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1. Optimal timing of anticoagulation after acute ischaemic stroke with atrial fibrillation (OPTIMAS): a multicentre, blinded-endpoint, phase 4, randomised controlled trial

Author

Jelley, Benjamin, Hughes, Tom, Evans, Mim, Esteban, Diego Garcia, Knibbs, Lucy, Broad, Lauren, Price, Rebecca, Griebel, Liz Hamer, Hewson, Sian, Thavanesan, Kamy, Mallon, Louise, Smith, Anna, White, Miranda, Zhang, Liqun, Clarke, Brian, Abousleiman, Youssif, Binnie, Lauren, Sim, Cai Hua, Castanheira, Margarida, Humphries, Fiona, Obarey, Sabaa, Feerick, Shez, Lee, Yee Chin, Lewis, Alex, Muhammad, Riham, Francia, Nina, Atang, Ndifreke, Banaras, Azra, Marinescu, Marilena, Ferdinand, Philip, Varquez, Resti, Ponce, Ida, Saxena, Surabhi, O'Brien, Eoin, Reyes, Juliana Delos, Mitchell-Douglas, Jennifer, Francis, Jobbin, Banerjee, Soma, Dave, Vaishali, Mashate, Sheila, Patel, Tulsi, Sekaran, Lakshmanan, Murad, Wahid, Asaipillai, Asokanathan, Sakthivel, Sethuraman, Tate, Margaret, Angus, Jane, Reid, Lisa, Fornolles, Caroline, Sundayi, Saul, Poolon, Lincy, Justin, Francis, Hunte, Sophy, Bhandari, Mohit, Kho, Jules, Cvoro, Vera, Parakramawansha, Ruwan, Couser, Mandy, Hughes, Hannah, Naqvi, Aaizza, Harkness, Kirsty, Richards, Emma, Howe, Jo, Kamara, Chris, Gardner, Jon, Bains, Harjit, Teal, Rachel, Joseph, Jeethu, Benjamin, Jithen, Al-Hussayni, Samer, Thomas, George, Robinson, Faye, Dixon, Lynn, Krishnan, Manju, Slade, Peter, Anjum, Tal, Storton, Sharon, Adie, Katja, Northcott, Keren, Morgan, Katie, Williams, Emilie, Chanashekar, Harinath, Maguire, Holly, Gabriel, Claire, Maren, Deborah, David, Hannah, Clarke, Sheron, Nagaratnam, Kiruba, Nelatur, Varun, Mannava, Neelima, Blasco, Lara, Devine, Joseph, Bathula, Rajaram, Gopi, Parvathy, Mehta, Niharika, Sreedevi Raj, Sreena, Teo, James, Sztriha, Laszio, Mah, Yee, Ankolekar, Sandeep, Sari, Beatrix, Tibajai, Maria, Morgan, Alicia, Recaman, Maria, Bayhonan, Samantha, Belo, Caroline, Finch, Sharon, Keenan, Samantha, Bowring, Angie, Shetty, Ashit, Chan, Siang, Gray, Lucy, Harrison, Thomas, Spooner, Oliver, Kinsella-Perks, Edward, Erumere, Esther, Sanders, Brittany, Sims, Don, Willmot, Mark, Littleton, Edward, Spruce, Elaine, Moody, Lisa, Sheriden, Christopher, Luxmore-Brown, Scott, Neal, Aoife, Beddows, Sophie, Tuna, Maria Assuncao, Misra, Amulya, Penn, Ruth, Mariampillai, Sonia, Anwar, Ijaz, Annamalai, Arunkumar, Whitehouse, Sarah, Shepherd, Lorna, Siddle, Elaine, Chatterjee, Kausik, Leason, Sandra, Davies, Angela, Marigold, Richard James, Frank, Sarah, Baird, Alix, Hannam-Penfold, Tomas, Inacio, Liliana, Smith, Simon, Eveson, David, Musarrat, Kashif, Khan, Shagufta, Harris, Tracy, Chowdhury, Muhibbur, Alam, Sajid, Jamieson, Elena, Anyankpele, Ebitare, Al Shalchi, Farah, Rivers, Vanessa, Bell, Stephanie, Francis, Rebecca, Beeby, Deborah, Finch, Jenny, Macleod, Mary Joan, Guzman-Gutierrez, German, Carter, Karla, Irvine, Janice, Gbadamoshi, Lukuman, Costa, Telma, Heirons, Sarah, Stoney, Hayley, Shaw, Louise, Choulerton, James, Catibog, Darwin, Sattar, Naweed, Myint, Min, Smith, Andy, Serac, Kwin, Emsley, Hedley, Sultan, Sulaiman, Gregary, Bindu, Brown, Allan, Mahmood, Afzal, Chattha, Navraj, Old, William, Pegg, Claire, Davey, Miriam, Page, Michelle, Sandhu, Banher, Phiri, Emily, Rashed, Khalid, Wilson, Elisabeth, Hindley, Esther, Board, Sarah, Antony, Sherly, Tanate, Alfonso, Davis, Michelle, Holland, Beth, Slater, Victoria, Fawcett, Michelle, England, Tim, Scott, James, Beavan, Jessica, Hedstrom, Amanda, Karunatilake, Dumin, Gillmain, Kimberley, Singh, Nishy, Hallows, Tracy, Barber, Mark, Yates, Luke, Micallef, Clayton, Esson, Derek, Meng Yu, Wai, Ming New, Benjamin Jaa, Matos, Alexandre, Burt, Clare, Cabrelli, Louise, Wilkie, Gillian, Meegada, Madana, Kirthivasan, Ramanathan, Fox, Caroline, Mead, Victoria, Lyle, Amanda, Saksena, Rajesh, Bakshi, Aashima, O'Kelly, Alison, Rehan, Jahanzeb, Ebueka, Osaretin, Cooper, Martin, Wynter, Inez, Smith, Susan, Kumar, Senthil, O'Brien, Linda, Parker, Cerrys, Parker, Emma, Khan, Numan, Patterson, Christopher, Maguire, Stuart, Quinn, Outi, Bellfield, Ruth, Behnam, Yousif, Costa, Janet, Padilla-Harris, Cheryl, Moram, Louise, Raza, Syed Abid, Tench, Helen, Sims, Tanya, McGuinness, Heather, Loosley, Ronda, Wolf-Roberts, Rebecca, Buddha, Sandeep, Salt, Irmak, Lewis, Kerry, Mavinamne, Sunanda, Ditchfield, Coleen, Dealing, Sharon, Shah, Alexander, Crossingham, Ginette, Mwadeyi, Memory, Kenton, Anthony, Omoregie, Faith, Abubakar, Saidu, Warwick, Allison, Hector, Gemma, Hassan, Ahamad, Veraque, Emelda, Farman, Michelle, Makawa, Linetty, Byrne, Anthony, Kirkham, Jackie, Blayney, Gareth, Selwyn, Jey, Kakar, Puneet, Al Khaddour, Mohammed, Dhami, Reena, Baker, Emelda, Esisi, Bernard, Clarkson, Emma, Fellowes, Dominic, Kresmir, Jergovic, Guyler, Paul, Ngo, David, Wijenayake, Indunil, Tysoe, Sharon, Galliford, Joanne, Harman, Paula, Garside, Mark, Badanahatti, Madhava, Riddell, Victoria, Gramizadeh, Gita, Dutta, Dipankar, Bajoriene, Milda, Erdogan, Hulya, Ward, Deborah, Doubal, Fergus, Samarasekera, Neshika, Risbridger, Sarah, MacRaild, Allan, Azim, Abul, Wood, Lisa, Tampset, Ruth, Shekhar, Raj, Rai, Umesh, Fuller, Tracy, Joshy, Aricsa, Nadar, Evelyn, Kini, Manohar, Ahmad, Syed, Robinson, Matthew, King, Lucia, Srinivasan, Venkatesan, Karwacka-Cichomska, Magdalena, Moore, Vicki, Smith, Kate, Kariyadil, Bincy, Kong, Kelvin, Hubbard, Kelly, Arif, Sarwat, Hasan, Muhammad, Temple, Natalie, Arcoria, Daniele, Horne, Zoey, Soe, Thandar, Wyllie, Hilary, Hacon, Christian, Sutherland, Helen, Menezes, Brian, Johnson, Venetia, Smyth, Nigel, Mehdi, Zehra, Tone, Ela, Bradley, Arian, Levell, Emma, Ekkert, Aleksandra, Mazzucco, Sara, McCafferty, Laura, Vonoven, Linda, Dewan, Suprita, Sridhar, Pagadala, Thomas, Jayne, Coetzee, Samantha, Icke, Becky, Williams, Jill, Saravanan, Narayanamoorthi, Bradley, Pamela, Gibson, Rebecca Marie, Antony, Jijimol, Ashraf, Imran, Mabuti, Jose, Kamundi, Charlotte, Patiola, Prasanna, Oakley, Naomi, Proeschel, Harold, Kelly, Debs, Longley, Wendy, Cave, Ashleigh, Ambrico, Carla, Black, Toby, Porretta, Elisa, Anthony, Alpha, Ragab, Suzanne, Dube, Judith, Kausar, Shahid, Gujjar, Abdullah, Abdullah, Mohammad, Kaur, Daljit, Gadapa, Naveen, Choudhary, Sumita, Nisar, Nabeela, Fawehinmi, Grace, Dunne, Karen, King, Sam, Kishore, Amit, Lee, Stephanie, Marsden, Tracy, Slaughter, Melanie, Cawley, Kathryn, Perez, Jane, Anderton, Peter, Soussi, Salem, Walstow, Deborah, Pugh, Rebecca, Manoj, Aravind, Fletcher, Glynn, Lopez, Paula, McCormick, Michael, Magee, Michael, Tallon, Grainne, McFarland, Denise, Cosgrove, Denise, Shinh, Naval, Metcalf, Kneale, Kostyuk, Alina, McDonald, Susan, Sayers, Sophie, Sayed, Walee, Abraham, Sam, Szabo, Gemma, Crosbie, Gareth, McIlmoyle, Jim, Fearon, Patricia, Courtney, Kerry, Tauro, Suzanne, Singh, Arun, Nair, Anand, Duberley, Stephen, Philip, Sheeba, Curley, Cath, Goddard, Wendy, Bridge, Luke, Willcoxson, Paul, Wanklyn, Peter, Owen, Jennifer, France, John, Reed, Bryony, Foulds, Angie, Richard, Bella, Parfitt, Louise, Affley, Brendan, Russo, Cristina, Dsouza, Margaret, Cruddas, Elizabeth, Hargroves, David, Rand, James, Shekar, Som, Bhat, Yaqoob, Marshall, Gail, Nash, Maxine, Ahmad, Nasar, Okoko, Blessing Oduh, Evans, Rachel, Taylor, Tegan, Dawson, Jesse, Colquhoun, Elizabeth, James, Christopher, Aguirre, Carlos, MacPhee, Catherine, Phipps, Janet, Ispoglou, Sissi, Hayes, Anne, Werring, David J, Dehbi, Hakim-Moulay, Ahmed, Norin, Arram, Liz, Best, Jonathan G, Balogun, Maryam, Bennett, Kate, Bordea, Ekaterina, Caverly, Emilia, Chau, Marisa, Cohen, Hannah, Cullen, Mairead, Doré, Caroline J, Engelter, Stefan T, Fenner, Robert, Ford, Gary A, Gill, Aneet, Hunter, Rachael, James, Martin, Jayanthi, Archana, Lip, Gregory Y H, Massingham, Sue, Murray, Macey L, Mazurczak, Iwona, Nash, Philip S, Ndoutoumou, Amalia, Norrving, Bo, Sims, Hannah, Sprigg, Nikola, Vanniyasingam, Tishok, and Freemantle, Nick

Published
2024
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2. Optimal timing of anticoagulation after acute ischaemic stroke with atrial fibrillation (OPTIMAS): a multicentre, blinded-endpoint, phase 4, randomised controlled trial

Author

Werring, David J, Dehbi, Hakim-Moulay, Ahmed, Norin, Arram, Liz, Best, Jonathan G, Balogun, Maryam, Bennett, Kate, Bordea, Ekaterina, Caverly, Emilia, Chau, Marisa, Cohen, Hannah, Cullen, Mairead, Doré, Caroline J, Engelter, Stefan T, Fenner, Robert, Ford, Gary A, Gill, Aneet, Hunter, Rachael, James, Martin, Jayanthi, Archana, Lip, Gregory Y H, Massingham, Sue, Murray, Macey L, Mazurczak, Iwona, Nash, Philip S, Ndoutoumou, Amalia, Norrving, Bo, Sims, Hannah, Sprigg, Nikola, Vanniyasingam, Tishok, Freemantle, Nick, Jelley, Benjamin, Hughes, Tom, Evans, Mim, Esteban, Diego Garcia, Knibbs, Lucy, Broad, Lauren, Price, Rebecca, Griebel, Liz Hamer, Hewson, Sian, Thavanesan, Kamy, Mallon, Louise, Smith, Anna, White, Miranda, Zhang, Liqun, Clarke, Brian, Abousleiman, Youssif, Binnie, Lauren, Sim, Cai Hua, Castanheira, Margarida, Humphries, Fiona, Obarey, Sabaa, Feerick, Shez, Lee, Yee Chin, Lewis, Alex, Muhammad, Riham, Francia, Nina, Atang, Ndifreke, Banaras, Azra, Marinescu, Marilena, Ferdinand, Philip, Varquez, Resti, Ponce, Ida, Saxena, Surabhi, O'Brien, Eoin, Reyes, Juliana Delos, Mitchell-Douglas, Jennifer, Francis, Jobbin, Banerjee, Soma, Dave, Vaishali, Mashate, Sheila, Patel, Tulsi, Sekaran, Lakshmanan, Murad, Wahid, Asaipillai, Asokanathan, Sakthivel, Sethuraman, Tate, Margaret, Angus, Jane, Reid, Lisa, Fornolles, Caroline, Sundayi, Saul, Poolon, Lincy, Justin, Francis, Hunte, Sophy, Bhandari, Mohit, Kho, Jules, Cvoro, Vera, Parakramawansha, Ruwan, Couser, Mandy, Hughes, Hannah, Naqvi, Aaizza, Harkness, Kirsty, Richards, Emma, Howe, Jo, Kamara, Chris, Gardner, Jon, Bains, Harjit, Teal, Rachel, Joseph, Jeethu, Benjamin, Jithen, Al-Hussayni, Samer, Thomas, George, Robinson, Faye, Dixon, Lynn, Krishnan, Manju, Slade, Peter, Anjum, Tal, Storton, Sharon, Adie, Katja, Northcott, Keren, Morgan, Katie, Williams, Emilie, Chanashekar, Harinath, Maguire, Holly, Gabriel, Claire, Maren, Deborah, David, Hannah, Clarke, Sheron, Nagaratnam, Kiruba, Nelatur, Varun, Mannava, Neelima, Blasco, Lara, Devine, Joseph, Bathula, Rajaram, Gopi, Parvathy, Mehta, Niharika, Sreedevi Raj, Sreena, Teo, James, Sztriha, Laszio, Mah, Yee, Ankolekar, Sandeep, Sari, Beatrix, Tibajai, Maria, Morgan, Alicia, Recaman, Maria, Bayhonan, Samantha, Belo, Caroline, Finch, Sharon, Keenan, Samantha, Bowring, Angie, Shetty, Ashit, Chan, Siang, Gray, Lucy, Harrison, Thomas, Spooner, Oliver, Kinsella-Perks, Edward, Erumere, Esther, Sanders, Brittany, Sims, Don, Willmot, Mark, Littleton, Edward, Spruce, Elaine, Moody, Lisa, Sheriden, Christopher, Luxmore-Brown, Scott, Neal, Aoife, Beddows, Sophie, Tuna, Maria Assuncao, Misra, Amulya, Penn, Ruth, Mariampillai, Sonia, Anwar, Ijaz, Annamalai, Arunkumar, Whitehouse, Sarah, Shepherd, Lorna, Siddle, Elaine, Chatterjee, Kausik, Leason, Sandra, Davies, Angela, Marigold, Richard James, Frank, Sarah, Baird, Alix, Hannam-Penfold, Tomas, Inacio, Liliana, Smith, Simon, Eveson, David, Musarrat, Kashif, Khan, Shagufta, Harris, Tracy, Chowdhury, Muhibbur, Alam, Sajid, Jamieson, Elena, Anyankpele, Ebitare, Al Shalchi, Farah, Rivers, Vanessa, Bell, Stephanie, Francis, Rebecca, Beeby, Deborah, Finch, Jenny, Macleod, Mary Joan, Guzman-Gutierrez, German, Carter, Karla, Irvine, Janice, Gbadamoshi, Lukuman, Costa, Telma, Heirons, Sarah, Stoney, Hayley, Shaw, Louise, Choulerton, James, Catibog, Darwin, Sattar, Naweed, Myint, Min, Smith, Andy, Serac, Kwin, Emsley, Hedley, Sultan, Sulaiman, Gregary, Bindu, Brown, Allan, Mahmood, Afzal, Chattha, Navraj, Old, William, Pegg, Claire, Davey, Miriam, Page, Michelle, Sandhu, Banher, Phiri, Emily, Rashed, Khalid, Wilson, Elisabeth, Hindley, Esther, Board, Sarah, Antony, Sherly, Tanate, Alfonso, Davis, Michelle, Holland, Beth, Slater, Victoria, Fawcett, Michelle, England, Tim, Scott, James, Beavan, Jessica, Hedstrom, Amanda, Karunatilake, Dumin, Gillmain, Kimberley, Singh, Nishy, Hallows, Tracy, Barber, Mark, Yates, Luke, Micallef, Clayton, Esson, Derek, Meng Yu, Wai, Ming New, Benjamin Jaa, Matos, Alexandre, Burt, Clare, Cabrelli, Louise, Wilkie, Gillian, Meegada, Madana, Kirthivasan, Ramanathan, Fox, Caroline, Mead, Victoria, Lyle, Amanda, Saksena, Rajesh, Bakshi, Aashima, O'Kelly, Alison, Rehan, Jahanzeb, Ebueka, Osaretin, Cooper, Martin, Wynter, Inez, Smith, Susan, Kumar, Senthil, O'Brien, Linda, Parker, Cerrys, Parker, Emma, Khan, Numan, Patterson, Christopher, Maguire, Stuart, Quinn, Outi, Bellfield, Ruth, Behnam, Yousif, Costa, Janet, Padilla-Harris, Cheryl, Moram, Louise, Raza, Syed Abid, Tench, Helen, Sims, Tanya, McGuinness, Heather, Loosley, Ronda, Wolf-Roberts, Rebecca, Buddha, Sandeep, Salt, Irmak, Lewis, Kerry, Mavinamne, Sunanda, Ditchfield, Coleen, Dealing, Sharon, Shah, Alexander, Crossingham, Ginette, Mwadeyi, Memory, Kenton, Anthony, Omoregie, Faith, Abubakar, Saidu, Warwick, Allison, Hector, Gemma, Hassan, Ahamad, Veraque, Emelda, Farman, Michelle, Makawa, Linetty, Byrne, Anthony, Kirkham, Jackie, Blayney, Gareth, Selwyn, Jey, Kakar, Puneet, Al Khaddour, Mohammed, Dhami, Reena, Baker, Emelda, Esisi, Bernard, Clarkson, Emma, Fellowes, Dominic, Kresmir, Jergovic, Guyler, Paul, Ngo, David, Wijenayake, Indunil, Tysoe, Sharon, Galliford, Joanne, Harman, Paula, Garside, Mark, Badanahatti, Madhava, Smith, Anna, Riddell, Victoria, Gramizadeh, Gita, Dutta, Dipankar, Bajoriene, Milda, Erdogan, Hulya, Ward, Deborah, Doubal, Fergus, Samarasekera, Neshika, Risbridger, Sarah, MacRaild, Allan, Azim, Abul, Wood, Lisa, Tampset, Ruth, Shekhar, Raj, Rai, Umesh, Fuller, Tracy, Joshy, Aricsa, Nadar, Evelyn, Kini, Manohar, Ahmad, Syed, Robinson, Matthew, King, Lucia, Srinivasan, Venkatesan, Karwacka-Cichomska, Magdalena, Moore, Vicki, Smith, Kate, Kariyadil, Bincy, Kong, Kelvin, Hubbard, Kelly, Arif, Sarwat, Hasan, Muhammad, Temple, Natalie, Arcoria, Daniele, Horne, Zoey, Soe, Thandar, Wyllie, Hilary, Hacon, Christian, Sutherland, Helen, Menezes, Brian, Johnson, Venetia, Smyth, Nigel, Mehdi, Zehra, Tone, Ela, Bradley, Arian, Levell, Emma, Ekkert, Aleksandra, Mazzucco, Sara, McCafferty, Laura, Vonoven, Linda, Dewan, Suprita, Sridhar, Pagadala, Thomas, Jayne, Coetzee, Samantha, Icke, Becky, Williams, Jill, Saravanan, Narayanamoorthi, Bradley, Pamela, Gibson, Rebecca Marie, Antony, Jijimol, Ashraf, Imran, Mabuti, Jose, Kamundi, Charlotte, Patiola, Prasanna, Oakley, Naomi, Proeschel, Harold, Kelly, Debs, Longley, Wendy, Cave, Ashleigh, Ambrico, Carla, Black, Toby, Porretta, Elisa, Anthony, Alpha, Ragab, Suzanne, Dube, Judith, Kausar, Shahid, Gujjar, Abdullah, Abdullah, Mohammad, Kaur, Daljit, Gadapa, Naveen, Choudhary, Sumita, Nisar, Nabeela, Fawehinmi, Grace, Dunne, Karen, King, Sam, Kishore, Amit, Lee, Stephanie, Marsden, Tracy, Slaughter, Melanie, Cawley, Kathryn, Perez, Jane, Anderton, Peter, Soussi, Salem, Walstow, Deborah, Pugh, Rebecca, Manoj, Aravind, Fletcher, Glynn, Lopez, Paula, McCormick, Michael, Magee, Michael, Tallon, Grainne, McFarland, Denise, Cosgrove, Denise, Shinh, Naval, Metcalf, Kneale, Kostyuk, Alina, McDonald, Susan, Sayers, Sophie, Sayed, Walee, Abraham, Sam, Szabo, Gemma, Crosbie, Gareth, McIlmoyle, Jim, Fearon, Patricia, Courtney, Kerry, Tauro, Suzanne, Singh, Arun, Nair, Anand, Duberley, Stephen, Philip, Sheeba, Curley, Cath, Goddard, Wendy, Bridge, Luke, Willcoxson, Paul, Wanklyn, Peter, Owen, Jennifer, France, John, Reed, Bryony, Foulds, Angie, Richard, Bella, Parfitt, Louise, Affley, Brendan, Russo, Cristina, Dsouza, Margaret, Cruddas, Elizabeth, Hargroves, David, Rand, James, Shekar, Som, Bhat, Yaqoob, Marshall, Gail, Nash, Maxine, Ahmad, Nasar, Okoko, Blessing Oduh, Evans, Rachel, Taylor, Tegan, Dawson, Jesse, Colquhoun, Elizabeth, James, Christopher, Aguirre, Carlos, MacPhee, Catherine, Phipps, Janet, Ispoglou, Sissi, Hayes, Anne, and Evans, Rachel

Abstract

The optimal timing of anticoagulation for patients with acute ischaemic stoke with atrial fibrillation is uncertain. We investigated the efficacy and safety of early compared with delayed initiation of direct oral anticoagulants (DOACs) in patients with acute ischaemic stroke associated with atrial fibrillation.

Published
2024
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4. Favipiravir, lopinavir-ritonavir, or combination therapy (FLARE): A randomised, double-blind, 2 x 2 factorial placebo-controlled trial of early antiviral therapy in COVID-19

Author

Lowe, David M., Brown, Li-An K., Chowdhury, Kashfia, Davey, Stephanie, Yee, Philip, Ikeji, Felicia, Ndoutoumou, Amalia, Shah, Divya, Lennon, Alexander, Rai, Abhulya, Agyeman, Akosua A., Checkley, Anna, Longley, Nicola, Dehbi, Hakim-Moulay, Freemantle, Nick, Breuer, Judith, and Standing, Joseph F.

Subjects
Lopinavir -- Dosage and administration -- Patient outcomes, Drug therapy, Combination -- Methods, Ritonavir -- Dosage and administration -- Patient outcomes, Clinical trials, Biological sciences
Abstract

Background Early antiviral treatment is effective for Coronavirus Disease 2019 (COVID-19) but currently available agents are expensive. Favipiravir is routinely used in many countries, but efficacy is unproven. Antiviral combinations have not been systematically studied. We aimed to evaluate the effect of favipiravir, lopinavir-ritonavir or the combination of both agents on Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) viral load trajectory when administered early. Methods and findings We conducted a Phase 2, proof of principle, randomised, placebo-controlled, 2 x 2 factorial, double-blind trial of ambulatory outpatients with early COVID-19 (within 7 days of symptom onset) at 2 sites in the United Kingdom. Participants were randomised using a centralised online process to receive: favipiravir (1,800 mg twice daily on Day 1 followed by 400 mg 4 times daily on Days 2 to 7) plus lopinavir-ritonavir (400 mg/100 mg twice daily on Day 1, followed by 200 mg/50 mg 4 times daily on Days 2 to 7), favipiravir plus lopinavir-ritonavir placebo, lopinavir-ritonavir plus favipiravir placebo, or both placebos. The primary outcome was SARS-CoV-2 viral load at Day 5, accounting for baseline viral load. Between 6 October 2020 and 4 November 2021, we recruited 240 participants. For the favipiravir+lopinavir-ritonavir, favipiravir+placebo, lopinavir-ritonavir+placebo, and placebo-only arms, we recruited 61, 59, 60, and 60 participants and analysed 55, 56, 55, and 58 participants, respectively, who provided viral load measures at Day 1 and Day 5. In the primary analysis, the mean viral load in the favipiravir+placebo arm had changed by -0.57 log.sub.10 (95% CI -1.21 to 0.07, p = 0.08) and in the lopinavir-ritonavir+placebo arm by -0.18 log.sub.10 (95% CI -0.82 to 0.46, p = 0.58) compared to the placebo arm at Day 5. There was no significant interaction between favipiravir and lopinavir-ritonavir (interaction coefficient term: 0.59 log.sub.10, 95% CI -0.32 to 1.50, p = 0.20). More participants had undetectable virus at Day 5 in the favipiravir+placebo arm compared to placebo only (46.3% versus 26.9%, odds ratio (OR): 2.47, 95% CI 1.08 to 5.65; p = 0.03). Adverse events were observed more frequently with lopinavir-ritonavir, mainly gastrointestinal disturbance. Favipiravir drug levels were lower in the combination arm than the favipiravir monotherapy arm, possibly due to poor absorption. The major limitation was that the study population was relatively young and healthy compared to those most affected by the COVID-19 pandemic. Conclusions At the current doses, no treatment significantly reduced viral load in the primary analysis. Favipiravir requires further evaluation with consideration of dose escalation. Lopinavir-ritonavir administration was associated with lower plasma favipiravir concentrations. Trial registration Clinicaltrials.gov NCT04499677 EudraCT: 2020-002106-68, Author(s): David M. Lowe 1,2,*, Li-An K. Brown 1, Kashfia Chowdhury 3, Stephanie Davey 4, Philip Yee 4, Felicia Ikeji 3, Amalia Ndoutoumou 3, Divya Shah 5, Alexander Lennon 5, [...]

Published
2022
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6. Favipiravir, lopinavir-ritonavir, or combination therapy (FLARE): A randomised, double-blind, 2 × 2 factorial placebo-controlled trial of early antiviral therapy in COVID-19.

Author

Lowe, David M., Brown, Li-An K., Chowdhury, Kashfia, Davey, Stephanie, Yee, Philip, Ikeji, Felicia, Ndoutoumou, Amalia, Shah, Divya, Lennon, Alexander, Rai, Abhulya, Agyeman, Akosua A., Checkley, Anna, Longley, Nicola, Dehbi, Hakim-Moulay, Freemantle, Nick, Breuer, Judith, Standing, Joseph F., and FLARE Investigators

Subjects
SARS-CoV-2, LOPINAVIR-ritonavir, COVID-19 treatment, COVID-19
Abstract

Background: Early antiviral treatment is effective for Coronavirus Disease 2019 (COVID-19) but currently available agents are expensive. Favipiravir is routinely used in many countries, but efficacy is unproven. Antiviral combinations have not been systematically studied. We aimed to evaluate the effect of favipiravir, lopinavir-ritonavir or the combination of both agents on Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) viral load trajectory when administered early.Methods and Findings: We conducted a Phase 2, proof of principle, randomised, placebo-controlled, 2 × 2 factorial, double-blind trial of ambulatory outpatients with early COVID-19 (within 7 days of symptom onset) at 2 sites in the United Kingdom. Participants were randomised using a centralised online process to receive: favipiravir (1,800 mg twice daily on Day 1 followed by 400 mg 4 times daily on Days 2 to 7) plus lopinavir-ritonavir (400 mg/100 mg twice daily on Day 1, followed by 200 mg/50 mg 4 times daily on Days 2 to 7), favipiravir plus lopinavir-ritonavir placebo, lopinavir-ritonavir plus favipiravir placebo, or both placebos. The primary outcome was SARS-CoV-2 viral load at Day 5, accounting for baseline viral load. Between 6 October 2020 and 4 November 2021, we recruited 240 participants. For the favipiravir+lopinavir-ritonavir, favipiravir+placebo, lopinavir-ritonavir+placebo, and placebo-only arms, we recruited 61, 59, 60, and 60 participants and analysed 55, 56, 55, and 58 participants, respectively, who provided viral load measures at Day 1 and Day 5. In the primary analysis, the mean viral load in the favipiravir+placebo arm had changed by -0.57 log10 (95% CI -1.21 to 0.07, p = 0.08) and in the lopinavir-ritonavir+placebo arm by -0.18 log10 (95% CI -0.82 to 0.46, p = 0.58) compared to the placebo arm at Day 5. There was no significant interaction between favipiravir and lopinavir-ritonavir (interaction coefficient term: 0.59 log10, 95% CI -0.32 to 1.50, p = 0.20). More participants had undetectable virus at Day 5 in the favipiravir+placebo arm compared to placebo only (46.3% versus 26.9%, odds ratio (OR): 2.47, 95% CI 1.08 to 5.65; p = 0.03). Adverse events were observed more frequently with lopinavir-ritonavir, mainly gastrointestinal disturbance. Favipiravir drug levels were lower in the combination arm than the favipiravir monotherapy arm, possibly due to poor absorption. The major limitation was that the study population was relatively young and healthy compared to those most affected by the COVID-19 pandemic.Conclusions: At the current doses, no treatment significantly reduced viral load in the primary analysis. Favipiravir requires further evaluation with consideration of dose escalation. Lopinavir-ritonavir administration was associated with lower plasma favipiravir concentrations.Trial Registration: Clinicaltrials.gov NCT04499677 EudraCT: 2020-002106-68. [ABSTRACT FROM AUTHOR]

Published
2022
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7. Plasma NRTI concentration and their associations with liver and renal parameters in people living with HIV

Author

Wang, Xinzhu, Boffito, Marta, Dickinson, Laura, Bagkeris, Emmanouil, Khoo, Saye, Post, Frank A, Vera, Jaime, Williams, Ian, Ndoutoumou, Amalia, Anderson, Jane, Mallon, Patrick, McClure, Myra, Winston, Alan, Sabin, Caroline, and POPPY Study

Subjects
immune system diseases, virus diseases
Abstract

Associations between markers of liver and renal dysfunction and NRTI plasma exposure are ill-defined. As part of a large cohort study (POPPY), we analysed associations between ALT and eGFR results in people living with HIV on tenofovir (TFV) disoproxil fumarate (TDF), emtricitabine (FTC), abacavir (ABC) and lamivudine (3TC). While we found no associations between NRTI concentrations and ALT, lower eGFR values were associated with greater TFV, FTC and 3TC exposure, whereas ABC showed no associations.

Published
2020

8. Level of agreement between frequently used cardiovascular risk calculators in people living with HIV

Author

Dhillon, S., Sabin, C. A., Alagaratnam, J., Bagkeris, E., Post, F. A., Boffito, M., Anderson, J., Vera, J., Williams, I., Johnson, M., Sachikonye, M., Babalis, D., Mallon, P. W., Winston, A., Ndoutoumou, Amalia, Post, Frank, Asboe, David, Garvey, Lucy, Pozniak, Anton, Clarke, Amanda, Bexley, Andrew, Richardson, Celia, Kirk, Sarah, Gleig, Rebecca, Bracchi, Margherita, Pagani, Nicole, Cerrone, Maddalena, Bradshaw, Daniel, Ferretti, Francesca, Higgs, Chris, Seah, Elisha, Fletcher, Stephen, Anthonipillai, Michelle, Moyes, Ashley, Deats, Katie, Syed, Irtiza, Matthews, Clive, Fernando, Peter, Chiwome, Chido, Hardwick, Shane, Anderson, Jane, Mguni, Sifiso, Clark, Rebecca, Nevin-Dolan, Rhiannon, Pelluri, Sambasivarao, Campbell, Lucy, Yurdakul, Selin, Okumu, Sara, Pollard, Louise, Santana-Suarez, Beatriz, Mallon, Paddy, Macken, Alan, Ghavani-Kia, Bijan, Maher, Joanne, Byrne, Maria, Flaherty, Ailbhe, Babu, Sumesh, Williams, Ian, Otiko, Damilola, Phillips, Laura, Laverick, Rosanna, Beynon, Michelle, Salz, Anna-Lena, Severn, Abigail, Winston, Alan, Underwood, Jonathan, Tembo, Lavender, Stott, Matthew, McDonald, Linda, Dransfield, Felix, Whitehouse, Andrew, Burgess, Laura, Babalis, Daphne, Johnson, Margaret, Ngwu, Nnenna, Hemat, Nargis, Jones, Martin, Carroll, Anne, Kinloch, Sabine, Youle, Mike, Madge, Sara, Sabin, Caroline, De Francesco, Davide, and Bagkeris, Emmanouil

Subjects
0301 basic medicine, Male, medicine.medical_specialty, Cvd risk, Human immunodeficiency virus (HIV), HIV Infections, medicine.disease_cause, Risk Assessment, Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) risk score, Pharmacokinetic and Clinical Observations in People over Fifty (POPPY) study, 03 medical and health sciences, 0302 clinical medicine, Interquartile range, Virology, Internal medicine, medicine, Clinical endpoint, Humans, Pharmacology (medical), 030212 general & internal medicine, Prospective Studies, Adverse effect, Framingham, Framingham Risk Score, business.industry, Health Policy, HIV, 1103 Clinical Sciences, Middle Aged, 030112 virology, QRISK2, United Kingdom, Infectious Diseases, Cardiovascular Diseases, cardiovascular risk prediction, Female, business, agreement, Kappa, Algorithms
Abstract

Objectives\ud\udThe aim of the study was to describe agreement between the QRISK2, Framingham and Data Collection on Adverse Events of Anti‐HIV Drugs (D:A:D) cardiovascular disease (CVD) risk calculators in a large UK study of people living with HIV (PLWH).\ud\ud\udMethods\ud\udPLWH enrolled in the Pharmacokinetic and Clinical Observations in People over Fifty (POPPY) study without a prior CVD event were included in this study. QRISK2, Framingham CVD and the full and reduced D:A:D CVD scores were calculated; participants were stratified into ‘low’ (< 10%), ‘intermediate’ (10–20%) and ‘high’ (> 20%) categories for each. Agreement between scores was assessed using weighted kappas and Bland–Altman plots.\ud\udResults\ud\udThe 730 included participants were predominantly male (636; 87.1%) and of white ethnicity (645; 88.5%), with a median age of 53 [interquartile range (IQR) 49–59] years. The median calculated 10‐year CVD risk was 11.9% (IQR 6.8–18.4%), 8.9% (IQR 4.6–15.0%), 8.5% (IQR 4.8–14.6%) and 6.9% (IQR 4.1–11.1%) when using the Framingham, QRISK2, and full and reduced D:A:D scores, respectively. Agreement between the different scores was generally moderate, with the highest level of agreement being between the Framingham and QRISK2 scores (weighted kappa = 0.65) but with most other kappa coefficients in the 0.50–0.60 range.\ud\ud\udConclusions\ud\udEstimates of predicted 10‐year CVD risk obtained with commonly used CVD risk prediction tools demonstrate, in general, only moderate agreement among PLWH in the UK. While further validation with clinical endpoints is required, our findings suggest that care should be taken when interpreting any score alone.

Published
2019

10. Anastrozole versus tamoxifen for the prevention of locoregional and contralateral breast cancer in postmenopausal women with locally excised ductal carcinoma in situ (IBIS-II DCIS): A double-blind, randomised controlled trial

Author

Forbes, John F, Sestak, Ivana, Howell, Anthony, Bonanni, Bernardo, Bundred, Nigel, Levy, Christelle, von Minckwitz, Gunter, Eiermann, Wolfgang, Neven, Patrick, Stierer, Michael, Holcombe, Chris, Coleman, Robert E, Jones, Louise, Ellis, Ian, Cuzick, Jack, Sainsbury, Richard, Garber, Judy, Warwick, Jane, Buchanan, Mary, Buser, Katharina, Cawthorn, Simon, Coleman, Robert, Dowsett, Mitch, Eastell, Richard, Ejlertsen, Bent, Forbes, John, Kahan, Zsuzsanna, Baclesse, François, Mansel, Robert, Palva, Tiina, Rydén, Lisa, Stuart, Mary, Vaz, Fatima, Marsiglia, Hugo, Benyoucef, Ahmed, Berton-Rigaud, Dominique, Loustalot, Catherine, Serin, Daniel, Kerbrat, Pierre, Eymard, Jean-Christophe, Giard-Lefevre, Sylvia, Bonichon-Lamichhane, Nathalie, Monnier, Alain, Tubiana-Mathieu, Nicole, Piot, Gilles, de Lara, Christine Tunon, Bernard, Olivier, Simon-Swirski, Hélène, Gladieff, Laurence, Regaud, I Claudius, Fouchet-Goudier, Marie-Joseph, Dohollou, Nadine, Aquitaine, Nord, Elgard-Maitre, Anne-Marie, Bergerat, Jean-Pierre, Petit, Thierry, Marti, Adina, Toussaint, Caroline, Del Piano, Francesco, Ibrahim, Mahmoud, Fric, Danièle, Hönig, Arnd, Müller, Volkmar, Marmé, Frederik, Rautenberg, Beate, Schmidt, Marcus, Hanusch, Claus, Paepke, Stefan, Kaltenecker, Gabriele, Lemster, Sabine, Tio, Joke, Reimer, Toralf, Schnappauf, Benjamin, Baumann, Klaus, Schrader, Iris, Mundhenke, Christoph, Liedtke, Cornelia, Meinerz, Wolfgang, Thomssen, Christoph, Christl, Klaus, Hitschold, Thomas, Goerke, Kay, Kast, Karin, Runnebaum, Ingo, Lindner, Christoph, Scheidel, Peter, Herwig, Uwe, Bangemann, Nikola, Sommer, Harald, Göhring, Kornelia, Tulusan, Augustinus, Stauß, Eva, Köhler, Günter, Zahm, Dirk, Augustin, Doris, Hocke, Andrea, Neunhöffer, Tanja, Schmatloch, Sabine, Heinrich, Georg, Groß, Sabine, Breitbach, G P, Scharl, Anton, Klare, Peter, Stefek, Andrea, Hoffmann, Gerald, Martignoni, Franca, Weiss, Erich, Emons, Günter, Tesch, Hans-Christian, Beckmann, Matthias, Schmutzler, Rita, Schütte, Martin, Aktas, Bahriye, Hille-Betz, Ursula, Deryal, Mustafa, Dan Costa, Serban, Blümel, Beate, Göhring, Uwe-Jochen, Kleine-Tebbe, Anke, Schumacher, Claudia, Jasmin, Pourfard, Christoph, Uleer, Kullmer, Uwe, Krabisch, Petra, Gätje, Regine, Schwenzer, Thomas, Hindenburg, Hans-Joachim, Rempen, Andreas, Höffkes, Heinz-Gert, Stickeler, Elmar, Reffert, Christian, Seitz, Stephan, Splitt, Gerd, Böhne, Petra, Gnauert, Karsten, Strittmatter, Hans-Joachim, Baake, Gerold, Rezai, Mahdi, Noesselt, Thomas, Köhne, C-H, Hanf, Volker, Strumberg, Dirk, Dall, Peter, Schleicher, Peter, Schleicher, Bernd, Beldermann, Frank, Berghorn, Michael, Baerens, Dirk-Thoralf, Kolberg, Hans-Christian, Bauer, Lelia, Brucker, Cosima, Steck, Thomas, Boyle, Frances, Chaudhuri, Anupam, Wagga, Wagga, Moylan, Eugene, Donovan, Jenny, Della-Fiorentina, Stephen, Abdi, Ehtesham, Marx, Gavin, Beadle, Geoffrey, Donovan, Michael, Bennett, Ian, Gill, Peter Grantley, Baker, Caroline, Masters, Richard, Blum, Robert, Collins, John, Law, Michael, Hart, Stewart, Kannourakis, George, Snyder, Raymond, Joseph, David, McCrystal, Michael, Campbell, Ian, Jakesz, Raimund, Selim, Ursula, Singer, Christian, Heck, Dietmar, Greil, Richard, Ramoni, Angela, Bjelic-Radisic, Vesna, Reichenauer, Arno, Horvath, Wilfried, Thaler, Josef, Fridrik, Michael, Keckstein, Joerg, Jan, Lamote, L'Hermitte, Marc, Roelstrate, Heidi, Dirix, Luc, Bambust, Inneke, Seret, Monique, Liebens, Fabienne, Maerevoet, Maria, D'Hondt, Lionel, Berliere, Martine, Nogaret, Jean-Marie, Simon, Phillipe, O'Hanlon, Deirdre, Redmond, Henry Paul, Hill, Arnold, Evoy, Denis, Kerin, Michael, Gupta, Rajnish, Martin, Michael J, Fritis, Marcela, Schwartz, Ricardo, Yañez, Maria Loreto, Peralta, Octavio, Graiff, Claudio, Artioli, Fabrizio, Generali, Daniele, Orzalesi, Lorenzo, Visini, Marilena, Michiara, Maria, Pavesi, Lorenzo, Ravaioli, Alberto, Porpiglia, Mauro, Puglisi, Fabio, Pinotti, Graziella, Brincat, Stephen, Buser, Katharina S, Rabaglio, Manuela, Rauch, Daniel, Chappuis, Pierre O, Zaman, Khalil, Bucher, Susanne, Bolliger, Barbara, Pagani, Olivia, Falck, Anna-Karin, Kaij, Jakob, Margolin, Sara, Muslumanoglum, Mahmut, Bertelli, Gianfilippo, Bramley, Maria, Bristol, James, Chandrasekharan, Sankaran, Crellin, Perric, Daoud, Raouf, Dodwell, David, Drew, Philip, Dubey, Sidharth, Evans, Abigail, Ferguson, Douglas, Gendy, Raafat, Hamed, Hisham, Harding-McKean, Claudia, Horgan, Kieran, Iqbal, Shabana, Jibril, Jibril A, Kokan, Jalal, Kneeshaw, Peter, Lansdown, Mark, Lennard, Tom, Linforth, Rick, McIntosh, Stuart, Mitra, Sankha, Neades, Glyn, Ooi, Jane Louise, Patel, Ashraf, Rayter, Zenon, Reichert, Robert, Roberts, Fiona, Roche, Nicola, Rogers, Colin, Royle, Gavin, Shah, Elizabeth, Sibbering, Mark, Skene, Anthony Iain, Smith, Simon, Sparrow, Geoffrey, Thompson, Alastair, Vaidya, Jayant, Wolstenholme, Virginia, Wood, Jeremy, Yiangou, Constantinos, Zammit, Charles, Thornton, Rochelle, Probert, Flonda, Fong, Akiko, Francis, Nicole, Gili, Manuela, Eigenberger, Rosita, Supply, Daisy, Lefever, Inge, Muller, Bettina, Zlatar, Zdenka, Feer, Petra, Gkantiragas, Ioannis, Virkki, Marjo, Everhard, Sibille, Lemonnier, Jerome, Garcia, Sara, Ghanem, Saliha, Cole, Anna, O'Hare, Debra, Cronin, Elaine, Roche, Trudi, Kennedy, Emer, Ballot, Jo, Killilea, Niamh, Jennings, Marian, Lowry, Laura, Maxwell, Moira, Burke, Margaret, Gonzaga, Aliana Guerrieri, Bollani, Giorgia, Bianchetti, Andrea, Scalvini, Anna, Cretella, Elisabetta, Pasqualini, Antonella, Gobbi, Angela, Roselli, Jenny, Lagati, Angelita, Rapacchi, Elena, Lanza, Annalisa, Pini, Emanuela, Picardo, Elisa, Maggiorotto, Furio, Sottile, Roberta, Vallini, Ilaria, Cilia, Nadia, Patel, Mital, Bamford, Linda, Robertshaw, Helen, Inman, Hayle, Hill, Naomi, Dexter, Jane, Peasgood, Emily, Batty, Imogen, Cocks, Shirley, Mistry, Raksha, Sidders, Mary, Foulstone, Emily, Garlicka, Helen, Dawe, Catherine, Elliott, Jackie, Rooke, Kathy, Morris, Christine, Lester, Yvonne, Gibson, Sian, Chittock, Jill, Skelton, Amy, Gallimore, Elizabeth, Downes, Charlotte, Billett, Lynn, Caddy, Simone, Cumming, Helen, Cowell-Smith, Sharon, Turner, Caroline, Fernando, Sunjalee, Goodwin, Sarah, Taylor, Jo-Anne, Baines, Kizzy, Downer, Susan, Pilcher, Alice, Dobson, Tracey, Osborne, Lynn, Kuenzig, Greg, Hancock, Denise, Melia, Deborah, Gullaksen, Elaine, Hartup, Susan, Henson, Amy, Gibb, Jane, Coombs, Sarah, Taylor, Caroline, Kirkby, Amy, Thomas, Issy, Makinson, Karen, Kano, Yukie, Shah, Zoheb, Hardstaff, Lisa, Townley, Barbara, Hill, Philippa, McCurrie, Marilyn, Grassby, Sue, Henderson, Pamela, Talbot, Elizabeth, Bell, Ashley, Kanani, Reshma, Johnson, Joanne, Jones, Richard, Foster, Mel, Troke, Becky, Congdon, Hilary, Pascoe, Julie, Whelan, Sian, Edwards, Jenna, Brinkworth, Elaine, Blizard, Sheila, Clarke, Alison, Stevens, Kim, Harvey, Carol, Stacey, Jill, Mitchell, Sadie, Lowry, Tracey, Buckley, Sarah, Collins, Clare, Green, Liz, Jones, Helen, Conteh, Veronica, Ducket, Tracey, Kotze, Michelle, Strider, Paula, Stouraitis, Marina, Sundberg, Jan, Babiker, Abdel, Collins, Rory, Klijn, Jan, Ralston, Stuart, Tattersall, Martin, Weller, Ian, De Sousa, Andreia, Edwards, Rob, Ferguson, Sheila, Hickman, Jane, Johnson, Damian, Haidar, Nadia, Hammond, Victoria, Heighway, Emma, Ndoutoumou, Amalia, Sahota, Navdip, White, Laura, Aigret, Benoit, Batra, Priyanka, Knox, Jill, Oke, Adedayo, Ostler, Richard, and Sasieni, Peter

Subjects
Medicine (all), Medizin, skin and connective tissue diseases
Abstract

Third-generation aromatase inhibitors are more effective than tamoxifen for preventing recurrence in postmenopausal women with hormone-receptor-positive invasive breast cancer. However, it is not known whether anastrozole is more effective than tamoxifen for women with hormone-receptor-positive ductal carcinoma in situ (DCIS). Here, we compare the efficacy of anastrozole with that of tamoxifen in postmenopausal women with hormone-receptor-positive DCIS.In a double-blind, multicentre, randomised placebo-controlled trial, we recruited women who had been diagnosed with locally excised, hormone-receptor-positive DCIS. Eligible women were randomly assigned in a 1:1 ratio by central computer allocation to receive 1 mg oral anastrozole or 20 mg oral tamoxifen every day for 5 years. Randomisation was stratified by major centre or hub and was done in blocks (six, eight, or ten). All trial personnel, participants, and clinicians were masked to treatment allocation and only the trial statistician had access to treatment allocation. The primary endpoint was all recurrence, including recurrent DCIS and new contralateral tumours. All analyses were done on a modified intention-to-treat basis (in all women who were randomised and did not revoke consent for their data to be included) and proportional hazard models were used to compute hazard ratios and corresponding confidence intervals. This trial is registered at the ISRCTN registry, number ISRCTN37546358.Between March 3, 2003, and Feb 8, 2012, we enrolled 2980 postmenopausal women from 236 centres in 14 countries and randomly assigned them to receive anastrozole (1449 analysed) or tamoxifen (1489 analysed). Median follow-up was 7·2 years (IQR 5·6-8·9), and 144 breast cancer recurrences were recorded. We noted no statistically significant difference in overall recurrence (67 recurrences for anastrozole vs 77 for tamoxifen; HR 0·89 [95% CI 0·64-1·23]). The non-inferiority of anastrozole was established (upper 95% CI

Published
2016

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