Nationwide population-based register linkage study covering the entire 5.9 million inhabitants in Denmark systematically investigating the associations between sustained long-term use of lithium versus lamotrigine and valproate, and the risk of a range of physical disorders emulating a randomized trial.
The study includes two cohorts. Cohort 1: all 12.607 patients with a diagnosis of bipolar disorder (ICD-10 code: DF30-31.9) who subsequently were exposed to either lithium, lamotrigine or valproate between 1997 and 2021. Cohort 2: as Cohort 1, but regardless of prior diagnosis of bipolar disorder (N= 156.678). Main analyses considered a patient exposed to a drug 92 days after a prescription and a 10-year follow-up and 4 sensitivity analyses considered a patient exposed to a drug for 60 and 180 days after a prescription, respectively, and with 5- and 15-years follow-up, respectively.
Study Type
OBSERVATIONAL
Enrollment
169,285
Sustained long-term exposure
Psychiatric Center Copenhagen
Copenhagen, Denmark
Incident stroke (separately for intracerebral hemorrhage and cerebral infarction)
Diagnosis in the Danish National Hospital Register
Time frame: 1997 to 2021
Arteriosclerosis
Diagnosis in the Danish National Hospital Register
Time frame: 1997 to 2021
Angina pectoris
Diagnosis in the Danish National Hospital Register
Time frame: 1997 to 2021
Myocardial infarction
Diagnosis in the Danish National Hospital Register
Time frame: 1997 to 2021
Diabetes mellitus (separately for type 1 diabetes and type 2 diabetes)
Diagnosis in the Danish National Hospital Register
Time frame: 1997 to 2021
Myxoedema
Diagnosis in the Danish National Hospital Register
Time frame: 1997 to 2021
Osteoporosis
Diagnosis in the Danish National Hospital Register
Time frame: 1997 to 2021
Dementia (separately for Alzheimer's disease and other dementia)
Diagnosis in the Danish National Hospital Register
Time frame: 1997 to 2021
Parkinson's disease
Diagnosis in the Danish National Hospital Register
Time frame: 1997 to 2021
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Chronic kidney disease (definite chronic kidney disease and possible Chronic kidney disease)
Diagnosis in the Danish National Hospital Register
Time frame: 1997 to 2021