Risk of Mortality Associated With Pimavanserin Use Compared With Other Atypical Antipsychotics in Patients With Parkinson’s Disease–Related Psychosis

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

• Name of medicine, 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.

Documents

Study publications

Layton JB, Forns J, McQuay LJ, Danysh HE, Dempsey C, Anthony MS, Turner ME. Mor…

Layton JB, McQuay L, Forns J, Danysh H, Dempsey C, Anthony M, Turner ME. Risk o…

Rao, S., McQuay, L.J., Forns, J., MacKay, R., Danysh, H.E., Doshi, D., Abler, V…