136 results on '"Farwell, W."'
Search Results
2. Demographic, dietary, and serum factors and parathyroid hormone in the National Health and Nutrition Examination Survey
- Author
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Paik, J. M., Farwell, W. R., and Taylor, E. N.
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- 2012
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3. Racial differences in the relationship between vitamin D, bone mineral density, and parathyroid hormone in the National Health and Nutrition Examination Survey
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Gutiérrez, O. M., Farwell, W. R., Kermah, D., and Taylor, E. N.
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- 2011
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4. Tunable SEU-tolerant latch
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She, Xiaoxuan, Li, N., and Farwell, W. Darresware
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Circuit design -- Research ,Radiation chemistry -- Research ,Control equipment -- Research ,Circuit designer ,Integrated circuit design ,Business ,Electronics ,Electronics and electrical industries - Published
- 2010
5. Longer-term Experience with Nusinersen in Teenagers and Young Adults with Spinal Muscular Atrophy: Phosphorylated Neurofilament Heavy Chain (pNF-H) and Efficacy Results From the CS2-12/SHINE Studies
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Muntoni, F, Darras, BT, Finkel, RS, Ryan, MM, Mercuri, E, Tulinius, M, Deconinck, N, Ramirez-Schrempp, D, Foster, R, Liu, Y, Petrillo, M, Wong, J, Kandinov, B, Farwell, W, Muntoni, F, Darras, BT, Finkel, RS, Ryan, MM, Mercuri, E, Tulinius, M, Deconinck, N, Ramirez-Schrempp, D, Foster, R, Liu, Y, Petrillo, M, Wong, J, Kandinov, B, and Farwell, W
- Published
- 2020
6. Plasma Phosphorylated Neurofilament Heavy Chain Levels Over Time in Participants With Infantile-and Later-onset SMA: Data from the SHINE Study
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Darras, BT, Sumner, CJ, Muntoni, F, Crawford, TO, Finkel, RS, Mercuri, E, De Vivo, DC, Oskoui, M, Tizzano, EF, Ryan, MM, Liu, Y, Petrillo, M, Kandinov, B, Wong, J, Farwell, W, Darras, BT, Sumner, CJ, Muntoni, F, Crawford, TO, Finkel, RS, Mercuri, E, De Vivo, DC, Oskoui, M, Tizzano, EF, Ryan, MM, Liu, Y, Petrillo, M, Kandinov, B, Wong, J, and Farwell, W
- Published
- 2020
7. PRO109 A Cautionary TALE for Indirect Treatment Comparisons: An Example from Infantile-Onset Spinal Muscular Atrophy
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Liao, S., primary, Bohn, J., additional, de Moor, C., additional, Valente, M., additional, Xaplanteris, L., additional, Farwell, W., additional, and Paradis, A.D., additional
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- 2020
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8. SMA – THERAPY
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Finkel, R., primary, Castro, D., additional, Farrar, M., additional, Tulinius, M., additional, Krosschell, K., additional, Saito, K., additional, Gambino, G., additional, Foster, R., additional, Ramirez-Schrempp, D., additional, Wong, J., additional, Kandinov, B., additional, and Farwell, W., additional
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- 2020
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9. SMA – THERAPY
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Crawford, T., primary, Ryan, M., additional, Kirschner, J., additional, Finkel, R., additional, Swoboda, K., additional, De Vivo, D., additional, Bertini, E., additional, Hwu, W., additional, Foster, R., additional, Ramirez-Schrempp, D., additional, Chin, R., additional, and Farwell, W., additional
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- 2020
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10. SMA – THERAPY
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Mercuri, E., primary, Darras, B., additional, Chiriboga, C., additional, Farrar, M., additional, Kirschner, J., additional, Kuntz, N., additional, Acsadi, G., additional, Tulinius, M., additional, Montes, J., additional, Gambino, G., additional, Foster, R., additional, Ramirez-Schrempp, D., additional, Garafolo, S., additional, and Farwell, W., additional
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- 2020
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11. SMA – THERAPY
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Darras, B., primary, Day, J., additional, Swoboda, K., additional, Chiriboga, C., additional, Iannaccone, S., additional, De Vivo, D., additional, Deconinck, N., additional, Finkel, R., additional, Tulinius, M., additional, Saito, K., additional, Montes, J., additional, Foster, R., additional, Ramirez-Schrempp, D., additional, Kandinov, B., additional, Wong, J., additional, and Farwell, W., additional
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- 2020
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12. SMA: REGISTRIES, BIOMARKERS & OUTCOME MEASURES
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Muntoni, F., primary, Sumner, C., additional, Crawford, T., additional, Finkel, R., additional, Mercuri, E., additional, Liu, Y., additional, Petrillo, M., additional, Kandinov, B., additional, and Farwell, W., additional
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- 2020
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13. Serum bicarbonate, anion gap and insulin resistance in the National Health and Nutrition Examination Survey
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Farwell, W. R. and Taylor, E. N.
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- 2008
14. Interim report on the safety and efficacy of longer-term treatment with nusinersen in later-onset spinal muscular atrophy (SMA): results from the SHINE study
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Kirschner, J, Darras, B, Farrar, M, Mercuri, E, Chiriboga, C, Kuntz, N, Shieh, P, Tulinius, M, Montes, J, Reyna, S, Gambino, G, Foster, R, Bhan, I, Wong, J, Farwell, W, Kirschner, J, Darras, B, Farrar, M, Mercuri, E, Chiriboga, C, Kuntz, N, Shieh, P, Tulinius, M, Montes, J, Reyna, S, Gambino, G, Foster, R, Bhan, I, Wong, J, and Farwell, W
- Published
- 2019
15. An Integrated Safety Analysis of Infants and Children with Symptomatic Spinal Muscular Atrophy (SMA) Treated with Nusinersen in Seven Clinical Trials
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Darras, BT, Farrar, MA, Mercuri, E, Finkel, RS, Foster, R, Hughes, SG, Bhan, I, Farwell, W, Gheuens, S, Darras, BT, Farrar, MA, Mercuri, E, Finkel, RS, Foster, R, Hughes, SG, Bhan, I, Farwell, W, and Gheuens, S
- Abstract
Background: Treatment with nusinersen has demonstrated significant and clinically meaningful benefits in clinical trials in infants and children with spinal muscular atrophy (SMA). Objective: The objective of this analysis was to characterize the safety of nusinersen across the clinical trial program in infants and children with symptomatic SMA. Methods: An integrated safety analysis evaluated end of study data from seven completed clinical trials that enrolled infants and children with symptomatic SMA who were treated with intrathecal nusinersen or underwent sham procedures. Two of the studies were conducted in symptomatic infants with infantile-onset SMA (most likely to develop SMA type I or II) and the remaining five in symptomatic children and adolescents with later-onset SMA (have or are most likely to develop SMA type II or III). Safety assessments included incidence of adverse events (AEs), physical and neurological examinations, vital signs, clinical laboratory tests (serum chemistry, hematology, and urinalysis), and electrocardiograms. Results: Data were analyzed from 323 infants and children, including 240 treated with nusinersen (100 with infantile-onset SMA and 140 with later-onset SMA) and 83 who underwent sham procedures (41 infantile-onset, 42 later-onset). Median (range) exposure to nusinersen was 449.0 (6–1538) days (375.9 participant-years). The most common AEs with nusinersen were pyrexia, upper respiratory tract infection, nasopharyngitis, vomiting, headache, and constipation. The incidence of serious AEs was lower with nusinersen than with the sham procedure (41% vs. 61%). The overall incidence of respiratory, thoracic, and mediastinal AEs was higher in participants with symptomatic infantile-onset SMA than those with symptomatic later-onset SMA and similar in nusinersen- versus sham procedure–treated participants. Rates of post–lumbar puncture syndrome and related events were higher with nusinersen versus sham procedure in later-onset SMA parti
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- 2019
16. Neurofilament as a potential biomarker for spinal muscular atrophy
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Darras, BT, Crawford, TO, Finkel, RS, Mercuri, E, De Vivo, DC, Oskoui, M, Tizzano, EF, Ryan, MM, Muntoni, F, Zhao, G, Staropoli, J, McCampbell, A, Petrillo, M, Stebbins, C, Fradette, S, Farwell, W, Sumner, CJ, Darras, BT, Crawford, TO, Finkel, RS, Mercuri, E, De Vivo, DC, Oskoui, M, Tizzano, EF, Ryan, MM, Muntoni, F, Zhao, G, Staropoli, J, McCampbell, A, Petrillo, M, Stebbins, C, Fradette, S, Farwell, W, and Sumner, CJ
- Abstract
OBJECTIVE: To evaluate plasma phosphorylated neurofilament heavy chain (pNF-H) as a biomarker in spinal muscular atrophy (SMA). METHODS: Levels of pNF-H were measured using the ProteinSimple® platform in plasma samples from infants with SMA enrolled in ENDEAR (NCT02193074) and infants/children without neurological disease. RESULTS: Median pNF-H plasma level was 167.0 pg/mL (7.46-7,030; n = 34) in children without SMA (aged 7 weeks-18 years) and was higher in those aged < 1 versus 1-18 years (P = 0.0002). In ENDEAR participants with infantile-onset SMA, median baseline pNF-H level (15,400 pg/mL; 2390-50,100; n = 117) was ~10-fold higher than that of age-matched infants without SMA (P < 0.0001) and ~90-fold higher than children without SMA (P < 0.0001). Higher pretreatment pNF-H levels in infants with SMA were associated with younger age at symptom onset, diagnosis, and first dose; lower baseline Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders score; and lower peroneal compound muscle potential amplitude. Nusinersen treatment was associated with a rapid and greater decline in pNF-H levels: nusinersen-treated infants experienced a steep 71.9% decline at 2 months to 90.1% decline at 10 months; sham control-treated infants declined steadily by 16.2% at 2 months and 60.3% at 10 months. INTERPRETATION: Plasma pNF-H levels are elevated in infants with SMA. Levels inversely correlate with age at first dose and several markers of disease severity. Nusinersen treatment is associated with a significant decline in pNF-H levels followed by relative stabilization. Together these data suggest plasma pNF-H is a promising marker of disease activity/treatment response in infants with SMA.
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- 2019
17. Nusinersen initiated in infants during the presymptomatic stage of spinal muscular atrophy: Interim efficacy and safety results from the Phase 2 NURTURE study
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De Vivo, DC, Bertini, E, Swoboda, KJ, Hwu, W-L, Crawford, TO, Finkel, RS, Kirschner, J, Kuntz, NL, Parsons, JA, Ryan, MM, Butterfield, RJ, Topaloglu, H, Ben-Omran, T, Sansone, VA, Jong, Y-J, Shu, F, Staropoli, JF, Kerr, D, Sandrock, AW, Stebbins, C, Petrillo, M, Braley, G, Johnson, K, Foster, R, Gheuens, S, Bhan, I, Reyna, SP, Fradette, S, Farwell, W, De Vivo, DC, Bertini, E, Swoboda, KJ, Hwu, W-L, Crawford, TO, Finkel, RS, Kirschner, J, Kuntz, NL, Parsons, JA, Ryan, MM, Butterfield, RJ, Topaloglu, H, Ben-Omran, T, Sansone, VA, Jong, Y-J, Shu, F, Staropoli, JF, Kerr, D, Sandrock, AW, Stebbins, C, Petrillo, M, Braley, G, Johnson, K, Foster, R, Gheuens, S, Bhan, I, Reyna, SP, Fradette, S, and Farwell, W
- Abstract
Spinal muscular atrophy (SMA) is a neurodegenerative disease associated with severe muscle atrophy and weakness in the limbs and trunk. We report interim efficacy and safety outcomes as of March 29, 2019 in 25 children with genetically diagnosed SMA who first received nusinersen in infancy while presymptomatic in the ongoing Phase 2, multisite, open-label, single-arm NURTURE trial. Fifteen children have two SMN2 copies and 10 have three SMN2 copies. At last visit, children were median (range) 34.8 [25.7-45.4] months of age and past the expected age of symptom onset for SMA Types I or II; all were alive and none required tracheostomy or permanent ventilation. Four (16%) participants with two SMN2 copies utilized respiratory support for ≥6 h/day for ≥7 consecutive days that was initiated during acute, reversible illnesses. All 25 participants achieved the ability to sit without support, 23/25 (92%) achieved walking with assistance, and 22/25 (88%) achieved walking independently. Eight infants had adverse events considered possibly related to nusinersen by the study investigators. These results, representing a median 2.9 years of follow up, emphasize the importance of proactive treatment with nusinersen immediately after establishing the genetic diagnosis of SMA in presymptomatic infants and emerging newborn screening efforts.
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- 2019
18. Nusinersen versus sham control in later-onset spinal muscular atrophy
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Vogt, Sibylle, Krueger, Marcus, Pechmann, Astrid, Rippberger, Bianca, Eckenweiler, Matthias, Schara, Ulrike, Koelbel, Heike, Andres, Barbara, Rupprich, Katrin, Gangfuss, Andrea, Jachertz, Philipp, Della Marina, Adela, Sponemann, Nina, Pane, Markia, Palermo, Concetta, Piastra, Marco, Fanelli, Lavinia, de Sanctis, Roberto, Genovese, Orazio, Antonaci, Laura, Pera, Maria Carmela, Lamendola, Priscilla, Messina, Sonia, Vita, Gianluca, Di Bella, Vincenzo, Sframeli, Maria, Rosa, Matteo, Barcellona, Costanza, Distefano, Maria Grazia, Cavallaro, Filippo, Versaci, Antonio, de Luca, Francesco, Vita, Giuseppe, Nacimento Osorio, Andres, Tizzano, Eduardo, Ortez Gonzalez, Carlos Ignacio, Ortigoza Escobar, Juan Dario, Colomer Oferil, Juame, Medina Cantillo, Julita, Febrer Rotger, Anna, Vigo Morancho, Meritxell, Eldblom, Johanneh, Darin, Niklas, Kroksmark, Anna Karin, Lindstedt, Asa, Michael, Eva, Kimber, Eva, Wahlgren, Lisa, Chan, Sophelia Hoi-Shan, Chim, Stella, Chiu, Joseph, Ho, Alvin Chi Chung, Ip, Jing Kun Janice, Lam, Wendy Wai Man, Ng, Maggie Chui-San, Wan, Connie, Wong, Virginia Chun Nei, Yue, Yvonne, Arakawa, Reiko, Yamauchi, Akemi, Nagata, Satoru, Ito, Yasushi, Nakatsukasa, Hidetsugu, Takeshita, Akiko, Hirasawa, Kyoko, Ikai, Tetsuo, Eto, Kaoru, Otamni, Yui, Takeshima, Yasuhiro, Fukuda, Noroki, Tanaka, Yasuhiro, Shimomura, Hideki, Lee, Tomoko, Shibano, Takayuki, Mercuri, E., Tachikawa, Tomohiro, Darras, B. T., Chae, Jong-Hee, Chiriboga, C. A., Lim, Byung Chan, Day, J. W., Shin, Hyung-Ik, Campbell, C., Kim, Soo Yeon, Connolly, A. M., Choi, Sun Ah, Iannaccone, S. T., Son, Woo Sung, Kirschner, J., Jo, Hyemi, Kuntz, N. L., Chun, Seong Min, Saito, K., Kim, Hyuna, Shieh, P. B., Tulinius, M., Mazzone, E. S., Montes, J., Bishop, K. M., Yang, Q., Foster, R., Gheuens, S., Bennett, C. F., Farwell, W., Schneider, E., de Vivo, D. C., Finkel, R. S., Bradley, Walter G., Kaufmann, Petra, Dickson, Patricia I., Reingold, Stephen C., Davis, Charles S., Arredondo, Kristen, Castro, Diana, Cowie, Margaret, Farrow-Gillespie, Alan, Hebert, Andrew, Kauk, Melissa, Miller, Nancy, Nelson, Leslie, Spain, Thomas, Cappell, Joshua, Constantinescu, Andrei, Cruz, Rosangel, Dastgir, Jahannaz, de Vivo, Darryl, Dunaway, Sally, Engelstad, Kristin, Khandji, Alexander G., Kramer, Samantha, Marra, Jonathan, Popolizio, Molly, Salazar, Rachel, Weimer, Louis H., Aziz-Zaman, Sonya, Lamarca, Nicole, Ghosh, Partha, Al-Ghamdi, Fouad, Liew, Wendy, Graham, Robert, Berde, Charles, Sethna, Navil, Koka, Anjali, Wang, Luke, Laine, Regina, Souris, Michelle, Ordonez, Grace, Harrington, Timothy, Szelag, Heather, Pasternak, Amy, Mirek, Elizabeth, Quigley, Janet, Finkel, Richard, Berry, Debbie, Civitello, Matthew, Endsley, Julie Duke, Eden, Candace, Leon, Wendy, O'Reardon, Kathleen, Sigurdardottir, Laufey, Johnson, Craig, Turner, Jenna, Vega, Melisa, Weber-Guzman, Fabiola, Zinn, Matthias, Rocha, Ana Carolina Tesi, Watson, Karolina, d'Souza, Genevieve, Ramamurthi, R. J., Gee, Richard, Kitsuwa-Lowe, Janis, Hagerman, Katharine, Crasta, Sheela, Welsh, Lesly, Paulose, Shirley, Mcfall, Danielle, Perez, Jennifer, Patnaik, Swetapadma, Sanjanwala, Bharati, Sakamuri, Sarada, Proud, Crystal, Purse, Bona Park, Duong, Trinh Tina, Sampson, Jacinda, Tennekoon, Gihan, Brandsema, John, Glanzman, Allan, Flickinger, Jean, Toms, Michele, Adang, Laura, Stanford, Delores, Mayer, Oscar, Zigmont, Joshua, Chadehumbe, Madeline, Kichula, Elizabeth, Finanger, Erika, Russman, Barry, Roberts, Colin, Frank, Andrea, Benjamin, Danielle, Zilke, Kirsten, Golumbek, Paul T., Zaidman, Craig M., Anand, Pallavi, Gadeken, Rebecca, Siener, Catherine, Kuntz, Nancy, Epstein, Leon, Krueger, Jena, Goldman, Stewart, Krosschell, Kristin, Blomgren, Colleen, Choi, Hyoung Won, Kurz, Jonathan, Parsons, Julie, Janas, Joanne, Yang, Michele, Ballard, Alison, Carry, Terri, Shea, Stephanie, Bielsky, Alan, Booker, Kaylee, Camuto, Alicia, Lord-Halvorson, Sierra, Gibbons, Melissa, Zimmerman, Carl, Allen, Victoria, Fuhr, Peter, Johnson, Hannah, Tran, Vi, Vanderveen, Gina, Shieh, Perry, Fowler, Eileen, Parziale, Nicholas, Rao, Lekha, Skura, Christy, Kelley, Carolyn, Shu, Francy, Oskoui, Maryam, Zielinski, David, Poulin, Chantal, Ingelmo, Pablo Mauricio, Desilets, Sarah Turgeon, Dinunzio, Pamela, Rivera, Gonzalo, Srour, Myriam, Arpin, Stephanie, Goobie, Sharan, Gibson, Paul, Scholtes, Cheryl, Mcdonald, Wendy, Zapata, Eugenio, Nguyen, Cam-Tu Emilie, Servais, Laurent, Gargaun, Elena, Le Moing, Anne-Gaelle, Gidaro, Teresa, Vialle, Raphael, Guye, Marie-Laurence, Lilien, Charlotte, Olliver, Gwenn, Gilabert, Stephanie, Borell, Sabine, Wider, Sabine, Stein, Sabine, Universität Duisburg-Essen = University of Duisburg-Essen [Essen], Department of Paediatrics, Università cattolica del Sacro Cuore = Catholic University of the Sacred Heart [Roma] (Unicatt), Vall d'Hebron University Hospital [Barcelona], CIBER de Enfermedades Raras (CIBERER), Handicaps génétiques de l'enfant (Inserm U393), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Seoul National University Hospital, Max-Planck-Institut für Mikrostrukturphysik (MPI-HALLE), Max-Planck-Gesellschaft, The University of Tokyo (UTokyo), Institut de Chimie Organique et Analytique (ICOA), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Université d'Orléans (UO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS), Institute of Plasma Physics, Chinese Academy of Sciences (ASIPP), Institut Necker Enfants-Malades (INEM - UM 111 (UMR 8253 / U1151)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPCité), Laboratoire de mécanique des solides (LMS), École polytechnique (X)-Mines Paris - PSL (École nationale supérieure des mines de Paris), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Centre National de la Recherche Scientifique (CNRS), CureSMA [Elk Grove Village, IL, USA], Harvard Medical School [Boston] (HMS), Institute for Marine and Antarctic Studies [Hobart] (IMAS), University of Tasmania [Hobart, Australia] (UTAS), The Hospital for sick children [Toronto] (SickKids), University of Toronto, The Open University [Milton Keynes] (OU), Department of Pediatrics, Feinberg School of Medicine, Northwestern University [Evanston]-Northwestern University [Evanston]-Northwestern University, University Hospital Basel [Basel], McGill University Health Center [Montreal] (MUHC), Service de génétique [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Bretonneau, Service of Clinical Trials and Databases, Institut de Myologie, Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Association française contre les myopathies (AFM-Téléthon)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Association française contre les myopathies (AFM-Téléthon)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Association française contre les myopathies (AFM-Téléthon)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), CHU Amiens-Picardie, Groupe de Recherche sur l'Analyse Multimodale de la Fonction Cérébrale - UMR INSERM_S 1105 (GRAMFC), Université de Picardie Jules Verne (UPJV)-CHU Amiens-Picardie-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), University of Oxford, Schara, Ulrike (Beitragende*r), Koelbel, Heike (Beitragende*r), Rupprich, Katrin (Beitragende*r), Gangfuss, Andrea (Beitragende*r), Della Marina, Adela (Beitragende*r), and Sponemann, Nina (Beitragende*r)
- Subjects
0301 basic medicine ,Male ,[SDV]Life Sciences [q-bio] ,spinal ,Medizin ,Oligonucleotides ,Spinal Muscular Atrophies of Childhood ,Pediatrics ,law.invention ,Age of Onset ,Child ,Child, Preschool ,Double-Blind Method ,Female ,Humans ,Infant ,Injections, Spinal ,Least-Squares Analysis ,Motor Skills ,Oligonucleotides, Antisense ,Medicine (all) ,0302 clinical medicine ,age of onset ,Randomized controlled trial ,law ,Clinical endpoint ,inglese ,injections ,Motor skill ,motor skills ,General Medicine ,SMA ,Settore MED/26 - NEUROLOGIA ,medicine.anatomical_structure ,female ,Anesthesia ,Nusinersen ,Spinal ,antisense ,preschool ,Injections ,03 medical and health sciences ,least-squares analysis ,Settore MED/39 - NEUROPSICHIATRIA INFANTILE ,Settore MED/41 - ANESTESIOLOGIA ,medicine ,Antisense ,Preschool ,business.industry ,Spinal muscular atrophy ,Motor neuron ,medicine.disease ,030104 developmental biology ,Age of onset ,business ,030217 neurology & neurosurgery - Abstract
Background: Nusinersen is an antisense oligonucleotide drug that modulates pre–messenger RNA splicing of the survival motor neuron 2 (SMN2) gene. It has been developed for the treatment of spinal muscular atrophy (SMA). Methods: We conducted a multicenter, double-blind, sham-controlled, phase 3 trial of nusinersen in 126 children with SMA who had symptom onset after 6 months of age. The children were randomly assigned, in a 2:1 ratio, to undergo intrathecal administration of nusinersen at a dose of 12 mg (nusinersen group) or a sham procedure (control group) on days 1, 29, 85, and 274. The primary end point was the least-squares mean change from baseline in the Hammersmith Functional Motor Scale–Expanded (HFMSE) score at 15 months of treatment; HFMSE scores range from 0 to 66, with higher scores indicating better motor function. Secondary end points included the percentage of children with a clinically meaningful increase from baseline in the HFMSE score (≥3 points), an outcome that indicates improvement in at least two motor skills. Results: In the prespecified interim analysis, there was a least-squares mean increase from baseline to month 15 in the HFMSE score in the nusinersen group (by 4.0 points) and a least-squares mean decrease in the control group (by –1.9 points), with a significant between-group difference favoring nusinersen (least-squares mean difference in change, 5.9 points; 95% confidence interval, 3.7 to 8.1; P Conclusions: Among children with later-onset SMA, those who received nusinersen had significant and clinically meaningful improvement in motor function as compared with those in the control group. (Funded by Biogen and Ionis Pharmaceuticals; CHERISH ClinicalTrials.gov number, NCT02292537. opens in new tab.)
- Published
- 2018
19. Phosphorylated neurofilament heavy chain (PNF-H) and motor function achievement in nusinersen-treated individuals with spinal muscular atrophy (SMA)
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Sumner, C.J., primary, Darras, B.T., additional, Muntoni, F., additional, Crawford, T.O., additional, Finkel, R.S., additional, Mercuri, E., additional, De Vivo, D.C., additional, Oskoui, M., additional, Tizzano, E.F., additional, Ryan, M.M., additional, Liu, Y., additional, Petrillo, M., additional, Stebbins, C., additional, Koenig, E., additional, Fradette, S., additional, and Farwell, W., additional
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- 2019
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20. Nusinersen in infants who initiate treatment in a presymptomatic stage of spinal muscular atrophy (SMA): Interim results from the phase 2 nurture study
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Ryan, M.M., primary, De Vivo, D.C., additional, Bertini, E., additional, Hwu, W.L., additional, Crawford, T.O., additional, Swoboda, K.J., additional, Finkel, R.S., additional, Kirschner, J., additional, Kuntz, N.L., additional, Parsons, J., additional, Butterfield, R.J., additional, Topaloglu, H., additional, Omran, T. Ben, additional, Sansone, V.A., additional, Jong, Y.J., additional, Shu, F., additional, Foster, R., additional, Bhan, I., additional, Fradette, S., additional, and Farwell, W., additional
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- 2019
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21. Interim report on the safety and efficacy of longer-term treatment with nusinersen in later-onset spinal muscular atrophy (SMA): Results from the shine study
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Kirschner, J., primary, Darras, B.T., additional, Farrar, M.A., additional, Mercuri, E., additional, Chiriboga, C.A., additional, Kuntz, N.L., additional, Shieh, P.B., additional, Tulinius, M., additional, Montes, J., additional, Reyna, S.P., additional, Gambino, G., additional, Foster, R., additional, Bhan, I., additional, Wong, J., additional, and Farwell, W., additional
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- 2019
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22. P.352Interim report on the safety and efficacy of longer-term treatment with nusinersen in later-onset spinal muscular atrophy (SMA): results from the SHINE study
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Kirschner, J., primary, Darras, B., additional, Farrar, M., additional, Mercuri, E., additional, Chiriboga, C., additional, Kuntz, N., additional, Shieh, P., additional, Tulinius, M., additional, Montes, J., additional, Reyna, S., additional, Gambino, G., additional, Foster, R., additional, Bhan, I., additional, Wong, J., additional, and Farwell, W., additional
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- 2019
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23. P.270Association between plasma phosphorylated neurofilament heavy chain and efficacy endpoints in the nusinersen NURTURE study
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Muntoni, F., primary, Sumner, C., additional, Darras, B., additional, Crawford, T., additional, Finkel, R., additional, Mercuri, E., additional, De Vivo, D., additional, Oskoui, M., additional, Tizzano, E., additional, Ryan, M., additional, Liu, Y., additional, Petrillo, M., additional, Stebbins, C., additional, Koenig, E., additional, Fradette, S., additional, and Farwell, W., additional
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- 2019
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24. P.356Nusinersen in infants who initiate treatment in a presymptomatic stage of spinal muscular atrophy: interim results from the phase 2 NURTURE study
- Author
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Ryan, M., primary, De Vivo, D., additional, Bertini, E., additional, Hwu, W., additional, Crawford, T., additional, Swoboda, K., additional, Finkel, R., additional, Kirschner, J., additional, Kuntz, N., additional, Parsons, J., additional, Butterfield, R., additional, Topaloğlu, H., additional, Ben Omran, T., additional, Sansone, V., additional, Jong, Y., additional, Shu, F., additional, Foster, R., additional, Bhan, I., additional, Fradette, S., additional, and Farwell, W., additional
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- 2019
- Full Text
- View/download PDF
25. Nusinersen versus Sham Control in Later-Onset Spinal Muscular Atrophy.
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Mercuri, E (ORCID:0000-0002-9851-5365), Darras, Bt, Chiriboga, Ca, Day, Jw, Campbell, C, Connolly, Am, Iannaccone, St, Kirschner, J, Kuntz, Nl, Saito, K, Shieh, Pb, Tulinius, M, Mazzone, Es, Montes, J, Bishop, Km, Yang, Q, Foster, R, Gheuens, S, Bennett, Cf, Farwell, W, Schneider, E, De Vivo DC, Finkel, Rs, CHERISH Study, Group., Mercuri, E (ORCID:0000-0002-9851-5365), Darras, Bt, Chiriboga, Ca, Day, Jw, Campbell, C, Connolly, Am, Iannaccone, St, Kirschner, J, Kuntz, Nl, Saito, K, Shieh, Pb, Tulinius, M, Mazzone, Es, Montes, J, Bishop, Km, Yang, Q, Foster, R, Gheuens, S, Bennett, Cf, Farwell, W, Schneider, E, De Vivo DC, Finkel, Rs, and CHERISH Study, Group.
- Abstract
BACKGROUND: Nusinersen is an antisense oligonucleotide drug that modulates pre-messenger RNA splicing of the survival motor neuron 2 ( SMN2) gene. It has been developed for the treatment of spinal muscular atrophy (SMA). METHODS: We conducted a multicenter, double-blind, sham-controlled, phase 3 trial of nusinersen in 126 children with SMA who had symptom onset after 6 months of age. The children were randomly assigned, in a 2:1 ratio, to undergo intrathecal administration of nusinersen at a dose of 12 mg (nusinersen group) or a sham procedure (control group) on days 1, 29, 85, and 274. The primary end point was the least-squares mean change from baseline in the Hammersmith Functional Motor Scale-Expanded (HFMSE) score at 15 months of treatment; HFMSE scores range from 0 to 66, with higher scores indicating better motor function. Secondary end points included the percentage of children with a clinically meaningful increase from baseline in the HFMSE score (≥3 points), an outcome that indicates improvement in at least two motor skills. RESULTS: In the prespecified interim analysis, there was a least-squares mean increase from baseline to month 15 in the HFMSE score in the nusinersen group (by 4.0 points) and a least-squares mean decrease in the control group (by -1.9 points), with a significant between-group difference favoring nusinersen (least-squares mean difference in change, 5.9 points; 95% confidence interval, 3.7 to 8.1; P<0.001). This result prompted early termination of the trial. Results of the final analysis were consistent with results of the interim analysis. In the final analysis, 57% of the children in the nusinersen group as compared with 26% in the control group had an increase from baseline to month 15 in the HFMSE score of at least 3 points (P<0.001), and the overall incidence of adverse events was similar in the nusinersen group and the control group (93% and 100%, respectively). CONCLUSIONS: Among children with later-onset SMA, those who received
- Published
- 2018
26. Nusinersen versus sham control in later-onset spinal muscular atrophy
- Author
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Mercuri, Eugenio Maria, Darras, B. T., Chiriboga, C. A., Day, J. W., Campbell, C., Connolly, A. M., Iannaccone, S. T., Kirschner, J., Kuntz, N. L., Saito, K., Shieh, P. B., Tulinius, M., Mazzone, Elena Stacy, Montes, J., Bishop, K. M., Yang, Q., Foster, R., Gheuens, S., Bennett, C. F., Farwell, W., Schneider-Moser, Elisabeth Margarete Ute, De Vivo, D. C., Finkel, R. S., Piastra, Marco, Mercuri, E. (ORCID:0000-0002-9851-5365), Mazzone, E. S., Piastra, Marco (ORCID:0000-0002-3144-8970), Mercuri, Eugenio Maria, Darras, B. T., Chiriboga, C. A., Day, J. W., Campbell, C., Connolly, A. M., Iannaccone, S. T., Kirschner, J., Kuntz, N. L., Saito, K., Shieh, P. B., Tulinius, M., Mazzone, Elena Stacy, Montes, J., Bishop, K. M., Yang, Q., Foster, R., Gheuens, S., Bennett, C. F., Farwell, W., Schneider-Moser, Elisabeth Margarete Ute, De Vivo, D. C., Finkel, R. S., Piastra, Marco, Mercuri, E. (ORCID:0000-0002-9851-5365), Mazzone, E. S., and Piastra, Marco (ORCID:0000-0002-3144-8970)
- Abstract
BACKGROUND: Nusinersen is an antisense oligonucleotide drug that modulates pre-messenger RNA splicing of the survival motor neuron 2 (SMN2) gene. It has been developed for the treatment of spinal muscular atrophy (SMA). METHODS: We conducted a multicenter, double-blind, sham-controlled, phase 3 trial of nusinersen in 126 children with SMA who had symptom onset after 6 months of age. The children were randomly assigned, in a 2:1 ratio, to undergo intrathecal administration of nusinersen at a dose of 12 mg (nusinersen group) or a sham procedure (control group) on days 1, 29, 85, and 274. The primary end point was the leastsquares mean change from baseline in the Hammersmith Functional Motor Scale-Expanded (HFMSE) score at 15 months of treatment; HFMSE scores range from 0 to 66, with higher scores indicating better motor function. Secondary end points included the percentage of children with a clinically meaningful increase from baseline in the HFMSE score (â¥3 points), an outcome that indicates improvement in at least two motor skills. RESULTS: In the prespecified interim analysis, there was a least-squares mean increase from baseline to month 15 in the HFMSE score in the nusinersen group (by 4.0 points) and a least-squares mean decrease in the control group (by -1.9 points), with a significant between-group difference favoring nusinersen (least-squares mean difference in change, 5.9 points; 95% confidence interval, 3.7 to 8.1; P<0.001). This result prompted early termination of the trial. Results of the final analysis were consistent with results of the interim analysis. In the final analysis, 57% of the children in the nusinersen group as compared with 26% in the control group had an increase from baseline to month 15 in the HFMSE score of at least 3 points (P<0.001), and the overall incidence of adverse events was similar in the nusinersen group and the control group (93% and 100%, respectively). CONCLUSIONS: Among children with later-onset SMA, those who r
- Published
- 2018
27. SMA THERAPIES II AND BIOMARKERS
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Crawford, T., primary, Sumner, C., additional, Finkel, R., additional, De Vivo, D., additional, Oskoui, M., additional, Tizzano, E., additional, Zhao, G., additional, Petrillo, M., additional, Stebbins, C., additional, and Farwell, W., additional
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- 2018
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- View/download PDF
28. SMA THERAPIES I
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Castro, D., primary, Farrar, M., additional, Finkel, R., additional, Tulinius, M., additional, Krosschell, K., additional, Saito, K., additional, Zhang, Y., additional, Bhan, I., additional, Farwell, W., additional, and Reyna, S., additional
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- 2018
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- View/download PDF
29. NEW GENES, FUNCTIONS AND BIOMARKERS
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Darras, B., primary, Finkel, R., additional, Mercuri, E., additional, Sumner, C., additional, Oskoui, M., additional, Tizzano, E., additional, Ryan, M., additional, Zhao, G., additional, Petrillo, M., additional, Stebbins, C., additional, and Farwell, W., additional
- Published
- 2018
- Full Text
- View/download PDF
30. B.05 Nusinersen in infants who initiate treatment in a presymptomatic stage of spinal muscular atrophy (SMA): interim results from the Phase 2 NURTURE study
- Author
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De Vivo, DC, primary, Bertini, E, additional, Hwu, W, additional, Foster, R, additional, Bhan, I, additional, Gheuens, S, additional, Farwell, W, additional, Reyna, SP, additional, and Vajsar, J, additional
- Published
- 2018
- Full Text
- View/download PDF
31. B.06 Safety and efficacy of nusinersen in infants/children with spinal muscular atrophy (SMA): part 1 of the phase 2 EMBRACE study
- Author
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Shieh, PB, primary, Acsadi, G, additional, Mueller-Felber, W, additional, Crawford, TO, additional, Richardson, R, additional, Natarajan, N, additional, Castro, D, additional, Gheuens, S, additional, Bhan, I, additional, Gambino, G, additional, Sun, P, additional, Farwell, W, additional, Reyna, SP, additional, and Vajsar, J, additional
- Published
- 2018
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- View/download PDF
32. Nusinersen versus sham control in infantile-onset spinal muscular atrophy
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Finkel, RS, Mercuri, E, Darras, BT, Connolly, AM, Kuntz, NL, Kirschner, J, Chiriboga, CA, Saito, K, Servais, L, Tizzano, E, Topaloglu, H, Tulinius, M, Montes, J, Glanzman, AM, Bishop, K, Zhong, ZJ, Gheuens, S, Bennett, CF, Schneider, E, Farwell, W, De Vivo, DC, Bradley, WG, Schroth, MK, Bodensteriner, JB, Davis, CS, Shell, R, Hen, J, Austin, ED, Aziz-Zaman, S, Cappell, J, Constantinescu, A, Cruz, R, Dastgir, J, Dunaway, S, Engelstad, K, Gormley, M, Holuba La Marca, N, Khandji, A, Kramer, S, Marra, J, Ortiz-Miller, C, Popolizio, M, Salazar, R, Sanabria, L, Weimer, L, Anand, P, Gadeken, R, Golumbek, PT, Siener, C, Zaidman, CM, Al-Ghamdi, F, Berde, C, Ghosh, P, Graham, R, Harrington, T, Koka, A, Laine, R, Liew, W, Mirek, E, Ordonez, G, Pasternak, A, Quigley, J, Sethna, N, Souris, M, Szelag, H, Wand, L, Day, JW, D'Souza, G, Duong, TT, Gee, R, Kitsuwa-Lowe, J, McFall, D, Patnaik, S, Paulose, S, Perez, J, Proud, C, Purse, B, Ramamurthi, RJ, Sakamuri, S, Sampson, J, Sanjanwala, B, Tesi Rocha, AC, Watson, K, Welsh, L, Pena, LDM, Case, L, Coates, J, DeArmey, S, Homi, MM, Milleson, C, Nelson, N, Ross, A, Smith, E, Taicher, B, Wootton, J, Finanger, E, Benjamin, D, Frank, A, Roberts, C, Russman, B, Finkel, RS, Mercuri, E, Darras, BT, Connolly, AM, Kuntz, NL, Kirschner, J, Chiriboga, CA, Saito, K, Servais, L, Tizzano, E, Topaloglu, H, Tulinius, M, Montes, J, Glanzman, AM, Bishop, K, Zhong, ZJ, Gheuens, S, Bennett, CF, Schneider, E, Farwell, W, De Vivo, DC, Bradley, WG, Schroth, MK, Bodensteriner, JB, Davis, CS, Shell, R, Hen, J, Austin, ED, Aziz-Zaman, S, Cappell, J, Constantinescu, A, Cruz, R, Dastgir, J, Dunaway, S, Engelstad, K, Gormley, M, Holuba La Marca, N, Khandji, A, Kramer, S, Marra, J, Ortiz-Miller, C, Popolizio, M, Salazar, R, Sanabria, L, Weimer, L, Anand, P, Gadeken, R, Golumbek, PT, Siener, C, Zaidman, CM, Al-Ghamdi, F, Berde, C, Ghosh, P, Graham, R, Harrington, T, Koka, A, Laine, R, Liew, W, Mirek, E, Ordonez, G, Pasternak, A, Quigley, J, Sethna, N, Souris, M, Szelag, H, Wand, L, Day, JW, D'Souza, G, Duong, TT, Gee, R, Kitsuwa-Lowe, J, McFall, D, Patnaik, S, Paulose, S, Perez, J, Proud, C, Purse, B, Ramamurthi, RJ, Sakamuri, S, Sampson, J, Sanjanwala, B, Tesi Rocha, AC, Watson, K, Welsh, L, Pena, LDM, Case, L, Coates, J, DeArmey, S, Homi, MM, Milleson, C, Nelson, N, Ross, A, Smith, E, Taicher, B, Wootton, J, Finanger, E, Benjamin, D, Frank, A, Roberts, C, and Russman, B
- Abstract
BACKGROUND: Spinal muscular atrophy is an autosomal recessive neuromuscular disorder that is caused by an insufficient level of survival motor neuron (SMN) protein. Nusinersen is an antisense oligonucleotide drug that modifies pre–messenger RNA splicing of the SMN2 gene and thus promotes increased production of full-length SMN protein. METHODS: We conducted a randomized, double-blind, sham-controlled, phase 3 efficacy and safety trial of nusinersen in infants with spinal muscular atrophy. The primary end points were a motor-milestone response (defined according to results on the Hammersmith Infant Neurological Examination) and event-free survival (time to death or the use of permanent assisted ventilation). Secondary end points included overall survival and subgroup analyses of event-free survival according to disease duration at screening. Only the first primary end point was tested in a prespecified interim analysis. To control the overall type I error rate at 0.05, a hierarchical testing strategy was used for the second primary end point and the secondary end points in the final analysis. RESULTS: In the interim analysis, a significantly higher percentage of infants in the nusinersen group than in the control group had a motor-milestone response (21 of 51 infants [41%] vs. 0 of 27 [0%], P<0.001), and this result prompted early termination of the trial. In the final analysis, a significantly higher percentage of infants in the nusinersen group than in the control group had a motor-milestone response (37 of 73 infants [51%] vs. 0 of 37 [0%]), and the likelihood of event-free survival was higher in the nusinersen group than in the control group (hazard ratio for death or the use of permanent assisted ventilation, 0.53; P=0.005). The likelihood of overall survival was higher in the nusinersen group than in the control group (hazard ratio for death, 0.37; P=0.004), and infants with a shorter disease duration at screening were more likely than those with a longer disea
- Published
- 2017
33. Outcomes after 1-year in presymptomatic infants with genetically diagnosed spinal muscular atrophy (SMA) treated with nusinersen: interim results from the NURTURE study
- Author
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Hwu, W., primary, De, D., additional, Bertini, E., additional, Foster, R., additional, Gheuens, S., additional, Farwell, W., additional, and Reyna, S., additional
- Published
- 2017
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- View/download PDF
34. Nusinersen demonstrates greater efficacy in infants with shorter disease duration: End of study results from the ENDEAR study in infants with spinal muscular atrophy (SMA)
- Author
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Servais, L., primary, Farrar, M., additional, Finkel, R., additional, Kirschner, J., additional, Muntoni, F., additional, Sun, P., additional, Gheuens, S., additional, Schneider, E., additional, and Farwell, W., additional
- Published
- 2017
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- View/download PDF
35. Infants and children with SMA treated with nusinersen in clinical trials: experience of risk for respiratory or other events with repeat anesthesia/sedation for intrathecal administration
- Author
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Finkel, R., primary, Mercuri, E., additional, Chiriboga, C., additional, Kuntz, N., additional, Richman, S., additional, Bhan, I., additional, Hughes, S., additional, Foster, R., additional, Farwell, W., additional, and Gheuens, S., additional
- Published
- 2017
- Full Text
- View/download PDF
36. Infants and children with SMA treated with nusinersen in clinical trials: an integrated safety analysis
- Author
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Mercuri, E., primary, Finkel, R., additional, Farrar, M., additional, Richman, S., additional, Foster, R., additional, Hughes, S., additional, Farwell, W., additional, and Gheuens, S., additional
- Published
- 2017
- Full Text
- View/download PDF
37. Safety and efficacy of nusinersen in infants/children with spinal muscular atrophy (SMA): part 1 of the phase 2 EMBRACE study
- Author
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Acsadi, G., primary, Shieh, P., additional, Crawford, T., additional, Richardson, R., additional, Natarajan, N., additional, Castro, D., additional, Gheuens, S., additional, Gambino, G., additional, Sun, P., additional, Reyna, S., additional, Farwell, W., additional, and Mueller-Felber, W., additional
- Published
- 2017
- Full Text
- View/download PDF
38. Efficacy and safety of nusinersen in children with later-onset spinal muscular atrophy (SMA): end of study results from the phase 3 CHERISH study
- Author
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Mercuri, E., primary, Finkel, R., additional, Kirschner, J., additional, Chiriboga, C., additional, Kuntz, N., additional, Sun, P., additional, Gheuens, S., additional, Bennett, C., additional, Schneider, E., additional, and Farwell, W., additional
- Published
- 2017
- Full Text
- View/download PDF
39. Efficacy and safety of nusinersen in infants with presymptomatic spinal muscular atrophy (SMA): Interim results from the NURTURE study
- Author
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Bertini, E., primary, Hwu, W.-L., additional, Reyna, S.P., additional, Farwell, W., additional, Gheuens, S., additional, Sun, P., additional, Zhong, Z.J., additional, and De Vivo, D.C., additional
- Published
- 2017
- Full Text
- View/download PDF
40. Efficacy and safety of nusinersen in infants with spinal muscular atrophy (SMA): Final results from the phase 3 ENDEAR study
- Author
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Finkel, R., primary, Kuntz, N., additional, Mercuri, E., additional, Chiriboga, C.A., additional, Darras, B., additional, Topaloglu, H., additional, Montes, J., additional, Su, J., additional, Zhong, Z.J., additional, Gheuens, S., additional, Bennett, C.F., additional, Schneider, E., additional, and Farwell, W., additional
- Published
- 2017
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41. Interim analysis of the phase 3 CHERISH study evaluating nusinersen in patients with later-onset spinal muscular atrophy (SMA): Primary and descriptive secondary endpoints
- Author
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Mercuri, E., primary, Finkel, R., additional, Kirschner, J., additional, Chiriboga, C.A., additional, Kuntz, N., additional, Darras, B., additional, Shieh, P.B., additional, Saito, K., additional, De Vivo, D.C., additional, Mazzone, E.S., additional, Montes, J., additional, Yang, Q., additional, Zhong, Z.J., additional, Gheuens, S., additional, Bennett, C.F., additional, Schneider, E., additional, and Farwell, W., additional
- Published
- 2017
- Full Text
- View/download PDF
42. Interim Efficacy and Safety Results from the Phase 3 ENDEAR Study of Nusinersen in Infants Diagnosed with Spinal Muscular Atrophy (SMA)
- Author
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Finkel, R., additional, Kuntz, N., additional, Mercuri, E., additional, Muntoni, F., additional, Chiriboga, C., additional, Darras, B., additional, Topaloglu, H., additional, Montes, J., additional, Su, J., additional, Zhong, Z., additional, Gheuens, S., additional, Bennett, C., additional, Schneider, E., additional, and Farwell, W., additional
- Published
- 2017
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43. Phase 2 study design of antisense oligonucleotide nusinersen in presymptomatic infants with spinal muscular atrophy
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Bertini, E., primary, Hwu, P., additional, Reyna, S., additional, Farwell, W., additional, and De, D., additional
- Published
- 2016
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44. PP09.1 – 2352: Systematic review of incidence and prevalence of spinal muscular atrophy (SMA)
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Jones, C., primary, Oskoui, M., additional, Zielinski, D., additional, Vinikoor, L., additional, and Farwell, W., additional
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- 2015
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45. T.O.16 - Phase 2 study design of antisense oligonucleotide nusinersen in presymptomatic infants with spinal muscular atrophy
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Bertini, E., Hwu, P., Reyna, S., Farwell, W., and De, D.
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- 2016
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46. Study of Heart and Renal Protection (SHARP): Randomized trial to assess the effects of lowering low-density lipoprotein cholesterol among 9,438 patients with chronic kidney disease.
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Reaich R., Schouten D., Rashid H., Birtcher K., Cantu J., Tait C., Taun W., Fadem S., Das D., Khosla U., Brown C., Brown T., Buquing J., Cromwell H., Dickson N., Najimipour B., Robeson J., Tabibi W., Mulloy L., Bailey K., Burton B., Fall P., Jagadeesan M., Paulson W., Szerlip H., White J., Faulkner M., Adeleye O., Boatright D., Mensah D., Nwankwo U., Crutcher L., Cummings C., Floyd M., Putatunda B., Ross J., Sanford V., Thadani U., Haragsim L., Parker B., Rogan L., Thresher M., Turner J., Dworkin L., Mignano D., O'Mara A., Shemin D., Bakris G., Basta E., Chua D., Neri G., Ahmed I., Elliott W., Fondren L., Hasabou N., Khosla N., Mazin A., Riehle J., Kovesdy C., Mendoza J., Ahmadzadeh S., Iranmanesh A., Lewis M., Lu J., Benabe J., Gonzalez-Melendez E., Padilla B., Serrano J., Russ T., Athmann L., Funke L., Larson P., Roach D., Salveson B., Nogueira J., Hanes D., Hise M., Light P., Copland E., Fink J., Hakim M., Hough K., McMinn S., Weir M., Young C., Kershaw G., Hill I., White B., Plumb T., Florescu M., Groggel G., Martin M., Rao V., Denu-Ciocca C., Candiani C., Cooper J., Gordon B., Joy M., Kiser M., Lambeth C., Rosas S., Cochetti P., Robinson J., Schankel K., Teng H., Weise W., Geneidy A., Murray P., Solomon R., De Waal D., LaPointe S., Schoenknecht A., Campese V., Habashy M., Ananthakrisna R., Bedwani D., Fazli U., Fetrat M., Frampton Q., Kaldas B., Kazarian V., Pitts L., Sadeghi A., Yeasmin N., Young E., Fissell R., Belanger K., Ricci N., Farwell W., Bowman T., Dhingra R., Pesenson A., Ambrosino J., Chittamooru S., Kaufman J., Ramos M., Yap C., Nakhle S., Aligaen L., Duren D., Laine B., Moore S., Tuazon H., Coyne D., Audrain J., Bryant B., Dombek S., Freeman S., Klein P., Germain M., Berkowitz A., Bokhari A., Braden G., Diaz A., Greco B., Mulhern J., O'Shea M., Poindexter A., Poppel D., Ryan M., Sweet S., Ye J., Osterman J., Lin T., Mays B., Rizvi A., Sonnier C., Twining C., Wang S., Hix M., Schenck J., Baigent C., Landray M., Reith C., Dasgupta T., Emberson J., Herrington W., Lewis D., Mafham M., Collins R., Bray C., Chen Y., Baxter A., Young A., Hill M., Knott C., Cass A., Feldt-Rasmussen B., Fellstrom B., Grobbee R., Gronhagen-Riska C., Haas M., Holdaas H., Hooi L.S., Jiang L., Kasiske B., Krairittichai U., Levin A., Massy Z., Tesar V., Walker R., Wanner C., Wheeler D., Wiecek A., Majoni W., Simpson D., Strony J., Musliner T., Agodoa L., Armitage J., Chen Z., Craig J., De Zeeuw D., Gaziano M., Grimm R., Krane V., Neal B., Ophascharoensuk V., Pedersen T., Sleight P., Tobert J., Tomson C., Sandercock P., Keech A., Whelton P., Yusuf S., Peto R., Parish S., Dolph L., Bahu T., Booth-Davey E., Brewster A., Yau F., Denis E., Frederick K., Haywood D., Heineman J., Howard S., Jayne K., Madgwick Z., Michell S., Murphy K., Ning L., Nolan J., Nunn M., Roberts J., Wickman M., Bowman L., Bulbulia R., Haynes R., Rahimi K., Rahman N., Ait-Sadi R., Barton I., Zhu W., Clark S., Kourellias K., Radley M., Brown K., Worthing D., Coates G., Goodenough B., Lucas N., Carreras A., Currie R., Donaldson O., Fjalling E., Gallagher M., Gibson K., Goddard J., Healy J., Hones L., Jardine M., Kwong I., Merai M., Murray S., Perkovic V., Rendina A., Gallo K., Caron S., Carlson K., Foley K., Matzek S., Mewhort L., O'Donoghue S., Perel-Winkler A., Terins T., Nie Q., Yu H., Ge L., Hao D., Li L., Pang X., Wei X., Yan G., Certikova Chabova V., Holst H., Molvadgaard T., Munksgaard D., Peltonen Y., Liabeuf S., Lebel C., Ouabou L., Bauer B., Bergmann K., Beusch M., Cavitt D., Drechsler C., Dulau I., Hugen K., Kempf S., Kuchenmeister B., Pscheidl V., Schmiedeke D., Schwarz M., Speerschneider K., Stahl B., Lim B.C., Nadia H., Zishareena M.F., Vasuthavan S., Ganesapillai A.T., Yuen S., Grobbee D., Bobbink I., Groot K., Sikking I., Raley J., Colban M., Smerud K., Trygg N., Waagaard E., Westad H., Rotkegel S., Spiechowicz U., Domoradzka M., Gawlowska M., Flygar A., Odmark I., Pettersson A., Blackwood S., Barclay J., Benham J., Brown R., Cureton L., Jackson D., Kennedy I., Leaper C., Taylor A., Winter C., Wise C., Nash M., Taylor Bennett A., Donaldson D., Chalmers K., Corderoy H., Bartkoske M., Bjerk C., Camarena A., Herskovitz L., Heuer C., Levin J., Robinson R., Wicklund B., Bentzel D., Cohen S., Costa C., Scranton R., Auwardt R., Boyer M., Cogdell P., Menahem S., Sheldrake J., Mount P., Fraenkel M., Bisscheroux P., Dempester J., Gleeson P., Harris G., Holmes C., Hyett K., Linton A., Miach P., Booth D., Druce L., Mantha M., Borg E., Green S., Killen J., Lynch Y., Colquhoun D., Herzig K., Row G., Addison J., Asa J., Beatson G., Calvird D., Edmunds J., Ferreira-Jardim A., Gwynne A., Mackay D., McLoughlin L., Wightwick C., Williams L., Ferrari P., Barry J., Hodson S., Zakrzewska W., Meagher E., Mulcahy M., Parnham A., Carney S., Garvey L., Gillies A., Hayes S., Mathew M., Fassett R., Anderson L., Clingeleffer C., Curnock A., Mayne L., Richardson D., Smith M., Smith S., Suranyi M., Howlin K., Chow J., Cleland B., Rayment G., Spicer T., Wong J., 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M., Kodras K., Leithner C., Magpantay L., Marterer C., Prager R., Prinz C., Seiringer E., Kramar R., Mitter E., Stummvoll H., Dieplinger G., Wenzel R., Stolz G., Drose S., Edlinger E., Headlam-Leitner E., Miska H., Then M., Weninger S., Lhotta K., Neyer U., Dickie H., Smodek S., Sprenger-Mahr H., Rosenkranz A., Zitt E., Mayr B., Schinner A., Soltys G., Begin V., Brunet S., Cournoyer S., Gelinas M., Giroux C., Martineau J., Roy M., Savoie L., Agharazii M., Blouin J., Desmeules S., Langlois S., Samson F., Wong G., Constantini L., Jing J., Malko J., Rivers C., Rochester D., Skilling C., Wadgymar A., Wu G., Kates D., Husch J., Mantle M., Turri L., Barrett B., Curtis B., Greeley B., Hannaford M., Harnett J., Kelly M., Langille E., Morgan J., Murphy S., Karim M., Arbo T., Carpenito G., Chan V., DaRoza G., Friesen M., Kraus D., Lam S., Lange B., Minhas S., Starko R., Torng S., Vela K., Madore F., Roy P., Troyanov S., Bonnardeaux A., Lauzon L., Pichette V., Yeates K., Mahoney K., Myers C., Pilkey R., Moist L., Edgar M., House A., Kortas C., Mindorff S., Tam P., Chow S., Fung J., Nagai G., Ng P., Sikaneta T., Ting R., Forzley B., Clouatre Y., Cooper S., DaCosta H., Granger S., Valley S., Karunakaran S., Abdulhadi M., Altwasser C., Anderson S., Bergquist L., Wijeyesinghe C., Berst L., Horgan K., Coles K., Lotter T., Robson L., Barre P., Golden J., Golden M., Tanguay N., Rigatto C., Armstrong S., Fine A., Fontaine B., Friesen D., Henry S., Kraushar M., Reslerova M., Verrelli M., Rabbat C., Clase C., Suva G., Winegard N., Goldstein M., Curvelo S., Donnelly S., Huckle J., Marticorena R., Chan-Yan C., Chiu A., DeLuca L., Flamer D., Gill J., Jamal A., Jung B., Kiaii M., Landsberg D., Rozen N., Taylor P., Werb R., Pylypchuk G., Ahmed A., Barton J., Hundseth M., Kappel J., Keindel I., Klassen J., Pylypchuk S., Rindall M., Tobe S., Naimark D., Agelopoulos M., Chessman M., Hladunewich M., Perkins N., Sainsbury S., McCready W., Adams B., Tonelli M., Caldwell S., Kumar U., McMahon 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V., Aerenlund H., Braemer-Jensen M., Kamper A., Raaschou S., Heaf J., Dreyer J., Freese P., Holm M., Munch M., Gade-Rasmussen E., Bredmose K., Daugaard H., Nielsen J., Friedberg M., Jensen D., Munk Plum M., Solling K., Dieperink H., Arp Nielsen L., Friborg E., Gloe-Jakobsen A., Thye Ronn P., Rasmussen K., Andersen C., Johansen A., Odum L., Ostergaard O., Pedersen L., Lykkegaard S., Aundal M., Faureholm Huess S., Danielsen H., Madsen J., Nyvang M., Ekstrand A., Boman H., Hartman J., Lipponen A., Lithovius R., Rauta V., Salmela A., Saloranta K., Forslund T., Koskiaho P., Jaaskelainen K., Kanninen M., Laine K., Asola M., Huhti J., Pentti M., Metsarinne K., Heiro M., Koivuviita N., Saarinen M., Tertti R., Choukroun G., Fournier A., Ducloux D., Marechal F., Simula Faivre D., Combe C., Douillet M., Lamblot T., Nardi H., Vendrely B., Bourbigot B., Ferlandin S., Zaoui P., Jouet C., Geffroy-Guiberteau S., Bugnazet L., Aldigier J., El Hamel-Belili C., Giraud S., Dussol B., Berland Y., Chollet 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Weyer J., Heine C., Kirste P., Zemann B., Alscher D., Rumpf D., Wullen B., Bengel A., Friedrich B., Kirschner T., Knodler U., Machleidt C., Niederstrasser K., Noack E., Wilhelm J., Heuer H., Dulea J., Piolot R., Rudke M., Treinen G., Elberg B., Hanke J., Nitschke T., Rosendahl C., Schmitz A., Schrader J., Kulschewski A., Lubcke C., Hammersen F., Luders S., Venneklaas U., Muhlfeld A., Arabi Al-Khanne F., Ketteler M., Politt D., Schuster C., Eitner F., Goretz U., Heidenreich S., Janssen U., Kranz A., Moormann E., Schneider B., Weber W., Frei U., Jovanovic T., Asmus H., Canaan-Kuhl S., Pannier L., Petersen S., Pluer M., Schaeffner E., Schafer C., Warncke S., Schmieder R., Donhauser C., Schulze B., Koziolek M., Bechtel W., Kurz B., Strutz F., Bramlage C., Dreyer S., Mommeyer E., Niemann J., Scheel A., Troche-Polzien I., Weber F., Heine G., Girndt M., Lizzi F., Rogacev K., Lindner T., Achenbach H., Peschel K., Beige J., Jentho S., Kreyssig C., Prill K., Renders L., Walcher J., Cerny S., Fulbier A., Kristen H., Nitschke M., Kramer J., Marek P., Meier M., Schlieter J., Heyne N., Bachmann F., Faber M., Klipp K., Kustner U., Risler T., Rath T., Ruf T., Budiman D., Seidel C., Weik S., Teo S.M., Lee L.Y., Azizah H., Faridunishah S.A., Foo S.M., Go K.W., Ghazali A., Koh K.H., Zaki M., Wong H.S., Bavanandan S., Boey L.M., Lily M., Wong S.L., Rosnawati Y., Zawawi N., Azimawati A., Hindun A., Hasnah J., Korina R., Yunaidah A., Noraidah P., Ong L.M., Noor Asma A., Liew Y.F., Rozina G., Cheong Y.H., Ang A.H., Dayang J., Lim L.S., Sukeri M., Ramli S., Zulkifli M., Wan Mahmood W.K., Goh B.L., Sarifah B., Bee B.C., Ramasamy C., Ruszarimah S., Liu W.J., Razali O., Haslinah S., Vaithilingam I., Jaaini A., Faridah L., Ng K.H., Krishnan P., Rosnah A.A., Nor Azizah A.S., Tam C.C., Tan S.H., Tan C.C., Shahnaz F.K., Wazir H., Munusamy P., Wan Shaariah M.Y., Chew T.F., Fuziah Z., Tan C.H.H., Maria L., Javelin P., Lim S.K., Nazatul S.B., Engkasan L.P., Tan S.Y., Wong M.G., Julita A.A., Ang B.B., Krishnan S., Seet W.W.T., Liew S.K., Keng T.C., Tobe T., Deelen M., Klaassen I., Grave W., Emmen M., Janssen W., Bossen W., Elzinga B., Van Der Velden A., Hemmelder M., Slagman M., Waanders F., Viergever P., Boerema I., Potter Van Loon B., Muthert B., Geers T., Schollaert N., Van Weverwijk I., Veen P., Woittiez A., Krikken J., Kwakernaak A., Visser F., Navis G., Hoekstra F., Hawkins S., McGregor D., Usher J., MacGinley R., Schollum J., Ellis G., Voss D., Rosman J., Upjohn M., Panlilio N., Madhan K., Naicker V., Anderson E., Bushell M., Lumb N., Pepperell B., Sizeland P., Hayett S., Sullivan N., Tuffery C., Macdonald A., Ostapowicz T., Wessel-Aas T., Wessel-Aas H., Bjorbaek E., Bjorbaek R., Simso I., Oien C., Bergrem H., Espedal S., Kronborg J., Solbakken K., Rocke J., Aakervik O., Haugen V., Eide T., Berglund J., Loland W., Schei T., Stromsaether C., Willadsen H., Lyngdal P., Vad A., Waldum B., Froslid G., Roaldsnes C., Rustad D., Soderblom P., Eriksen B., Hanssen E., Julsrud J., Mathisen U., Pedersen M., Rumsfeld M., Toft I., Berget K., Landsverk K., Tveiten G., Wamstad H., Klinger M., Krajewska M., Golebiowski T., Kusztal M., Spiechowicz-Zaton U., Rutkowski B., Renke M., Tylicki L., Czekalski S., Koziol L., Wanic-Kossowska M., Wasik-Olejnik A., Nowicki M., Dryja P., Kurnatowska I., Zawiasa A., Ciszek M., Gomolka M., Mysliwiec M., Brzosko S., Mazerska M., Hruby Z., Koscielniak K., Stanek-Piotrowska M., Mesjasz J., Rudka R., Baranski M., Jupowiecki J., Klein D., Switalski M., Kuriga M., Ostrowski M., Lidman A., Linde T., Waltersson K., Weiss L., Andersson G., Lindell C., Welander G., Jacobson S., Edensjo P., Wallin J., Linder M., Karsberg M., Hellgren K., Lonn I., Frisenette-Fich C., Johansson A., Lundstrom A., Mauritz N., Stahl-Nilsson A., Tobafard N., Hellberg O., Ejemar E., Von Schmalensee N., Gunne T., Eriksson A., Ostberg S., Svensson C., Mulec H., Jacobsson A., Karlsson M., Onnermalm L., Osagie S., Ekengren U., Larsson M., Lindberger K., Olofsson A., Samuelsson O., Beagan L., Dezfoolian H., Just M., Ortegren L., Saeed A., Strand U., Ramsauer B., Hultstrom D., Nordlinder K., Sundberg I., Oqvist B., Green C., Fernstrom A., Cassel A., Goransson I., Gylling M., Jorgensen A., Sterner G., Christensson A., Hjelmstedt P., Nystrom A., Sundin P., Samuelsson I., Tidman M., Johansson M., Lofgren Andersson M., Ohman M., Andersson P., Hallberg Karlsson A., Ringstad L., Chittinandana A., Chailimpamontree W., Gojaseni P., Singprasert R., Tungsanga K., Amphun W., Intim P., Kanjanabuch T., Poowarattanakul D., Treratha C., Wongvan P., Jittikanont S., Suriya T., Indrasthitya P., Sumethkul V., Ingsathit A., Jansomwong J., Lertchalorarn K., Phachiyanukul V., Phiromkit T., Saengsri S., Vareesangthip K., Chawanasuntorapoj R., Kiattisunthorn K., Larpkitkachorn R., Webster J., Henderson J., Jayne D., Hollis J., Townsend K., Harron C., Bleakley N., Hanley N., Morgan S., Brittney L., Brown H., Maxwell P., Murtagh H., Thomas M., Burke E., Carmody M., Cox G., Dasgin J., Ali G., Whitehouse L., Williams V., Brown E., Dlelana G., Esson A., Fagerbrink S., Marshall F., Mazibuko B., Nelson C., Russell E., Williams R., Altmann P., McNichols-Thomas C., Parsons K., MacGregor M., McGowan J., Mead P., Gilbanks K., Sanderson M., Fluck R., Chandler G., Hulme L., Smith J., Tse Y., West C., Taylor J., Breakspear S., Burgess B., Isles C., Bell J., Duignan J., Gorman J., Swainson C., Beveridge C., Cairns A., Miller D., Paterson F., Smith L., Kumwenda M., Glover R., Geddes C., Gemmell C., Grieve I., Matthews E., McLaren B., Meyer B., Spiers A., Banks R., Apperley P., Patterson T., Paynter H., Scoble J., Thom D., Watkins J., Kalra P., Gowland S., Haydock L., Smart I., Bhandari S., Gillett P., James K., Lewis R., Melville H., Tamimi A., Williams P., Heath T., Small S., Paterson A., Gibson N., Laven C., Wilson T., Cairns H., Casley-Ready K., Warwick G., Fentum B., James J., Kumar T., Marshall R., Ratcliffe F., Shenton A., Warwicker P., Bowser M., Mumford C., 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Wong M., Packham D., Alison C., Fraser I., Mitchell J., Nagle J., Brown F., Ellery C., Monkhouse J., Nandkumar J., Reith-Myers L., Gray N., Cocks C., Courtney M., Hollett P., Johnston C., Larsen H., Pollock A., Stewart S., Styles G., Wyndham R., Fanning M., Gibson W., Jackson S., Mannering M., Mercado E., Oliphant R., Sud K., Ubera N., Wood C., Karrasch J., Brinkley T., Estensen K., Moroney A., Sutton J., Warren R., Saltissi D., Jahke H., Roach H., Saltissi J., Wiederroth O'Brien M., Johnson D., Bali V., Evans M., Franzen K., Halbish S., Helyar J., Martin A., Mudge D., Sonnenburg K., Sudak J., Roger S., Almeida S., Andrews H., Bohringer L., Bouwhuis L., Brady L., Carpenter A., Warren S., Elias T., Bannister K., Chew G., Clarke J., Faull R., Hooper A., Jeffs L., Napier A., Peh C., Pirone K., Skilton F., Ranganathan D., Best J., Hart L., Healy H., Morgan C., Ratanjee S., Salisbury A., Jose M., Freeman J., Hamilton R., Kirkland G., Read G., Anderson H., Boekel K., Farrell M., Foreman A., 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M., Sichez H., Cristol J., Canaud B., Morena M., Rodriguez A., Kessler M., Mizejewski B., Risse B., Urena Torres P., Bou-Bekr M.A., Arezki C., Ras El Qdim P., Vela C., Borsato F., Talairach A., Normand M., Normand V., Rieu P., Gauthier B., Vigneron-Foy C., Wolak A., Menoyo V., Alos L., Caillette-Beaudoin A., Berger V., Al-Sarraf S., Konnerth I., Urban C., Weiner S., Boesken W., Jochum E., Kiefer C., Wagner A., Krumme B., Bohler J., Bonow B., Hohenstatt U., Mettang T., Rockel A., Langanke J., Lipponer H., Dunschen-Weimar G., Dunst R., Hubel E., Petrik R., Rengel R., Schmidgen M., Mayr H., Garschhammer C., Weirauch S., Anger H., Goock T., Mai A., Bast I., Suptitz C., Iwig B., Florschutz K., Hasselbacher R., Sauerbrey G., Delrieux S., Rau S., Poley M., Laux R., Schonfelder O., Kunowski G., Fuchs G., Hoffmann K., Schurger R., Brensing K., Guven Z., Immenkamp C., Kottmann C., Schmitt H., Schulz M., Arnold P., Knaup R., Schneider H., Siemsen H., Pyriki P., Korkemeyer F., Pyriki R., Siebrecht A., Schulz E., Krumwiede A., Kruse D., Lucke S., Keim H., Fink H., Fischer S., Klingbeil A., Kuhlmei K., Ortwein-Horn N., Merker L., Bayer B., Benamar K., Emmert S., Floten E., Holzheuer K., Lummer M., Ossendorf E., Scholz M., Oppitz M., Georgiew L., Tripps C., Wendehake M., Lange D., Pingel V., Brause M., Schanze W., Duygulu E., Dellanna F., Heinemann-Nieberding S., Sturmer C., Wieczorek K., Zarga O., Kullmer B., Kullmer S., Akin M., Gondolf M., Schutterle S., Walker G., Bertsch R., Seul M., Allendorff J., Siehler R., Stemmler S., Baldus M., Adler A., Harter S., Wurmell W., Moller M., Hame C., Muller M., Schreiber M., Schurfeld C., Millington-Herrmann M., Benschneider A., Gaffal J., Sprunken U., Bohling M., Wunderlich S., Schramm L., Kollenbrath C., Netzer K., Sieber T., Zimmermann J., Bellersen M., Uerkvitz M., David-Walek T., Hauschildt B., Leimenstoll G., Lonnemann G., Hilfenhaus M., Benedetto C., Stockmann S., Ichtiaris P., Jungmann A., Neumeier K., Stoof A., Bohmer K., Kirpal A., Knogl A., Flege F., Franke K., Groth P., Parensen E., Bockmann M., Przyklenk P., Piazolo L., Thinius-Jaudas L., Versen A., Hettich R., Arendt R., Geiger K., Hoppe H., Schwarting A., Beyer T., Faust J., Hazenbiller A., Tschirner S., Grupp C., Dorsch O., Eigner-Schmidtchen M., Michler K., Roth J., Schramm S., Waldmuller G., Riedl B., Vogele-Dirks H., Linz J., Biggar P., Hennemann H., Bauer G., Buchholz J., Fischer P., Bihlmaier W., Baumann A., Peichl B., Roser S., Ludewig S., Ricksgers M., Szendzielorz M., Baus A., Baust K., Schaller P., Schnellbacher G., Sorensen S., Buschges-Seraphin B., Hauenstein L., Hofmann B., Nikolay J., Merkel F., Nebel M., Petersen J., Schweb S., Zeissler H., Baumhackel K., Krauss A., Schafer R., Pastor A., Zielinski B., Strauss H., Theis H., Burkhardt K., Heckel M., Hussendorfer K., Bahner U., Brandl M., Hammerl-Kraus B., Herrmann D., Kramer H., Baudenbacher H., Blaser C., Buschmann G., Eckert G., Ehrich H., Hofmann K., Huller U., Geiger H., Becker B., Hoischen 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Weyer J., Heine C., Kirste P., Zemann B., Alscher D., Rumpf D., Wullen B., Bengel A., Friedrich B., Kirschner T., Knodler U., Machleidt C., Niederstrasser K., Noack E., Wilhelm J., Heuer H., Dulea J., Piolot R., Rudke M., Treinen G., Elberg B., Hanke J., Nitschke T., Rosendahl C., Schmitz A., Schrader J., Kulschewski A., Lubcke C., Hammersen F., Luders S., Venneklaas U., Muhlfeld A., Arabi Al-Khanne F., Ketteler M., Politt D., Schuster C., Eitner F., Goretz U., Heidenreich S., Janssen U., Kranz A., Moormann E., Schneider B., Weber W., Frei U., Jovanovic T., Asmus H., Canaan-Kuhl S., Pannier L., Petersen S., Pluer M., Schaeffner E., Schafer C., Warncke S., Schmieder R., Donhauser C., Schulze B., Koziolek M., Bechtel W., Kurz B., Strutz F., Bramlage C., Dreyer S., Mommeyer E., Niemann J., Scheel A., Troche-Polzien I., Weber F., Heine G., Girndt M., Lizzi F., Rogacev K., Lindner T., Achenbach H., Peschel K., Beige J., Jentho S., Kreyssig C., Prill K., Renders L., Walcher J., Cerny S., 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Samuelsson O., Beagan L., Dezfoolian H., Just M., Ortegren L., Saeed A., Strand U., Ramsauer B., Hultstrom D., Nordlinder K., Sundberg I., Oqvist B., Green C., Fernstrom A., Cassel A., Goransson I., Gylling M., Jorgensen A., Sterner G., Christensson A., Hjelmstedt P., Nystrom A., Sundin P., Samuelsson I., Tidman M., Johansson M., Lofgren Andersson M., Ohman M., Andersson P., Hallberg Karlsson A., Ringstad L., Chittinandana A., Chailimpamontree W., Gojaseni P., Singprasert R., Tungsanga K., Amphun W., Intim P., Kanjanabuch T., Poowarattanakul D., Treratha C., Wongvan P., Jittikanont S., Suriya T., Indrasthitya P., Sumethkul V., Ingsathit A., Jansomwong J., Lertchalorarn K., Phachiyanukul V., Phiromkit T., Saengsri S., Vareesangthip K., Chawanasuntorapoj R., Kiattisunthorn K., Larpkitkachorn R., Webster J., Henderson J., Jayne D., Hollis J., Townsend K., Harron C., Bleakley N., Hanley N., Morgan S., Brittney L., Brown H., Maxwell P., Murtagh H., Thomas M., Burke E., Carmody M., Cox G., 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- Abstract
Background: Lowering low-density lipoprotein (LDL) cholesterol with statin therapy has been shown to reduce the incidence of atherosclerotic events in many types of patient, but it remains uncertain whether it is of net benefit among people with chronic kidney disease (CKD). Method(s): Patients with advanced CKD (blood creatinine >=1.7 mg/dL [>= 150 mumol/L] in men or >=1.5 mg/dL [ >= 130 mumol/L] in women) with no known history of myocardial infarction or coronary revascularization were randomized in a ratio of 4:4:1 to ezetimibe 10 mg plus simvastatin 20 mg daily versus matching placebo versus simvastatin 20 mg daily (with the latter arm rerandomized at 1 year to ezetimibe 10 mg plus simvastatin 20 mg daily vs placebo). The key outcome will be major atherosclerotic events, defined as the combination of myocardial infarction, coronary death, ischemic stroke, or any revascularization procedure. Results A total of 9,438 CKD patients were randomized, of whom 3,056 were on dialysis. Mean age was 61 years, two thirds were male, one fifth had diabetes mellitus, and one sixth had vascular disease. Compared with either placebo or simvastatin alone, allocation to ezetimibe plus simvastatin was not associated with any excess of myopathy, hepatic toxicity, or biliary complications during the first year of follow-up. Compared with placebo, allocation to ezetimibe 10 mg plus simvastatin 20 mg daily yielded average LDL cholesterol differences of 43 mg/dL (1.10 mmol/L) at 1 year and 33 mg/dL (0.85 mmol/L) at 2.5 years. Follow-up is scheduled to continue until August 2010, when all patients will have been followed for at least 4 years. Conclusions SHARP should provide evidence about the efficacy and safety of lowering LDL cholesterol with the combination of ezetimibe and simvastatin among a wide range of patients with CKD.Copyright © 2010, Mosby, Inc. All rights reserved.
- Published
- 2010
47. The EMPOWER Study: Design, Methodology and Baseline Features of the First Phase III Clinical Trial of Dexpramipexole for Patients with ALS (S25.004)
- Author
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Cudkowicz, M., primary, Van den Berg, L., additional, Bozik, M., additional, Ingersoll, E., additional, Coppell, A., additional, Farwell, W., additional, Dong, Y., additional, and Kerr, D., additional
- Published
- 2012
- Full Text
- View/download PDF
48. Demographic, dietary, and serum factors and parathyroid hormone in the National Health and Nutrition Examination Survey
- Author
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Paik, J. M., primary, Farwell, W. R., additional, and Taylor, E. N., additional
- Published
- 2011
- Full Text
- View/download PDF
49. Clinical Meaningfulness of the Changes in Muscle Performance and Physical Function Associated With Testosterone Administration in Older Men With Mobility Limitation
- Author
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Travison, T. G., primary, Basaria, S., additional, Storer, T. W., additional, Jette, A. M., additional, Miciek, R., additional, Farwell, W. R., additional, Choong, K., additional, Lakshman, K., additional, Mazer, N. A., additional, Coviello, A. D., additional, Knapp, P. E., additional, Ulloor, J., additional, Zhang, A., additional, Brooks, B., additional, Nguyen, A.-H., additional, Eder, R., additional, LeBrasseur, N., additional, Elmi, A., additional, Appleman, E., additional, Hede-Brierley, L., additional, Bhasin, G., additional, Bhatia, A., additional, Lazzari, A., additional, Davis, S., additional, Ni, P., additional, Collins, L., additional, and Bhasin, S., additional
- Published
- 2011
- Full Text
- View/download PDF
50. Statins and Prostate Cancer Diagnosis and Grade in a Veterans Population
- Author
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Farwell, W. R., primary, D'Avolio, L. W., additional, Scranton, R. E., additional, Lawler, E. V., additional, and Gaziano, J. M., additional
- Published
- 2011
- Full Text
- View/download PDF
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