Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Medicinal product name, other

NUPLAZID

Study drug International non-proprietary name (INN) or common name

PIMAVANSERIN

Anatomical Therapeutic Chemical (ATC) code

(N05AX17) pimavanserin
pimavanserin

Medical condition to be studied

Parkinson's disease psychosis
Population studied

Age groups

  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)

Estimated number of subjects

6000
Study design details

Main study objective

To compare the risk of mortality among patients with PDP after initiation of pimavanserin with the risk of mortality after initiation of comparator atypical antipsychotics (i.e. clozapine, quetiapine, risperidone, olanzapine, aripiprazole, or brexpiprazole)

Outcomes

All-cause mortality

Data analysis plan

Descriptive statistics will describe the baseline characteristics in the unmatched cohorts.
Exposure propensity scores will be estimated that will be used to control for confounding by matching the comparator atypical antipsychotic group to the pimavanserin.
Incidence rates and 95% confidence interval (CI) of mortality will be estimated by treatment group, and HRs and 95% CIs in the unmatched and matched cohorts will be estimated with Cox proportional hazards regression models comparing new users of pimavanserin versus new users of atypical antipsychotics.
Estimation of the HRs and 95% CIs will be repeated comparing new users of pimavanserin versus new users of atypical antipsychotics among long-term care residents only.
Secondary analyses evaluating changing hazards over time and in clinically relevant subgroups will be conducted. Sensitivity analyses will be performed.