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

Study Overview
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Brief Summary
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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.

Official Title
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Stroke Risk Among Users of Typical vs. Atypical Antipsychotics Stratified by Broad Age Group, a Post-authorization Safety Study

Conditions
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Stroke

Intervention / Treatment
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* Drug: Haloperidol
* Drug: Typical Antipsychotics
* Drug: Atypical Antipsychotics


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Target Cohort 1<br>Participants will be analyzed for stroke-risk who are new users of typical antipsychotics aged 18 to 64 years without a recent dementia diagnosis. | Drug: Typical Antipsychotics<br>* 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.<br>|
| Target Cohort 2<br>Participants will be analyzed for stroke-risk who are new users of haloperidol aged 18 to 64 years without a recent dementia diagnosis. | Drug: Haloperidol<br>* 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.<br>|
| Target Cohort 3<br>Participants will be analyzed for stroke-risk who are new users of typical antipsychotics aged greater than or equal to (>=) 65 years. | Drug: Typical Antipsychotics<br>* 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.<br>|
| Target Cohort 4<br>Participants will be analyzed for stroke-risk who are new users of haloperidol aged >= 65 year. | Drug: Haloperidol<br>* 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.<br>|
| Target Cohort 5<br>Participants will be analyzed for stroke-risk who are new users of typical antipsychotics aged 18 to 64 years. | Drug: Typical Antipsychotics<br>* 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.<br>|
| Target Cohort 6<br>Participants will be analyzed for stroke-risk who are new users of haloperidol aged 18 to 64 years. | Drug: Haloperidol<br>* 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.<br>|
| Comparator Cohort 7<br>Participants will be analyzed for stroke-risk who are new users of atypical antipsychotics aged 18-64 years without a recent dementia diagnosis. | Drug: Atypical Antipsychotics<br>* 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.<br>|
| Comparator Cohort 8<br>Participants will be analyzed for stroke-risk who are new users of atypical antipsychotics aged >= 65 years. | Drug: Atypical Antipsychotics<br>* 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.<br>|
| Comparator Cohort 9<br>Participants will be analyzed for stroke-risk who are new users of atypical antipsychotics aged 18-64 years. | Drug: Atypical Antipsychotics<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 16 years (from 01-January-2002 through 31-December-2017) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 16 years (from 01-January-2002 through 31-December-2017) |