Abstract | OBJECTIVE: METHODS: Through retrospective analyses of patient files, the benefit (the score from the Epworth Sleepiness Scale [ESS], authorization renewal) and tolerance (side-effects) of pitolisant were assessed. RESULTS: A total of 78 patients with IH (n=65%, 78% women) and SH (n=13%, 54% women) received pitolisant 5-50 mg once per day over the course of five days to 37 months. The median (interquartile range) ESS scores of patients with IH decreased from 17 (15.5-18.5) to 14 (12-17). There were 36% responders (ESS fall of > or =3). The improvement in ESS score (-1.9±2.6) was different from 0 in IH without long sleep time (P<0.002) and in IH with a long sleep time (P<0.0001), but not in SH. Forty-four (63%) patients with IH and 12 (77%) patients with SH stopped pitolisant, mostly due to a lack of efficacy. Side-effects included gastrointestinal pain (15.4%), increased appetite and weight gain (14.1%), headache (12.8%), insomnia (11.5%), and anxiety (9%), as well as exceptional reports of depression and persistent genital arousal. CONCLUSION:
Pitolisant had a long-term favorable benefit/risk ratio in 23-38% of drug-resistant patients with IH and SH, suggesting that histamine neurons can be stimulated in severe idiopathic and symptomatic hypersomnia.
|
Authors | Smaranda Leu-Semenescu, Nandy Nittur, Jean-Louis Golmard, Isabelle Arnulf |
Journal | Sleep medicine
(Sleep Med)
Vol. 15
Issue 6
Pg. 681-7
(Jun 2014)
ISSN: 1878-5506 [Electronic] Netherlands |
PMID | 24854887
(Publication Type: Journal Article)
|
Copyright | Copyright © 2014 Elsevier B.V. All rights reserved. |
Chemical References |
- Histamine Agonists
- Piperidines
- pitolisant
|
Topics |
- Adult
- Disorders of Excessive Somnolence
(drug therapy)
- Female
- Histamine Agonists
(administration & dosage, adverse effects, therapeutic use)
- Humans
- Idiopathic Hypersomnia
(drug therapy)
- Male
- Middle Aged
- Piperidines
(administration & dosage, adverse effects, therapeutic use)
- Polysomnography
- Retrospective Studies
- Treatment Outcome
|