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1. Post-acute COVID-19 outcomes including participant-reported long COVID: amubarvimab/romlusevimab versus placebo in the ACTIV-2 trialResearch in context

Author

Teresa H. Evering, Carlee Moser, Nikolaus Jilg, Justin Ritz, David A. Wohl, Jonathan Z. Li, David Margolis, Arzhang Cyrus Javan, Joseph J. Eron, Judith S. Currier, Eric S. Daar, Davey M. Smith, Michael D. Hughes, Kara W. Chew, Kara Chew, David (Davey) Smith, Eric Daar, David Wohl, Judith Currier, Joseph Eron, Michael Hughes, Mark Giganti, Lara Hosey, Jhoanna Roa, Nilam Patel, Kelly Colsh, Irene Rwakazina, Justine Beck, Scott Sieg, Jonathan Li, Courtney Fletcher, William Fischer, Rachel Bender Ignacio, Sandra Cardoso, Katya Corado, Prasanna Jagannathan, Alan Perelson, Sandy Pillay, Cynthia Riviere, Upinder Singh, Babafemi Taiwo, Joan Gottesman, Matthew Newell, Susan Pedersen, Joan Dragavon, Cheryl Jennings, Brian Greenfelder, William Murtaugh, Jan Kosmyna, Morgan Gapara, Akbar Shahkolahi, Verónica Lacal, Diego Salusso, Sebastian Nuñez, Marcelo Rodrigo Rodriguez, Luciana Laborde, Marcelo Papasidero, Luis Wehbe, Mariana Gonzalez, Felicitas Fernandez Voena, Tomas Alvarez, Amaru Lopez, Virginia Huhn, Ulises D'Andrea Nores, Pablo Dieser, Fernando Bordese, Marisa Mussi, Rodrigo de Carvalho Santana, Adriana Aparecida Tiraboschi Bárbaro, Breno Santos, Rita de Cássia Alves Lira, Andre Luiz Machado da Silva, Sandra Wagner Cardoso, Maria Pia Diniz Ribeiro, Nathália Soliva, Eduardo Vasconcellos, Jorge Eurico Ribeiro, Miriam Amaral Enéas, Jorge Pinto, Julia Fonseca de Morais Caporali, Flávia Gomes Faleiro Ferreira, Norma Erendira Rivera Martinez, Victor Casildo Bohorquez Lopez, Melchor Victor Frias, Krystle Fetalvero, Alyxzza Maranan, Jennifer Rosa, Thomas Coetzer, Maureen Mohata, Sr., Umesh Lalloo, Penelope Madlala, Larisha Pillay-Ramaya, Jaclyn Ann Bennet, Noluthando Mwelase, Nokuphiwa Mbhele, Frederick Petrick, Leonard Joubert, Rose Mbali, Sr., Natasha Joseph, Mmatsie Manentsa, Eugene van der Walt, Mduduzi Sandile Lawrance Masilela, Zinhle Zwane, Tendai Chiperera, Lerato Mohapi, Suri Moonsamy, Usha Singh, Kirsten McHarry, Elizma Snyman, Pieter Lennox, James Craig Innes, Oteng Letlape, Olebogeng Jonkane, William Brumskine, Tania Adonis, Ni Ni Sein, Modulakgotla Sebe, Yacoob Vahed, Nazreen Jeewa Hussen, Ismail Mitha, Vasundhara Cheekati, Purna Cheekati, Christie Lummus, Samuel Idarraga, Andrew Kim, David N. Pham, Wei-Hsin Kao, Michael M. Pfeffer, Miriam Batule Dominguez, Anju Malik, Anna Bryan, Melanie Arnold, Idania Fernandez, Cinzia Karpf, Aniuska Ruiz, David Taylor, Eric Folkens, Jennifer Manne, Sigal Yawetz, Cheryl Keenan, Emeka Eziri, Carl Fichtenbaum, Jenifer Baer, Sarah Trentman, Robert Call, Leroy Vaughan, Aaron Milstone, Jamie Alex Slandzicki, Jessica Wallan, Clinton Guillory, Nancy Andrews, Leslie Hughes, Jonathan Berardi, Celine Arar, Randall Quinn, Jorge P. Amaya, Marissa Gomez-Martinez, Luis Cantu, Monica Betancourt-Garcia, Nwora Lance Okeke, Charles M. Burns, Fadi Haddad, Victoria Haddad, Augusto Focil, Griselda Rosas, Susana Moyano, Yaneicy Gonzalez Rojas, Ahmad Aswad, Yevgeniy Bukhman, Manish Jain, Eugene Bukhman, Humam Farah, Rebekah McClain, Sadia Shaik, Timothy Hatlen, Deepa Gotur, Joseph Surber, Jeffrey Kingsley, April Pixler, Alex Zopo, Jack Herman, Craig Herman, Ramon Leon, Boris Nikolov, Fernando Gonzalez Vergara, Ana I. Gonzalez, Noemi Gonzalez, Michael Gelman, Olga Andriunas, Zarema Jagizarov, Jan Westerman, David Davis, Donna Sherer, Kelly Dooley, Becky Becker, Adaliah Wilkins, Jose Pérez, Eloy Roman, Heriberto Fernández, Bharat Mocherla, Kelly Beck, Valarie Maldonado, Jennifer Veltman, Rajesh Gandhi, Katrina Shea, Matthew Planchon, Laura Bogan Herpel, Kaushlendra K. Tripathi, Donald C. Day, John Pullman, Sr., Erin Williams-Leber, Misty Johnson, Michelle Hecker, Ann Avery, Keila Hoover, George W. Monlux, Elizabeth Juneja, Jr., Arthur Wernick, Karelia Ruiz, Maureen Hernández, Yadilys Pérez, Babafemi O. Taiwo, Claudia Hawkins, Baiba Berzins, Carlos Malvestutto, Heather Harber, Robyn Cicarella, Edwin DeJesus, Charlotte-Paige Rolle, Almena L. Free, Sallie D. Pulliam, Debra Weinstein, Rosa M. Suarez, Ezequiel Socorro, Estefania Socorro, Gene Neytman, Raymond Easley, Mariam Aziz, Joan Swiatek, Avish Nagpal, Breanna Kompelien, Kathryn McEvoy, Susan E. Hoover, Allison Lutz, Jessica Just, Manuel Hernandez, Yanly B. Victoria, Gabriel Rodriguez, Divya Pathak, Joshua J. Ordway, Megan Heffner, Patrick Weston, Khalilah Weston, Madhu Choudhary, Jennifer Sullivano, Olayemi Osiyemi, Myriam Izquierdo, Odelsey Torna, Brian Clemency, Renoj Varughese, Joshua Lynch, Aleen Khodabakhshian, Samantha Fortier, Christopher Coyne, Alexandrea Cronin, Constance Benson, Steven Hendrickx, Rosemarie Ramirez, Anne Luetkemeyer, Suzanne Hendler, Dennis Dentoni-Lasofsky, Mobeen Rathore, Saniyyah Mahmoudi, Amna Riaz, Mario Castro, Leslie Spikes, Chase Hall, Jonathan Oakes, Amy James Loftis, Pablo Tebas, William Short, Michael P. Dube, Saahir Khan, Luis M. Mendez, Sarah McGuffin, Chris Jonsson, Mamta K. Jain, Smruthi Senthil, Kimberly Turner-Gray, Sanjay Mehta, Mary Lewinski, Masoud Azizad, Christopher Chow, Lisa Nakatani, Derrick Williamson, Hisham Atriss, Matthew Caloura, Midhun Malla, Hannah Hazard-Jenkins, Aimee Wilkin, Jamraus Fayssoux, Hannah Seagle, Rachel Presti, and Alem Haile

Subjects
COVID-19, Monoclonal antibodies, Outpatient treatment, Clinical trial, Post COVID conditions, Long COVID, Medicine (General), R5-920
Abstract

Summary: Background: It is unknown if early COVID-19 monoclonal antibody (mAb) therapy can reduce risk of Long COVID. The mAbs amubarvimab/romlusevimab were previously demonstrated to reduce risk of hospitalization/death by 79%. This study assessed the impact of amubarvimab/romlusevimab on late outcomes, including Long COVID. Methods: Non-hospitalized high-risk adults within 10 days of COVID-19 symptom onset enrolled in a randomized, double-blind, placebo-controlled phase 2/3 trial of amubarvimab/romlusevimab for COVID-19 treatment. Late symptoms, assessed using a participant-completed symptom diary, were a pre-specified exploratory endpoint. The primary outcome for this analysis was the composite of Long COVID by participant self-report (presence of COVID-19 symptoms as recorded in the diary at week 36) or hospitalization or death by week 36. Inverse probability weighting (IPW) was used to address incomplete outcome ascertainment, giving weighted risk ratios (wRR) comparing amubarvimab/romlusevimab to placebo. Findings: Participants received amubarvimab/romlusevimab (n = 390) or placebo (n = 390) between January and July 2021. Median age was 49 years, 52% were female, 18% Black/African American, 49% Hispanic/Latino, and 9% COVID-19-vaccinated at entry. At week 36, 103 (13%) had incomplete outcome ascertainment, and 66 (17%) on amubarvimab/romlusevimab and 92 (24%) on placebo met the primary outcome (wRR = 0.70, 95% confidence interval (CI) 0.53–0.93). The difference was driven by fewer hospitalizations/deaths with amubarvimab/romlusevimab (4%) than placebo (13%). Among 652 participants with available diary responses, 53 (16%) on amubarvimab/romlusevimab and 44 (14%) on placebo reported presence of Long COVID. Interpretation: Amubarvimab/romlusevimab treatment, while highly effective in preventing hospitalizations/deaths, did not reduce risk of Long COVID. Additional interventions are needed to prevent Long COVID. Funding: National Institute of Allergy and Infectious Diseases of the National Institutes of Health. Amubarvimab and romlusevimab supplied by Brii Biosciences.

Published
2024
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2. Long-term safety and efficacy of tezepelumab in people with severe, uncontrolled asthma (DESTINATION): a randomised, placebo-controlled extension study

Author

Andrew Menzies-Gow, Michael E Wechsler, Christopher E Brightling, Stephanie Korn, Jonathan Corren, Elliot Israel, Geoffrey Chupp, Artur Bednarczyk, Sandhia Ponnarambil, Scott Caveney, Gun Almqvist, Monika Gołąbek, Linda Simonsson, Kaitlyn Lawson, Karin Bowen, Gene Colice, Jorge Lima Hetzel, Jussara Fiterman, Adelmir Souza Machado, Martti Anton Antila, Marina Andrade Lima, Suzana Erico Tanni Minamoto, Daniela Cavalet Blanco, Patricia Gomes de Matos Bezerra, Pierre-Alain Houle, Catherine Lemiere, Lyle S Melenka, Richard Leigh, Patrick Mitchell, Syed Anees, Bonavuth Pek, Guy Chouinard, Amarjit S Cheema, William Ho-Ching Yang, George Philteos, Pascal Chanez, Arnaud Bourdin, Gilles Devouassoux, Camille Taille, Frédéric De Blay, Christophe Leroyer, Antoine Beurnier, Gilles Garcia, Pierre-Olivier Girodet, François-Xavier Blanc, Antoine Magnan, Stéphanie Wanin, Jocelyne Just, Richard Linde, Stefan Zielen, Karin Förster, Christian Geßner, Margret Jandl, Roland Otto Buhl, Marc Oliver Kornmann, Anneliese Linnhoff, Andrea Ludwig-Sengpiel, Martin Ehlers, Tibor Schmoller, Heiner Steffen, Martin Hoffmann, Joachim Kirschner, Olaf Schmidt, Tobias Welte, Hilke Temme, Ori Wand, Amir Bar-Shai, Gabriel Izbicki, Neville Berkman, Gershon Fink, David Shitrit, Yochai Adir, Piotr Kuna, Barbara Rewerska, Ewa Pisarczyk-Bogacka, Oksana Kurbacheva, Sergey L Mikhailov, Maksim Vasilev, Alexander Emelyanov, Siraj Wali, Amr Albanna, Richard van Zyl-Smit, Ismail Abdullah, David Bernhardi, Farzana Hoosen, Elvis Irusen, Ismail Kalla, Deepak Lakha, Essack Mitha, Visvakuren Naidoo, Haylene Nell, Trevenesan Padayachee, Jeevren Reddy, Friedrich Petrick, Eugene van der Walt, Zubar Fazal Ahmed Vawda, Hae-Sim Park, Sang Haak Lee, Mi-Kyeong Kim, Jung-Won Park, You Sook Cho, Byung Jae Lee, Yoon-Seok Chang, Choon-Sik Park, Kwan Ho Lee, Sook Young Lee, HyoungKyu Yoon, Kyoung Hee Sohn, Myung Jae Park, Kyung Hoon Min, Young Joo Cho, Han Ki Park, YongChul Lee, Jaechun Lee, Chau-Chyun Sheu, Chih-Yen Tu, Kang-Yun Lee, Sevim Bavbek, Bilun Gemicioglu, Dane Ediger, Ilkay Koca Kalkan, Nataliia Makieieva, Mykola Ostrovskyy, Yevgeniya Dytyatkovs'ka, Yuriy Mykhaylovych Mostovoy, Kyrylo Lebed, Oleh Yakovenko, Atoya Adams, Timothy Mooring, Louis Torres Jr, Marvin Sexton, Ernest Thompson, Jonathan A Bernstein, Paul Lisi, Christopher M Chappel, Jeremy Cole, Gary I Greenwald, Conigliaro Jones, Ryan Mitchell Klein, David N Pham, Selwyn Spangenthal, Steven F Weinstein, Hugh H Windom, Neil L Kao, Mila A Leong, Vinay Mehta, Wendy C Moore, Saligrama Bhat, Bassil Aish, Steven M Meltzer, Mark H Moss, Edward M Kerwin, John Palsted Delgado, Gregg Hudson Lucksinger, Charles A Thompson, Sady A Alpizar, Sanjay Virgi Vadgama, Zahid Zafar, Joshua S Jacobs, NJira Lugogo, Neal Jain, Lawrence D Sher, Nabil S Andrawis, David Fuentes, Eric Jason Boren, Erika G Gonzalez, Neetu Talreja, Sheharyar Sandy Durrani, Sudhir Sekhsaria, Samuel DeLeon, Mayank Shukla, Martha M Totszollosy Tarpay, Faisal Fakih, Golda Hudes, Jeffrey P Tillinghast, Phillip E Korenblat, Kartik Shenoy, Loretta Que, Shahrukh Ahmad Kureishy, Fred Chukwuemeka Umeh, Vinh Nhu Nguyen, Hanh Thi Chu, and Thuy Thi Dieu Nguyen

Subjects
Pulmonary and Respiratory Medicine
Published
2023
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3. Long-term safety and efficacy of alirocumab in South African patients with heterozygous familial hypercholesterolaemia: the ODYSSEY Open-Label Extension study

Author

Poobalan Naidoo, Frederick J. Raal, Graham Ellis, Dirk J. Blom, Eugene van der Walt, Prashilla Soma, Alet van Tonder, Lesley J. Burgess, Johannes Breedt, and Iftikhar O. Ebrahim

Subjects
medicine.medical_specialty, Statin, medicine.drug_class, business.industry, Cardiovascular Topics, Extension study, General Medicine, 030204 cardiovascular system & hematology, Discontinuation, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, lipids (amino acids, peptides, and proteins), In patient, Long term safety, Open label, Cardiology and Cardiovascular Medicine, business, Lipoprotein cholesterol, Alirocumab
Abstract

Background Alirocumab reduces low-density lipoprotein cholesterol (LDL-C) levels by up to 61%. The ODYSSEY Open-Label Extension study investigated the effect of alirocumab in patients with heterozygous familial hypercholesterolaemia (HeFH) over 144 weeks. Methods Eligible patients with HeFH had completed an earlier double-blind, randomised, placebo-controlled parent study. Patients were initiated on 75 mg alirocumab Q2W subcutaneous (SC) unless baseline LDL-C was > 8.9 mmol/l, in which case they received 150 mg alirocumab Q2W. Dose titration to 150 mg Q2W was at the investigator's discretion. Results The study enrolled 167 patients and the parent study mean (± SD) baseline LDL-C level was 3.65 ± 1.9 mmol/l. Mean LDL-C level was reduced by 48.7% at week 144; mean on-treatment LDL-C was 2.30 ± 1.24 mmol/l. Eight patients reported injection-site reactions, with one treatment discontinuation. Treatment emergent anti-drug antibodies were identified in five patients but these did not affect the efficacy. Conclusions Alirocumab effectively and safely reduced LDL-C in these patients.

Published
2019
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4. Odanacatib for the treatment of postmenopausal osteoporosis: results of the LOFT multicentre, randomised, double-blind, placebo-controlled trial and LOFT Extension study

Author

Michael R McClung, Michelle L O'Donoghue, Socrates E Papapoulos, Henry Bone, Bente Langdahl, Kenneth G Saag, Ian R Reid, Douglas P Kiel, Ilaria Cavallari, Marc P Bonaca, Stephen D Wiviott, Tobias de Villiers, Xu Ling, Kurt Lippuner, Toshitaka Nakamura, Jean-Yves Reginster, Jose Adolfo Rodriguez-Portales, Christian Roux, José Zanchetta, Cristiano A F Zerbini, Jeong-Gun Park, KyungAh Im, Abby Cange, Laura T Grip, Norman Heyden, Carolyn DaSilva, Dosinda Cohn, Rachid Massaad, Boyd B Scott, Nadia Verbruggen, Deborah Gurner, Deborah L Miller, Micki L Blair, Adam B Polis, S Aubrey Stoch, Arthur Santora, Antonio Lombardi, Albert T Leung, Keith D Kaufman, Marc S Sabatine, Carlos Alfredo Mautalén, Zulema Man, Jose Ruben Zanchetta, Clelia Haydee Magaril, Philip Sambrook, Piet Geusens, Stefan Goemaere, Ben Hur Albergaria, Cristiano Augusto de Freitas Zerbini, Marise Lazaretti Castro, Luiz Henrique Gregorio, Rumen Stoilov, Anna-Maria I Borissova, Kiril Hristov Hristozov, Nataliya L Temelkova, Ivona Kirilova Daskalova, Stefka Ivanova Kuzmanova, Daniela Yaneva-Bichovska, Anastas Zgurov Batalov, Pablo Riedemann, José Adolfo Rodriguez Portales, Hai Tang, hanmin Zhu, Zhenlin Zhang, Aijun Chao, Yali Hu, Zhiming Liu, Juming Lu, Mingcai Qiu, Xin Gao, Shaofen Zhang, Ling Xu, Weibo Xia, Eryuan Liao, Wenying Yang, Wen Wu, Kerong Dai, Renming Hu, Juan Jose Jaller, Francisco Cabal, José Fernando Molina, Carlos A Cure Cure, Hernan Yupanqui-Lozno, Philippe Chalem, John Londono, Mauricio Abello, Edgardo D Tobias, William Otero, Tatjana Nikolic, Blazenka Miskic, Jan Stepan, Vaclav Vyskocil, Libor Novosad, Jan Slesinger, Pavel Novosad, Erika Vlckova, Ladislav Bortlik, Eva Dokoupilova, Tomas Hala, Jens-Erik Beck Jensen, Kim Torsten Brixen, Bente Lomholt Langdahl, Peter Schwarz, Peter Claes Eskildsen, Pia Agnete Eiken, Anne Pernille Hermann, Jeppe Gram, Maiken Brix Schou, Peter Alexandersen, Bettina Nedergaard, Dolores Magdalena Mejía, Lourdes Estrella De Henriquez, Norka Páez, Casimiro Velazco, Ivo Valter, Kadri-Liina Vahula, Ingrid Kull, Katre Maasalu, Roland Chapurlat, Patrice Fardellone, Claude Laurent Benhamou, Georges Weryha, Volkmar Herkt, Rene Martz, Ruth Nischik, Wolfgang Spieler, Christel Contzen, Dieter Felsenberg, Isolde Frieling, Eike Frahm, Henry Briones, Boris Sandoval, Patricia Barrios, Abraham García, Carlos Avendaño, Magdalena González, Jeremías Guerra, Maria Tuna, Olga Marina Díaz, Eduardo Samayoa, Edgar López, José Raúl Barrera, Mainor Palencia, Mayra Cifuentes, Georgina Alvarado, Miriam López, Nilmo Chavez, Franklin Haase, Ruddy Rivera, Claudio González, Kathryn Tan, Ping Chung Leung, Sheshadri Mandalam, Shailesh Umakant Pitale, Ganapathi Bantwal, Ariachery Chinamma Ammini, Shehla Sajid Akhta Shaikh, Prasanna Kumar Kanakatte Mylariah, Mala Dharmalingam, Satinath Mukhopadhyay, Arpit Jain, Parminder Singh, Naresh Shetty, Srikanta Shamanna Sathyanarayana, Nalini Shah, Manoj Dharam Chadha, Rajendra Bhandankar, Kumaravel Velayutham, Sudha Marwah, Mathew John, Rakesh Kumar Sahay, Silvano Adami, Ranuccio Nuti, Gerolamo Bianchi, Maria Luisa Brandi, Salvatore Minisola, Carmelo Erio Fiore, Alessandro Rubinacci, Hisayuki Miyajima, Hiroo Yamane, Yuji Nakatani, Sumiaki Okamoto, Koji Kuroda, Motoaki Fujimori, Akira Itabashi, Kuniaki Katayama, Satoru Nakajo, Yoshiaki Somekawa, Yoshimitsu Ohsawa, Wataru Tajima, Katsunori Mizuno, Shigeru Mori, Takato Kanabuchi, Hiroyuki Hashizume, Nobuyuki Oka, Kazutoshi Hamada, Motoi Yamaguchi, Fumiki Hirahara, Masaaki Atobe, Yoshiharu Ohtake, Shuichi Ichikawa, Tomoyuki Onishi, Kou Matsumoto, Tetsuro Nakamura, Eishi Shirasawa, Ko Katayama, Mitsugu Takahashi, Tadanori Oguma, Hideo Matsui, Yoshiharu Katoh, Keiichi Shigenobu, Tsutomu Onishi, Masato Shibukawa, Satoshi Ikeda, Kazuhiro Osaka, Ryosuke Kanda, Yoshito Inobe, Masaharu Shigenobu, Morimasa Hasegawa, Tetsuo Yamaji, Yu Miyazaki, Takayasu Ito, Eisuke Nakamura, Shinji Nagai, Sung-Kil Lim, Yoon-Sok Chung, Chan-Soo Shin, Yong-Ki Min, Ghi Su Kim, Hyun Koo Yoon, Moo-Il Kang, Kyu-Hyun Yang, Hyoung Moo Park, In Joo Kim, Dong Jin Chung, Ho Yeon Chung, Sandra Jaundzeikare, Dace Andersone, Agita Medne, Yasser Yaghi, Vidmantas Alekna, Vytautas Kasiulevicius, Irina Purtokaite - Labutiniene, Aurelija Krasauskiene, Jurate Varanaviciene, Vida Basijokiene, Agne Abraitiene, Lina Radzeviciene, Jesus Walliser, Pedro Alberto García Hernández, Maria Frida Araujo, Hilario Ernesto Avila Armengol, Pilar De la Peña, Juan Tamayo, Beatriz Zazueta, Fidencio Cons, Nigel Leslie Gilchrist, Ian Reginald Reid, Robert Leikis, Peter Jones, Joe Gragrath Pradeep Singh, Johan Inge Halse, Unni Syversen, Hans Olav Høivik, Erik Snorre Øfjord, Hans Christian Gulseth, Sigbjørn Elle, Paal Dag Norheim, Armando A. Calvo Quiroz, Pastor A. Cesar Augusto, Manuel Gustavo León Portocarrero, Luis Fernando Vidal Neira, Jose Chavez, Boris Garro Barrera, Rita Kuroiwa Sampei, Bellatín V. Luis Fernando, Rogger Oquelis Cabredo, Sonia Castillo, Agustin Miguel G Morales, Perry Pua Tan, Liberato Antonio C Leagogo, Edward HM Wang, Julie T Li-Yu, Andrzej Z Sawicki, Barbara Stasiuk, Grzegorz Kania, Roman Lorenc, Anna Sidorowicz-Bialynicka, Leszek Szczepanski, Edward Franek, Rafal Filip, Jan Sekula, Tomasz Blicharski, Piotr Leszczynski, Ewa Sewerynek, Tomasz Miazgowski, Andrzej Milewicz, Magda Dabrowska, Jerzy Romaszko, Wojciech Pluskiewicz, Lukasz Wojnowski, Catalin Codreanu, Horatiu Bolosiu, Ruxandra Ionescu, Ioana Zosin, Liviu Macovei, Mihai Bojinca, Florin Radulescu, Simona Pop, Adrian Sarbu, Lidia I Benevolenskaya, Evgeny L Nasonov, Lyudmila Ya Rozhinskaya, Raphael G Oganov, Svetlana S Rodionova, Eugeny Vladimirovich Shlyakhto, Vasiliy Trofimov, Eugeny G Zotkin, Irina E Zazerskaya, Elena N Grineva, Olga Ershova, Olga Lesnyak, Olga D Ostroumova, Svetlana B Malichenko, Eduard G Pikhlak, Valery G Pilyaev, Tatiana Raskina, Elena V Zonova, Valery S Shirinsky, Aleksandar N Dimic, Goran Cobeljic, Svetlana Vujovic, Graham Charlston Ellis, Stanley Lipschitz, Tobias Johannes De Villiers, Albert Jan De Weerd, Tasneem Vally, Yvonne Trinder, Jacobus Ludewikus Coetsee, Charles Pierre Davis, Savithree Nayiager, Frans Stephanus Hough, Louis F Oelofse, Eugene van der Walt, Johannes Jurgens Lombaard, Suzanne Blignaut, Uttam Govind, Leon Frederik Fouche, Dawid Stephanus Kruger, Johannes Paul Dalmeyer, Mada M Ferreira, Alejandro Escudero-Contreras, Manuel Muñoz Torres, Federico Hawkins Carranza, Jose Luis Perez Castrillon, Juan Antonio García Meijide, Esteban Jodar Gimeno, Santiago Palacios Gil-Antuñana, Luis de Teresa Parreno, Emilio Martín Mola, Carmen Alvarez Sanchez, Keh-Sung Tsai, Shih-Te Tu, Jung-Fu Chen, Oscar Kuang-Sheng Lee, Wen-Wei Hsu, Natalia Viktorivna Grygorieva, Vladyslav Volodymyrovych Povoroznyuk, Mykola Oleksiiovych Korzh, Oleksandr Levgeniiovych Loskutov, Andriy Borysovych Chukov, Rex Sarmiento, Hawys Thomas, Hugh Donnachie, Irina Pavel-Knox, Hilary Shaw, Hana Hassanin, Essam Eldin Ahmed Abdulhakim, Naren Savani, Gloria A Bachmann, Elizabeth Barrett-Connor, Neil C Binkley, Henry G Bone, Donald M Brandon, Darin David Checketts, Neil J Fraser, Nelson B Watts, Steven A Geller, Joseph S Gimbel, Maria White Greenwald, Peter A Holt, Cyrus Conrad Johnston, Chien Fang, David J Klashman, E. Michael Lewiecki, Mitchell B Lowenstein, Michael Roy McClung, Susan M Nattrass, Alberto Odio, Julie Levengood, Josefina Romaguera, Mohamed Bassam Sebai, Brian Snyder, Mark Eliot Kutner, Dan Streja, Elliott P Schwartz, and Mark G Christiansen

Subjects
cathepsin-k inhibitor, Endocrinology, Diabetes and Metabolism, Osteoporosis, Placebo-controlled study, law.invention, Fractures, Bone, chemistry.chemical_compound, 0302 clinical medicine, Endocrinology, Randomized controlled trial, Bone Density, law, Outpatient clinic, 030212 general & internal medicine, Osteoporosis, Postmenopausal, Aged, 80 and over, density, Hip fracture, Bone Density Conservation Agents, odanacatib, postmenopausal osteoporosis, LOFT, extension study, Treatment Outcome, medicine.anatomical_structure, Spinal Fractures, Female, women, strength, Odanacatib, medicine.medical_specialty, 030209 endocrinology & metabolism, Placebo, 03 medical and health sciences, Double-Blind Method, Internal medicine, Internal Medicine, medicine, Humans, bone mass, fracture, mortality, denosumab, turnover, therapy, Aged, Femoral neck, Hip Fractures, business.industry, Biphenyl Compounds, medicine.disease, chemistry, business, Osteoporotic Fractures
Abstract

Background: Odanacatib, a cathepsin K inhibitor, reduces bone resorption while maintaining bone formation. Previous work has shown that odanacatib increases bone mineral density in postmenopausal women with low bone mass. We aimed to investigate the efficacy and safety of odanacatib to reduce fracture risk in postmenopausal women with osteoporosis. Methods: The Long-term Odanacatib Fracture Trial (LOFT) was a multicentre, randomised, double-blind, placebo-controlled, event-driven study at 388 outpatient clinics in 40 countries. Eligible participants were women aged at least 65 years who were postmenopausal for 5 years or more, with a femoral neck or total hip bone mineral density T-score between −2·5 and −4·0 if no previous radiographic vertebral fracture, or between −1·5 and −4·0 with a previous vertebral fracture. Women with a previous hip fracture, more than one vertebral fracture, or a T-score of less than −4·0 at the total hip or femoral neck were not eligible unless they were unable or unwilling to use approved osteoporosis treatment. Participants were randomly assigned (1:1) to either oral odanacatib (50 mg once per week) or matching placebo. Randomisation was done using an interactive voice recognition system after stratification for previous radiographic vertebral fracture, and treatment was masked to study participants, investigators and their staff, and sponsor personnel. If the study completed before 5 years of double-blind treatment, consenting participants could enrol in a double-blind extension study (LOFT Extension), continuing their original treatment assignment for up to 5 years from randomisation. Primary endpoints were incidence of vertebral fractures as assessed using radiographs collected at baseline, 6 and 12 months, yearly, and at final study visit in participants for whom evaluable radiograph images were available at baseline and at least one other timepoint, and hip and non-vertebral fractures adjudicated as being a result of osteoporosis as assessed by clinical history and radiograph. Safety was assessed in participants who received at least one dose of study drug. The adjudicated cardiovascular safety endpoints were a composite of cardiovascular death, myocardial infarction, or stroke, and new-onset atrial fibrillation or flutter. Individual cardiovascular endpoints and death were also assessed. LOFT and LOFT Extension are registered with ClinicalTrials.gov (number NCT00529373) and the European Clinical Trials Database (EudraCT number 2007-002693-66). Findings: Between Sept 14, 2007, and Nov 17, 2009, we randomly assigned 16 071 evaluable patients to treatment: 8043 to odanacatib and 8028 to placebo. After a median follow-up of 36·5 months (IQR 34·43–40·15) 4297 women assigned to odanacatib and 3960 assigned to placebo enrolled in LOFT Extension (total median follow-up 47·6 months, IQR 35·45–60·06). In LOFT, cumulative incidence of primary outcomes for odanacatib versus placebo were: radiographic vertebral fractures 3·7% (251/6770) versus 7·8% (542/6910), hazard ratio (HR) 0·46, 95% CI 0·40–0·53; hip fractures 0·8% (65/8043) versus 1·6% (125/8028), 0·53, 0·39–0·71; non-vertebral fractures 5·1% (412/8043) versus 6·7% (541/8028), 0·77, 0·68–0·87; all p

Published
2019
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