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1. Treatment of idiopathic anaphylaxis with dupilumab: a case report

Author

Elizabeth Pepper and Luke Pittman

Subjects
Idiopathic anaphylaxis, Dupilumab, Th2 inflammation, Omalizumab, Mast cell activation syndrome, Chronic spontaneous urticaria, Immunologic diseases. Allergy, RC581-607
Abstract

Abstract Background Anaphylaxis is an acute, potentially life-threatening allergic reaction that typically occurs after exposure to a trigger, while idiopathic anaphylaxis (IA) occurs in the absence of a trigger. Acute management of both triggered anaphylaxis and IA relies on the use of epinephrine. In some patients with recurrent IA, glucocorticoid prophylaxis with prednisone can be effective. While there is currently no high quality evidence for the use of other prophylactic options to prevent recurrent IA, evolving data exists to support the consideration of biologics that target IgE or the Th2 pathway. Case presentation We present the case of a 28 year old female with no atopic or autoimmune history with recurrent episodes of IA since childhood occurring up to twice weekly. There was improvement in acute symptoms with administration of first or second generation antihistamines and/or intramuscular epinephrine. Without an identifiable trigger, she was diagnosed with IA and frequent idiopathic urticaria and omalizumab was added to her treatment regimen with improvement in symptom frequency. After being lost to follow up, she had recurrence of symptom frequency and severity without omalizumab therapy and subsequently presented to our institution. Her workup at this point was negative for food allergy, alpha gal syndrome, systemic mastocytosis, hereditary alpha tryptasemia, carcinoid syndrome, and pheochromocytoma, and she was trialed on dupilumab with near resolution of her symptom frequency over a six month time period. Conclusion Recurrent IA is a diagnosis of exclusion that is associated with high morbidity. Prophylaxis remains an area of uncertainty, although prednisone has been effective in some cases. When prednisone is contraindicated or ineffective for the prevention of IA, biologic therapies that target IgE or the Th2 pathway may present a reasonable consideration. This case adds support to the suggestion that dupilumab may be a logical off-label consideration for prophylaxis of recurrent IA. The data for dupilumab in this clinical scenario is still very limited, and further research is required before any recommendation can be made.

Published
2023
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2. Telestroke Assessment With Perfusion CT Improves the Diagnostic Accuracy of Stroke vs. Mimic

Author

Lucinda Tran, Longting Lin, Neil Spratt, Andrew Bivard, Beng Lim Alvin Chew, James W. Evans, William O'Brien, Christopher Levi, Timothy Ang, Khaled Alanati, Elizabeth Pepper, Carlos Garcia-Esperon, and Mark Parsons

Subjects
stroke, telestroke, imaging—computed tomography, transient ischaemic attack (TIA), CT perfusion (CTP), stroke mimic, Neurology. Diseases of the nervous system, RC346-429
Abstract

Background and Purpose: CT perfusion (CTP) has been implemented widely in regional areas of Australia for telestroke assessment. The aim of this study was to determine if, as part of telestroke assessment, CTP provided added benefit to clinical features in distinguishing between strokes and mimic and between transient ischaemic attack (TIA) and mimic.Methods: We retrospectively analysed 1,513 consecutively recruited patients referred to the Northern New South Wales Telestroke service, where CTP is performed as a part of telestroke assessment. Patients were classified based on the final diagnosis of stroke, TIA, or mimic. Multivariate regression models were used to determine factors that could be used to differentiate between stroke and mimic and between TIA and mimic.Results: There were 693 strokes, 97 TIA, and 259 mimics included in the multivariate regression models. For the stroke vs. mimic model using symptoms only, the area under the curve (AUC) on the receiver operator curve (ROC) was 0.71 (95% CI 0.67–0.75). For the stroke vs. mimic model using the absence of ischaemic lesion on CTP in addition to clinical features, the AUC was 0.90 (95% CI 0.88–0.92). The multivariate regression model for predicting mimic from TIA using symptoms produced an AUC of 0.71 (95% CI 0.65–0.76). The addition of absence of an ischaemic lesion on CTP to clinical features for the TIA vs. mimic model had an AUC of 0.78 (95% CI 0.73–0.83)Conclusions: In the telehealth setting, the absence of an ischaemic lesion on CTP adds to the diagnostic accuracy in distinguishing mimic from stroke, above that from clinical features.

Published
2021
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3. Endovascular thrombectomy versus standard bridging thrombolytic with endovascular thrombectomy within 4·5 h of stroke onset: an open-label, blinded-endpoint, randomised non-inferiority trial

Author

Peter J Mitchell, Bernard Yan, Leonid Churilov, Richard J Dowling, Steven J Bush, Andrew Bivard, Xiao Chuan Huo, Guoqing Wang, Shi Yong Zhang, Mai Duy Ton, Dennis J Cordato, Timothy J Kleinig, Henry Ma, Ronil V Chandra, Helen Brown, Bruce C V Campbell, Andrew K Cheung, Brendan Steinfort, Rebecca Scroop, Kendal Redmond, Ferdinand Miteff, Yan Liu, Dang Phuc Duc, Hal Rice, Mark W Parsons, Teddy Y Wu, Huy-Thang Nguyen, Geoffrey A Donnan, Zhong Rong Miao, Stephen M Davis, Patricia Desmond, Nawaf Yassi, Henry Zhao, Cameron Williams, Fana Alemseged, Felix C Ng, Vignan Yogendrakumar, Peter Bailey, Laetitia De Villiers, Thanh Phan, Tharani Thirugnanachandran, Winston Chong, Hamed Asadi, Lee Anne Slater, Nathan Manning, Jason Wenderoth, Alan McDougall, Cecilia Cappelen-Smith, Justin Whitley, Leon Edwards, Carlos Garcia Esperon, Neil Spratt, Elizabeth Pepper, Chris Levi, Ken Faulder, Timothy Harrington, Martin Krause, Michael Waters, John Fink, Gaoting Ma, Xiangpeng Shen, Xiangkong Song, Yonglei Gao, Nam Guangxian, Zaiyu Guo, Heliang Zhang, Hongxing Han, Hao Wang, Geng Liao, Zhenyu Zhang, Chaomao Li, Zhi Yang, Chuwei Cai, Chuming Huang, and Yifan Hong

Subjects
Adult, Stroke, Treatment Outcome, Fibrinolytic Agents, Endovascular Procedures, Australia, Humans, Prospective Studies, General Medicine, Brain Ischemia, Thrombectomy
Abstract

The benefit of combined treatment with intravenous thrombolysis before endovascular thrombectomy in patients with acute ischaemic stroke caused by large vessel occlusion remains unclear. We hypothesised that the clinical outcomes of patients with stroke with large vessel occlusion treated with direct endovascular thrombectomy within 4·5 h would be non-inferior compared with the outcomes of those treated with standard bridging therapy (intravenous thrombolysis before endovascular thrombectomy).DIRECT-SAFE was an international, multicentre, prospective, randomised, open-label, blinded-endpoint trial. Adult patients with stroke and large vessel occlusion in the intracranial internal carotid artery, middle cerebral artery (M1 or M2), or basilar artery, confirmed by non-contrast CT and vascular imaging, and who presented within 4·5 h of stroke onset were recruited from 25 acute-care hospitals in Australia, New Zealand, China, and Vietnam. Eligible patients were randomly assigned (1:1) via a web-based, computer-generated randomisation procedure stratified by site of baseline arterial occlusion and by geographic region to direct endovascular thrombectomy or bridging therapy. Patients assigned to bridging therapy received intravenous thrombolytic (alteplase or tenecteplase) as per standard care at each site; endovascular thrombectomy was also per standard of care, using the Trevo device (Stryker Neurovascular, Fremont, CA, USA) as first-line intervention. Personnel assessing outcomes were masked to group allocation; patients and treating physicians were not. The primary efficacy endpoint was functional independence defined as modified Rankin Scale score 0-2 or return to baseline at 90 days, with a non-inferiority margin of -0·1, analysed by intention to treat (including all randomly assigned and consenting patients) and per protocol. The intention-to-treat population was included in the safety analyses. The trial is registered with ClinicalTrials.gov, NCT03494920, and is closed to new participants.Between June 2, 2018, and July 8, 2021, 295 patients were randomly assigned to direct endovascular thrombectomy (n=148) or bridging therapy (n=147). Functional independence occurred in 80 (55%) of 146 patients in the direct thrombectomy group and 89 (61%) of 147 patients in the bridging therapy group (intention-to-treat risk difference -0·051, two-sided 95% CI -0·160 to 0·059; per-protocol risk difference -0·062, two-sided 95% CI -0·173 to 0·049). Safety outcomes were similar between groups, with symptomatic intracerebral haemorrhage occurring in two (1%) of 146 patients in the direct group and one (1%) of 147 patients in the bridging group (adjusted odds ratio 1·70, 95% CI 0·22-13·04) and death in 22 (15%) of 146 patients in the direct group and 24 (16%) of 147 patients in the bridging group (adjusted odds ratio 0·92, 95% CI 0·46-1·84).We did not show non-inferiority of direct endovascular thrombectomy compared with bridging therapy. The additional information from our study should inform guidelines to recommend bridging therapy as standard treatment.Australian National Health and Medical Research Council and Stryker USA.

Published
2022

5. Twelve-Month Outcomes of the AFFINITY Trial of Fluoxetine for Functional Recovery After Acute Stroke: AFFINITY Trial Steering Committee on Behalf of the AFFINITY Trial Collaboration

Author

Graeme J. Hankey, Maree L. Hackett, Osvaldo P. Almeida, Leon Flicker, Gillian E. Mead, Martin S. Dennis, Christopher Etherton-Beer, Andrew H. Ford, Laurent Billot, Stephen Jan, Thomas Lung, Erik Lundström, Katharina S. Sunnerhagen, Craig S. Anderson, Huy Thang-Nguyen, John Gommans, Qilong Yi, Veronica Murray, Robert Herbert, Gregory Carter, Geoffrey A. Donnan, Huy-Thang Nguyen, Qiang Li, Severine Bompoint, Sarah Barrett, Anne Claxton, Julia O’Dea, Michelle Tang, Clare Williams, Shenae Peterson, Christie Drummond, Uyen-Ha Hong, Linh-Thi My Le, Tram-Thi Bich Ngo, Yen-Bao Mai, Huyen-Thanh Han, Nhu-Quynh Truong, Huong-Thi Nguyen, Hai-Thanh Ngo, Thi Binh Nguyen, Oanh-Thi Kieu Ha, Trang-Le Huyen Nguyen, Richard I. Lindley, Peter New, Andrew Lee, Thanh-Trung Tran, Loan-Tran Truc Mai Le, Thuy-Le Vu Kieu, Sang-Van Nguyen, Thuy-Anh Diem Nguyen, Tam-Nhat Dang, Hanh-Thi Truc Phan, Loan-Thi Ngoc Vo, Mai-Hue Nguyen, Hanh-Cao Dang, Hong-Thi Tran, Linh-Thi Cam Dam, Trinh-Thi Kim Ngo, Thai-Nguyen Thanh Pham, Binh-Nguyen Pham, Nha-Thi Thanh Dao, Huong-Thi Bich Nguyen, Linh-Thi Cam Le, Chi-Minh Do, Huy-Quoc Huynh, Giau-Thi Kim Tran, Oanh-Thi Le, Ly-Thi Khanh Tran, Chinh-Dinh Duong, Duong-Van Kieu, Na Le, Hoa-Ngoc Nguyen, Binh-Van Le, Long-Thanh Nguyen, Long-Van Nguyen, Tuan-Quoc Dinh, Tan-Van Vo, Tram-Ngoc Bui, Uyen-Thi To Hoang, Hien-Thi Bich Nguyen, Ha-Thi Thu Nguyen, Nga-Thuy Lam, Khanh-Kim Le, Phuong-Thanh Trinh, Hop-Quang Huynh, Thao-Thi Thu Nguyen, Huyen-Ngoc Lu, Tham-Hong Pham, Sam-Hoanh Nguyen, Ninh-Hong Le, Giang-Truong Nguyen, Bich-Thi Doan, Sung-Phuoc Pham, Duong-Huu Luong, Ha-Van Mai, Thuc-Van Tran, Phuong-Thi Do, Hoai-Thi Le, Chi-Van Nguyen, Phuong-Doan Nguyen, Ton-Duy Mai, Phuong-Viet Dao, Dung-Tien Nguyen, Dai-Quoc Khuong, Trung-Xuan Vuong, Lan-Tuong Vu, Ngoc-Duc Ngo, Hanh-Hong Dang, Phuong-Thai Truong, Ngan-Thi Le, Hoa-Van Hoang, Chung-Quang Do, Minh-Thao Nguyen, Anh-Hai Dam, Quynh-Nhu Le, Ngoc-Hoang Nguyen, Tuyen-Van Nguyen, Toan-Dinh Le, Ha-Thi Hai Dinh, Cuong–Van Pham, Khanh-Thi Ngoc Thach, Linh-Hai Nguyen, Loan-Thi Nguyen, Vien-Chi Le, Phuong-Hong Tran, Tai-Anh Nguyen, Tuan-Van Le, Luyen-Van Truong, Tue-Chau Bui, Ngoc-Xuan Huynh, Lap-Van Dinh, An-Gia Pham, Trang-Thi Huyen Le, Vy-Tuong Nguyen, Yen-Hai Nguyen, Thang-Ba Nguyen, Huy Thai, Quyen-Thi Ngoc Pham, Khoa-Duy Dao, Quoc-Nguyen Bao Pham, Thuong-Thi Huyen Dang, Huong-Huynh To Dinh, Trang-Mai Tong, Thuy-Thi Vu, Si-Tri Le, Tai-Ngoc Tran, Phuong-Hoai Tran, Ngoc-Thuy Nhu Dinh, Binh-Thanh Nguyen, Vinh-Phuong Do, Anh-Ngoc Nguyen, Binh-Thi Thanh Nguyen, David Blacker, Lindsey Bunce, Ai Ling Tan, Darshan Ghia, Gillian Edmonds, Nicole O’Loughlin, Megan Ewing, Kerri-Ann Whittaker, Lorralee Deane, Yash Gawarikar, Brett Jones, Maria Lopez, Koushik Nagesh, Emma Siracusa, Stephen Davis, Amy McDonald, Jess Tsoleridis, Rachael McCoy, David Jackson, Gab Silver, Timothy R. Bates, Amanda Boudville, Lynda Southwell, Dennis Cordato, Alan J. McDougall, Cecilia Cappelen-Smith, Zeljka Calic, Shabeel Askar, Qi Cheng, Raymond Kumar, Richard Geraghty, Maree Duroux, Megan Ratcliffe, Samantha Shone, Cassandra McLennan, Ramesh Sahathevan, Casey Hair, Stanley Levy, Beverley Macdonald, Benjamin Nham, Louise Rigney, Dev Nathani, Sumana Gopinath, Vishal Patel, Abul Mamun, Benjamin Trewin, Chun Phua, Ho Choong, Lauren Tarrant, Kerry Boyle, Luisa Hewitt, Monique Hourn, Amanda Masterson, Kim Oakley, Karen Ruddell, Colette Sanctuary, Kimberley Veitch, Camelia Burdusel, Lina Lee, Gary Cheuk, Jeremy Christley, Tabitha Hartwell, Craig Davenport, Kate Hickey, Rosanna Robertson, Michelle Carr, Sam Akbari, Hannah Coyle, Megan O’Neill, Cameron Redpath, Caroline Roberts, Marjan Tabesh, Toni Withiel, Kapila Abeysuriya, Andrew Granger, Angela Abraham, Chermaine Chua, Dung Do Nguyen, Vathani Surendran, Melissa Daines, David Shivlal, Mudassar Latif, Noreen Mughal, Patricia Morgan, Martin Krause, Miriam Priglinger, Ehsan E. Shandiz, Susan Day, Lay Kho, Michael Pollack, Judith Dunne, Helen Baines, Merridie Rees, Jenni White, Aicuratiya Withanage, Candice Delcourt, Cheryl Carcel, Alejandra Malavera, Amy Kunchok, Elizabeth Ray, Elizabeth Pepper, Emily Duckett, Sally Ormond, Andrew Moey, Timothy Kleinig, Vanessa Maxwell, Chantal Baldwin, Wilson Vallat, Deborah Field, Romesh Markus, Kirsty Page, Danielle Wheelwright, Sam Bolitho, Steven Faux, Fix Sangvatanakul, Alexis Brown, Susan Walker, Jennifer Massey, Hillary Hayes, Pesi Katrak, Annie Winker, Alessandro Zagami, Alanah Bailey, Sarah Mccormack, Andrew Murray, Mark Rollason, Christopher Taylor, Fintan O’Rourke, Ye Min Kuang, Heike Burnet, Yvonne Liu, Aileen Wu, Diana Ramirez, Tissa Wijeratne, Sherisse Celestino, Essie Low, Cynthia Chen, Jennifer Bergqvist, Andrew Evans, Queenie Leung, Martin Jude, Rachael McQueen, Katherine Mohr, Latitia Kernaghan, Paul Stockle, Boon L. Tan, Sara Laubscher, Diana Schmid, Melissa Spooner, Bhavesh Lallu, Bronwen Pepperell, John Chalissery, Karim Mahawish, Susan DeCaigney, Paula Broughton, Karen Knight, Veronica Duque, Harry McNaughton, Jeremy Lanford, Vivian Fu, and Lai-Kin Wong

Subjects
Male, medicine.medical_specialty, Steering committee, medicine.medical_treatment, Placebo, B700, Fractures, Bone, Cognition, Double-Blind Method, Recurrence, Seizures, Fluoxetine, Internal medicine, Humans, Medicine, Stroke, Fatigue, Aged, Ischemic Stroke, Acute stroke, Advanced and Specialized Nursing, business.industry, Recovery of Function, Middle Aged, Functional recovery, medicine.disease, Clinical trial, Affect, Hemorrhagic Stroke, Quality of Life, Accidental Falls, Female, Neurology (clinical), Cardiology and Cardiovascular Medicine, business, Stroke recovery, Selective Serotonin Reuptake Inhibitors, medicine.drug
Abstract

Background and Purpose: The AFFINITY trial (Assessment of Fluoxetine in Stroke Recovery) reported that oral fluoxetine 20 mg daily for 6 months after acute stroke did not improve functional outcome and increased the risk of falls, bone fractures, and seizures. After trial medication was ceased at 6 months, survivors were followed to 12 months post-randomization. This preplanned secondary analysis aimed to determine any sustained or delayed effects of fluoxetine at 12 months post-randomization. Methods: AFFINITY was a randomized, parallel-group, double-blind, placebo-controlled trial in adults (n=1280) with a clinical diagnosis of stroke in the previous 2 to 15 days and persisting neurological deficit who were recruited at 43 hospital stroke units in Australia (n=29), New Zealand (4), and Vietnam (10) between 2013 and 2019. Participants were randomized to oral fluoxetine 20 mg once daily (n=642) or matching placebo (n=638) for 6 months and followed until 12 months after randomization. The primary outcome was function, measured by the modified Rankin Scale, at 6 months. Secondary outcomes for these analyses included measures of the modified Rankin Scale, mood, cognition, overall health status, fatigue, health-related quality of life, and safety at 12 months. Results: Adherence to trial medication was for a mean 167 (SD 48) days and similar between randomized groups. At 12 months, the distribution of modified Rankin Scale categories was similar in the fluoxetine and placebo groups (adjusted common odds ratio, 0.93 [95% CI, 0.76–1.14]; P =0.46). Compared with placebo, patients allocated fluoxetine had fewer recurrent ischemic strokes (14 [2.18%] versus 29 [4.55%]; P =0.02), and no longer had significantly more falls (27 [4.21%] versus 15 [2.35%]; P =0.08), bone fractures (23 [3.58%] versus 11 [1.72%]; P =0.05), or seizures (11 [1.71%] versus 8 [1.25%]; P =0.64) at 12 months. Conclusions: Fluoxetine 20 mg daily for 6 months after acute stroke had no delayed or sustained effect on functional outcome, falls, bone fractures, or seizures at 12 months poststroke. The lower rate of recurrent ischemic stroke in the fluoxetine group is most likely a chance finding. Registration: URL: http://www.anzctr.org.au/ ; Unique identifier: ACTRN12611000774921.

Published
2021

7. Safety and efficacy of fluoxetine on functional outcome after acute stroke (AFFINITY): a randomised, double-blind, placebo-controlled trial

Author

Graeme J. Hankey, Maree L. Hackett, Osvaldo P. Almeida, Leon Flicker, Gillian E. Mead, Martin S. Dennis, Christopher Etherton-Beer, Andrew H. Ford, Laurent Billot, Stephen Jan, Thomas Lung, Veronica Murray, Erik Lundström, Craig S. Anderson, Robert Herbert, Gregory Carter, Geoffrey A. Donnan, Huy-Thang Nguyen, John Gommans, Qilong Yi, Qiang Li, Severine Bompoint, Sarah Barrett, Anne Claxton, Julia O'Dea, Michelle Tang, Clare Williams, Shenae Peterson, Christie Drummond, Uyen-Ha Hong, Linh-Thi My Le, Tram-Thi Bich Ngo, Yen-Bao Mai, Huyen-Thanh Han, Nhu-Quynh Truong, Huong-Thi Nguyen, Hai-Thanh Ngo, Thi Binh Nguyen, Oanh-Thi Kieu Ha, Trang-Le Huyen Nguyen, Richard I. Lindley, Peter New, Andrew Lee, Thanh-Trung Tran, Loan-Tran Truc Mai Le, Thuy-Le Vu Kieu, Sang-Van Nguyen, Thuy-Anh Diem Nguyen, Tam-Nhat Dang, Hanh-Thi Truc Phan, Loan-Thi Ngoc Vo, Mai-Hue Nguyen, Hanh-Cao Dang, Hong-Thi Tran, Linh-Thi Cam Dam, Trinh-Thi Kim Ngo, Thai-Nguyen Thanh Pham, Binh-Nguyen Pham, Nha-Thi Thanh Dao, Huong-Thi Bich Nguyen, Linh-Thi Cam Le, Chi-Minh Do, Huy-Quoc Huynh, Giau-Thi Kim Tran, Oanh-Thi Le, Ly-Thi Khanh Tran, Chinh-Dinh Duong, Duong-Van Kieu, Na Le, Hoa-Ngoc Nguyen, Binh-Van Le, Long-Thanh Nguyen, Long-Van Nguyen, Tuan-Quoc Dinh, Tan-Van Vo, Tram-Ngoc Bui, Uyen-Thi To Hoang, Hien-Thi Bich Nguyen, Ha-Thi Thu Nguyen, Nga-Thuy Lam, Khanh-Kim Le, Phuong-Thanh Trinh, Hop-Quang Huynh, Thao-Thi Thu Nguyen, Huyen-Ngoc Lu, Tham-Hong Pham, Sam-Hoanh Nguyen, Ninh-Hong Le, Giang-Truong Nguyen, Bich-Thi Doan, Sung-Phuoc Pham, Duong-Huu Luong, Ha-Van Mai, Thuc-Van Tran, Phuong-Thi Do, Hoai-Thi Le, Chi-Van Nguyen, Phuong-Doan Nguyen, Ton-Duy Mai, Phuong-Viet Dao, Dung-Tien Nguyen, Dai-Quoc Khuong, Trung-Xuan Vuong, Lan-Tuong Vu, Ngoc-Duc Ngo, Hanh-Hong Dang, Phuong-Thai Truong, Ngan-Thi Le, Hoa-Van Hoang, Chung-Quang Do, Minh-Thao Nguyen, Anh-Hai Dam, Quynh-Nhu Le, Ngoc-Hoang Nguyen, Tuyen-Van Nguyen, Toan-Dinh Le, Ha-Thi Hai Dinh, Cuong-Van Pham, Khanh-Thi Ngoc Thach, Linh-Hai Nguyen, Loan-Thi Nguyen, Vien-Chi Le, Phuong-Hong Tran, Tai-Anh Nguyen, Tuan-Van Le, Luyen-Van Truong, Tue-Chau Bui, Ngoc-Xuan Huynh, Lap-Van Dinh, An-Gia Pham, Trang-Thi Huyen Le, Vy-Tuong Nguyen, Yen-Hai Nguyen, Thang-Ba Nguyen, Huy Thai, Quyen-Thi Ngoc Pham, Khoa-Duy Dao, Quoc-Nguyen Bao Pham, Thuong-Thi Huyen Dang, Huong-Huynh To Dinh, Trang-Mai Tong, Thuy-Thi Vu, Si-Tri Le, Tai-Ngoc Tran, Phuong-Hoai Tran, Ngoc-Thuy Nhu Dinh, Binh-Thanh Nguyen, Vinh-Phuong Do, Anh-Ngoc Nguyen, Binh-Thi Thanh Nguyen, David Blacker, Lindsey Bunce, Ai Ling Tan, Darshan Ghia, Gillian Edmonds, Nicole O'Loughlin, Megan Ewing, Kerri-Ann Whittaker, Lorralee Deane, Yash Gawarikar, Brett Jones, Maria Lopez, Koushik Nagesh, Emma Siracusa, Stephen Davis, Amy McDonald, Jess Tsoleridis, Rachael McCoy, David Jackson, Gab Silver, Timothy R. Bates, Amanda Boudville, Lynda Southwell, Dennis Cordato, Alan J. McDougall, Cecilia Cappelen-Smith, Zeljka Calic, Shabeel Askar, Qi Cheng, Raymond Kumar, Richard Geraghty, Maree Duroux, Megan Ratcliffe, Samantha Shone, Cassandra McLennan, Ramesh Sahathevan, Casey Hair, Stanley Levy, Beverley Macdonald, Benjamin Nham, Louise Rigney, Dev Nathani, Sumana Gopinath, Vishal Patel, Abul Mamun, Benjamin Trewin, Chun Phua, Ho Choong, Lauren Tarrant, Kerry Boyle, Luisa Hewitt, Monique Hourn, Amanda Masterson, Kim Oakley, Karen Ruddell, Colette Sanctuary, Kimberley Veitch, Camelia Burdusel, Lina Lee, Gary Cheuk, Jeremy Christley, Tabitha Hartwell, Craig Davenport, Kate Hickey, Rosanna Robertson, Michelle Carr, Sam Akbari, Hannah Coyle, Megan O'Neill, Cameron Redpath, Caroline Roberts, Marjan Tabesh, Toni Withiel, Kapila Abeysuriya, Andrew Granger, Angela Abraham, Chermaine Chua, Dung Do Nguyen, Vathani Surendran, Melissa Daines, David Shivlal, Mudassar Latif, Noreen Mughal, Patricia Morgan, Martin Krause, Miriam Priglinger, Ehsan E. Shandiz, Susan Day, Lay Kho, Michael Pollack, Judith Dunne, Helen Baines, Merridie Rees, Jenni White, Aicuratiya Withanage, Candice Delcourt, Cheryl Carcel, Alejandra Malavera, Amy Kunchok, Elizabeth Ray, Elizabeth Pepper, Emily Duckett, Sally Ormond, Andrew Moey, Timothy Kleinig, Vanessa Maxwell, Chantal Baldwin, Wilson Vallat, Deborah Field, Romesh Markus, Kirsty Page, Danielle Wheelwright, Sam Bolitho, Steven Faux, Fix Sangvatanakul, Alexis Brown, Susan Walker, Jennifer Massey, Hillary Hayes, Pesi Katrak, Annie Winker, Alessandro Zagami, Alanah Bailey, Sarah Mccormack, Andrew Murray, Mark Rollason, Christopher Taylor, Fintan O'Rourke, Ye Min Kuang, Heike Burnet, Yvonne Liu, Aileen Wu, Diana Ramirez, Tissa Wijeratne, Sherisse Celestino, Essie Low, Cynthia Chen, Jennifer Bergqvist, Andrew Evans, Queenie Leung, Martin Jude, Rachael McQueen, Katherine Mohr, Latitia Kernaghan, Paul Stockle, Boon L. Tan, Sara Laubscher, Diana Schmid, Melissa Spooner, Bhavesh Lallu, Bronwen Pepperell, John Chalissery, Karim Mahawish, Susan DeCaigney, Paula Broughton, Karen Knight, Veronica Duque, Harry McNaughton, Jeremy Lanford, Vivian Fu, and Lai-Kin Wong

Subjects
Adult, Male, medicine.medical_specialty, medicine.medical_treatment, Population, Placebo-controlled study, Placebo, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, Modified Rankin Scale, Fluoxetine, Internal medicine, medicine, Humans, 030212 general & internal medicine, education, Stroke, Aged, education.field_of_study, business.industry, B790, Recovery of Function, Odds ratio, Middle Aged, medicine.disease, Clinical trial, Treatment Outcome, Female, Neurology (clinical), Stroke recovery, business, Selective Serotonin Reuptake Inhibitors, 030217 neurology & neurosurgery, Follow-Up Studies
Abstract

Background: Trials of fluoxetine for recovery after stroke report conflicting results. The Assessment oF FluoxetINe In sTroke recoverY (AFFINITY) trial aimed to show if daily oral fluoxetine for 6 months after stroke improves functional outcome in an ethnically diverse population.Methods: AFFINITY was a randomised, parallel-group, double-blind, placebo-controlled trial done in 43 hospital stroke units in Australia (n=29), New Zealand (four), and Vietnam (ten). Eligible patients were adults (aged ≥18 years) with a clinical diagnosis of acute stroke in the previous 2–15 days, brain imaging consistent with ischaemic or haemorrhagic stroke, and a persisting neurological deficit that produced a modified Rankin Scale (mRS) score of 1 or more. Patients were randomly assigned 1:1 via a web-based system using a minimisation algorithm to once daily, oral fluoxetine 20 mg capsules or matching placebo for 6 months. Patients, carers, investigators, and outcome assessors were masked to the treatment allocation. The primary outcome was functional status, measured by the mRS, at 6 months. The primary analysis was an ordinal logistic regression of the mRS at 6 months, adjusted for minimisation variables. Primary and safety analyses were done according to the patient's treatment allocation. The trial is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12611000774921.Findings: Between Jan 11, 2013, and June 30, 2019, 1280 patients were recruited in Australia (n=532), New Zealand (n=42), and Vietnam (n=706), of whom 642 were randomly assigned to fluoxetine and 638 were randomly assigned to placebo. Mean duration of trial treatment was 167 days (SD 48·1). At 6 months, mRS data were available in 624 (97%) patients in the fluoxetine group and 632 (99%) in the placebo group. The distribution of mRS categories was similar in the fluoxetine and placebo groups (adjusted common odds ratio 0·94, 95% CI 0·76–1·15; p=0·53). Compared with patients in the placebo group, patients in the fluoxetine group had more falls (20 [3%] vs seven [1%]; p=0·018), bone fractures (19 [3%] vs six [1%]; p=0·014), and epileptic seizures (ten [2%] vs two [Interpretation: Oral fluoxetine 20 mg daily for 6 months after acute stroke did not improve functional outcome and increased the risk of falls, bone fractures, and epileptic seizures. These results do not support the use of fluoxetine to improve functional outcome after stroke.Funding: National Health and Medical Research Council of Australia.

Published
2020

9. Rapid MRI Brain Sequences for Ischaemic Stroke

Author

Mark Fiorentino, Elizabeth Pepper, Jameen Arm, and Siobhan Lee

Subjects
medicine.medical_specialty, business.industry, Internal medicine, education, Ischaemic stroke, Cardiology, medicine, food and beverages, Mri brain, respiratory system, business
Abstract

Poster: "2018 ASM / R-0018 / Rapid MRI Brain Sequences for Ischaemic Stroke " by: " S. Lee , M. Fiorentino, E. Pepper, J. Arm; NSW/AU"

Published
2018

10. Stroke in Older Survivors of Ischemic Stroke: Standard Care or Something Different?

Author

Suzanne Wass, Elizabeth Pepper, and Isobel J. Hubbard

Subjects
Gerontology, Aging, medicine.medical_specialty, Health (social science), medicine.medical_treatment, MEDLINE, 030204 cardiovascular system & hematology, Stroke care, 03 medical and health sciences, 0302 clinical medicine, Older patients, Standard care, Health care, medicine, cardiovascular diseases, Stroke, Rehabilitation, business.industry, medicine.disease, stroke, ageing, Perspective, secondary prevention and rehabilitation, Ischemic stroke, Physical therapy, Geriatrics and Gerontology, business, 030217 neurology & neurosurgery
Abstract

Stroke is one of the leading causes of death and disability and it is more likely to occur in those who are older. Because people are living longer, the definition of “old” continues to evolve. Age alone should not influence the healthcare that a patient receives, however, evidence indicates that this does occur, especially in older patients. On the basis of the available evidence, it is time to reconsider whether or not stroke care should differ in older survivors of stroke and if so, why. This is a narrative review of stroke-related health care in those with a recent ischemic stroke. It seeks to answer the following question: Should patients aged ≥80 years who have experienced a recent ischemic stroke receive standard care or something different, and if they should receive something different, what should they receive and why? The review focusses on long-term survival, hyper-acute care, secondary prevention, and rehabilitation. The authors propose a number of recommendations in relation to stroke care in older survivors of a recent ischemic stroke.

Published
2017

11. Reply

Author

Mark Parsons, Elizabeth Pepper, Virgil Chan, Sabbir Siddique, Siva Rajaratnam, Siva Rajarabram, Grant Bateman, and Christopher Levi

Subjects
Neurology, Neurology (clinical)
Published
2006

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