No Effect of Digoxin on Rosuvastatin Pharmacokinetics in Healthy Subjects: Utility of Oita Combination for Clinical Drug-Drug Interaction Study
Abstract
This study evaluated the utility of combination of digoxin (0.25 mg) and rosuvastatin (5 mg) as a new transporter (P‐glycoprotein/breast cancer resistance protein/organic anion‐transporting polypeptide ( OATP )1B1/ OATP 1B3) probe cocktail (Oita combination) for drug–drug interaction ( DDI ) studies by demonstrating lack of DDI of digoxin on the pharmacokinetics ( PK s) of rosuvastatin, as it was already known that rosuvastatin did not affect digoxin PK . This was an open‐label, two‐period study in which the primary end points were the geometric mean ratio ( GMR ) of the area under the plasma rosuvastatin concentration‐time curve from time zero to last ( AUC last ) after rosuvastatin administration combined with digoxin to that after rosuvastatin administration alone and its 90% confidence interval ( CI ). As the GMR of AUC last was 0.974 and its 90% CI was 0.911–1.042, it was judged that digoxin does not affect rosuvastatin PK . Results of this study have rationalized utility of the Oita combination as a transporter probe cocktail for clinical DDI studies.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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