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Sodium oxybate demonstrates long-term efficacy for the treatment of cataplexy in patients with narcolepsy.
Sleep Med. 2004 Mar; 5(2):119-23.SM

Abstract

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.

Authors

No affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15033130

Citation

U.S. Xyrem Multicenter Study Group. "Sodium Oxybate Demonstrates Long-term Efficacy for the Treatment of Cataplexy in Patients With Narcolepsy." Sleep Medicine, vol. 5, no. 2, 2004, pp. 119-23.
U.S. Xyrem Multicenter Study Group. Sodium oxybate demonstrates long-term efficacy for the treatment of cataplexy in patients with narcolepsy. Sleep Med. 2004;5(2):119-23.
U.S. Xyrem Multicenter Study Group. (2004). Sodium oxybate demonstrates long-term efficacy for the treatment of cataplexy in patients with narcolepsy. Sleep Medicine, 5(2), 119-23.
U.S. Xyrem Multicenter Study Group. Sodium Oxybate Demonstrates Long-term Efficacy for the Treatment of Cataplexy in Patients With Narcolepsy. Sleep Med. 2004;5(2):119-23. PubMed PMID: 15033130.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Sodium oxybate demonstrates long-term efficacy for the treatment of cataplexy in patients with narcolepsy. A1 - ,, PY - 2003/08/12/received PY - 2003/11/12/revised PY - 2003/11/20/accepted PY - 2004/3/23/pubmed PY - 2004/7/3/medline PY - 2004/3/23/entrez SP - 119 EP - 23 JF - Sleep medicine JO - Sleep Med VL - 5 IS - 2 N2 - 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. SN - 1389-9457 UR - https://www.unboundmedicine.com/medline/citation/15033130/Sodium_oxybate_demonstrates_long_term_efficacy_for_the_treatment_of_cataplexy_in_patients_with_narcolepsy_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1389945703002491 DB - PRIME DP - Unbound Medicine ER -