A Study to Assess Stroke Risk Among Users of Typical Versus Atypical Antipsychotics Stratified by Broad Age Group

Janssen Research & Development, LLC1,234,412 enrolled

Overview

The purpose of this study is to extend the recent Food and Drug Administration (FDA) Sentinel tabulations regarding stroke risk among new users of typical and atypical antipsychotics to participants who were aged 18-64 years and did not have dementia to participants aged 65 years and older regardless of dementia status.

Study Type

OBSERVATIONAL

Enrollment

1,234,412

Conditions

Stroke

Interventions

HaloperidolDRUG

Stroke rates among participants from 01 January, 2002 through 31 December 2017 will be estimated among new users of haloperidol. No drug will be administered as part of this study.

Typical AntipsychoticsDRUG

Stroke rates among participants from 01 January, 2002 through 31 December 2017 will be estimated among new users of typical antipsychotics which includes Haloperidol, Loxapine, Thioridazine, Molindone, Thiothixene, Fluphenazine, Trifluoperazine, Perphenazine, Chlorpromazine. No drug will be administered as part of this study.

Atypical AntipsychoticsDRUG

Stroke rates among participants from 01 January, 2002 through 31 December 2017 will be estimated among new users of atypical antipsychotics which includes Aripriprazole, Asenapine, Brexpiprazole, Cariprazine, Clozapine, Iloperidone, Lurasidone, Paliperidone, Ziprasidone, Risperidone, Quetiapine, Olanzapine. No drug will be administered as part of this study.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: For entry event of an initial drug exposure: * First exposure to the particular drug(s) in the past 183 days (index date) * Had at least 183 days of continuous observation time prior to index * Exactly 0 condition occurrences of 'Cancer' any time in the 183 days before or on the index date * Exactly 0 condition occurrences of 'Stroke' any time in the 183 days before or on the index date * Exactly 0 exposures to any other typical or atypical antipsychotics any time in the 183 days before or on the index date

Locations (1)

Janssen Investigative Site

Titusville, New Jersey, United States

Outcomes

Primary Outcomes

Number of Participants with Stroke as a Principal Inpatient Diagnosis

Number of participants with stroke in each target cohort versus comparator cohort (aged 65 years and older) per person years at risk will be reported. It is defined defined by the presence of the relevant ICD codes (ICD-9 or ICD-10 according to date) in the inpatient setting as the primary diagnoses.

Time frame: Up to 16 years (from 01-January-2002 through 31-December-2017)

Secondary Outcomes

Number of Participants at Stroke Risk when Compared Among New Users of Typical Antipsychotics/Haloperidol versus Atypical Antipsychotics

The number of participants with the risk of stroke among participants exposed to typical antipsychotics versus atypical antipsychotics will be reported.

Time frame: Up to 16 years (from 01-January-2002 through 31-December-2017)

Data from ClinicalTrials.gov

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