Effects of Esomeprazole on the Pharmacokinetics of Lapatinib in Breast Cancer Patients

被引：23

作者：

Koch, Kevin M. ^{[1
]}

Im, Young-Hyuck ^{[2
]}

Kim, Sung-Bae ^{[3
]}

Ribate, Ander Urruticoechea ^{[4
]}

Stephenson, Joe ^{[5
]}

Botbyl, Jeffrey ^{[6
]}

Cartee, Leanne ^{[7
]}

Holshouser, Jane ^{[8
]}

Ridgway, Derry ^{[7
]}

机构：

[1] GlaxoSmithKline, Clin Pharmacol Modeling & Simulat, Res Triangle Pk, NC USA

[2] Samsung Med Ctr, Seoul, South Korea

[3] Asan Med Ctr, Seoul, South Korea

[4] Hosp Duran & Reynals, Inst Catala Oncol, Barcelona, Spain

[5] Canc Ctr Carolinas, Greenville, SC USA

[6] Provonix LLC, Cincinnati, OH USA

[7] GlaxoSmithKline, Oncol Drug Dev, London, England

[8] ICON Clin Res, Dublin, Ireland

来源：

CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT | 2013年 / 2卷 / 04期

关键词：

esomeprazole; lapatinib; breast cancer; proton pump inhibitor; drug interaction;

D O I：

10.1002/cpdd.45

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

The aqueous solubility of lapatinib declines significantly at pH>4, suggesting that its bioavailability might be lowered by acid-reducing drugs. A study was therefore conducted to assess the effects of esomeprazole on lapatinib pharmacokinetics (PK). Women with metastatic human epidermal growth factor receptor 2 positive (HER2(+)) breast cancer were enrolled. Patients received 1,250 mg lapatinib once daily (QD) in the morning on Days 1-7 (Period 1) and Days 8-14 (Period 2) with 40 mg esomeprazole QD at bedtime 3 hours after dinner on Days 8-14. Lapatinib PK sampling occurred during the 24-hour steady-state dosing intervals on Day 7 (lapatinib alone) and Day 14 (lapatinib with esomeprazole). Esomeprazole treatment resulted in decreased lapatinib bioavailability (mean 26%, range 6-49%) that was inversely associated with patient age as a significant covariate.

引用

页码：336 / 341

页数：6

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