This HTML5 document contains 55 embedded RDF statements represented using HTML+Microdata notation.

The embedded RDF content will be recognized by any processor of HTML5 Microdata.

Namespace Prefixes

PrefixIRI
dctermshttp://purl.org/dc/terms/
n11http://localhost/temp/predkladatel/
n10http://linked.opendata.cz/resource/domain/vavai/riv/tvurce/
n15http://linked.opendata.cz/resource/domain/vavai/vysledek/RIV%2F00216208%3A11110%2F14%3A10282823%21RIV15-MSM-11110___/
n17http://linked.opendata.cz/ontology/domain/vavai/
shttp://schema.org/
rdfshttp://www.w3.org/2000/01/rdf-schema#
skoshttp://www.w3.org/2004/02/skos/core#
n3http://linked.opendata.cz/ontology/domain/vavai/riv/
n13http://bibframe.org/vocab/
n2http://linked.opendata.cz/resource/domain/vavai/vysledek/
rdfhttp://www.w3.org/1999/02/22-rdf-syntax-ns#
n6http://linked.opendata.cz/ontology/domain/vavai/riv/klicoveSlovo/
n8http://linked.opendata.cz/ontology/domain/vavai/riv/duvernostUdaju/
xsdhhttp://www.w3.org/2001/XMLSchema#
n18http://linked.opendata.cz/ontology/domain/vavai/riv/jazykVysledku/
n9http://linked.opendata.cz/ontology/domain/vavai/riv/aktivita/
n19http://linked.opendata.cz/ontology/domain/vavai/riv/obor/
n16http://linked.opendata.cz/ontology/domain/vavai/riv/druhVysledku/
n7http://reference.data.gov.uk/id/gregorian-year/

Statements

Subject Item
n2:RIV%2F00216208%3A11110%2F14%3A10282823%21RIV15-MSM-11110___
rdf:type
n17:Vysledek skos:Concept
rdfs:seeAlso
http://dx.doi.org/10.1016/S2213-8587(14)70006-3
dcterms:description
Eprotirome is a liver-selective thyroid hormone receptor agonist that has been shown to lower plasma LDL cholesterol concentrations in previous phase 1 and 2 studies of patients with dyslipidaemia. We used a computer-generated randomisation sequence to allocate patients to one of three groups: 50 mu g eprotirome, 100 mu g eprotirome, or placebo. T Analysis was done in all patients who received 6 weeks of treatment. This study is registered with ClinicalTrials.gov, number NCT01410383. We enrolled 236 patients, randomly allocating 80 to receive placebo, 79 to receive 50 mu g eprotirome, and 77 to receive 100 mu g eprotirome. 69 patients reached the 6 week timepoint (23 given placebo, 24 given 50 mu g eprotirome, and 22 given 100 mu g eprotirome). Mean LDL cholesterol concentrations increased by 9% (95% CI -2 to 20) in the placebo group, decreased by 12% (-28 to 4%; p=0.0677 vs placebo) in the 50 mu g eprotirome group, and decreased by 22% (-32 to -13%; p=0.0045 vs placebo) in the 100 mu g eprotirome group. Four patients had to discontinue or interrupt study treatment before trial termination due to AST increases between the upper limit of normal (ULN) and six times ULN, and ALT concentrations between three and seven times ULN. Although we detected no changes in serum concentrations of thyroid-stimulating hormone or free tri-iodothyronine, free tetra-iodothyronine decreased by 19% (23 to 16) in the 50 mu g eprotirome group and 27% (30 to 23) in the 100 mu g eprotirome group (p<0.0001 vs placebo for both groups). Interpretation Our findings show that eprotirome can lower LDL cholesterol concentrations in patients with familial hypercholesterolaemia when added to conventional statin treatment with or without ezetimibe, but that it has the potential to induce liver injury. These findings, along with findings of cartilage damage in dogs, raise serious doubts about selective thyroid hormone mimetics as a therapeutic approach to lower LDL cholesterol concentrations. Eprotirome is a liver-selective thyroid hormone receptor agonist that has been shown to lower plasma LDL cholesterol concentrations in previous phase 1 and 2 studies of patients with dyslipidaemia. We used a computer-generated randomisation sequence to allocate patients to one of three groups: 50 mu g eprotirome, 100 mu g eprotirome, or placebo. T Analysis was done in all patients who received 6 weeks of treatment. This study is registered with ClinicalTrials.gov, number NCT01410383. We enrolled 236 patients, randomly allocating 80 to receive placebo, 79 to receive 50 mu g eprotirome, and 77 to receive 100 mu g eprotirome. 69 patients reached the 6 week timepoint (23 given placebo, 24 given 50 mu g eprotirome, and 22 given 100 mu g eprotirome). Mean LDL cholesterol concentrations increased by 9% (95% CI -2 to 20) in the placebo group, decreased by 12% (-28 to 4%; p=0.0677 vs placebo) in the 50 mu g eprotirome group, and decreased by 22% (-32 to -13%; p=0.0045 vs placebo) in the 100 mu g eprotirome group. Four patients had to discontinue or interrupt study treatment before trial termination due to AST increases between the upper limit of normal (ULN) and six times ULN, and ALT concentrations between three and seven times ULN. Although we detected no changes in serum concentrations of thyroid-stimulating hormone or free tri-iodothyronine, free tetra-iodothyronine decreased by 19% (23 to 16) in the 50 mu g eprotirome group and 27% (30 to 23) in the 100 mu g eprotirome group (p<0.0001 vs placebo for both groups). Interpretation Our findings show that eprotirome can lower LDL cholesterol concentrations in patients with familial hypercholesterolaemia when added to conventional statin treatment with or without ezetimibe, but that it has the potential to induce liver injury. These findings, along with findings of cartilage damage in dogs, raise serious doubts about selective thyroid hormone mimetics as a therapeutic approach to lower LDL cholesterol concentrations.
dcterms:title
Eprotirome in patients with familial hypercholesterolaemia (the AKKA trial): a randomised, double-blind, placebo-controlled phase 3 study Eprotirome in patients with familial hypercholesterolaemia (the AKKA trial): a randomised, double-blind, placebo-controlled phase 3 study
skos:prefLabel
Eprotirome in patients with familial hypercholesterolaemia (the AKKA trial): a randomised, double-blind, placebo-controlled phase 3 study Eprotirome in patients with familial hypercholesterolaemia (the AKKA trial): a randomised, double-blind, placebo-controlled phase 3 study
skos:notation
RIV/00216208:11110/14:10282823!RIV15-MSM-11110___
n3:aktivita
n9:V
n3:aktivity
V
n3:cisloPeriodika
6
n3:dodaniDat
n7:2015
n3:domaciTvurceVysledku
n10:9950702
n3:druhVysledku
n16:J
n3:duvernostUdaju
n8:S
n3:entitaPredkladatele
n15:predkladatel
n3:idSjednocenehoVysledku
14884
n3:idVysledku
RIV/00216208:11110/14:10282823
n3:jazykVysledku
n18:eng
n3:klicovaSlova
society; agonists; guidelines; update; diagnosis; dyslipidemia; ldl cholesterol; subclinical hypothyroidism; thyroid-hormone receptor; Cholesterol-lowering treatment
n3:klicoveSlovo
n6:Cholesterol-lowering%20treatment n6:ldl%20cholesterol n6:subclinical%20hypothyroidism n6:guidelines n6:society n6:dyslipidemia n6:thyroid-hormone%20receptor n6:diagnosis n6:update n6:agonists
n3:kodStatuVydavatele
NL - Nizozemsko
n3:kontrolniKodProRIV
[4A9758B6E7F2]
n3:nazevZdroje
The Lancet Diabetes and Endocrinology
n3:obor
n19:FA
n3:pocetDomacichTvurcuVysledku
1
n3:pocetTvurcuVysledku
10
n3:rokUplatneniVysledku
n7:2014
n3:svazekPeriodika
2
n3:tvurceVysledku
Sjouke, Barbara Kastelein, John J. P. Olsson, Anders G. Langslet, Gisle Češka, Richard Ladenson, Paul W. Nicholls, Stephen J. Nissen, Steven E. Ohlander, Maria Hovingh, G. Kees
n3:wos
000336724300022
s:issn
2213-8587
s:numberOfPages
9
n13:doi
10.1016/S2213-8587(14)70006-3
n11:organizacniJednotka
11110