula Fontana, Aline de Souza Pagnussat, and Adriana Bastos Conforto

Subjects
stroke, patient discharge, referral and consultation, rehabilitation, Neurosciences. Biological psychiatry. Neuropsychiatry, RC321-571
Abstract

Background Most of the Brazilian population relies on public healthcare and stroke is a major cause of disability in this country of continental dimensions. There is limited information about access to rehabilitation after stroke in Brazil. Objective To provide comprehensive information about Access to Rehabilitation After discharge from public hospitals in Brazil (AReA study), up to 6 months after stroke. Methods The present study intends to collect information from 17 public health centers in 16 Brazilian cities in the 5 macroregions of the country. Each center will include 36 participants (n = 612). The inclusion criteria are: age ≥ 18 years old; ischemic or hemorrhagic stroke, from 6 months to 1 year prior to the interview; admission to a public hospital in the acute phase after stroke; any neurological impairment poststroke; patient or caregiver able to provide informed consent and answer the survey. Patients can only be recruited in public neurology or internal medicine outpatient clinics. Outcomes will be assessed by a standard questionnaire about rehabilitation referrals, the rehabilitation program (current status, duration in months, number of sessions per week) and instructions received. In addition, patients will be asked about preferences for locations of rehabilitation (hospitals, clinics, or at home). Trial Status The study is ongoing. Recruitment started on January 31st, 2020 and is planned to continue until June 2022. Conclusion The AReA study will fill a gap in knowledge about access to stroke rehabilitation in the public health system in different Brazilian regions.

Published
2022
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2. Brazilian Academy of Neurology practice guidelines for stroke rehabilitation: part I

Author

Cesar Minelli, Rodrigo Bazan, Marco Túlio Araújo Pedatella, Luciana de Oliveira Neves, Roberta de Oliveira Cacho, Sheila Cristina Sayuri Abe Magalhães, Gustavo José Luvizutto, Carla Heloísa Cabral Moro, Marcos Christiano Lange, Gabriel Pinheiro Modolo, Bruna Correia Lopes, Elisandra Leites Pinheiro, Juli Thomaz de Souza, Guilherme Riccioppo Rodrigues, Soraia Ramos Cabette Fabio, Gilmar Fernandes do Prado, Karla Carlos, Juliana Junqueira Marques Teixeira, Clara Monteiro Antunes Barreira, Rodrigo de Souza Castro, Thalita Dayrell Leite Quinan, Eduardo Damasceno, Kelson James Almeida, Octávio Marques Pontes-Neto, Marina Teixeira Ramalho Pereira Dalio, Millene Rodrigues Camilo, Michelle Hyczy de Siqueira Tosin, Bianca Campos Oliveira, Beatriz Guitton Renaud Baptista de Oliveira, João José Freitas de Carvalho, and Sheila Cristina Ouriques Martins

Subjects
Stroke, Guideline, Neurological Rehabilitation, Practice Guidelines as Topic, Neurosciences. Biological psychiatry. Neuropsychiatry, RC321-571
Abstract

ABSTRACT The Guidelines for Stroke Rehabilitation are the result of a joint effort by the Scientific Department of Neurological Rehabilitation of the Brazilian Academy of Neurology aiming to guide professionals involved in the rehabilitation process to reduce functional disability and increase individual autonomy. Members of the group participated in web discussion forums with predefined themes, followed by videoconference meetings in which issues were discussed, leading to a consensus. These guidelines, divided into two parts, focus on the implications of recent clinical trials, systematic reviews, and meta-analyses in stroke rehabilitation literature. The main objective was to guide physicians, physiotherapists, speech therapists, occupational therapists, nurses, nutritionists, and other professionals involved in post-stroke care. Recommendations and levels of evidence were adapted according to the currently available literature. Part I discusses topics on rehabilitation in the acute phase, as well as prevention and management of frequent conditions and comorbidities after stroke.

Published
2022
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3. Brazilian practice guidelines for stroke rehabilitation: Part II

Author

Cesar Minelli, Gustavo José Luvizutto, Roberta de Oliveira Cacho, Luciana de Oliveira Neves, Sheila Cristina Sayuri Abe Magalhães, Marco Túlio Araújo Pedatella, Lucia Iracema Zanotto de Mendonça, Karin Zazo Ortiz, Marcos Christiano Lange, Priscila Watson Ribeiro, Luciane Aparecida Pascucci Sande de Souza, Cristiano Milani, Daniel Marinho Cezar da Cruz, Rafael Dalle Molle da Costa, Adriana Bastos Conforto, Fernanda Martins Maia Carvalho, Bruna Silva Ciarlini, Norberto Anizio Ferreira Frota, Kelson James Almeida, Eliane Schochat, Tatiana de Paula Oliveira, Camila Miranda, Maria Elisa Pimentel Piemonte, Laura Cardia Gomes Lopes, Camila Galvão Lopes, Michelle Hyczy de Siqueira Tosin, Bianca Campos Oliveira, Beatriz Guitton Renaud Baptista de Oliveira, Shamyr Sulyvan de Castro, João Brainier Clares de Andrade, Gisele Sampaio Silva, Octávio Marques Pontes-Neto, João José Freitas de Carvalho, Sheila C. Ouriques Martins, and Rodrigo Bazan

Subjects
stroke, neurological rehabilitation, health planning guidelines, practice guidelines as topic, Neurosciences. Biological psychiatry. Neuropsychiatry, RC321-571
Abstract

The Brazilian Practice Guidelines for Stroke Rehabilitation – Part II, developed by the Scientific Department of Neurological Rehabilitation of the Brazilian Academy of Neurology (Academia Brasileira de Neurologia, in Portuguese), focuses on specific rehabilitation techniques to aid recovery from impairment and disability after stroke. As in Part I, Part II is also based on recently available evidence from randomized controlled trials, systematic reviews, meta-analyses, and other guidelines. Part II covers disorders of communication, dysphagia, postural control and balance, ataxias, spasticity, upper limb rehabilitation, gait, cognition, unilateral spatial neglect, sensory impairments, home rehabilitation, medication adherence, palliative care, cerebrovascular events related to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, the future of stroke rehabilitation, and stroke websites to support patients and caregivers. Our goal is to provide health professionals with more recent knowledge and recommendations for better rehabilitation care after stroke.

Published
2022
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4. Reply to the letter regarding the article entitled: 'Access to rehabilitation after stroke in Brazil (AReA study): multicenter study protocol'

Author

Roberta de Oliveira Cacho, Carla Heloisa Cabral Moro, Rodrigo Bazan, Suzete Nascimento Farias da Guarda, Elen Beatriz Pinto, Suellen Mary Marinho dos Santos Andrade, Lenise Valler, Kelson James Almeida, Tatiana Souza Ribeiro, Renata Viana Brígido de Moura Jucá, Cesar Minelli, Maria Elisa Pimentel Piemonte, Eric Homero Albuquerque Paschoal, Marco Túlio Araújo Pedatella, Octávio Marques Pontes-Neto, Ana Paula Fontana, Aline de Souza Pagnussat, Adriana Bastos Conforto, and AReA Study Group

Subjects
Neurosciences. Biological psychiatry. Neuropsychiatry, RC321-571
Published
2023
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5. Matão Controlling Hypertension (MatCH) project: Rationale and design

Author

Cesar Minelli, Norberto Cabral, Ariany de Souza Leite, Paulo Cicogna Neto, Maria Silvia Vichi, João Luiz Carmo, Fumiu Iwachima, Antônio Durval Martins Peres, Arthur Augusto Ribeiro Ferreira, Flavio Borsetti Neto, Liliana Tiene Ujikawa, Lucileni Aparecida Borin, Geraldo Cassio dos Reis, Denise Paolinetti Camara Minelli, and Esther Langhi Chiozzini

Subjects
Hypertension, Awareness, Blood-pressure control, Population community-based study, Medicine (General), R5-920
Abstract

Background: Hypertension is the main risk factor for most cardiovascular diseases. A coordinated and organized system from the Brazilian Ministry of Healthy involving Family Health Strategy (FHS), a program for the prevention of chronic disease, and the Popular Pharmacy Program (PPP), which subsidizes medications for the population, could allow an earlier identification and better blood pressure (BP) control. Matão Controlling Hypertension (MatCH) is a community-based population project that aims to apply an organized, integrated and coordinated program in the city of Matão, Brazil, involving FHS and PPP in order to actively search, treat and follow-up hypertensive subjects. Method: This is a population community-based, interventional, follow-up study where all subjects aged ≥ 40 years assisted by the FHS program in Matão will have BP assessed monthly by trained Community Health Agents (CHA) during a domiciliary visit. Identified hypertensive subjects will be referred to FHS physicians for nonpharmacological and pharmacological treatment. Most of the hypertensive drugs used will be available through the PPP. Prevalence of hypertension, awareness, demographics and risk factors will be correlated with BP control. The population study is expected to involve approximately 18.600 subjects. The study period will be four years. Discussion: Considering that hypertension is asymptomatic in most cases, to reduce the population burden of BP-related deaths and diseases it is essential to detect and treat early all hypertensive patients. If we achieve our large-scale BP control, this program can be applied to other populations from developing countries.

Published
2017
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6. Sex Differences in Severity of Stroke in the INSTRUCT Study: a Meta‐Analysis of Individual Participant Data

Author

Hoang T. Phan, Mathew J. Reeves, Christopher L. Blizzard, Amanda G. Thrift, Dominique A. Cadilhac, Jonathan Sturm, Petr Otahal, Peter Rothwell, Yannick Bejot, Norberto L. Cabral, Peter Appelros, Janika Kõrv, Riina Vibo, Cesar Minelli, and Seana L. Gall

Subjects
epidemiology, sex difference, stroke, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Background Women have worse outcomes after stroke than men, and this may be partly explained by stroke severity. We examined factors contributing to sex differences in severity of acute stroke assessed by the National Institutes of Health Stroke Scale. Methods and Results We pooled individual participant data with National Institutes of Health Stroke Scale assessment (N=6343) from 8 population‐based stroke incidence studies (1996–2014), forming part of INSTRUCT (International Stroke Outcomes Study). Information on sociodemographics, stroke‐related clinical factors, comorbidities, and pre‐stroke function were obtained. Within each study, relative risk regression using log‐binominal modeling was used to estimate the female:male relative risk (RR) of more severe stroke (National Institutes of Health Stroke Scale>7) stratified by stroke type (ischemic stroke and intracerebral hemorrhage). Study‐specific unadjusted and adjusted RRs, controlling for confounding variables, were pooled using random‐effects meta‐analysis. National Institutes of Health Stroke Scale data were recorded in 5326 (96%) of 5570 cases with ischemic stroke and 773 (90%) of 855 participants with intracerebral hemorrhage. The pooled unadjusted female:male RR for severe ischemic stroke was 1.35 (95% CI 1.24–1.46). The sex difference in severity was attenuated after adjustment for age, pre‐stroke dependency, and atrial fibrillation but remained statistically significant (pooled RRadjusted 1.20, 95% CI 1.10–1.30). There was no sex difference in severity for intracerebral hemorrhage (RRcrude 1.08, 95% CI 0.97–1.21; RRadjusted 1.08, 95% CI 0.96–1.20). Conclusions Although women presented with more severe ischemic stroke than men, much although not all of the difference was explained by pre‐stroke factors. Sex differences could potentially be ameliorated by strategies to improve pre‐stroke health in the elderly, the majority of whom are women. Further research on the potential biological origin of sex differences in stroke severity may also be warranted.

Published
2019
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7. Functional versus Nonfunctional Rehabilitation in Chronic Ischemic Stroke: Evidences from a Randomized Functional MRI Study

Author

Maristela C. X. Pelicioni, Morgana M. Novaes, Andre S. C. Peres, Altay A. Lino de Souza, Cesar Minelli, Soraia R. C. Fabio, Octavio M. Pontes-Neto, Antonio C. Santos, and Draulio B. de Araujo

Subjects
Neurosciences. Biological psychiatry. Neuropsychiatry, RC321-571
Abstract

Motor rehabilitation of stroke survivors may include functional and/or nonfunctional strategy. The present study aimed to compare the effect of these two rehabilitation strategies by means of clinical scales and functional Magnetic Resonance Imaging (fMRI). Twelve hemiparetic chronic stroke patients were selected. Patients were randomly assigned a nonfunctional (NFS) or functional (FS) rehabilitation scheme. Clinical scales (Fugl-Meyer, ARA test, and modified Barthel) and fMRI were applied at four moments: before rehabilitation (P1) and immediately after (P2), 1 month after (P3), and three months after (P4) the end of rehabilitation. The NFS group improved significantly and exclusively their Fugl-Meyer scores at P2, P3, and P4, when compared to P1. On the other hand, the FS group increased significantly in Fugl-Meyer at P2, when compared to P1, and also in their ARA and Barthel scores. fMRI inspection at the individual level revealed that both rehabilitation schemes most often led to decreased activation sparseness, decreased activity of contralesional M1, increased asymmetry of M1 activity to the ipsilesional side, decreased perilesional activity, and decreased SMA activity. Increased M1 asymmetry with rehabilitation was also confirmed by Lateralization Indexes. Our clinical analysis revealed subtle differences between FS and NFS.

Published
2016
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8. Rehabilitation of the upper extremity and basic activities of daily living in the first month after ischemic stroke: an international cohort comparison study

Author

Cesar Minelli, Francisco A.A. Gondim, Amilton Antunes Barreira, and Alexander W. Dromerick

Subjects
Rehabilitation, Arm, Activities of Daily Living, Outcome Assessment, Internationality Randomized Controlled trials, Medicine, Internal medicine, RC31-1245, Neurosciences. Biological psychiatry. Neuropsychiatry, RC321-571
Abstract

Background: Inpatient rehabilitation has been traditionally employed in developed countries, while in developing countries, outpatient rehabilitation is the rule. The purpose of this study was to compare the patterns of recovery of upper extremity (UE) function, global impairment and independence in activities of daily living (ADL) during the first month after ischaemic stroke in inpatient (United States) and outpatient (Brazil) rehabilitation settings. Design and Methods: This is a prospective cohort comparison study. Twenty patients from each country were selected using identical inclusion criteria. The study measures employed were the UE portion of the Fugl-Meyer scale, the Action Research Arm test, the National Institutes of Health Stroke Scale and Barthel Index. Changes from baseline to the end of treatment, efficiency and effectiveness of each treatment were compared. Results: Both populations exhibited significant improvement between the first and second evaluations in the four outcome scales (P 0.05). Conclusions: Substantially different treatment approaches after ischaemic stroke led to similar results in UE function, global impairment and ADL. Further studies in larger populations should be performed in order to confirm the present results.

Published
2009
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9. Efficacy and safety of baricitinib for the treatment of hospitalised adults with COVID-19 (COV-BARRIER): a randomised, double-blind, parallel-group, placebo-controlled phase 3 trial

Author

Vincent C Marconi, Athimalaipet V Ramanan, Stephanie de Bono, Cynthia E Kartman, Venkatesh Krishnan, Ran Liao, Maria Lucia B Piruzeli, Jason D Goldman, Jorge Alatorre-Alexander, Rita de Cassia Pellegrini, Vicente Estrada, Mousumi Som, Anabela Cardoso, Sujatro Chakladar, Brenda Crowe, Paulo Reis, Xin Zhang, David H Adams, E Wesley Ely, Mi-Young Ahn, Miriam Akasbi, Javier David Altclas, Federico Ariel, Horacio Alberto Ariza, Chandrasekhar Atkar, Anselmo Bertetti, Meenakshi Bhattacharya, Maria Luisa Briones, Akshay Budhraja, Aaliya Burza, Adrian Camacho Ortiz, Roberto Caricchio, Marcelo Casas, Valeria Cevoli Recio, Won Suk Choi, Emilia Cohen, Angel Comulada-Rivera, Paul Cook, Dora Patricia Cornejo Juarez, Carnevali Daniel, Luiz Fernando Degrecci Relvas, Jose Guillermo Dominguez Cherit, Todd Ellerin, Dmitry Enikeev, Suzana Erico Tanni Minamoto, Elie Fiss, Motohiko Furuichi, Kleber Giovanni Luz, Jason D. Goldman, Omar Gonzalez, Ivan Gordeev, Thomas Gruenewald, Victor Augusto Hamamoto Sato, Eun Young Heo, Jung Yeon Heo, Maria Hermida, Yuji Hirai, David Hutchinson, Claudio Iastrebner, Octavian Ioachimescu, Manish Jain, Maria Patelli Juliani Souza Lima, Akram Khan, Andreas E. Kremer, Thomas Lawrie, Mark MacElwee, Farah Madhani-Lovely, Vinay Malhotra, Michel Fernando Martínez Resendez, James McKinnell, Patrick Milligan, Cesar Minelli, Miguel Angel Moran Rodriguez, Maria Leonor Parody, Priscila Paulin, Priscilla Pemu, Ana Carolina Procopio Carvalho, Massimo Puoti, Joshua Purow, Mayur Ramesh, Alvaro Rea Neto, Philip Robinson, Cristhieni Rodrigues, Gustavo Rojas Velasco, Jose Francisco Kerr Saraiva, Morton Scheinberg, Stefan Schreiber, Dario Scublinsky, Anete Sevciovic Grumach, Imad Shawa, Jesus Simon Campos, Nidhi Sofat, Christoph D. Spinner, Eduardo Sprinz, Roger Stienecker, Jose Suarez, Natsuo Tachikawa, Hasan Tahir, Brian Tiffany, Alexander Vishnevsky, Adilson Westheimer Cavalcante, Kapil Zirpe, Marconi, V, Ramanan, A, de Bono, S, Kartman, C, Krishnan, V, Liao, R, Piruzeli, M, Goldman, J, Alatorre-Alexander, J, de Cassia Pellegrini, R, Estrada, V, Som, M, Cardoso, A, Chakladar, S, Crowe, B, Reis, P, Zhang, X, Adams, D, Ely, E, Ahn, M, Akasbi, M, Altclas, J, Ariel, F, Ariza, H, Atkar, C, Bertetti, A, Bhattacharya, M, Briones, M, Budhraja, A, Burza, A, Camacho Ortiz, A, Caricchio, R, Casas, M, Cevoli Recio, V, Choi, W, Cohen, E, Comulada-Rivera, A, Cook, P, Cornejo Juarez, D, Daniel, C, Degrecci Relvas, L, Dominguez Cherit, J, Ellerin, T, Enikeev, D, Erico Tanni Minamoto, S, Fiss, E, Furuichi, M, Giovanni Luz, K, Gonzalez, O, Gordeev, I, Gruenewald, T, Hamamoto Sato, V, Heo, E, Heo, J, Hermida, M, Hirai, Y, Hutchinson, D, Iastrebner, C, Ioachimescu, O, Jain, M, Juliani Souza Lima, M, Khan, A, Kremer, A, Lawrie, T, Macelwee, M, Madhani-Lovely, F, Malhotra, V, Martinez Resendez, M, Mckinnell, J, Milligan, P, Minelli, C, Moran Rodriguez, M, Parody, M, Paulin, P, Pellegrini, R, Pemu, P, Procopio Carvalho, A, Puoti, M, Purow, J, Ramesh, M, Rea Neto, A, Robinson, P, Rodrigues, C, Rojas Velasco, G, Saraiva, J, Scheinberg, M, Schreiber, S, Scublinsky, D, Sevciovic Grumach, A, Shawa, I, Simon Campos, J, Sofat, N, Spinner, C, Sprinz, E, Stienecker, R, Suarez, J, Tachikawa, N, Tahir, H, Tiffany, B, Vishnevsky, A, Westheimer Cavalcante, A, and Zirpe, K

Subjects
Pulmonary and Respiratory Medicine, Adult, medicine.medical_specialty, Asia, medicine.medical_treatment, Population, Placebo, Antiviral Agents, Corrections, Dexamethasone, Baricitinib, Double-Blind Method, Adrenal Cortex Hormones, Internal medicine, Clinical endpoint, medicine, Humans, education, Adverse effect, Mechanical ventilation, education.field_of_study, Sulfonamides, Alanine, business.industry, SARS-CoV-2, Hazard ratio, Absolute risk reduction, COVID-19, Odds ratio, Articles, South America, Adenosine Monophosphate, COVID-19 Drug Treatment, Europe, Treatment Outcome, Purines, North America, Azetidines, Pyrazoles, business
Abstract

Summary Background Baricitinib is an oral selective Janus kinase 1/2 inhibitor with known anti-inflammatory properties. This study evaluates the efficacy and safety of baricitinib in combination with standard of care for the treatment of hospitalised adults with COVID-19. Methods In this phase 3, double-blind, randomised, placebo-controlled trial, participants were enrolled from 101 centres across 12 countries in Asia, Europe, North America, and South America. Hospitalised adults with COVID-19 receiving standard of care were randomly assigned (1:1) to receive once-daily baricitinib (4 mg) or matched placebo for up to 14 days. Standard of care included systemic corticosteroids, such as dexamethasone, and antivirals, including remdesivir. The composite primary endpoint was the proportion who progressed to high-flow oxygen, non-invasive ventilation, invasive mechanical ventilation, or death by day 28, assessed in the intention-to-treat population. All-cause mortality by day 28 was a key secondary endpoint, and all-cause mortality by day 60 was an exploratory endpoint; both were assessed in the intention-to-treat population. Safety analyses were done in the safety population defined as all randomly allocated participants who received at least one dose of study drug and who were not lost to follow-up before the first post-baseline visit. This study is registered with ClinicalTrials.gov , NCT04421027 . Findings Between June 11, 2020, and Jan 15, 2021, 1525 participants were randomly assigned to the baricitinib group (n=764) or the placebo group (n=761). 1204 (79·3%) of 1518 participants with available data were receiving systemic corticosteroids at baseline, of whom 1099 (91·3%) were on dexamethasone; 287 (18·9%) participants were receiving remdesivir. Overall, 27·8% of participants receiving baricitinib and 30·5% receiving placebo progressed to meet the primary endpoint (odds ratio 0·85 [95% CI 0·67 to 1·08], p=0·18), with an absolute risk difference of −2·7 percentage points (95% CI −7·3 to 1·9). The 28-day all-cause mortality was 8% (n=62) for baricitinib and 13% (n=100) for placebo (hazard ratio [HR] 0·57 [95% CI 0·41–0·78]; nominal p=0·0018), a 38·2% relative reduction in mortality; one additional death was prevented per 20 baricitinib-treated participants. The 60-day all-cause mortality was 10% (n=79) for baricitinib and 15% (n=116) for placebo (HR 0·62 [95% CI 0·47–0·83]; p=0·0050). The frequencies of serious adverse events (110 [15%] of 750 in the baricitinib group vs 135 [18%] of 752 in the placebo group), serious infections (64 [9%] vs 74 [10%]), and venous thromboembolic events (20 [3%] vs 19 [3%]) were similar between the two groups. Interpretation Although there was no significant reduction in the frequency of disease progression overall, treatment with baricitinib in addition to standard of care (including dexamethasone) had a similar safety profile to that of standard of care alone, and was associated with reduced mortality in hospitalised adults with COVID-19. Funding Eli Lilly and Company. Translations For the French, Japanese, Portuguese, Russian and Spanish translations of the abstract see Supplementary Materials section.

Published
2021

10. Access to rehabilitation after stroke in Brazil (AReA study): multicenter study protocol.

Author

de Oliveira Cacho, Roberta, Cabral Moro, Carla Heloisa, Bazan, Rodrigo, Farias da Guarda, Suzete Nascimento, Beatriz Pinto, Elen, Marinho dos Santos Andrade, Suellen Mary, Valler, Lenise, James Almeida, Kelson, Souza Ribeiro, Tatiana, Brígido de Moura Jucá10 Cesar Minelli, Renata Viana, Pimentel Piemonte, Maria Elisa, Albuquerque Paschoal, Eric Homero, Araújo Pedatella, Marco Túlio, Marques Pontes-Neto, Octávio, Paula Fontana, Ana, de Souza Pagnussat, Aline, and Bastos Conforto, Adriana

Abstract

Copyright of Arquivos de Neuro-Psiquiatria is the property of Thieme Medical Publishing Inc. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2022
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11. Safety and efficacy of GABAA α5 antagonist S44819 in patients with ischaemic stroke : A multicentre, double-blind, randomised, placebo-controlled trial

Author

Peter D. Schellinger, Agnes Koves, Usman A. Khan, Didier Smadja, Gabriel Rodriguez Freitas, Ralf Lindert, Bill O'brien, Jaime Masjuan Vallejo, Aida Lago Martin, Cesar Minelli, Hassan Hosseini, Marine Wattez, Martin Grond, Claudio L. Bassetti, Konrad Rejdak, Marie-Laure Audoli-Inthavong, Luisa Rover, Pere Cardona, Kenneth Butcher, Gabriel R. de Freitas, Gyula Panczel, Tomas Segura Martin, Marianna Gottschal, Maurício André Gheller Friedrich, Hugues Chabriat, Alvaro Ximenez Carrillo, Laura Dorado, Jean-Philippe Neau, Joerg Berrouschot, D. G. Nabavi, Carla H.C. Moro, Nina De Klippel, Norbert Szegedi, Tomasz Berkowicz, Jesse Dawson, Andras Folyovich, Christian Denier, Jean-Louis Mas, Klaus Gröschel, Amit K Mistri, Thanh G. Phan, Timothy Kleinig, Aurore Sors, Dirk M. Hermann, Louise Shaw, Christine Roffe, Nikola Sprigg, Man Seok Park, Hans-Christoph Diener, Hassan Soda, Maite Martinez Zabaleta, Pietro Bassi, Luiz Carlos Porcello Marrone, Dylan Blacquiere, László Vécsei, Stephen N. Davis, Giuseppe Lembo, Rohan Grimley, Charlotte Cordonnier, Geert Vanhooren, Bernd Kallmuenzer, Peter Dioszeghy, Mikael Mazighi, Waldemar Brola, Francisco Moniche Alvarez, Yangha Hwang, Attila Valikovics, Waldemar Fryze, Philippe Desfontaines, Jaume Roquer Gonzalez, David Cohen, Zbigniew Bak, Csaba Ovary, Jae-Kwan Cha, Gisele Sampaio Silva, Carlos A. Molina, Rodrigo Bazan, Hee-Joon Bae, Rubens José Gagliardi, Geoffrey Cloud, Anna Członkowska, Attila Csanyi, Leonardo Barbarini, Sergi Amaro, Jong Sung Kim, Daniel Bereczki, Katharina Althaus, Robin Lemmens, Anetta Lasek-Bal, Theodore Wein, Piotr Sobolewski, Diederik Willem Dippel, Danilo Toni, Laszlo Szapary, Suzanne Ragab, Andrew Wong, Ute Marx, Estelle Lambert, Igor Sibon, Wim M. Mulleners, Ondrej Skoda, and Maciej Swiat

Subjects
0301 basic medicine, medicine.medical_specialty, business.industry, medicine.medical_treatment, Placebo-controlled study, Medizin, Placebo, law.invention, Clinical trial, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Randomized controlled trial, law, Modified Rankin Scale, Internal medicine, ischemic stroke, medicine, Clinical endpoint, Neurology (clinical), Stroke recovery, business, Adverse effect, 030217 neurology & neurosurgery
Abstract

Summary Background S44819, a selective GABAA α5 receptor antagonist, reduces tonic post-ischaemic inhibition of the peri-infarct cortex. S44819 improved stroke recovery in rodents and increased cortical excitability in a transcranial magnetic stimulation study in healthy volunteers. The Randomized Efficacy and Safety Trial of Oral GABAA α5 antagonist S44819 after Recent ischemic Event (RESTORE BRAIN) aimed to evaluate the safety and efficacy of S44819 for enhancing clinical recovery of patients with ischaemic stroke. Methods RESTORE BRAIN was an international, randomised, double-blind, parallel-group, placebo-controlled, multicentre phase 2 trial that evaluated the safety and efficacy of oral S44189 in patients with recent ischaemic stroke. The study was done in specialised stroke units in 92 actively recruiting centres in 14 countries: ten were European countries (Belgium, Czech Republic, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, and the UK) and four were non-European countries (Australia, Brazil, Canada, and South Korea). Patients aged 18–85 years with acute ischaemic stroke involving cerebral cortex (National Institute of Health Stroke Scale [NIHSS] score 7–20) without previous disability were eligible for inclusion. Participants were randomly assigned to receive 150 mg S44819 twice a day, 300 mg S44819 twice a day, or placebo twice a day by a balanced, non-adaptive randomisation method with a 1:1:1 ratio. Treatment randomisation and allocation were centralised via the interactive web response system using computer-generated random sequences with a block size of 3. Blinding of treatment was achieved by identical appearance and taste of all sachets. Patients, investigators and individuals involved in the analysis of the trial were masked to group assignment. The primary endpoint was the modified Rankin Scale (mRS) score 90 days from onset of treatment, evaluated by shift analysis (predefined main analysis) or by dichotomised analyses using 0–1 versus 2–6 and 0–2 versus 3–6 cutoffs (predefined secondary analysis). Secondary endpoints were the effects of S44819 on the NIHSS and Montreal Cognitive Assessment (MoCA) scores, time needed to complete parts A and B of the Trail Making Test, and the Barthel index. Efficacy analyses were done on all patients who received at least one dose of treatment and had at least one mRS score taken after day 5 (specifically, on or after day 30). Safety was compared across treatment groups for all patients who received at least one dose of treatment. The study was registered at ClinicalTrials.gov , NCT02877615 . Findings Between Dec 19, 2016, and Nov 16, 2018, 585 patients were enrolled in the study. Of these, 197 (34%) were randomly assigned to receive 150 mg S44819 twice a day, 195 (33%) to receive 300 mg S44819 twice a day, and 193 (33%) to receive placebo twice a day. 189 (96%) of 197 patients in the 150 mg S44819 group, 188 (96%) of 195 patients in the 300 mg S44819 group, and 191 (99%) patients in the placebo group received at least one dose of treatment and had at least one mRS score taken after day 5, and were included in efficacy analyses. 195 (99%) of 197 patients in the 150 mg S44819 group, 194 (99%) of 195 patients in the 300 mg S44819 group, and 193 (100%) patients in the placebo group received at least one dose of treatment, and were included in safety analyses. The primary endpoint of mRS at day 90 did not differ between each of the two S44819 groups and the placebo group (OR 0·91 [95% CI 0·64–1·31]; p=0·80 for 150 mg S44819 compared with placebo and OR 1·17 [95% CI 0·81–1·67]; p=0·80 for 300 mg S44819 compared with placebo). Likewise, dichotomised mRS scores at day 90 (mRS 0–2 vs 3–6 or mRS 0–1 vs 2–6) did not differ between groups. Secondary endpoints did not reveal any significant group differences. The median NIHSS score at day 90 did not differ between groups (4 [IQR 2–8] in 150 mg S44819 group, 4 [2–7] in 300 mg S44819 group, and 4 [2–6] in placebo group), nor did the number of patients at day 90 with an NIHSS score of up to 5 (95 [61%] of 156 in 150 mg S44819 group, 106 [66%] of 161 in 300 mg S44819 group, and 104 [66%] of 157 in placebo group) versus more than 5 (61 [39%] in 150 mg S44819 group, 55 [34%] in 300 mg S44819 group, and 53 [34%] in placebo group). Likewise, the median MoCA score (22·0 [IQR 17·0–26·0] in 150 mg S44819 group, 23·0 [19·0–26·5] in 300 mg S44819 group, and 22·0 [17·0–26·0] in placebo group), time needed to complete parts A (50 s [IQR 42–68] in 150 mg S44819 group, 49 s [36–63] in 300 mg S44819 group, and 50 s [38–68] in placebo group) and B (107 s [81–144] in 150 mg S44819 group, 121 s [76–159] in 300 mg S44819 group, and 130 s [86–175] in placebo group) of the Trail Making Test, and the Barthel index (90 [IQR 60–100] in 150 mg S44819 group, 90 [70–100] in 300 mg S44819 group, and 90 [70–100] in placebo group) were similar in all groups. Number and type of adverse events were similar between the three groups. There were no drug-related adverse events and no drug-related deaths. Interpretation There was no evidence that S44819 improved clinical outcome in patients after ischaemic stroke, and thus S44819 cannot be recommended for stroke therapy. The concept of tonic inhibition after stroke should be re-evaluated in humans. Funding Servier.

Published
2020

12. Sex differences in long-term mortality after stroke in the INSTRUCT (INternational STRoke oUtComes sTudy): A meta-analysis of individual participant data

Author

Jonathan Sturm, Riina Vibo, Priya Parmar, Carolina Silva, Christopher L. Blizzard, Hoang T Phan, Norberto L. Cabral, Janika Kõrv, Yannick Béjot, Amanda G. Thrift, Dominique A Cadilhac, Simona Sacco, Stéphane Olindo, Peter Appelros, Emma Heeley, Manuel Correia, Seana L. Gall, Rui Magalhães, Suzanne Barker-Collo, Mathew J. Reeves, Petr Otahal, Vemmos Konstantinos, Cesar Minelli, Peter M. Rothwell, Nicolas Chausson, Antonio Carolei, Valery L. Feigin, Craig S. Anderson, and Rita Krishnamurthi

Subjects
Male, medicine.medical_specialty, Time Factors, Neurology, 030204 cardiovascular system & hematology, Risk Assessment, Severity of Illness Index, 03 medical and health sciences, Sex Factors, 0302 clinical medicine, Risk Factors, Odds Ratio, Humans, Medicine, Stroke, Aged, Australasia, business.industry, Incidence, Individual participant data, Incidence (epidemiology), Age Factors, Health Status Disparities, Middle Aged, South America, Prognosis, medicine.disease, Europe, Caribbean Region, Meta-analysis, Emergency medicine, Physical therapy, Female, Long term mortality, Cardiology and Cardiovascular Medicine, business, 030217 neurology & neurosurgery
Abstract

Background— Women are reported to have greater mortality after stroke than men, but the reasons are uncertain. We examined sex differences in mortality at 1 and 5 years after stroke and identified factors contributing to these differences. Methods and Results— Individual participant data for incident strokes were obtained from 13 population-based incidence studies conducted in Europe, Australasia, South America, and the Caribbean between 1987 and 2013. Data on sociodemographics, stroke-related factors, prestroke health, and 1- and 5-year survival were obtained. Poisson modeling was used to estimate the mortality rate ratio (MRR) for women compared with men at 1 year (13 studies) and 5 years (8 studies) after stroke. Study-specific adjusted MRRs were pooled to create a summary estimate using random-effects meta-analysis. Overall, 16 957 participants with first-ever stroke followed up at 1 year and 13 216 followed up to 5 years were included. Crude pooled mortality was greater for women than men at 1 year (MRR 1.35; 95% confidence interval, 1.24–1.47) and 5 years (MRR 1.24; 95% confidence interval, 1.12–1.38). However, these pooled sex differences were reversed after adjustment for confounding factors (1 year MRR, 0.81; 95% confidence interval, 0.72–0.92 and 5-year MRR, 0.76; 95% confidence interval, 0.65–0.89). Confounding factors included age, prestroke functional limitations, stroke severity, and history of atrial fibrillation. Conclusions— Greater mortality in women is mostly because of age but also stroke severity, atrial fibrillation, and prestroke functional limitations. Lower survival after stroke among the elderly is inevitable, but there may be opportunities for intervention, including better access to evidence-based care for cardiovascular and general health.

Published
2019

13. Rivaroxaban with or without aspirin in patients with stable coronary artery disease : an international, randomised, double-blind, placebo-controlled trial

Author

Stuart J Connolly, John W Eikelboom, Jackie Bosch, Gilles Dagenais, Leanne Dyal, Fernando Lanas, Kaj Metsarinne, Martin O'Donnell, Anthony L Dans, Jong-Won Ha, Alexandr N Parkhomenko, Alvaro A Avezum, Eva Lonn, Liu Lisheng, Christian Torp-Pedersen, Petr Widimsky, Aldo P Maggioni, Camilo Felix, Katalin Keltai, Masatsugu Hori, Khalid Yusoff, Tomasz J Guzik, Deepak L Bhatt, Kelley R H Branch, Nancy Cook Bruns, Scott D Berkowitz, Sonia S Anand, John D Varigos, Keith A A Fox, Salim Yusuf, JORGELINA SALA, LUIS CARTASEGNA, MARISA VICO, MIGUEL ANGEL HOMINAL, EDUARDO HASBANI, ALBERTO CACCAVO, CESAR ZAIDMAN, DANIEL VOGEL, ADRIAN HRABAR, PABLO OMAR SCHYGIEL, CARLOS CUNEO, HUGO LUQUEZ, IGNACIO J. MACKINNON, RODOLFO ANDRES AHUAD GUERRERO, JUAN PABLO COSTABEL, INES PALMIRA BARTOLACCI, OSCAR MONTANA, MARIA BARBIERI, OSCAR GOMEZ VILAMAJO, RUBEN OMAR GARCIA DURAN, LILIA BEATRIZ SCHIAVI, MARCELO GARRIDO, ADRIAN INGARAMO, ANSELMO PAULINO BORDONAVA, MARIA JOSE PELAGAGGE, LEONARDO NOVARETTO, JUAN PABLO ALBISU DI GENNERO, LUZ MARIA IBANEZ SAGGIA, MOIRA ALVAREZ, NESTOR ALEJANDRO VITA, STELLA MARIS MACIN, RICARDO DARIO DRAN, MARCELO CARDONA, LUIS GUZMAN, RODOLFO JUAN SARJANOVICH, JESUS CUADRADO, SEBASTIAN NANI, MARCOS RAUL LITVAK BRUNO, CAROLINA CHACON, LAURA ELENA MAFFEI, DIEGO GRINFELD, NATALIA VENSENTINI, CLAUDIO RODOLFO MAJUL, HECTOR LUCAS LUCIARDI, PATRICIA DEL CARMEN GONZALEZ COLASO, FREDY ANTONI FERRE PACORA, PAUL VAN DEN HEUVEL, PETER VERHAMME, BAVO ECTOR, PHILIPPE DEBONNAIRE, PHILIPPE VAN DE BORNE, JEAN LEROY, HERMAN SCHROE, PASCAL VRANCKX, IVAN ELEGEERT, ETIENNE HOFFER, KARL DUJARDIN, CLARISSE INDIO DO BRASIL, DALTON PRECOMA, JOSE ANTONIO ABRANTES, EULER MANENTI, GILMAR REIS, JOSE SARAIVA, LILIA MAIA, MAURO HERNANDES, PAULO ROSSI, FABIO ROSSI DOS SANTOS, SERGIO LUIZ ZIMMERMANN, RAFAEL RECH, EDUARDO ABIB JR, PAULO LEAES, ROBERTO BOTELHO, OSCAR DUTRA, WEIMAR SOUZA, MARIA BRAILE, NILO IZUKAWA, JOSE CARLOS NICOLAU, LUIZ FERNANDO TANAJURA, CARLOS VICENTE SERRANO JUNIOR, CESAR MINELLI, LUIZ ANTONIO NASI, LIVIA OLIVEIRA, MARCELO JOSE DE CARVALHO CANTARELLI, RICHARD TYTUS, SHEKHAR PANDEY, EVA LONN, JAMES CHA, SAUL VIZEL, MOHAN BABAPULLE, ANDRE LAMY, KEVIN SAUNDERS, JOSEPH BERLINGIERI, BOB KIAII, RAKESH BHARGAVA, PRAVINSAGAR MEHTA, LAURIE HILL, DAVID FELL, ANDY LAM, FAISAL AL-QOOFI, CRAIG BROWN, ROBERT PETRELLA, JOSEPH A RICCI, ANTHONY GLANZ, NICOLAS NOISEUX, KEVIN BAINEY, FATIMA MERALI, MICHAEL HEFFERNAN, ANTHONY DELLA SIEGA, GILLES R DAGENAIS, FRANCOIS DAGENAIS, STEEVE BRULOTTE, MICHEL NGUYEN, MICHAEL HARTLEIB, RANDOLPH GUZMAN, RONALD BOURGEOIS, DENNIS RUPKA, YAARIV KHAYKIN, GILBERT GOSSELIN, THAO HUYNH, CLAUDE PILON, JEAN CAMPEAU, FRANCIS PICHETTE, ARIEL DIAZ, JAMES JOHNSTON, PRAVIN SHUKLE, GREGORY HIRSCH, PAUL RHEAULT, WLODZIMIERZ CZARNECKI, ANNIE ROY, SHAH NAWAZ, STEPHEN FREMES, DINKAR SHUKLA, GABRIEL JANO, JORGE LEONARDO COBOS, RAMON CORBALAN, MARCELO MEDINA, LEONARDO NAHUELPAN, CARLOS RAFFO, LUIS PEREZ, SERGIO POTTHOFF, BENJAMIN STOCKINS, PABLO SEPULVEDA, CHRISTIAN PINCETTI, MARGARITA VEJAR, HONGYAN TIAN, XUESI WU, YUANNAN KE, KAIYING JIA, PENGFEI YIN, ZHAOHUI WANG, LITIAN YU, SHULIN WU, ZONGQUI WU, SHAO WEN LIU, XIAO JUAN BAI, YANG ZHENG, PING YANG, YUN MEI YANG, JIWEI ZHANG, JUNBO GE, XIAO PING CHEN, JUNXIA LI, TAO HONG HU, RUIYAN ZHANG, ZHE ZHENG, XIN CHEN, LIANG TAO, JIANPING LI, WEIJIAN HUANG, GUOSHENG FU, CHUNJIAN LI, YUGANG DONG, CHUNSHENG WANG, XINMIN ZHOU, YE KONG, ARISTIDES SOTOMAYOR, JOSE LUIS ACCINI MENDOZA, HENRY CASTILLO, MIGUEL URINA, GUSTAVO AROCA, MARITZA PEREZ, DORA INES MOLINA DE SALAZAR, GREGORIO SANCHEZ VALLEJO, MANZUR J FERNANDO, HENRY GARCIA, LUIS HERNANDO GARCIA, EDGAR ARCOS, JUAN GOMEZ, FRANCISCO CUERVO MILLAN, FREDY ALBERTO TRUJILLO DADA, BORIS VESGA, GUSTAVO ADOLFO MORENO SILGADO, EVA ZIDKOVA, JEAN-CLAUDE LUBANDA, MARKETA KALETOVA, RADIM KRYZA, GABRIEL MARCINEK, MAREK RICHTER, JINDRICH SPINAR, JIRI MATUSKA, MARTIN TESAK, ZUZANA MOTOVSKA, MARIAN BRANNY, JIRI MALY, MARTIN MALY, MARTIN WIENDL, LENKA FOLTYNOVA CAISOVA, JOSEF SLABY, PETR VOJTISEK, JAN PIRK, LENKA SPINAROVA, MIROSLAVA BENESOVA, JULIA CANADYOVA, MIROSLAV HOMZA, JINDRICH FLORIAN, ROSTISLAV POLASEK, ZDENEK COUFAL, VLADIMIRA SKALNIKOVA, RADIM BRAT, MIROSLAV BRTKO, PETR JANSKY, JAROSLAV LINDNER, PAVEL MARCIAN, ZBYNEK STRAKA, MARTIN TRETINA, YAN CARLOS DUARTE, FREDDY POW CHON LONG, MAYRA SANCHEZ, JOSE LOPEZ, CARMITA PERUGACHI, RICARDO MARMOL, FREDDY TRUJILLO, PABLO TERAN, JAAKKO TUOMILEHTO, HENRI TUOMILEHTO, MARJA-LEENA TUOMINEN, ILKKA KANTOLA, GABRIEL STEG, VICTOR ABOYANS, FLORENCE LECLERCQ, EMILE FERRARI, FRANCK BOCCARA, EMMANUEL MESSAS, PATRICK MISMETTI, MARIE ANTOINETTE SEVESTRE, GUILLAUME CAYLA, PASCAL MOTREFF, STEFAN STOERK, HANS-DIRK DUENGEN, CHRISTOPH STELLBRINK, OSMAN GUEROCAK, CHRISTOPH KADEL, RUEDIGER BRAUN-DULLAEUS, MICHAEL JESERICH, CHRISTIAN OPITZ, HANS-FRIEDRICH VOEHRINGER, KARL-FRIEDRICH APPEL, BERNHARD WINKELMANN, THOMAS DORSEL, SIGRID NIKOL, HARALD DARIUS, JURGEN RANFT, SEBASTIAN SCHELLONG, WOLFGANG JUNGMAIR, PIROZE DAVIERWALA, MARC VORPAHL, LASZLO BAJNOK, ZOLTAN LASZLO, EBRAHIM NOORI, GABOR VERESS, ANDRAS VERTES, ANDRAS ZSARY, ERNO KIS, LASZLO KORANYI, JUDIT BAKAI, ZOLTAN BODA, FERENC POOR, ZOLTAN JARAI, VENDEL KEMENY, JOHN BARTON, BRENDAN MCADAM, ANDREW MURPHY, PETER CREAN, NIALL MAHON, RONAN CURTIN, BRIAIN MACNEILL, SEAN DINNEEN, MAJDI HALABI, REUVEN ZIMLICHMAN, DAVID ZELTSER, YOAV TURGEMAN, ELIEZER KLAINMAN, BASIL LEWIS, AMOS KATZ, SHAUL ATAR, EUGENIA NIKOLSKY, STEFANO BOSI, MONICA NALDI, POMPILIO FAGGIANO, DEBORA ROBBA, LUCIO MOS, GIANFRANCO SINAGRA, FRANCO COSMI, LUIGI OLTRONA VISCONTI, DE MATTEIS CARMINE, GIUSEPPE DI PASQUALE, MATTEO DI BIASE, SARA MANDORLA, MARINO BERNARDINANGELI, GIOVANNI CARLO PICCINNI, MICHELE MASSIMO GULIZIA, MARCELLO GALVANI, FLAVIO VENTURI, GIORGIO MOROCUTTI, MARIA GRAZIA BALDIN, CARLO OLIVIERI, GIAN PIERO PERNA, VINCENZO CIRRINCIONE, TAKAYASU KANNO, HIROYUKI DAIDA, YUKIO OZAKI, NAOMASA MIYAMOTO, SHINICHI HIGASHIUE, HIROSHI DOMAE, SHINOBU HOSOKAWA, HIROO KOBAYASHI, TAKEHIKO KURAMOCHI, KENSHI FUJII, KAZUAKI MIZUTOMI, KEIJIRO SAKU, KAZUO KIMURA, YOSHIHARU HIGUCHI, MITSUNORI ABE, HARUHITO OKUDA, TOSHIYUKI NODA, TERUAKI MITA, ATSUSHI HIRAYAMA, HARUHIKO ONAKA, MORIAKI INOKO, MITSUGU HIROKAMI, MUNENORI OKUBO, YUTAKA AKATSUKA, MIZUHO IMAMAKI, HARUO KAMIYA, MAMORU MANITA, TOSHIHARU HIMI, HIDEKI UENO, YUJI HISAMATSU, JUNYA AKO, YASUHIRO NISHINO, HIDEO KAWAKAMI, YUTAKA YAMADA, YUKIHIRO KORETSUNE, TAKAHISA YAMADA, TETSURO YOSHIDA, HIDEKI SHIMOMURA, NORIYUKI KINOSHITA, AKIHIKO TAKAHASHI, KHALID YUSOFF, WAN AZMAN WAN AHMAD, MUHAMMAD RADZI ABU HASSAN, SAZZLI KASIM, AIZAI AZAN ABDUL RAHIM, DIMON MOHD ZAMRIN, MASAHARU MACHIDA, YORIHIKO HIGASHINO, NORIAKI UTSU, AKIHIKO NAKANO, SHIGERU NAKAMURA, TETSUO HASHIMOTO, KENJI ANDO, TOMOHIRO SAKAMOTO, F.J. PRINS, DIRK LOK, JOHANNES GERT-JAN MILHOUS, ERIC VIERGEVER, FRANK WILLEMS, HENK SWART, MARCO ALINGS, ROB BREEDVELD, KEES-JAN DE VRIES, ROGER VAN DER BORGH, FANNY OEI, STIENEKE ZOET-NUGTEREN, HANS KRAGTEN, JEAN PAUL HERRMAN, PAUL VAN BERGEN, MARCEL GOSSELINK, EDUARD HOEKSTRA, ERWIN ZEGERS, EELKO RONNER, FRANK DEN HARTOG, GERARD BARTELS, PETER NIEROP, COEN VAN DER ZWAAN, JACOB VAN ECK, EDWIN VAN GORSELEN, BJORN GROENEMEIJER, PIETER HOOGSLAG, MARC ROBERT DE GROOT, ALDRIN LOYOLA, DENNIS JOSE SULIT, NANNETTE REY, MARIA TERESA ABOLA, DANTE MORALES, ELLEN PALOMARES, MARC EVANS ABAT, GREGORIO ROGELIO, PHILIP CHUA, JOSE CARLO DEL PILAR, JOHN DENNIS ALCARAZ, GERALDINE EBO, LOUIE TIRADOR, JOSEFINA CRUZ, JOHN ANONUEVO, ARTHUR PITARGUE, MARIANNA JANION, TOMASZ GUZIK, GRZEGORZ GAJOS, MACIEJ ZABOWKA, ANDRZEJ RYNKIEWICZ, MARLENA BRONCEL, ANDRZEJ SZUBA, DANUTA CZARNECKA, PAWEL MAGA, IRINA STRAZHESKO, YURY VASYUK, ZHANNA SIZOVA, YURY POZDNYAKOV, OLGA BARBARASH, MIKHAIL VOEVODA, TATIANA POPONINA, ALEXEY REPIN, IRINA OSIPOVA, ANNA EFREMUSHKINA, NINA NOVIKOVA, OLEG AVERKOV, DMITRY ZATEYSHCHIKOV, ARKADIY VERTKIN, AZA AUSHEVA, PATRICK COMMERFORD, SAADIYA SEEDAT, LOUIS VAN ZYL, JAN ENGELBRECHT, ELLEN MAKONLI MAKOTOKO, CATHARINA ELIZABETH PRETORIUS, ZAID MOHAMED, ADRIAN HORAK, THOMAS MABIN, ERIC KLUG, JANG-HO BAE, CHEOLHO KIM, CHONG-JIN KIM, DONG-SOO KIM, YONG JIN KIM, SEUNGJAE JOO, JONG-WON HA, CHUL SOO PARK, JANG YOUNG KIM, YOUNG-KWON KIM, CHRISTINA JARNERT, THOMAS MOOE, MIKAEL DELLBORG, INGEMAR TORSTENSSON, PER ALBERTSSON, LARS JOHANSSON, FARIS AL-KHALILI, HENRIK ALMROTH, TOMMY ANDERSSON, EMIL PANTEV, BENGT-OLOV TENGMARK, BO LIU, GUNDARS RASMANIS, CARL-MAGNUS WAHLGREN, TIZIANO MOCCETTI, ALEXANDER PARKHOMENKO, VIRA TSELUYKO, VOLODYMYR VOLKOV, OLENA KOVAL, LYUDMYLA KONONENKO, OLEKSANDR PROKHOROV, VALERIY VDOVYCHENKO, ANDRIY BAZYLEVYCH, LEONID RUDENKO, VADYM VIZIR, OLEKSANDR KARPENKO, YAROSLAV MALYNOVSKY, VALENTYNA KOVAL, BORYS STOROZHUK, JAMES COTTON, ASOK VENKATARAMAN, ANDREW MORIARTY, DEREK CONNOLLY, PATRICK DAVEY, ROXY SENIOR, INDERPAUL BIRDI, JOHN CALVERT, PATRICK DONNELLY, JASPER TREVELYAN, JUSTIN CARTER, AARON PEACE, DAVID AUSTIN, NEVILLE KUKREJA, THOMAS HILTON, SUNNY SRIVASTAVA, RONALD WALSH, RONALD FIELDS, JOSEPH HAKAS, EDWARD PORTNAY, HARINDER GOGIA, ABRAHAM SALACATA, JOHN J. HUNTER, J MICHAEL BACHARACH, NICOLAS SHAMMAS, DAMODHAR SURESH, RICKY SCHNEIDER, PAUL GURBEL, SUBHASH BANERJEE, PAUL GRENA, NOEL BEDWELL, STEPHEN SLOAN, STEVEN LUPOVITCH, ANAND SONI, KATHLEEN GIBSON, RENEE SANGRIGOLI, RAJENDRA MEHTA, PETER I-HSUAN TSAI, EVE GILLESPIE, STEPHEN DEMPSEY, GLENN HAMROFF, ROBERT BLACK, ELLIS LADER, JOHN B. KOSTIS, VERA BITTNER, WILLIAM MCGUINN, KELLEY BRANCH, VINAY MALHOTRA, STEPHEN MICHAELSON, MICHAEL VACANTE, MATTHEW MCCORMICK, RALUCA ARIMIE, ALAN CAMP, GEORGE DAGHER, N. MATHEW KOSHY, STEPHEN THEW, FREDERICK COSTELLO, MARK HEIMAN, ROBERT CHILTON, MICHAEL MORAN, FREDRIC ADLER, ANTHONY COMEROTA, ANDREW SEIWERT, WILLIAM FRENCH, HARVEY SEROTA, ROBERT HARRISON, FAISAL BAKAEEN, SHUAB OMER, LOKESH CHANDRA, ALAN WHELAN, ANDREW BOYLE, PHILIP ROBERTS-THOMSON, JAMES ROGERS, PATRICK CARROLL, DAVID COLQUHOUN, JAMES SHAW, PETER BLOMBERY, JOHN AMERENA, CHRIS HII, ALISTAIR ROYSE, BHUWAN SINGH, JOSEPH SELVANAYAGAM, SHIRLEY JANSEN, WINGCHI LO, CHRISTOPHER HAMMETT, ROHAN POULTER, SESHASAYEE NARASIMHAN, HENRIK WIGGERS, HENRIK NIELSEN, GUNNAR GISLASON, LARS KOBER, KIM HOULIND, VIBEKE BOENELYKKE SOERENSEN, ULRIK DIXEN, JENS REFSGAARD, ELISABETH ZEUTHEN, PETER SOEGAARD, MARIAN HRANAI, LUDOVIT GASPAR, DANIEL PELLA, KATARINA HATALOVA, ERIKA DROZDAKOVA, IOAN COMAN, DOINA DIMULESCU, DRAGOS VINEREANU, MIRCEA CINTEZA, CRINA SINESCU, CATALINA ARSENESCU, IMRE BENEDEK, ELENA BOBESCU, DAN DOBREANU, DAN GAITA, ADRIAN IANCU, ADRIANA ILIESIU, DANIEL LIGHEZAN, LUCIAN PETRESCU, OCTAVIAN PIRVU, IULIA TEODORESCU, DAN TESLOIANU, MARIUS MARCIAN VINTILA, and OVIDIU CHIONCEL

Subjects
Male, medicine.medical_treatment, Myocardial Infarction, Coronary Artery Disease, 030204 cardiovascular system & hematology, Stroke/epidemiology, Coronary artery disease, 0302 clinical medicine, Rivaroxaban, Hemorrhage/chemically induced, Carotid artery disease, 030212 general & internal medicine, Myocardial infarction, Cardiovascular Diseases/mortality, Aspirin, Atrial fibrillation, General Medicine, Stroke, ORAL RIVAROXABAN, Cardiovascular Diseases, Factor Xa Inhibitors/administration & dosage, Cardiology, Female, Drug Therapy, Combination, medicine.drug, medicine.medical_specialty, Rivaroxaban/administration & dosage, Coronary Artery Disease/drug therapy, Hemorrhage, Drug Administration Schedule, 03 medical and health sciences, Double-Blind Method, Internal medicine, Journal Article, Myocardial Infarction/epidemiology, medicine, Humans, Aspirin/administration & dosage, Platelet Aggregation Inhibitors/administration & dosage, Aged, Dose-Response Relationship, Drug, business.industry, Unstable angina, Percutaneous coronary intervention, medicine.disease, PREVENTION, Morbidity, business, Platelet Aggregation Inhibitors, Factor Xa Inhibitors
Abstract

BACKGROUND: Coronary artery disease is a major cause of morbidity and mortality worldwide, and is a consequence of acute thrombotic events involving activation of platelets and coagulation proteins. Factor Xa inhibitors and aspirin each reduce thrombotic events but have not yet been tested in combination or against each other in patients with stable coronary artery disease.METHODS: In this multicentre, double-blind, randomised, placebo-controlled, outpatient trial, patients with stable coronary artery disease or peripheral artery disease were recruited at 602 hospitals, clinics, or community centres in 33 countries. This paper reports on patients with coronary artery disease. Eligible patients with coronary artery disease had to have had a myocardial infarction in the past 20 years, multi-vessel coronary artery disease, history of stable or unstable angina, previous multi-vessel percutaneous coronary intervention, or previous multi-vessel coronary artery bypass graft surgery. After a 30-day run in period, patients were randomly assigned (1:1:1) to receive rivaroxaban (2·5 mg orally twice a day) plus aspirin (100 mg once a day), rivaroxaban alone (5 mg orally twice a day), or aspirin alone (100 mg orally once a day). Randomisation was computer generated. Each treatment group was double dummy, and the patients, investigators, and central study staff were masked to treatment allocation. The primary outcome of the COMPASS trial was the occurrence of myocardial infarction, stroke, or cardiovascular death. This trial is registered with ClinicalTrials.gov, number NCT01776424, and is closed to new participants.FINDINGS: Between March 12, 2013, and May 10, 2016, 27 395 patients were enrolled to the COMPASS trial, of whom 24 824 patients had stable coronary artery disease from 558 centres. The combination of rivaroxaban plus aspirin reduced the primary outcome more than aspirin alone (347 [4%] of 8313 vs 460 [6%] of 8261; hazard ratio [HR] 0·74, 95% CI 0·65-0·86, pINTERPRETATION: In patients with stable coronary artery disease, addition of rivaroxaban to aspirin lowered major vascular events, but increased major bleeding. There was no significant increase in intracranial bleeding or other critical organ bleeding. There was also a significant net benefit in favour of rivaroxaban plus aspirin and deaths were reduced by 23%. Thus, addition of rivaroxaban to aspirin has the potential to substantially reduce morbidity and mortality from coronary artery disease worldwide.FUNDING: Bayer AG.

Published
2018

14. Hydroxychloroquine versus placebo in the treatment of non-hospitalised patients with COVID-19 (COPE – Coalition V): A double-blind, multicentre, randomised, controlled trial

Author

Álvaro Avezum, Gustavo B F Oliveira, Haliton Oliveira, Rosa C Lucchetta, Valéria F A Pereira, André L Dabarian, Ricardo D´O Vieira, Daniel V Silva, Adrian P M Kormann, Alexandre P Tognon, Ricardo De Gasperi, Mauro E Hernandes, Audes D M Feitosa, Agnaldo Piscopo, André S Souza, Carlos H Miguel, Vinicius O Nogueira, César Minelli, Carlos C Magalhães, Karen M L Morejon, Letícia S Bicudo, Germano E C Souza, Marco A M Gomes, José J F Raposo Fo, Alexandre V Schwarzbold, Alexandre Zilli, Roberto B Amazonas, Frederico R Moreira, Lucas B O Alves, Silvia R L Assis, Precil D M M Neves, Jessica Y Matuoka, Icaro Boszczowski, Daniela G M Catarino, Viviane C Veiga, Luciano C P Azevedo, Regis G Rosa, Renato D Lopes, Alexandre B Cavalcanti, and Otavio Berwanger

Subjects
Public aspects of medicine, RA1-1270
Abstract

Summary: Background: Previous Randomised controlled trials (RCT) evaluating chloroquine and hydroxychloroquine in non-hospitalised COVID-19 patients have found no significant difference in hospitalisation rates. However, low statistical power precluded definitive answers. Methods: We conducted a multicenter, double-blind, RCT in 56 Brazilian sites. Adults with suspected or confirmed COVID-19 presenting with mild or moderate symptoms with ≤ 07 days prior to enrollment and at least one risk factor for clinical deterioration were randomised (1:1) to receive hydroxychloroquine 400 mg twice a day (BID) in the first day, 400 mg once daily (OD) thereafter for a total of seven days, or matching placebo. The primary outcome was hospitalisation due to COVID-19 at 30 days, which was assessed by an adjudication committee masked to treatment allocation and following the intention-to-treat (ITT) principle. An additional analysis was performed only in participants with SARS-CoV-2 infection confirmed by molecular or serology testing (modified ITT [mITT] analysis). This trial was registered at ClinicalTrials.gov, NCT04466540. Findings: From May 12, 2020 to July 07, 2021, 1372 patients were randomly allocated to hydroxychloroquine or placebo. There was no significant difference in the risk of hospitalisation between hydroxychloroquine and placebo groups (44/689 [6·4%] and 57/683 [8·3%], RR 0·77 [95% CI 0·52–1·12], respectively, p=0·16), and similar results were found in the mITT analysis with 43/478 [9·0%] and 55/471 [11·7%] events, RR 0·77 [95% CI 0·53–1·12)], respectively, p=0·17. To further complement our data, we conducted a meta-analysis which suggested no significant benefit of hydroxychloroquine in reducing hospitalisation among patients with positive testing (69/1222 [5·6%], and 88/1186 [7·4%]; RR 0·77 [95% CI 0·57–1·04]). Interpretation: In outpatients with mild or moderate forms of COVID-19, the use of hydroxychloroquine did not reduce the risk of hospitalisation compared to the placebo control. Our findings do not support the routine use of hydroxychloroquine for treatment of COVID-19 in the outpatient setting. Funding: COALITION COVID-19 Brazil and EMS.

Published
2022
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15. Rehabilitation of the Upper Extremity and Basic Activities of Daily Living in the First Month after Ischemic Stroke: An International Cohort Comparison Study

Author

Dromerick, Cesar Minelli, Francisco A.A. Gondim, Amilton Antunes Barreira, and Alexander W.

Subjects
rehabilitation, arm, activities of daily living, outcome assessment, international randomized controlled trials
Abstract

Inpatient rehabilitation has been traditionally employed in developed countries, while in developing countries, outpatient rehabilitation is the rule. The purpose of this study was to compare the patterns of recovery of upper extremity (UE) function, global impairment and independence in activities of daily living (ADL) during the first month after ischaemic stroke in inpatient (United States) and outpatient (Brazil) rehabilitation settings. Design and Methods: This is a prospective cohort comparison study. Twenty patients from each country were selected using identical inclusion criteria. The study measures employed were the UE portion of the Fugl-Meyer scale, the Action Research Arm test, the National Institutes of Health Stroke Scale and Barthel Index. Changes from baseline to the end of treatment, efficiency and effectiveness of each treatment were compared. Results: Both populations exhibited significant improvement between the first and second evaluations in the four outcome scales (P 0.05). Conclusions: Substantially different treatment approaches after ischaemic stroke led to similar results in UE function, global impairment and ADL. Further studies in larger populations should be performed in order to confirm the present results.

Published
2009
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16. Assessment of autonomic nervous system dysfunction in multiple sclerosis and the association with clinical disability

Author

Cesar Minelli, Alexander W. Dromerick, Amilton Antunes Barreira, and Francisco de Assis Aquino Gondim

Subjects
medicine.medical_specialty, Activities of daily living, Multiple Sclerosis, Barthel index, medicine.medical_treatment, Developing country, sympathetic skin reaction, Neurosciences. Biological psychiatry. Neuropsychiatry, 03 medical and health sciences, 0302 clinical medicine, Physical medicine and rehabilitation, Medicine, 030212 general & internal medicine, 10. No inequality, Prospective cohort study, Internal medicine, Cohort comparison, Rehabilitation, business.industry, autonomic nervous system, RC31-1245, 3. Good health, disability, Ischemic stroke, Physical therapy, Neurology (clinical), EDSS, business, Developed country, 030217 neurology & neurosurgery, RC321-571
Abstract

Background: Recent studies have reported autonomic dysfunction (AD) in multiple sclerosis (MS), bladder and/or bowel dysfunction, orthostatic hypotension, and cardiac adaptation disorders have been observed in a wide range (15-80%). The primary aim of this study is to investigate the frequency and association of AD in MS patients, assessed by sympathetic skin reaction (SSR) and a symptoms questionnaire. The secondary aims of this study are to study the association of AD and disease disability assessed by expanded disability status scale (EDSS), as well as disease duration. Design and Methods: 100 clinically definite MS patients were evaluated for ANS dysfunction by use of an autonomic symptoms questionnaire and SSR testing. The relationship between these methods, AD and disease-related parameters, such as the expanded disability status scale (EDSS) and disease duration were all evaluated. Results: 65% of the patients presented with AD and 29% of these patients had abnormal SSR results. MS patients with high EDSS values (EDSS >4) and longer disease duration were more likely to have ANS dysfunction (p less than 0.0001). Conclusions. ANS dysfunction is not uncommon in CDMS patients and thus noninvasive investigations of AD are warranted to optimize AD evaluation and disease management.

Published
2009

17. Translation, cross-cultural adaptation and validation of the Cincinnati prehospital stroke scale in Brazil

Author

Priscila Masquetto Vieira de ALMEIDA, Rodrigo BAZAN, Octávio Marques PONTES-NETO, César MINELLI, José Eduardo CORRENTE, Gabriel Pinheiro MODOLO, Gustavo José LUVIZUTTO, and Alessandro Lia MONDELLI

Subjects
Stroke, Early Diagnosis, Emergency Medical Service, Sensitivity and Specificity, Neurosciences. Biological psychiatry. Neuropsychiatry, RC321-571
Abstract

ABSTRACT Background: Use of internationally standardized instruments to assist healthcare professionals in accurately recognizing stroke early is recommended. The process of translation and cross-cultural adaptation is important for ensuring that scales are interpreted in the same way in different languages, thus ensuring applicability in several countries. Objective: To translate into Brazilian Portuguese, cross-culturally adapt and validate the Cincinnati Prehospital Stroke Scale, using a representative sample of the Brazilian population. Method: The present study included patients with suspected stroke who were treated at a Brazilian emergency medical service and referred to a stroke center. A systematic process of translation and cross-cultural adaptation of the original scale and application of the final instrument was performed. Statistical analysis was used to assess the sensitivity, specificity and accuracy of the scale. Cohen’s kappa coefficient was used to assess inter-rater reliability. Results: After translation and cross-cultural adaptation, the scale was applied to 64 patients. It showed 93.0% accuracy and 92.4% sensitivity in relation to the final “gold standard” diagnosis. Cohen’s kappa coefficient was calculated using data from 26 patients (40.6%) and showed excellent inter-rater reliability between items on the scale (0.8385 to 1.0000). Conclusion: The scale demonstrated excellent accuracy, sensitivity and inter-rater reliability. It was a useful tool for assisting healthcare professionals during initial assessments on patients with suspected stroke and significantly contributed to early recognition of stroke in a simple and quick manner.

Published
2021
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18. Translation, cross-cultural adaptation, and validation of the Los Angeles Prehospital Stroke Screen for use in Brazil

Author

Priscila Masquetto Vieira de Almeida, Rodrigo Bazan, Octávio Marques Pontes-Neto, César Minelli, José Eduardo Corrente, Gabriel Pinheiro Modolo, Gustavo José Luvizutto, and Alessandro Lia Mondelli

Subjects
Stroke, Emergency Medical Services, Early Diagnosis., Neurosciences. Biological psychiatry. Neuropsychiatry, RC321-571
Abstract

ABSTRACT Background: Stroke is one of the leading causes of death and neurological disability in the world. Several scales help professionals in the early recognition of the disease. However, none of these were developed in Brazil. Objectives: To translate the Los Angeles Prehospital Stroke Screen (LAPSS) into Brazilian Portuguese, and cross-culturally adapt and validate the scale in a representative sample of the Brazilian population. Methods: This study was carried out in two phases: the first consisted in the translation and cross-cultural validation of the LAPSS, and the second in a cross-sectional study with prospectively collected data in patients with suspected stroke treated in a Brazilian prehospital and referred to a stroke center. Statistical analysis was used to assess the sensitivity, specificity, and accuracy of the scale. Cohen's Kappa coefficient (κ) was used for psychometric assessment. Results: After translation and cross-cultural adaptation, the scale was applied to 86 patients. The scale presented a sensitivity of 83.8%, positive predictive value of 79.50%, specificity of 40.70%, negative predictive value of 47.80%, and accuracy of 77%. Cohen’s kappa coefficient was calculated using data from 26 (30.23%) patients and the results showed excellent inter-rater reliability in the majority of the items (52.96%). Conclusions: The scale was translated and cross-culturally adapted for use in Brazil. The scale presented high sensitivity and accuracy but low specificity, and the Cohen’s kappa demonstrated inter-rater reliability. The greatest difficulties occurred when the evaluation included subjective identifications. The scale excluded patients < 45 years old as stroke suspects.

Published
2022
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