Pitolisant versus placebo for excessive daytime sleepiness in narcolepsy and obstructive sleep apnea: A meta-analysis from randomized controlled trials.
Pharmacol Res
; 167: 105522, 2021 05.
Article
em En
| MEDLINE
| ID: mdl-33667687
ABSTRACT
Excessive daytime sleepiness is considered as the prominent symptom in narcolepsy and Obstructive Sleep Apnea (OSA). Pitolisant is a novel selective histamine H3 receptor antagonist approved for improving excessive daytime sleepiness. The meta-analysis is conducted to assess the efficacy and safety of pitolisant versus placebo for excessive daytime sleepiness in narcolepsy and OSA. PubMed, Embase and Cochrane Library databases were searched from earliest date to November 2020 for randomized controlled trials (RCTs). The primary outcomes were mean changes in Epworth Sleepiness Scale (ESS), mean sleep latency, European quality-of-life questionnaire (EQ-5D), and risk ratio of treatment-emergent adverse events (TEAEs). We pooled 678 patients from four RCTs and found pitolisant significantly decreased ESS by mean difference (MD) of - 2.86 points (95% CI -3.75 to -1.96), increased mean sleep latency by MD of 3.14 min (95% CI 2.18-4.11), and increased EQ-5D by MD of 3.32 points (95% CI 0.26-6.39) compared with placebo. The risk ratio of TEAE was 1.37 (95% CI 1.08-1.74). Insomnia was the only TEAE significantly associated with pitolisant treatment. In conclusion, pitolisant showed great efficacy and controllable security versus placebo for excessive daytime sleepiness in narcolepsy and OSA. Compared with narcolepsy, patients with OSA were deemed to benefit more from pitolisant especially in terms of improving mobility and quality of life of patients without continuous positive airway pressure therapy.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Piperidinas
/
Apneia Obstrutiva do Sono
/
Antagonistas dos Receptores Histamínicos
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Distúrbios do Sono por Sonolência Excessiva
/
Narcolepsia
Tipo de estudo:
Clinical_trials
/
Etiology_studies
/
Systematic_reviews
Limite:
Humans
Idioma:
En
Revista:
Pharmacol Res
Assunto da revista:
FARMACOLOGIA
Ano de publicação:
2021
Tipo de documento:
Article