4 results
A long-term, open-label study of valbenazine for tardive dyskinesia
- Jean-Pierre Lindenmayer, Cherian Verghese, Stephen R. Marder, Joshua Burke, Roland Jimenez, Scott Siegert, Grace S. Liang, Christopher F. O’Brien
-
- Journal:
- CNS Spectrums / Volume 26 / Issue 4 / August 2021
- Published online by Cambridge University Press:
- 18 May 2020, pp. 345-353
-
- Article
-
- You have access Access
- Open access
- HTML
- Export citation
-
Background
Individuals with tardive dyskinesia (TD) who completed a long-term study (KINECT 3 or KINECT 4) of valbenazine (40 or 80 mg/day, once-daily for up to 48 weeks followed by 4-week washout) were enrolled in a subsequent study (NCT02736955) that was primarily designed to further evaluate the long-term safety of valbenazine.
MethodsParticipants were initiated at 40 mg/day (following prior valbenazine washout). At week 4, dosing was escalated to 80 mg/day based on tolerability and clinical assessment of TD; reduction to 40 mg/day was allowed for tolerability. The study was planned for 72 weeks or until termination due to commercial availability of valbenazine. Assessments included the Clinical Global Impression of Severity-TD (CGIS-TD), Patient Satisfaction Questionnaire (PSQ), and treatment-emergent adverse events (TEAEs).
ResultsAt study termination, 85.7% (138/161) of participants were still active. Four participants had reached week 60, and none reached week 72. The percentage of participants with a CGIS-TD score ≤2 (normal/not ill or borderline ill) increased from study baseline (14.5% [23/159]) to week 48 (64.3% [36/56]). At baseline, 98.8% (158/160) of participants rated their prior valbenazine experience with a PSQ score ≤2 (very satisfied or somewhat satisfied). At week 48, 98.2% (55/56) remained satisfied. Before week 4 (dose escalation), 9.4% of participants had ≥1 TEAE. After week 4, the TEAE incidence was 49.0%. No TEAE occurred in ≥5% of participants during treatment (before or after week 4).
ConclusionsValbenazine was well-tolerated and persistent improvements in TD were found in adults who received once-daily treatment for >1 year.
Contributors
-
- By Cecil S. Ash, Paul Barach, Ulrike Buehner, M. Ross Bullock, Leonardo Canale, Henry G. Chou, Jeffrey A. Claridge, John J. Como, Armagan Dagal, Martin Dauber, James S. Davis, Shalini Dhir, François Donati, Roman Dudaryk, Richard P. Dutton, Talmage D. Egan, Yashar Eshraghi, John R. Fisgus, Jeff Gadsden, Sugantha Ganapathy, Mark A. Gerhardt, Inderjit Gill, Joseph F. Golob, Glenn P. Gravlee, Marcello Guglielmi, Jana Hambley, Peter Hebbard, Elena J. Holak, Khadil Hosein, Ken Johnson, Matthew A. Joy, George W. Kanellakos, Olga Kaslow, Arthur M. Lam, Vanetta Levesque, Jessica Anne Lovich-Sapola, M. Jocelyn Loy, Peter F. Mahoney, Donn Marciniak, Maureen McCunn, Craig C. McFarland, Maroun J. Mhanna, Timothy Moore, Cynthia Nguyen, Maxim Novikov, E. Orestes O’Brien, Ketan P. Parekh, Claire L. Park, Michael J. A. Parr, Elie Rizkala, Steven Roth, Alistair Royse, Colin Royse, Kasia Petelenz Rubin, David Ryan, Claire Sandstrom, Carl I. Schulman, Rishad Shaikh, Ranjita Sharma, Jeffrey H. Silverstein, Peter Slinger, Charles E. Smith, Christopher Smith, Paul Soeding, Rakesh V. Sondekoppam, P. David Soran, Eldar Søreide, Elizabeth A. Steele, Kristian Strand, Dennis M. Super, Kutaiba Tabbaa, Nicholas T. Tarmey, Joshua M. Tobin, Kalpana Tyagaraj, Heather A. Vallier, Sandra Werner, Earl Willis Weyers, William C. Wilson, Shoji Yokobori, Charles J. Yowler
- Edited by Charles E. Smith
-
- Book:
- Trauma Anesthesia
- Published online:
- 05 April 2015
- Print publication:
- 09 April 2015, pp vii-x
-
- Chapter
- Export citation
Contributors
-
- By Amy F.T. Arnsten, Darrick T. Balu, Anthony W. Bannon, James E. Barrett, Craig W. Berridge, David L. Braff, Jiang-Fan Chen, Guang Chen, Joseph T. Coyle, David M. Devilbiss, Wayne C. Drevets, Craig A. Erickson, Michael Gandal, Maciej Gasior, Charles F. Gillespie, Donald C. Goff, Swati Gupta, Ioline D. Henter, Tong Li, Farah D. Lubin, Christopher J. McDougle, Husseini K. Manji, Nicholas J. Maragakis, Charles P. O'Brien, Ryley Parrish, David J. Posey, Donald L. Price, Jorge A. Quiroz, Kerry J. Ressler, Timothy P.L. Roberts, Richard A. Rudick, Alfred W. Sandrock, Alena V. Savonenko, Brooke E. Schmeichel, Steven J. Siegel, Robert C. Spencer, Kimberly A. Stigler, Paulo Vianney-Rodrigues, John P. Welsh, Tamara Weiss, Frank Wiegand, Michael Williams, Philip C. Wong
- Edited by James E. Barrett, Joseph T. Coyle, Michael Williams
-
- Book:
- Translational Neuroscience
- Published online:
- 05 July 2012
- Print publication:
- 28 June 2012, pp vi-viii
-
- Chapter
- Export citation
Summary for Policymakers
- from Section II
-
- By Simon K. Allen, Vicente Barros, Ian Burton, Diarmid Campbell-Lendrum, Omar-Dario Cardona, Susan L. Cutter, O. Pauline Dube, Kristie L. Ebi, Christopher B. Field, John W. Handmer, Padma N. Lal, Allan Lavell, Katharine J. Mach, Michael D. Mastrandrea, Gordon A. McBean, Reinhard Mechler, Tom Mitchell, Neville Nicholls, Karen L. O'Brien, Taikan Oki, Michael Oppenheimer, Mark Pelling, Gian-Kasper Plattner, Roger S. Pulwarty, Sonia I. Seneviratne, Thomas F. Stocker, Maarten K. van Aalst, Carolina S. Vera, Thomas J. Wilbanks
- Edited by Christopher B. Field, Vicente Barros, Thomas F. Stocker, Qin Dahe
-
- Book:
- Managing the Risks of Extreme Events and Disasters to Advance Climate Change Adaptation
- Published online:
- 05 August 2012
- Print publication:
- 28 May 2012, pp 3-22
-
- Chapter
- Export citation
-
Summary
Context
This Summary for Policymakers presents key findings from the Special Report on Managing the Risks of Extreme Events and Disasters to Advance Climate Change Adaptation (SREX). The SREX approaches the topic by assessing the scientific literature on issues that range from the relationship between climate change and extreme weather and climate events (‘climate extremes’) to the implications of these events for society and sustainable development. The assessment concerns the interaction of climatic, environmental, and human factors that can lead to impacts and disasters, options for managing the risks posed by impacts and disasters, and the important role that non-climatic factors play in determining impacts. Box SPM.1 defines concepts central to the SREX.
The character and severity of impacts from climate extremes depend not only on the extremes themselves but also on exposure and vulnerability. In this report, adverse impacts are considered disasters when they produce widespread damage and cause severe alterations in the normal functioning of communities or societies. Climate extremes, exposure, and vulnerability are influenced by a wide range of factors, including anthropogenic climate change, natural climate variability, and socioeconomic development (Figure SPM.1). Disaster risk management and adaptation to climate change focus on reducing exposure and vulnerability and increasing resilience to the potential adverse impacts of climate extremes, even though risks cannot fully be eliminated (Figure SPM.2). Although mitigation of climate change is not the focus of this report, adaptation and mitigation can complement each other and together can significantly reduce the risks of climate change. [SYR AR4, 5.3]