MARC details
000 -LEADER |
fixed length control field |
04746nam a22006257a 4500 |
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
fixed length control field |
171016s20162016 xxu||||| |||| 00| 0 eng d |
022 ## - INTERNATIONAL STANDARD SERIAL NUMBER |
International Standard Serial Number |
0066-4804 |
040 ## - CATALOGING SOURCE |
Original cataloging agency |
Ovid MEDLINE(R) |
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC) |
PMID |
27697758 |
245 ## - TITLE STATEMENT |
Title |
Pharmacokinetic Interactions between Tafenoquine and Dihydroartemisinin-Piperaquine or Artemether-Lumefantrine in Healthy Adult Subjects. |
251 ## - Source |
Source |
Antimicrobial Agents & Chemotherapy. 60(12):7321-7332, 2016 Dec |
252 ## - Abbreviated Source |
Abbreviated source |
Antimicrob Agents Chemother. 60(12):7321-7332, 2016 Dec |
253 ## - Journal Name |
Journal name |
Antimicrobial agents and chemotherapy |
260 ## - PUBLICATION, DISTRIBUTION, ETC. |
Year |
2016 |
260 ## - PUBLICATION, DISTRIBUTION, ETC. |
Manufacturer |
FY2017 |
266 ## - Date added to catalog |
Date added to catalog |
2017-10-16 |
501 ## - WITH NOTE |
Local holdings |
Available online from MWHC library: 1972 - present (after 4 months), Available in print through MWHC library: July 1996 - 2006 |
520 ## - SUMMARY, ETC. |
Abstract |
Tafenoquine is in development as a single-dose treatment for relapse prevention in individuals with Plasmodium vivax malaria. Tafenoquine must be coadministered with a blood schizonticide, either chloroquine or artemisinin-based combination therapy (ACT). This open-label, randomized, parallel-group study evaluated potential drug interactions between tafenoquine and two ACTs: dihydroartemisinin-piperaquine and artemether-lumefantrine. Healthy volunteers of either sex aged 18 to 65 years without glucose-6-phosphate dehydrogenase deficiency were randomized into five cohorts (n = 24 per cohort) to receive tafenoquine on day 1 (300 mg) plus once-daily dihydroartemisinin-piperaquine on days 1, 2, and 3 (120 mg/960 mg for 36 to <75 kg of body weight and 160 mg/1,280 mg for >=75 to 100 kg of body weight), or plus artemether-lumefantrine (80 mg/480 mg) in two doses 8 h apart on day 1 and then twice daily on days 2 and 3, or each drug alone. The pharmacokinetic parameters of tafenoquine, piperaquine, lumefantrine, artemether, and dihydroartemisinin were determined by using noncompartmental methods. Point estimates and 90% confidence intervals were calculated for area under the concentration-time curve (AUC) and maximum observed plasma concentration (C<sub>max</sub>) comparisons of tafenoquine plus ACT versus tafenoquine or ACT. All subjects receiving dihydroartemisinin-piperaquine experienced QTc prolongation (a known risk with this drug), but tafenoquine coadministration had no clinically relevant additional effect. Tafenoquine coadministration had no clinically relevant effects on dihydroartemisinin, piperaquine, artemether, or lumefantrine pharmacokinetics. Dihydroartemisinin-piperaquine coadministration increased the tafenoquine C<sub>max</sub> by 38% (90% confidence interval, 25 to 52%), the AUC from time zero to infinity (AUC<sub>0-</sub>) by 12% (1 to 26%), and the half-life (t<sub>1/2</sub>) by 29% (19 to 40%), with no effect on the AUC from time zero to the time of the last nonzero concentration (AUC<sub>0-last</sub>). Artemether-lumefantrine coadministration had no effect on tafenoquine pharmacokinetics. Tafenoquine can be coadministered with dihydroartemisinin-piperaquine or artemether-lumefantrine without dose adjustment for any of these compounds. (This study has been registered at ClinicalTrials.gov under registration no. NCT02184637.). Copyright (c) 2016 Green et al. |
546 ## - LANGUAGE NOTE |
Language note |
English |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
*Aminoquinolines/pk [Pharmacokinetics] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
*Antimalarials/pk [Pharmacokinetics] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
*Artemisinins/pk [Pharmacokinetics] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
*Ethanolamines/pk [Pharmacokinetics] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
*Fluorenes/pk [Pharmacokinetics] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
*Malaria, Vivax/dt [Drug Therapy] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
*Quinolines/pk [Pharmacokinetics] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Adolescent |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Adult |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Aged |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Aminoquinolines/ae [Adverse Effects] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Antimalarials/ae [Adverse Effects] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Artemisinins/ae [Adverse Effects] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Drug Interactions |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Drug Therapy, Combination |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Ethanolamines/ae [Adverse Effects] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Female |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Fluorenes/ae [Adverse Effects] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Half-Life |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Healthy Volunteers |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Humans |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Male |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Middle Aged |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Plasmodium vivax/de [Drug Effects] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Quinolines/ae [Adverse Effects] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Young Adult |
651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME |
Institution |
MedStar Harbor Hospital |
656 ## - INDEX TERM--OCCUPATION |
Department |
PAREXEL Early Phase Clinical Unit |
657 ## - INDEX TERM--FUNCTION |
Medline publication type |
Journal Article |
657 ## - INDEX TERM--FUNCTION |
Medline publication type |
Randomized Controlled Trial |
700 ## - ADDED ENTRY--PERSONAL NAME |
Local Authors |
Hussaini, Azra |
700 ## - ADDED ENTRY--PERSONAL NAME |
Local Authors |
Kostov, Ivan |
790 ## - Authors |
All authors |
Bouhired S, Duparc S, Goyal N, Green JA, Hussaini A, Jones SW, Koh GC, Kostov I, Mohamed K, Taylor M, Wolstenholm A |
856 ## - ELECTRONIC LOCATION AND ACCESS |
DOI |
<a href="https://dx.doi.org/10.1128/AAC.01588-16">https://dx.doi.org/10.1128/AAC.01588-16</a> |
Public note |
https://dx.doi.org/10.1128/AAC.01588-16 |
942 ## - ADDED ENTRY ELEMENTS (KOHA) |
Koha item type |
Journal Article |
Item type description |
Article |