Tags

Type your tag names separated by a space and hit enter

Further evidence supporting the use of sodium oxybate for the treatment of cataplexy: a double-blind, placebo-controlled study in 228 patients.
Sleep Med. 2005 Sep; 6(5):415-21.SM

Abstract

BACKGROUND AND PURPOSE

To measure the effect of the nocturnal administration of sodium oxybate on cataplexy in patients with narcolepsy.

PATIENTS AND METHODS

This trial was conducted with 228 adult narcolepsy/cataplexy patients in 42 sleep clinics. Patients using anticataplectic medications were weaned from these medications, then randomized to receive 4.5, 6 or 9 g sodium oxybate nightly or placebo for 8 weeks. Patients receiving 6 and 9 g doses were titrated to their final dose in weekly 1.5 g increments. Placebo patients underwent a randomized mock dose-titration schedule. The effect of sodium oxybate on weekly cataplexy attacks was measured using patient daily diaries.

RESULTS

Compared to placebo, nightly doses of 4.5, 6 and 9 g sodium oxybate for 8 weeks resulted in statistically significant median decreases in weekly cataplexy attacks of 57.0, 65.0 and 84.7%, respectively. The decrease in cataplexy at the 4.5 g dose represents a novel finding. The weekly increase in sodium oxybate dose was associated with fewer adverse events than previously reported in double-blind sodium oxybate trials using fixed doses. Some adverse events reported demonstrated a clear dose-response relationship.

CONCLUSIONS

In the largest study of its kind, sodium oxybate was highly effective for the treatment of cataplexy. The improvements in cataplexy are dependent on the dosage of sodium oxybate as well on the duration of treatment. Weekly dose titration appears to be well-tolerated.

Authors

No affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

16099718

Citation

Xyrem International Study Group. "Further Evidence Supporting the Use of Sodium Oxybate for the Treatment of Cataplexy: a Double-blind, Placebo-controlled Study in 228 Patients." Sleep Medicine, vol. 6, no. 5, 2005, pp. 415-21.
Xyrem International Study Group. Further evidence supporting the use of sodium oxybate for the treatment of cataplexy: a double-blind, placebo-controlled study in 228 patients. Sleep Med. 2005;6(5):415-21.
Xyrem International Study Group. (2005). Further evidence supporting the use of sodium oxybate for the treatment of cataplexy: a double-blind, placebo-controlled study in 228 patients. Sleep Medicine, 6(5), 415-21.
Xyrem International Study Group. Further Evidence Supporting the Use of Sodium Oxybate for the Treatment of Cataplexy: a Double-blind, Placebo-controlled Study in 228 Patients. Sleep Med. 2005;6(5):415-21. PubMed PMID: 16099718.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Further evidence supporting the use of sodium oxybate for the treatment of cataplexy: a double-blind, placebo-controlled study in 228 patients. A1 - ,, PY - 2004/11/19/received PY - 2005/03/17/revised PY - 2005/03/17/accepted PY - 2005/8/16/pubmed PY - 2006/2/8/medline PY - 2005/8/16/entrez SP - 415 EP - 21 JF - Sleep medicine JO - Sleep Med VL - 6 IS - 5 N2 - BACKGROUND AND PURPOSE: To measure the effect of the nocturnal administration of sodium oxybate on cataplexy in patients with narcolepsy. PATIENTS AND METHODS: This trial was conducted with 228 adult narcolepsy/cataplexy patients in 42 sleep clinics. Patients using anticataplectic medications were weaned from these medications, then randomized to receive 4.5, 6 or 9 g sodium oxybate nightly or placebo for 8 weeks. Patients receiving 6 and 9 g doses were titrated to their final dose in weekly 1.5 g increments. Placebo patients underwent a randomized mock dose-titration schedule. The effect of sodium oxybate on weekly cataplexy attacks was measured using patient daily diaries. RESULTS: Compared to placebo, nightly doses of 4.5, 6 and 9 g sodium oxybate for 8 weeks resulted in statistically significant median decreases in weekly cataplexy attacks of 57.0, 65.0 and 84.7%, respectively. The decrease in cataplexy at the 4.5 g dose represents a novel finding. The weekly increase in sodium oxybate dose was associated with fewer adverse events than previously reported in double-blind sodium oxybate trials using fixed doses. Some adverse events reported demonstrated a clear dose-response relationship. CONCLUSIONS: In the largest study of its kind, sodium oxybate was highly effective for the treatment of cataplexy. The improvements in cataplexy are dependent on the dosage of sodium oxybate as well on the duration of treatment. Weekly dose titration appears to be well-tolerated. SN - 1389-9457 UR - https://www.unboundmedicine.com/medline/citation/16099718/Further_evidence_supporting_the_use_of_sodium_oxybate_for_the_treatment_of_cataplexy:_a_double_blind_placebo_controlled_study_in_228_patients_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1389-9457(05)00074-2 DB - PRIME DP - Unbound Medicine ER -