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Abstract Details

Long-Term Evaluation of Safety and Efficacy of Pitolisant in Narcolepsy: HARMONY 3 Study
Sleep
S46 - Sleep Science and Therapy Updates (2:28 PM-2:39 PM)
009
HARMONY 3 is a long-term (up to 5 years) study of pitolisant, the first potent and highly selective histamine 3 (H3)-receptor antagonist/inverse agonist, in patients with narcolepsy.
To evaluate the long-term safety and efficacy of pitolisant.

This pragmatic, open-label, multicenter study evaluated the effect of pitolisant (18 or 36 mg once daily) in adult patients with narcolepsy (with or without cataplexy) according to ICSD-2 criteria with excessive daytime sleepiness (EDS; Epworth Sleepiness Scale [ESS] score ≥12). Concomitant use of stimulants and anticataplectic agents was permitted. The 1-year results are presented here.

Of 102 patients who received study drug, 73 were not previously treated (de novo) with pitolisant; 29 were previously treated (compassionate use program [n=16], another pitolisant trial [n=13]). Mean age was 36 years; 44.1% were male. At baseline, mean ESS was 17.1 ± 3.1; 73.5% of patients had cataplexy. Sixty-eight patients completed ≥12 months of treatment. Mean pitolisant exposure was 260 and 548 days for de novo and previously treated patients, respectively; 72% of patients received pitolisant 36 mg/d. During this 12-month period, 56.9% of patients reported adverse events: headaches (11.8%), insomnia (8.8%), weight gain (7.8%), anxiety (6.9%), depression (4.9%), and nausea (9%). Mean ESS reduction was 4.3 points overall; 4.9 (P<0.01) in de novo patients and 4.2 in previously treated patients. Overall, 63.2% (43/68) of patients were responders (ESS final <10 and/or ESS baseline - ESS final >3) and 36.8% (25/68) were normalized (ESS final <10); mean ESS decreased from 15.3 to 6.6 in normalized patients. Partial and total cataplexy attacks were reduced (-64% and -75%, respectively), as were hypnagogic hallucinations (-54%) and sleep paralysis (-63%).

This 1-year analysis of a long-term, open-label study supported the safety and efficacy of pitolisant for the treatment of EDS in narcolepsy and cataplexy in narcolepsy.

Authors/Disclosures
Yves Dauvilliers, MD, PhD (Hopital Gui De Chaulliac)
PRESENTER
Yves Dauvilliers, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for idorsia. Yves Dauvilliers, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for JAZZ. Yves Dauvilliers, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Takeda. Yves Dauvilliers, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Avadel.
Isabelle Arnulf, MD (Hopital Pitie-Salpetriere) Dr. Arnulf has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ONO Pharma. Dr. Arnulf has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ROCHE pharma. Dr. Arnulf has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for IDORSIA Pharma. Dr. Arnulf has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for UCB Pharma. The institution of Dr. Arnulf has received research support from BIOPROJET pharma. The institution of Dr. Arnulf has received research support from VITALAIRE. The institution of Dr. Arnulf has received research support from French SLEEP Socity (SFRMS). The institution of Dr. Arnulf has received research support from Paris Brain Insitute. Dr. Arnulf has a non-compensated relationship as a scientific advisory with Jazz Pharma that is relevant to AAN interests or activities. Dr. Arnulf has a non-compensated relationship as a scientific advisory with Theranexus that is relevant to AAN interests or activities.
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