Incident Type II Diabetes Mellitus Among Patients Exposed to the Combination of Pravastatin and Paroxetine
N/A
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Depression, Postpartum
Both
Depression, Postpartum
Trial Information
Incident Type II Diabetes Mellitus Among Patients Exposed to the Combination of Pravastatin and Paroxetine
Inclusion Criteria:
- patients 18 years of age or older at the index date
- patients newly prescribed pravastatin or paroxetine
- patients enrolled in the database for at least 180 days prior to the index date
Exclusion Criteria:
- patients prescribed any statins, fibrates, or SRRIs other than the one defined per
cohort during the duration of follow-up (in- class medication switching will result
in censoring at the date of switch);
- patients with T2DM or gestational diabetes ever recorded in their record
- patients with impaired glucose tolerance ever recorded in their record
- patients ever prescribed any oral anti-diabetic medications or insulin; or injectable
GLP¬1 analogues
- patients considered to have Type 1 diabetes
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Retrospective
Outcome Measure:
Incidence of T2DM defined as having at least 2 diagnostic codes indicating T2DM after the index date, or 1 diagnostic code and 1 prescription of oral anti-diabetic medications or insulin (or Byetta and Victoza) after the index date
Outcome Time Frame:
Up to ten years
Safety Issue:
Yes
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
United States: No Health Authority
Study ID:
116554
NCT ID:
NCT01602913
Start Date:
December 2011
Completion Date:
December 2013
Related Keywords:
- Depression, Postpartum
- Pravastatin
- Adverse Events
- Type II Diabetes Mellitus
- Incidence
- Paroxetine
- Depression
- Depressive Disorder
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Depression, Postpartum
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