About: Randomized, placebo-controlled trial of mipomersen in patients with severe hypercholesterolemia receiving maximally tolerated lipid-lowering therapy

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Attributes	Values
rdf:type	skos:Concept http://linked.opendata.cz/ontology/domain/vavai/Vysledek
rdfs:seeAlso	http://dx.doi.org/10.1371/journal.pone.0049006
Description	Mipomersen, an antisense oligonucleotide targeting apolipoprotein B synthesis, significantly reduces LDL-C and other atherogenic lipoproteins in familial hypercholesterolemia when added to ongoing maximally tolerated lipid-lowering therapy. Safety and efficacy of mipomersen in patients with severe hypercholesterolemia was evaluated. Methods and Results: Randomized, double-blind, placebo-controlled, multicenter trial. Patients (n = 58) were >= 18 years with LDL-C >= 7.8 mmol/L or LDL-C >= 5.1 mmol/L plus CHD disease, on maximally tolerated lipid-lowering therapy that excluded apheresis. Weekly subcutaneous injections of mipomersen 200 mg (n = 39) or placebo (n = 19) were added to lipid-lowering therapy for 26 weeks. Main outcome: percent reduction in LDL-C from baseline to 2 weeks after the last dose of treatment. Mipomersen (n = 27) reduced LDL-C by 36%, from a baseline of 7.2 mmol/L, for a mean absolute reduction of 2.6 mmol/L. Mipomersen, an antisense oligonucleotide targeting apolipoprotein B synthesis, significantly reduces LDL-C and other atherogenic lipoproteins in familial hypercholesterolemia when added to ongoing maximally tolerated lipid-lowering therapy. Safety and efficacy of mipomersen in patients with severe hypercholesterolemia was evaluated. Methods and Results: Randomized, double-blind, placebo-controlled, multicenter trial. Patients (n = 58) were >= 18 years with LDL-C >= 7.8 mmol/L or LDL-C >= 5.1 mmol/L plus CHD disease, on maximally tolerated lipid-lowering therapy that excluded apheresis. Weekly subcutaneous injections of mipomersen 200 mg (n = 39) or placebo (n = 19) were added to lipid-lowering therapy for 26 weeks. Main outcome: percent reduction in LDL-C from baseline to 2 weeks after the last dose of treatment. Mipomersen (n = 27) reduced LDL-C by 36%, from a baseline of 7.2 mmol/L, for a mean absolute reduction of 2.6 mmol/L. (en)
Title	Randomized, placebo-controlled trial of mipomersen in patients with severe hypercholesterolemia receiving maximally tolerated lipid-lowering therapy Randomized, placebo-controlled trial of mipomersen in patients with severe hypercholesterolemia receiving maximally tolerated lipid-lowering therapy (en)
skos:prefLabel	Randomized, placebo-controlled trial of mipomersen in patients with severe hypercholesterolemia receiving maximally tolerated lipid-lowering therapy Randomized, placebo-controlled trial of mipomersen in patients with severe hypercholesterolemia receiving maximally tolerated lipid-lowering therapy (en)
skos:notation	RIV/00064165:_____/12:13124!RIV13-MZ0-00064165
http://linked.open...avai/predkladatel	Všeobecná fakultní nemocnice v Praze
http://linked.open...avai/riv/aktivita	V
http://linked.open...avai/riv/aktivity	V
http://linked.open...iv/cisloPeriodika	11
http://linked.open...vai/riv/dodaniDat	2013
http://linked.open...aciTvurceVysledku	Češka, Richard
http://linked.open.../riv/druhVysledku	J - Článek v odborném periodiku
http://linked.open...iv/duvernostUdaju	S - Úplné a pravdivé údaje nepodléhající ochraně podle zvláštních právních předpisů
http://linked.open...titaPredkladatele	Všeobecná fakultní nemocnice v Praze / (nerozlišená součást)
http://linked.open...dnocenehoVysledku	164056
http://linked.open...ai/riv/idVysledku	RIV/00064165:_____/12:13124
http://linked.open...riv/jazykVysledku	eng - angličtina
http://linked.open.../riv/klicovaSlova	Heterozygous familial hypercholesterolemia; chemistry standardization project; international reference material; b synthesis inhibitor; apolipoprotein-a-i; double-blind; cardiovascular risk; ldl cholesterol; statin therapy; efficacy (en)
http://linked.open.../riv/klicoveSlovo	efficacy statin therapy double-blind Heterozygous familial hypercholesterolemia apolipoprotein-a-i b synthesis inhibitor chemistry standardization project international reference material ldl cholesterol cardiovascular risk
http://linked.open...odStatuVydavatele	US - Spojené státy americké
http://linked.open...ontrolniKodProRIV	[86F2633FE793]
http://linked.open...i/riv/nazevZdroje	PLoS One
http://linked.open...in/vavai/riv/obor	FB
http://linked.open...ichTvurcuVysledku	1 (xsd:int)
http://linked.open...cetTvurcuVysledku	8 (xsd:int)
http://linked.open...UplatneniVysledku	2012
http://linked.open...v/svazekPeriodika	7
http://linked.open...iv/tvurceVysledku	Češka, Richard Burgess, L., J. Chasan-Taber, S. Gouni-Berthold, I. McGowan, M., P. Soran, H. Tardif, J., C. Wagener, G.
http://linked.open...ain/vavai/riv/wos	000311234600018
issn	1932-6203
number of pages	10 (xsd:int)
is http://linked.open...avai/riv/vysledek of	Randomized, placebo-controlled trial of mipomersen in patients with severe hypercholesterolemia receiving maximally tolerated lipid-lowering therapy

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