Study type

Study topic

Human medicinal product

Study topic, other

pharmacogenetics

Study type

Non-interventional study

Scope of the study

Other

If ‘other’, further details on the scope of the study

To estimate the association between SLCO1B1 (and additionally ABCG2) genetic variants and the risk of statin-associated myopathy

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine, other

Statins

Medical condition to be studied

Myopathy
Population studied

Short description of the study population

The source population will comprise of all incident statin users during the study period.

Age groups

Adult and elderly population (≥18 years)
Study design details

Study design

New User Cohorts

Main study objective

Primary objectives
1a - To estimate the risk of myopathy in new users of atorvastatin (any dose) according to genotype status
1b - To estimate the risk of myopathy in new users of lower-dose atorvastatin according to genotype status
1c - To estimate the risk of myopathy in new users of higher-dose atorvastatin according to genotype status

Secondary objectives
2a - To estimate the risk of myopathy in new users of simvastatin (separately for any dose, lower-dose and higher-dose) according to genotype status
2b - To estimate the risk of myopathy in new users of rosuvastatin (separately for any dose, lower-dose and higher-dose) according to genotype status if feasible (See Section 8.7 "Study Size" for more details on how to determine if this analysis is feasible)
2c - To estimate the risk of myopathy in new users of fluvastatin (separately for any dose, lower-dose and higher-dose) according to genotype status if feasible (See Section 8.7 "Study Size" for more details on how to determine if this analysis is feasible)
2d - To estimate the risk of myopathy in new users of pravastatin (separately for any dose, lower-dose and higher-dose) according to genotype status if feasible (See Section 8.7 "Study Size" for more details on how to determine if this analysis is feasible).

Setting

This study will be conducted using two prospective Biobank cohorts with primarily collected genetic data linked to routinely collected electronic health records in two European countries. Except for the genetic information, all other data have been previously mapped to the OMOP CDM to allow for federated analytics, and DARWIN EU data quality controls have been completed during onboarding to the network.
1. UK Biobank (UKBB), United Kingdom
2. Estonian Biobank (EBB), Estonia