Rosuvastatin and asian

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FDA Issues Public Advisory on Crestor Dose in Asian Patients

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Rosuvastatin - Wikipedia

The FDA recommends rosuvastatin dosage reductions in Asian patients because pharmacokinetic studies have demonstrated an approximate two-fold increase in median exposure to rosuvastatin in Asian subjects when compared to Caucasian controls. Yet, no explanation for this ethnic difference has been confirmed. For single rosuvastatin doses, AUC 0—48 were When transporters were inhibited by intravenous rifampin, rosuvastatin AUC 0—48 and C max also showed no ethnic differences. Our study suggests that both SLCO1B1 and ABCG2 polymorphisms are better predictors of rosuvastatin exposure than ethnicity alone and could be considered in precision medicine dosing of rosuvastatin. Statins have been utilized worldwide in millions of patients to prevent cardiovascular disease and treat lipid disorders. A number of large clinical trials and post marketing surveys have demonstrated the substantial health benefit to statin use 1 — 3.
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Safety and Efficacy of Statins in Asians

Asian patients frequently have heightened responses to therapeutic drugs. As a consequence, the recommended drug doses are often lower in Asian countries than in Western countries. This practice extends to the use of cardiovascular drugs, including statins for the treatment of dyslipidemia. Pharmacokinetic investigations have noted higher plasma levels of statins in Asians compared with Caucasians, although postmarketing data for all statins have not identified any particular safety issues, even when statins are given at equivalent doses.
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