Annotation of PMDA Label for atorvastatin and LDLR
PharmGKB ID
Summary
The PMDA package insert for atorvastatin states that an indication for the drug is familial hypercholesterolemia, a genetically determined condition caused by mutations in the low density lipoprotein receptor gene (LDLR).
Please note that this drug label annotation was created from a collaboration between PharmGKB and Japanese Society of Pharmacogenomics and Silicon Valley Tech KK in 2016. The label has not been subsequently reviewed or updated.
Annotation
Please note that the information contained within this drug label annotation is available through a collaboration with the Japanese Society of Pharmacogenomics, who provided a translation of the pharmacogenetic information contained in the PMDA package insert.
Excerpts from the package insert for atorvastatin (Lipitor):
It is recommended that adequate tests be performed before considering the initiation of the product to confirm nonfamilial and familial hypercholesterolemia.
In patients with homozygous familial hypercholesterolemia, the product should be considered as an adjunct to other non-pharmaceutical treatments, e.g., LDL apheresis...
Familial Hypercholesterolemia Studies...Twenty-four patients with heterozygous familial hypercholesterolemia received 10 mg of the product for the first 8 weeks...In another study, 9 patients with homozygous familial hypercholesterolemia receiving LDL apheresis received 10 mg of the product for 4 weeks or 8 weeks...
For the complete drug label text with sections containing pharmacogenetic information highlighted, see the atorvastatin package insert (in Japanese).
*Disclaimer: The contents of this page have not been endorsed by the PMDA and are the sole responsibility of PharmGKB.
Evidence for Clinical Annotations
This annotation has been used as evidence for the following clinical annotations.