Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Atypical Antipsychotics and Hyperglycemic Emergencies: Multicentre, Retrospective Cohort Study of Administrative Data
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.
Status | Completed |
Enrollment | 725489 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Canada | Women's College Hospital, Women's College Research Institute | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Canadian Network for Observational Drug Effect Studies, CNODES | Canadian Institutes of Health Research (CIHR), Drug Safety and Effectiveness Network, Canada |
Canada,
Lipscombe LL, Austin PC, Alessi-Severini S, Blackburn DF, Blais L, Bresee L, Filion KB, Kawasumi Y, Kurdyak P, Platt RW, Tamim H, Paterson JM; Canadian Network for Observational Drug Effect Studies (CNODES) Investigators. Atypical antipsychotics and hyper — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hospitalization for a hyperglycemic emergency | 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). | 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. | Yes |
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