Abstract | STUDY OBJECTIVES: DESIGN: Randomized, double-blind, placebo-controlled 28-day parallel-group study. SETTING: Eleven sleep centers in Germany. PATIENTS: INTERVENTIONS: Patients received vestipitant (15 mg) or placebo for 28 days; 2-night polysomnographic assessment occurred on nights 1/2 and 27/28. MEASUREMENTS AND RESULTS: Wake after sleep onset (WASO) was improved on nights 1/2 and 27/28 (ratio, vestipitant versus placebo [95% confidence interval]: 0.76 [0.65, 0.90], P = 0.001 and 0.79 [0.65, 0.96], P = 0.02, respectively), demonstrating maintenance of the effect following repeated dosing. Latency to persistent sleep was shorter with vestipitant on nights 1/2 (P = 0.0006 versus placebo), but not on nights 27/28. Total sleep time (TST) improved with vestipitant (nights 1/2: P < 0.0001, nights 27/28: P = 0.02 versus placebo). Next-day cognitive function tests demonstrated no residual effects of vestipitant (P > 0.05 versus placebo). Adverse events (AEs) occurred in 25% of vestipitant patients versus 22% for placebo. Headache was the most common AE (8% of vestipitant patients versus 9% for placebo). CONCLUSIONS:
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Authors | Emiliangelo Ratti, David J Carpenter, Stefano Zamuner, Sofia Fernandes, Lisa Squassante, Heidi Danker-Hopfe, Graeme Archer, Jonathan Robertson, Robert Alexander, David G Trist, Emilio Merlo-Pich |
Journal | Sleep
(Sleep)
Vol. 36
Issue 12
Pg. 1823-30
(Dec 01 2013)
ISSN: 1550-9109 [Electronic] United States |
PMID | 24293756
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Fluorobenzenes
- Neurokinin-1 Receptor Antagonists
- Piperidines
- vestipitant
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Topics |
- Adult
- Double-Blind Method
- Female
- Fluorobenzenes
(therapeutic use)
- Humans
- Male
- Middle Aged
- Neurokinin-1 Receptor Antagonists
(therapeutic use)
- Piperidines
(therapeutic use)
- Polysomnography
- Sleep Initiation and Maintenance Disorders
(drug therapy)
- Treatment Outcome
- Young Adult
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