Antipsychotics and Risk of Hyperglycemic Emergencies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02582736|
Recruitment Status : Completed
First Posted : October 21, 2015
Last Update Posted : October 21, 2015
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.
|Condition or disease||Intervention/treatment|
|Psychotic Disorders Schizophrenia Schizoaffective Disorder Bipolar Disorder Diabetes Mellitus, Type 2||Drug: Olanzapine Drug: Risperidone Drug: atypical antipsychotics (other) Drug: typical antipsychotics|
|Study Type :||Observational|
|Actual Enrollment :||725489 participants|
|Official Title:||Atypical Antipsychotics and Hyperglycemic Emergencies: Multicentre, Retrospective Cohort Study of Administrative Data|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
Exposure to olanzapine will be defined as a prescription for olanzapine on the date of cohort entry.
Exposure to olanzapine (ATC N05AH03) will be defined as a prescription for olanzapine on the date of cohort entry.
Other Name: atypical antipsychotic
Other atypical antipsychotics
Exposure to atypical antipsychotics will be defined as a prescription for an atypical antipsychotic other than olanzapine (clozapine, quetiapine, ziprasidone, paliperidone, or aripiprazole) on the date of cohort entry.
Drug: atypical antipsychotics (other)
Exposure to other atypitical antipsychotics (ATC N05AH02, N05AH04, N05AE04, N05AX13, N05AX12) will be defined will be defined as a prescription for an atypical antipsychotic other than olanzapine on the date of cohort entry.
Exposure to typical antipsychotics will be defined as a prescription for a typical antipsychotic (chlormezanone, chlorpromazine, chlorprothixene, flupenthixol, fluphenazine, fluspirilene, haloperidol, levomepromazine, loxapine, mesoridazine, methotrimeprazine, perphenazine, pimozide, pipotiazine, tetrabenazine, thiopropazate, thioproperazine, thioridazine, thiothixene, trifluoperazine or zuclopenthixol) on the date of cohort entry.
Drug: typical antipsychotics
Exposure to typical antipsychotics (M03BB02, N05AA01, N05AF03, N05AF01, N05AB02, N05AG01, N05AD01, N05AA02, N05AH01, N05AC03, N05AB03, N05AG02, N05AC04, N07XX06, N05AB05, N05AB08, N05AC02, N05AF04, N05AB06, N05AF05) will be defined as a prescription for a typical antipsychotic on the date of cohort entry.
Exposure to risperidone will be defined as a prescription for risperidone on the date of cohort entry.
Exposure to risperidone (ATC N05AX08) will be defined will be defined as a prescription for risperidone on the date of cohort entry.
Other Name: atypical antipsychotic
- Hospitalization for a hyperglycemic emergency [ Time Frame: Patients will be followed from the date of study cohort entry until the occurrence of a hyperglycemic emergency, censoring, or for up to 365 days. ]A first hospital admission associated with an admission diagnosis of hyperglycemia (ICD-9: 790.20; ICD-10: R739), diabetic ketoacidosis (DKA) (ICD-9: 250.10,250.11,250.12,250.13; ICD-10: E10.1, E11.1, E13.1, E14.1), or hyperglycemic hyperosmolar state (HHS) (ICD-9: 250.20, 250.21,250.22,250.23; ICD-10: E11.0,E13.0, E14.0) in the 365 days following antipsychotic medication initiation (cohort entry).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02582736
|Women's College Hospital, Women's College Research Institute|
|Toronto, Ontario, Canada, M5G 1N8|
|Principal Investigator:||Lorraine Lipscombe, MD, MSc||Women's College Hospital, Women's College Research Institute|