An academic debate: OnabotulinumtoxinA for chronic migraine: PREEMPT-derived vs "customized" dosing/injection paradigm

被引:3
作者
Green, Mark W. [1 ]
Rothrock, John F. [2 ]
机构
[1] Icahn Sch Med Mt Sinai, New York, NY 10029 USA
[2] George Washington Sch, Med Sch, Washington, DC 20037 USA
关键词
OnabotulinumtoxinA; Chronic migraine; PREEMPT; PLACEBO-CONTROLLED PHASE; TOXIN TYPE-A; DOUBLE-BLIND; MENINGEAL NOCICEPTORS; INHIBITION;
D O I
10.1016/j.toxicon.2018.03.011
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
In 2010 onabotulinumtoxinA (OnabotA) was approved by the United States Food and Drug Administration for the treatment of chronic migraine (CM). Data supporting approval were derived primarily from two parallel placebo-controlled trials, the PREEMPT studies. Many clinicians and research investigators critical of those data have recommended that the dosing/injection paradigm for treating CM be "customized" to the needs of the individual patient rather than administered in a uniform fashion conforming to the methodology utilized in the PREEMPT studies. In this paper the authors debate the issue of whether treatment of CM with OnabotA should be standardized versus customized. (C) 2018 Elsevier Ltd. All rights reserved.
引用
收藏
页码:116 / 119
页数:4
相关论文
共 17 条
  • [1] OnabotulinumtoxinA for chronic migraine: efficacy, safety, and tolerability in patients who received all five treatment cycles in the PREEMPT clinical program
    Aurora, S. K.
    Dodick, D. W.
    Diener, H. -C.
    DeGryse, R. E.
    Turkel, C. C.
    Lipton, R. B.
    Silberstein, S. D.
    [J]. ACTA NEUROLOGICA SCANDINAVICA, 2014, 129 (01): : 61 - 70
  • [2] Aurora SK, 2010, CEPHALALGIA, V30, P793, DOI 10.1177/0333102410364676
  • [3] OnabotulinumtoxinA for Treatment of Chronic Migraine: Pooled Analyses of the 56-Week PREEMPT Clinical Program
    Aurora, Sheena K.
    Winner, Paul
    Freeman, Marshall C.
    Spierings, Egilius L.
    Heiring, Jessica O.
    DeGryse, Ronald E.
    VanDenburgh, Amanda M.
    Nolan, Marissa E.
    Turkel, Catherine C.
    [J]. HEADACHE, 2011, 51 (09): : 1358 - 1373
  • [4] Selective inhibition of meningeal nociceptors by botulinum neurotoxin type A: Therapeutic implications for migraine and other pains
    Burstein, Rami
    Zhang, XiChun
    Levy, Dan
    Aoki, K. Roger
    Brin, Mitchell F.
    [J]. CEPHALALGIA, 2014, 34 (11) : 853 - 869
  • [5] Glucosamine, chondroitin sulfate, and the two in combination for painful knee osteoarthritis
    Clegg, DO
    Reda, DJ
    Harris, CL
    Klein, MA
    O'Dell, JR
    Hooper, MM
    Bradley, JD
    Bingham, CO
    Weisman, MH
    Jackson, CG
    Lane, NE
    Cush, JJ
    Moreland, LW
    Schumacher, HR
    Oddis, CV
    Wolfe, F
    Molitor, JA
    Yocum, DE
    Schnitzer, TJ
    Furst, DE
    Sawitzke, AD
    Shi, H
    Brandt, KD
    Moskowitz, RW
    Williams, HJ
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 2006, 354 (08) : 795 - 808
  • [6] OnabotulinumtoxinA for treatment of chronic migraine: Results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial
    Diener, H. C.
    Dodick, D. W.
    Aurora, S. K.
    Turkel, C. C.
    DeGryse, R. E.
    Lipton, R. B.
    Silberstein, S. D.
    Brin, M. F.
    [J]. CEPHALALGIA, 2010, 30 (07) : 804 - 814
  • [7] OnabotulinumtoxinA for Treatment of Chronic Migraine: Pooled Results From the Double-Blind, Randomized, Placebo-Controlled Phases of the PREEMPT Clinical Program
    Dodick, David W.
    Turkel, Catherine C.
    DeGryse, Ronald E.
    Aurora, Sheena K.
    Silberstein, Stephen D.
    Lipton, Richard B.
    Diener, Hans-Christoph
    Brin, Mitchell F.
    [J]. HEADACHE, 2010, 50 (06): : 921 - 936
  • [8] Regulation of calcitonin gene-related peptide secretion from trigeminal nerve cells by botulinum toxin type A: Implications for migraine therapy
    Durham, PL
    Cady, R
    Cady, R
    [J]. HEADACHE, 2004, 44 (01): : 35 - 42
  • [9] Fragoso G., 2014, J NEUROL DISORD, V02, P2
  • [10] Grogan P, 2016, NEUROLOGY, V86