Antipsychotics and Risk of Hyperglycemic Emergencies

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether the use of atypical antipsychotic medication increases the risk of hospitalization for a hyperglycemic emergency.

The investigators will carry out separate population-based cohort studies using administrative health databases in eight jurisdictions in Canada and the UK. Cohort entry will be defined by the initiation of a new antipsychotic medication. Follow-up will continue until hospitalization for a hyperglycemic emergency or the end of 365 days. The results from the separate sites will be combined to provide an overall assessment of the risk of hyperglycemic emergencies among new users of various antipsychotic drugs.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Canadian Network for Observational Drug Effect Studies, CNODES
• Collaborators: Canadian Institutes of Health Research (CIHR); Drug Safety and Effectiveness Network, Canada
• Treatments: Antipsychotic Agents; Aripiprazole; Chlormezanone; Chlorpromazine; Chlorprothixene; Clopenthixol; Clozapine; Flupenthixol; Flupenthixol decanoate; Fluphenazine; Fluphenazine depot; Fluphenazine enanthate; Fluspirilene; Haloperidol; Haloperidol decanoate; Loxapine; Mesoridazine; Methotrimeprazine; Olanzapine; Paliperidone Palmitate; Perphenazine; Pimozide; Quetiapine Fumarate; Risperidone; Tetrabenazine; Thioridazine; Thiothixene; Trifluoperazine; Ziprasidone

Criteria

Inclusion Criteria:

• Patients with a with a first-time prescription for an antipsychotic medication

• Patients at least 18 years of age at cohort entry (except Alberta, Ontario, and Nova Scotia, where patients will be a least 66 years of age)

• Patients with at least 1 year of history in the database

Exclusion Criteria:

• Patients aged <18 years on the date of cohort entry (or < 66 years in Alberta, Ontario and Nova Scotia)

• Received a prescription for an antipsychotic medication in the 365 days prior to cohort entry

• Patients who were hospitalized with the primary study outcome <30 days prior to cohort entry

• Had <1 year of provincial Medicare or GPRD enrollment preceding cohort entry

• Hospitalized for >30 consecutive days in the 365 days prior to cohort entry

• Received renal dialysis or palliative care in the 365 days prior to cohort entry

• Patients in a long term care facility

• Patients who received >1 antipsychotic medication on the date of cohort entry