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Pimavanserin: A Novel Antipsychotic With Potentials to Address an Unmet Need of Older Adults With Dementia-Related Psychosis.

ABSTRACT: Dementia affects more than 40 million people worldwide. When it is accompanied by psychosis, symptom management is especially challenging. Although no drug has been approved by the US Food and Drug Administration (FDA) for psychosis in patients with dementia, atypical antipsychotics are used off-label in severe cases in patients who do not respond to non-pharmacological interventions. However, antipsychotic use in elderly patients with dementia-related psychosis (DRP) is associated with adverse reactions including motor function disorders, cognitive impairment, cerebrovascular events, and increased risk of death. In 2017, the US FDA granted breakthrough therapy designation to the new antipsychotic pimavanserin for the treatment of DRP. Topline result of the pivotal phase III HARMONY (NCT03325556) trial suggests that pimavanserin reduces the relapse of psychosis by 2.8-folds compared to placebo. This favorable result may open path for the potential approval of pimavanserin in DRP. In this review, we discuss the pharmacological activity, clinical efficacy and safety of pimavanserin as a novel atypical antipsychotic with potentials to address the unmet needs of older adults with DRP.

SUBMITTER: Yunusa I

PROVIDER: S-EPMC7054448 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Pimavanserin: A Novel Antipsychotic With Potentials to Address an Unmet Need of Older Adults With Dementia-Related Psychosis.

Yunusa Ismaeel I El Helou Marie Line ML Alsahali Saud S

Frontiers in pharmacology 20200226

Dementia affects more than 40 million people worldwide. When it is accompanied by psychosis, symptom management is especially challenging. Although no drug has been approved by the US Food and Drug Administration (FDA) for psychosis in patients with dementia, atypical antipsychotics are used off-label in severe cases in patients who do not respond to non-pharmacological interventions. However, antipsychotic use in elderly patients with dementia-related psychosis (DRP) is associated with adverse ...[more]

PMID: 32174828

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Project description:ImportanceHome modification through seemingly mundane equipment, such as grab bars and shower seats, mitigates injury, dependence, and reduced quality of life in older adults coping with increasing disability. However, whether these interventions are underused in the US is unclear.ObjectiveTo estimate how many older adults who need equipment to help with bathing and toileting do not have it, describe factors associated with not having equipment, and describe how many who did not initially have equipment acquired equipment over time.DesignThis observational cohort study of participants 65 years or older used secondary data from the 2015 to 2019 waves of the US National Health and Aging Trends Study. Participants included community-dwelling older adults who would unequivocally benefit from equipment, defined as those with poor physical performance or substantial difficulty bathing, toileting, transferring, or walking. Respondents were representative of the US population 65 years and older. Data were collected from May 2015 to October 2019 and analyzed from August 1, 2019, to February 24, 2021.ExposuresPopulation characteristics (eg, age, sex, income, health conditions, and physical performance), environmental factors (eg, home ownership and living arrangement), and health behaviors (eg, prior knee and/or hip surgery).Main outcomes and measuresPrevalence of any unmet need for equipment, defined as either needing bathing equipment (bath grab bars and shower seat) but having none or needing toileting equipment (toilet grab bars and raised toilet seat) but having none and the cumulative incidence of equipment acquisition during 4 years of follow-up.ResultsA total of 2614 participants representing 12 million US individuals would benefit from equipment. The mean (SD) age was 80.5 (8.2) years, and 1619 individuals (62%) were women. Of these, an estimated 5 million individuals (42%; 95% CI, 39%-44%) had an unmet need. After adjustment for age, sex, and race/ethnicity, unmet need was associated with younger age (49% if aged 65-74 years, 37% if aged 75-84 years, and 29% if aged ≥85 years; P < .001), having fewer health conditions (55% if none vs 39% if ≥3; P = .002), non-White race/ethnicity (40% if White vs 51% if Black, 54% if Hispanic, and 55% if other; P < .001), no recent hospitalization (46% vs 37% if hospitalized; P = .001), and no prior knee and/or hip fracture or surgery (46% vs 35% if prior fracture or surgery; P < .001). After 4 years of follow-up, 35% of those with bathing equipment needs and 52% of those with toileting equipment needs never received equipment.Conclusions and relevanceThis cohort study suggests that in the US, 42% of older adults with impairments that would make bathing or toileting difficult lack equipment to assist. This situation is a missed opportunity to help 5 million individuals live independently and safely.

Project description:Behavioral and psychological symptoms of dementia are symptoms of disturbed perception, mood, behavior, and thought content that occurred frequently. These symptoms, which include apathy, depression, anxiety, psychosis, agitation, and aggression, can serve as predictors of and early clinical diagnostic markers for Alzheimer's disease (AD) and are common precipitants of institutional care. Agitation and psychosis are associated with accelerated disease progression and increased tau phosphorylation in patients with AD. Current guidelines recommend the use of second-generation antipsychotics for the treatment of agitation and psychosis in AD, but only after first-line non-pharmacological interventions and for no longer than 12 weeks because long-term use of these drugs is associated with an increased risk of mortality and an increased frequency of cerebrovascular events. Therefore, new antipsychotic drugs with improved efficacy and safety are needed as an alternative to current antipsychotic drugs. In this report, we discuss some of the most relevant advances in the field of agitation and psychosis in AD and focus on the recent positive clinical evidence observed with two new antipsychotics drugs: brexpiprazole and pimavanserin. Brexpiprazole is a receptor partial agonist (D2, D3, 5-HT1A), receptor antagonist (5-HT2A/B, ?1B/?2C) according to the neuroscience-based nomenclature. Two recent phase III clinical trials have shown that brexpiprazole 2 mg/day is effective for the treatment of agitation in patients with AD and has an improved tolerability and safety profile compared with currently available second-generation antipsychotics. Pimavanserin is a receptor antagonist (5-HT2A, 5-HT2C) that has been given market authorization for psychosis occurring in Parkinson's disease. Recent phase II studies suggest that this drug is effective in AD patients with more severe psychosis, although further long-term studies are needed to better define the efficacy and long-term safety profile of pimavanserin for the treatment of psychosis in AD.

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Pimavanserin: A Novel Antipsychotic With Potentials to Address an Unmet Need of Older Adults With Dementia-Related Psychosis.

Publications

Pimavanserin: A Novel Antipsychotic With Potentials to Address an Unmet Need of Older Adults With Dementia-Related Psychosis.

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