Sodium oxybate demonstrates long-term efficacy for the treatment of cataplexy in patients with narcolepsy

被引:121
作者
Black, J [1 ]
Emsellem, H
Chase, C
Feldman, N
Hagaman, M
Hayduk, R
Lankford, D
Kathawalla, S
Marmion, L
Mitler, M
Pascualy, R
Sahota, P
Scharf, M
Scrima, L
Swick, T
Ware, J
机构
[1] Stanford Sleep Disorders Clin, Stanford, CA USA
[2] Ctr Sleep Wake Disorders, Chevy Chase, MD USA
[3] St Petersburg Sleep Disorders Ctr, St Petersburg, FL USA
[4] St Thomas Hosp, Nashville, TN USA
[5] Pacific Sleep Med Serv, La Jolla, CA USA
[6] Pulm Dept Pk Nicollet Clin, Minneapolis, MN USA
[7] Sleep Disorders Ctr Georgia, Atlanta, GA USA
[8] Spectrum Hlth Sleep Disorders Ctr, Kentwood, MI USA
[9] Pacific Sleep Med Serv, La Jolla, CA USA
[10] Swedish Med Ctr, Seattle, WA USA
[11] Univ Missouri, Div Neurol, Columbia, MO USA
[12] Ctr Res Sleep Disorders, Cincinnati, OH USA
[13] Sleep Alertness Disorders Ctr Inc, Aurora, CO USA
[14] Houston Sleep Ctr, Houston, TX USA
[15] Eastern Virginia Med Sch, Norfolk, VA 23501 USA
关键词
sodium oxybate; gamma-hydroxybutyrate; narcolepsy; cataplexy;
D O I
10.1016/j.sleep.2003.11.002
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
Background and purpose: This study was conducted to demonstrate the long-term efficacy of sodium oxybate for the long-term treatment of cataplexy in patients with narcolepsy. Patients and methods: Fifty-five (55) narcoleptic patients with cataplexy who had received continuous treatment with sodium oxybate for 7-44 months (mean 21 months) were enrolled in a double-blind treatment withdrawal paradigm. A 2-week single-blind sodium oxybate treatment phase established a baseline for the weekly occurrence of cataplexy. This was followed by a 2-week double-blind phase in which patients were randomized to receive unchanged drug therapy or placebo. Patients recorded the incidence of cataplexy attacks and adverse events in daily diaries. Results: During the 2-week double-blind phase, the abrupt cessation of sodium oxybate therapy in the placebo patients resulted in a significant increase in the number of cataplexy attacks (median = 21; P < 0.001) compared to patients who remained on sodium oxybate (median = 0). Cataplexy attacks returned gradually with placebo patients reporting a median of 4.2 and 11.7 cataplexy attacks during the first and second weeks, respectively. There were no symptoms of frank withdrawal. Conclusions: This controlled trial provides evidence supporting the long-term efficacy of sodium oxybate for the treatment of cataplexy. In contrast with antidepressant drug therapy, there is no evidence of rebound cataplexy upon abrupt discontinuation of treatment. (C) 2004 Elsevier B.V. All rights reserved.
引用
收藏
页码:119 / 123
页数:5
相关论文
共 20 条
[1]  
Black J, 2003, SLEEP, V26, P31
[2]   The abrupt cessation of therapeutically administered sodium oxybate (GHB) does not cause withdrawal symptoms [J].
Black, J ;
Emsellem, H ;
Feldman, N ;
Hagaman, M ;
Hayduk, R ;
Kathawalla, S ;
Lankford, D ;
Marmion, L ;
Mitler, M ;
Pascualy, R ;
Sahota, P ;
Scharf, M ;
Scrima, L ;
Swick, T ;
Ware, J .
JOURNAL OF TOXICOLOGY-CLINICAL TOXICOLOGY, 2003, 41 (02) :131-135
[3]  
Black J, 2002, SLEEP, V25, P42
[4]  
BROUGHTON R, 1979, CAN J NEUROL SCI, V6, P1
[5]  
BROUGHTON R, 1980, CAN J NEUROL SCI, V7, P23
[6]  
*CEPH INC, 2002, PROV PRESCR INF
[7]   Narcolepsy in orexin knockout mice:: Molecular genetics of sleep regulation [J].
Chemelli, RM ;
Willie, JT ;
Sinton, CM ;
Elmquist, JK ;
Scammell, T ;
Lee, C ;
Richardson, JA ;
Williams, SC ;
Xiong, YM ;
Kisanuki, Y ;
Fitch, TE ;
Nakazato, M ;
Hammer, RE ;
Saper, CB ;
Yanagisawa, M .
CELL, 1999, 98 (04) :437-451
[8]   Effects of lateral hypothalamic lesion with the neurotoxin hypocretin-2-saporin on sleep in Long-Evans rats [J].
Gerashchenko, D ;
Blanco-Centurion, C ;
Greco, MA ;
Shiromani, PJ .
NEUROSCIENCE, 2003, 116 (01) :223-235
[9]   Narcolepsy - Current drug treatment options [J].
Hublin, C .
CNS DRUGS, 1996, 5 (06) :426-436
[10]   Hypocretin (Orexin) levels in cerebrospinal fluid of patients with narcolepsy: Relationship to cataplexy and HLA DQB1*0602 status [J].
Krahn, LE ;
Pankratz, VS ;
Oliver, L ;
Boeve, BF ;
Silber, MH .
SLEEP, 2002, 25 (07) :733-736