About: An analysis of TRITON-TIMI 38, based on the 12 month recommended length of therapy in the European label for prasugrel

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Description	In TRITON-TIMI 38, patients with acute coronary syndromes were treated with prasugrel or clopidogrel, with aspirin, for a median of 14.5 (maximum of 15) months. Based on this trial, the EU label for prasugrel recommends treatment for up to 12 months and excludes patients with prior stroke/transient ischemic attack (TIA). Furthermore, the EU label recommends the 10 mg maintenance dose (MD) for patients with body weight >=60 kg and age <75 years. A lower MD of 5 mg is recommended for those with body weight <60 kg; although generally not recommended, 5 mg can be prescribed to patients >=75 years after individual risk-benefit evaluation. This paper presents the one-year outcome data for this 10 mg indicated cohort. METHODS AND RESULTS: From the overall cohort of 13,608 patients in TRITON-TIMI 38, 10,804 fulfilled inclusion criteria for the 10 mg indicated cohort, of whom 22% had a history of diabetes, 73% an index diagnosis of unstable angina/non-ST-segment-elevation myocardial infarction (UA/NSTEMI), and 27% an index diagnosis of ST-segment-elevation myocardial infarction (STEMI). In this cohort at 12 months, those given prasugrel experienced significantly fewer ischemic events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke, 7.8% vs 10.5%, hazard ratio (HR) = 0.73, p < 0.001, than those given clopidogrel, with a non-significant increase in non-coronary artery bypass graft (CABG) TIMI major bleeding, 1.7% vs 1.5%, HR = 1.15, p = 0.40; similarly, in the overall cohort these frequencies were 9.4% vs 11.4%, HR = 0.81, p < 0.001, for cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke, and 2.2% vs 1.8%, HR = 1.24, p = 0.10, for non-CABG TIMI major bleeding. There was a significant reduction in stent thrombosis in the prasugrel group, with similar mortality rates and no excess of strokes. In TRITON-TIMI 38, patients with acute coronary syndromes were treated with prasugrel or clopidogrel, with aspirin, for a median of 14.5 (maximum of 15) months. Based on this trial, the EU label for prasugrel recommends treatment for up to 12 months and excludes patients with prior stroke/transient ischemic attack (TIA). Furthermore, the EU label recommends the 10 mg maintenance dose (MD) for patients with body weight >=60 kg and age <75 years. A lower MD of 5 mg is recommended for those with body weight <60 kg; although generally not recommended, 5 mg can be prescribed to patients >=75 years after individual risk-benefit evaluation. This paper presents the one-year outcome data for this 10 mg indicated cohort. METHODS AND RESULTS: From the overall cohort of 13,608 patients in TRITON-TIMI 38, 10,804 fulfilled inclusion criteria for the 10 mg indicated cohort, of whom 22% had a history of diabetes, 73% an index diagnosis of unstable angina/non-ST-segment-elevation myocardial infarction (UA/NSTEMI), and 27% an index diagnosis of ST-segment-elevation myocardial infarction (STEMI). In this cohort at 12 months, those given prasugrel experienced significantly fewer ischemic events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke, 7.8% vs 10.5%, hazard ratio (HR) = 0.73, p < 0.001, than those given clopidogrel, with a non-significant increase in non-coronary artery bypass graft (CABG) TIMI major bleeding, 1.7% vs 1.5%, HR = 1.15, p = 0.40; similarly, in the overall cohort these frequencies were 9.4% vs 11.4%, HR = 0.81, p < 0.001, for cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke, and 2.2% vs 1.8%, HR = 1.24, p = 0.10, for non-CABG TIMI major bleeding. There was a significant reduction in stent thrombosis in the prasugrel group, with similar mortality rates and no excess of strokes. (en)
Title	An analysis of TRITON-TIMI 38, based on the 12 month recommended length of therapy in the European label for prasugrel An analysis of TRITON-TIMI 38, based on the 12 month recommended length of therapy in the European label for prasugrel (en)
skos:prefLabel	An analysis of TRITON-TIMI 38, based on the 12 month recommended length of therapy in the European label for prasugrel An analysis of TRITON-TIMI 38, based on the 12 month recommended length of therapy in the European label for prasugrel (en)
skos:notation	RIV/00216208:11120/14:43909178!RIV15-MSM-11120___
http://linked.open...avai/riv/aktivita	N
http://linked.open...avai/riv/aktivity	N
http://linked.open...iv/cisloPeriodika	11
http://linked.open...vai/riv/dodaniDat	2015
http://linked.open...aciTvurceVysledku	Widimský, P.
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	Univerzita Karlova v Praze / 3. lékařská fakulta
http://linked.open...dnocenehoVysledku	2401
http://linked.open...ai/riv/idVysledku	RIV/00216208:11120/14:43909178
http://linked.open...riv/jazykVysledku	eng - angličtina
http://linked.open.../riv/klicovaSlova	TRITON-TIMI 38; Prasugrel; One-year; Diabetes; Clopidogrel; Acute coronary syndrome (en)
http://linked.open.../riv/klicoveSlovo	Clopidogrel Diabetes Prasugrel Acute coronary syndrome One-year TRITON-TIMI 38
http://linked.open...odStatuVydavatele	GB - Spojené království Velké Británie a Severního Irska
http://linked.open...ontrolniKodProRIV	[CA863487B708]
http://linked.open...i/riv/nazevZdroje	Current Medical Research and Opinion
http://linked.open...in/vavai/riv/obor	FA
http://linked.open...ichTvurcuVysledku	1 (xsd:int)
http://linked.open...cetTvurcuVysledku	6 (xsd:int)
http://linked.open...UplatneniVysledku	2014
http://linked.open...v/svazekPeriodika	30
http://linked.open...iv/tvurceVysledku	Widimský, Petr
http://linked.open...ain/vavai/riv/wos	000344606300006
issn	0300-7995
number of pages	13 (xsd:int)
http://bibframe.org/vocab/doi	10.1185/03007995.2014.944638
http://localhost/t...ganizacniJednotka	11120

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