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Efficacy results of pimavanserin from a multi-center, open-label extension study in Parkinson's disease psychosis patients
- Source :
- Repositório Científico de Acesso Aberto de Portugal, Repositório Científico de Acesso Aberto de Portugal (RCAAP), instacron:RCAAP
- Publication Year :
- 2020
-
Abstract
- © 2021 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license.<br />Introduction: Pimavanserin, a selective 5-HT2A inverse agonist/antagonist, was approved for hallucinations and delusions associated with Parkinson's disease psychosis (PDP). We present durability of response with pimavanserin in patients with PDP for an additional 4 weeks of treatment. Methods: This was an open-label extension (OLE) study in patients previously completing one of three double-blind, placebo-controlled (Core) studies. All patients received pimavanserin 34 mg once daily. Efficacy assessments included the Scale for the Assessment of Positive Symptoms (SAPS) PD and H + D scales, Clinical Global Impression (CGI) Improvement and Severity scales and Caregiver Burden Scale (CBS), through 4 weeks in the OLE. Safety assessments were conducted at each visit. Results: Of 459 patients, 424 (92.4%) had a Week 4 efficacy assessment. At Week 4 (10 weeks total treatment), SAPS-PD mean (standard deviation) change from OLE baseline was -1.8 (5.5) and for SAPS-H + D was -2.1 (6.2) with pimavanserin 34 mg. Patients receiving placebo during the Core studies had greater improvements (SAPS-PD -2.9 [5.6]; SAPS-H + D -3.5 [6.3]) during the OLE. For participants treated with pimavanserin 8.5 or 17 mg during the Core studies, further improvement was observed during the OLE with pimavanserin 34 mg. The mean change from Core Study baseline for SAPS-PD score was similar among prior pimavanserin 34 mg and prior placebo-treated participants (-7.1 vs. -7.0). The CGI-I response rate (score of 1 or 2) at Week 4 was 51.4%. Adverse events were reported by 215 (46.8%) patients during the first 4 weeks of OLE. The most common AEs were fall (5.9%), hallucination (3.7%), urinary tract infection (2.8%), insomnia (2.4%), and peripheral edema (2.2%) CONCLUSIONS: Patients previously on pimavanserin 34 mg during three blinded core studies had durability of efficacy during the subsequent 4 week OLE SAPS-PD assessment. Patients previously on blinded placebo improved after 4 weeks of OL pimavanserin treatment. These results in over 400 patients from 14 countries support the efficacy of pimavanserin for treating PDP.
- Subjects :
- 0301 basic medicine
Male
medicine.medical_specialty
Psychosis
Parkinson's disease
Peripheral edema
Pimavanserin
Placebo
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Double-Blind Method
Piperidines
Internal medicine
Outcome Assessment, Health Care
medicine
Humans
Urea
Adverse effect
Aged
Response rate (survey)
Aged, 80 and over
business.industry
Parkinson Disease
Middle Aged
medicine.disease
030104 developmental biology
Neurology
chemistry
Psychotic Disorders
Clinical Global Impression
Female
Neurology (clinical)
Geriatrics and Gerontology
medicine.symptom
business
030217 neurology & neurosurgery
Antipsychotic Agents
Subjects
Details
- ISSN :
- 18735126
- Volume :
- 87
- Database :
- OpenAIRE
- Journal :
- Parkinsonismrelated disorders
- Accession number :
- edsair.doi.dedup.....b3e9bd59836a830420547e27197b6fc6