In:
Clinical Pharmacology & Therapeutics, Wiley, Vol. 105, No. 6 ( 2019-06), p. 1456-1461
Abstract:
Regorafenib exposure could potentially be influenced by an interaction with acid‐reducing drugs. In this crossover trial, patients were randomized into two sequence groups consisting of three phases: regorafenib intake alone, regorafenib with concomitant esomeprazole, and regorafenib with esomeprazole 3 hours prior. The primary end point was the relative difference ( RD ) in geometric means for regorafenib 0–24‐hour area under the concentration‐time curve ( AUC 0–24h ) and was analyzed by a linear mixed model in 14 patients. AUC 0–24h for regorafenib alone was 55.9 μg·hour/mL (coefficient of variance ( CV ): 40%), and for regorafenib with concomitant esomeprazole or with esomeprazole 3 hours prior AUC 0–24h was 53.7 μg·hour/mL ( CV : 34%) and 53.6 μg·hour/mL ( CV : 43%), respectively. No significant differences were identified when regorafenib alone was compared with regorafenib with concomitant esomeprazole ( RD : −3.9%; 95% confidence interval ( CI ): −20.5 to 16.1%; P = 1.0) or regorafenib with esomeprazole 3 hours prior ( RD : −4.1%; 95% CI : −22.8 to 19.2%; P = 1.0). These findings indicate that regorafenib and esomeprazole can be safely combined in clinical practice.
Type of Medium:
Online Resource
ISSN:
0009-9236
,
1532-6535
DOI:
10.1002/cpt.2019.105.issue-6
Language:
English
Publisher:
Wiley
Publication Date:
2019
detail.hit.zdb_id:
2040184-X
SSG:
15,3
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