TY - JOUR
T1 - Nighttime Sleep and Daytime Sleepiness Improved with Pimavanserin during Treatment of Parkinson's Disease Psychosis
AU - Patel, Neepa J
AU - LeWitt, Peter
AU - Neikrug, Ariel B.
AU - Kesslak, Patrick
AU - Coate, Bruce
AU - Ancoli-Israel, Sonia
N1 - Publisher Copyright:
© 2018 The Author(s). Published by Wolters Kluwer Health, Inc.
PY - 2018/11/1
Y1 - 2018/11/1
N2 - Introduction Impaired nocturnal sleep and excessive daytime sleepiness are common problems for patients with Parkinson's disease, and patients with Parkinson's disease with sleep dysfunction are 5 times more likely to experience psychotic symptoms. Pimavanserin, a 5-HT 2A inverse agonist approved to treat Parkinson's disease psychosis, may improve sleep quality in patients with Parkinson's disease experiencing sleep disturbances. Methods Scales for Outcomes in Parkinson's Disease nighttime sleep (SCOPA-NS) and SCOPA-daytime sleepiness (DS) data obtained during 2 double-blind placebo-controlled studies of pimavanserin in persons with Parkinson's disease psychosis were evaluated. Data from the placebo and pimavanserin 34 mg groups in the 2 studies were pooled to provide further information on the effect of pimavanserin 34 mg on sleep. Additional analyses on the pooled study data were performed on participants with significantly impaired nighttime sleep and daytime sleepiness, defined as SCOPA-NS ≥7 and SCOPA-DS ≥5, respectively. Results In the pooled analysis, treatment effects, expressed as least squares mean reductions in SCOPA-NS at week 6, were -1.4 for pimavanserin 34 mg and -0.5 for placebo. At week 6, the decrease from baseline in SCOPA-DS for the pimavanserin 34 mg group was -1.7 and -1.2 for the placebo group (P = 0.108). When evaluating participants with impaired nighttime sleep and daytime sleepiness at baseline, the SCOPA-NS score change was -4.4 for the pimavanserin 34 mg group and -2.3 for the placebo group (P = 0.002), whereas the SCOPA-DS change was -2.9 and -1.9 for the pimavanserin 34 mg and placebo groups (P = 0.120), respectively. Conclusion The data from the trials suggest that nighttime sleep improved with administration of pimavanserin, a novel 5-HT 2A receptor inverse agonist/antagonist.
AB - Introduction Impaired nocturnal sleep and excessive daytime sleepiness are common problems for patients with Parkinson's disease, and patients with Parkinson's disease with sleep dysfunction are 5 times more likely to experience psychotic symptoms. Pimavanserin, a 5-HT 2A inverse agonist approved to treat Parkinson's disease psychosis, may improve sleep quality in patients with Parkinson's disease experiencing sleep disturbances. Methods Scales for Outcomes in Parkinson's Disease nighttime sleep (SCOPA-NS) and SCOPA-daytime sleepiness (DS) data obtained during 2 double-blind placebo-controlled studies of pimavanserin in persons with Parkinson's disease psychosis were evaluated. Data from the placebo and pimavanserin 34 mg groups in the 2 studies were pooled to provide further information on the effect of pimavanserin 34 mg on sleep. Additional analyses on the pooled study data were performed on participants with significantly impaired nighttime sleep and daytime sleepiness, defined as SCOPA-NS ≥7 and SCOPA-DS ≥5, respectively. Results In the pooled analysis, treatment effects, expressed as least squares mean reductions in SCOPA-NS at week 6, were -1.4 for pimavanserin 34 mg and -0.5 for placebo. At week 6, the decrease from baseline in SCOPA-DS for the pimavanserin 34 mg group was -1.7 and -1.2 for the placebo group (P = 0.108). When evaluating participants with impaired nighttime sleep and daytime sleepiness at baseline, the SCOPA-NS score change was -4.4 for the pimavanserin 34 mg group and -2.3 for the placebo group (P = 0.002), whereas the SCOPA-DS change was -2.9 and -1.9 for the pimavanserin 34 mg and placebo groups (P = 0.120), respectively. Conclusion The data from the trials suggest that nighttime sleep improved with administration of pimavanserin, a novel 5-HT 2A receptor inverse agonist/antagonist.
KW - Impaired sleep
KW - Insomnia
KW - Parkinson's disease
KW - Pimavanserin
UR - http://www.scopus.com/inward/record.url?scp=85056352756&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85056352756&partnerID=8YFLogxK
U2 - 10.1097/WNF.0000000000000307
DO - 10.1097/WNF.0000000000000307
M3 - Article
C2 - 30303817
AN - SCOPUS:85056352756
SN - 0362-5664
VL - 41
SP - 210
EP - 215
JO - Clinical neuropharmacology
JF - Clinical neuropharmacology
IS - 6
ER -