Effects of a 5-Lipoxygenase–Activating Protein Inhibitor on Biomarkers Associated With Risk of Myocardial Infarction: A Randomized Trial
CONTEXT Myocardial infarction (MI) is the leading cause of death in the world. Variants in the 5-lipoxygenase–activating protein (FLAP) gene are associated with risk of MI. OBJECTIVE To determine the effect of an inhibitor of FLAP on levels of biomarkers associated with MI risk. DESIGN, SETTING, AND...
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Published in | JAMA : the journal of the American Medical Association Vol. 293; no. 18; pp. 2245 - 2256 |
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Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
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Chicago, IL
American Medical Association
11.05.2005
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Abstract | CONTEXT Myocardial infarction (MI) is the leading cause of death in the world.
Variants in the 5-lipoxygenase–activating protein (FLAP) gene are associated
with risk of MI. OBJECTIVE To determine the effect of an inhibitor of FLAP on levels of biomarkers
associated with MI risk. DESIGN, SETTING, AND PATIENTS A randomized, prospective, placebo-controlled, crossover trial of an
inhibitor of FLAP (DG-031) in MI patients who carry at-risk variants in the
FLAP gene or in the leukotriene A4 hydrolase gene. Of 268 patients
screened, 191 were carriers of at-risk variants in FLAP (87%) or leukotriene
A4 hydrolase (13%). Individuals were enrolled in April 2004 and
were followed up by designated cardiologists from a university hospital in
Iceland until September 2004. INTERVENTIONS Patients were first randomized to receive 250 mg/d of DG-031, 500 mg/d
of DG-031, 750 mg/d of DG-031, or placebo. After a 2-week washout period,
patients received DG-031 if they had received placebo first or placebo if
they had received DG-031 first. Treatment periods lasted for 4 weeks. MAIN OUTCOME MEASURES Changes in levels of biomarkers associated with risk of MI. RESULTS In response to 750 mg/d of DG-031, production of leukotriene B4 was significantly reduced by 26% (95% confidence interval [CI], 10%-39%; P = .003) and myeloperoxidase was significantly
reduced by 12% (95% CI, 2%-21%; P = .02).
The higher 2 doses of DG-031 produced a nonsignificant reduction in C-reactive
protein (16%; 95% CI, −2% to 31%; P = .07)
at 2 weeks. However, there was a more pronounced reduction (25%; 95% CI, 5%-40%; P = .02) in C-reactive protein at the end of
the washout period that persisted for another 4 weeks thereafter. The FLAP
inhibitor DG-031 was well tolerated and was not associated with any serious
adverse events. CONCLUSION In patients with specific at-risk variants of 2 genes in the leukotriene
pathway, DG-031 led to significant and dose-dependent suppression of biomarkers
that are associated with increased risk of MI events. |
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AbstractList | CONTEXTMyocardial infarction (MI) is the leading cause of death in the world. Variants in the 5-lipoxygenase-activating protein (FLAP) gene are associated with risk of MI.OBJECTIVETo determine the effect of an inhibitor of FLAP on levels of biomarkers associated with MI risk.DESIGN, SETTING, AND PATIENTSA randomized, prospective, placebo-controlled, crossover trial of an inhibitor of FLAP (DG-031) in MI patients who carry at-risk variants in the FLAP gene or in the leukotriene A4 hydrolase gene. Of 268 patients screened, 191 were carriers of at-risk variants in FLAP (87%) or leukotriene A4 hydrolase (13%). Individuals were enrolled in April 2004 and were followed up by designated cardiologists from a university hospital in Iceland until September 2004.INTERVENTIONSPatients were first randomized to receive 250 mg/d of DG-031, 500 mg/d of DG-031, 750 mg/d of DG-031, or placebo. After a 2-week washout period, patients received DG-031 if they had received placebo first or placebo if they had received DG-031 first. Treatment periods lasted for 4 weeks.MAIN OUTCOME MEASURESChanges in levels of biomarkers associated with risk of MI.RESULTSIn response to 750 mg/d of DG-031, production of leukotriene B4 was significantly reduced by 26% (95% confidence interval [CI], 10%-39%; P = .003) and myeloperoxidase was significantly reduced by 12% (95% CI, 2%-21%; P = .02). The higher 2 doses of DG-031 produced a nonsignificant reduction in C-reactive protein (16%; 95% CI, -2% to 31%; P = .07) at 2 weeks. However, there was a more pronounced reduction (25%; 95% CI, 5%-40%; P = .02) in C-reactive protein at the end of the washout period that persisted for another 4 weeks thereafter. The FLAP inhibitor DG-031 was well tolerated and was not associated with any serious adverse events.CONCLUSIONIn patients with specific at-risk variants of 2 genes in the leukotriene pathway, DG-031 led to significant and dose-dependent suppression of biomarkers that are associated with increased risk of MI events. Hakonarson et al determine the effect of an inhibitor of 5-lipoxygenase-activating protein on levels of biomarkers associated with myocardial infarction (MI) risk. They conclude that in patients with specific at-risk variants of two genes in the leukotriene pathway, DG-031 led to significant and dose-dependent suppression of biomarkers that are associated with increased risk of MI events. Myocardial infarction (MI) is the leading cause of death in the world. Variants in the 5-lipoxygenase-activating protein (FLAP) gene are associated with risk of MI. To determine the effect of an inhibitor of FLAP on levels of biomarkers associated with MI risk. A randomized, prospective, placebo-controlled, crossover trial of an inhibitor of FLAP (DG-031) in MI patients who carry at-risk variants in the FLAP gene or in the leukotriene A4 hydrolase gene. Of 268 patients screened, 191 were carriers of at-risk variants in FLAP (87%) or leukotriene A4 hydrolase (13%). Individuals were enrolled in April 2004 and were followed up by designated cardiologists from a university hospital in Iceland until September 2004. Patients were first randomized to receive 250 mg/d of DG-031, 500 mg/d of DG-031, 750 mg/d of DG-031, or placebo. After a 2-week washout period, patients received DG-031 if they had received placebo first or placebo if they had received DG-031 first. Treatment periods lasted for 4 weeks. Changes in levels of biomarkers associated with risk of MI. In response to 750 mg/d of DG-031, production of leukotriene B4 was significantly reduced by 26% (95% confidence interval [CI], 10%-39%; P = .003) and myeloperoxidase was significantly reduced by 12% (95% CI, 2%-21%; P = .02). The higher 2 doses of DG-031 produced a nonsignificant reduction in C-reactive protein (16%; 95% CI, -2% to 31%; P = .07) at 2 weeks. However, there was a more pronounced reduction (25%; 95% CI, 5%-40%; P = .02) in C-reactive protein at the end of the washout period that persisted for another 4 weeks thereafter. The FLAP inhibitor DG-031 was well tolerated and was not associated with any serious adverse events. In patients with specific at-risk variants of 2 genes in the leukotriene pathway, DG-031 led to significant and dose-dependent suppression of biomarkers that are associated with increased risk of MI events. CONTEXT: Myocardial infarction (MI) is the leading cause of death in the world. Variants in the 5-lipoxygenase-activating protein (FLAP) gene are associated with risk of MI. OBJECTIVE: To determine the effect of an inhibitor of FLAP on levels of biomarkers associated with MI risk. DESIGN, SETTING, AND PATIENTS: A randomized, prospective, placebo-controlled, crossover trial of an inhibitor of FLAP (DG-031) in MI patients who carry at-risk variants in the FLAP gene or in the leukotriene A sub(4) hydrolase gene. Of 268 patients screened, 191 were carriers of at-risk variants in FLAP (87%) or leukotriene A sub(4) hydrolase (13%). Individuals were enrolled in April 2004 and were followed up by designated cardiologists from a university hospital in Iceland until September 2004. INTERVENTIONS: Patients were first randomized to receive 250 mg/d of DG-031, 500 mg/d of DG-031, 750 mg/d of DG-031, or placebo. After a 2-week washout period, patients received DG-031 if they had received placebo first or placebo if they had received DG-031 first. Treatment periods lasted for 4 weeks. MAIN OUTCOME MEASURES: Changes in levels of biomarkers associated with risk of MI. RESULTS: In response to 750 mg/d of DG-031, production of leukotriene B sub(4) was significantly reduced by 26% (95% confidence interval [CI], 10%-39%; P = .003) and myeloperoxidase was significantly reduced by 12% (95% CI, 2%-21%; P = .02). The higher 2 doses of DG-031 produced a nonsignificant reduction in C-reactive protein (16%; 95% CI, -2% to 31%; P = .07) at 2 weeks. However, there was a more pronounced reduction (25%; 95% CI, 5%-40%; P = .02) in C-reactive protein at the end of the washout period that persisted for another 4 weeks thereafter. The FLAP inhibitor DG-031 was well tolerated and was not associated with any serious adverse events. CONCLUSION: In patients with specific at-risk variants of 2 genes in the leukotriene pathway, DG-031 led to significant and dose-dependent suppression of biomarkers that are associated with increased risk of MI events. CONTEXT Myocardial infarction (MI) is the leading cause of death in the world. Variants in the 5-lipoxygenase–activating protein (FLAP) gene are associated with risk of MI. OBJECTIVE To determine the effect of an inhibitor of FLAP on levels of biomarkers associated with MI risk. DESIGN, SETTING, AND PATIENTS A randomized, prospective, placebo-controlled, crossover trial of an inhibitor of FLAP (DG-031) in MI patients who carry at-risk variants in the FLAP gene or in the leukotriene A4 hydrolase gene. Of 268 patients screened, 191 were carriers of at-risk variants in FLAP (87%) or leukotriene A4 hydrolase (13%). Individuals were enrolled in April 2004 and were followed up by designated cardiologists from a university hospital in Iceland until September 2004. INTERVENTIONS Patients were first randomized to receive 250 mg/d of DG-031, 500 mg/d of DG-031, 750 mg/d of DG-031, or placebo. After a 2-week washout period, patients received DG-031 if they had received placebo first or placebo if they had received DG-031 first. Treatment periods lasted for 4 weeks. MAIN OUTCOME MEASURES Changes in levels of biomarkers associated with risk of MI. RESULTS In response to 750 mg/d of DG-031, production of leukotriene B4 was significantly reduced by 26% (95% confidence interval [CI], 10%-39%; P = .003) and myeloperoxidase was significantly reduced by 12% (95% CI, 2%-21%; P = .02). The higher 2 doses of DG-031 produced a nonsignificant reduction in C-reactive protein (16%; 95% CI, −2% to 31%; P = .07) at 2 weeks. However, there was a more pronounced reduction (25%; 95% CI, 5%-40%; P = .02) in C-reactive protein at the end of the washout period that persisted for another 4 weeks thereafter. The FLAP inhibitor DG-031 was well tolerated and was not associated with any serious adverse events. CONCLUSION In patients with specific at-risk variants of 2 genes in the leukotriene pathway, DG-031 led to significant and dose-dependent suppression of biomarkers that are associated with increased risk of MI events. |
Author | Arnar, David O Adalsteinsdottir, Asdis E Thorgeirsson, Gudmundur Helgadottir, Anna Einarsson, Atli Hakonarson, Hakon Andresdottir, Margret Agnarsson, Uggi Manolescu, Andrei Gottskalksson, Gizur Hardarson, Thordur Gurney, Mark Gudmundsdottir, Hrefna Thorgeirsson, Gestur Sigurdsson, Axel Kristinsson, Arni Kong, Augustine Thorvaldsson, Sverrir Stefansson, Kari Gulcher, Jeffrey Topol, Eric J Jonsson, Asgeir Gudmundsson, Kolbeinn Kristjansson, Kristleifur Andersen, Karl Zink, Florian Gudbjartsson, Daniel Bjornsdottir, Halldora |
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Snippet | CONTEXT Myocardial infarction (MI) is the leading cause of death in the world.
Variants in the 5-lipoxygenase–activating protein (FLAP) gene are associated... Myocardial infarction (MI) is the leading cause of death in the world. Variants in the 5-lipoxygenase-activating protein (FLAP) gene are associated with risk... Hakonarson et al determine the effect of an inhibitor of 5-lipoxygenase-activating protein on levels of biomarkers associated with myocardial infarction (MI)... CONTEXT: Myocardial infarction (MI) is the leading cause of death in the world. Variants in the 5-lipoxygenase-activating protein (FLAP) gene are associated... CONTEXTMyocardial infarction (MI) is the leading cause of death in the world. Variants in the 5-lipoxygenase-activating protein (FLAP) gene are associated with... |
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SubjectTerms | 5-Lipoxygenase-Activating Proteins Aged Biological and medical sciences Biomarkers - metabolism Cardiology. Vascular system Carrier Proteins - antagonists & inhibitors Carrier Proteins - genetics Coronary Artery Disease - drug therapy Coronary Artery Disease - genetics Coronary Artery Disease - metabolism Coronary heart disease Cross-Over Studies Epoxide Hydrolases - genetics Female General aspects Heart Heart attacks Humans Inhibitor drugs Leukotriene B4 - metabolism Leukotriene E4 - metabolism Lipoxygenase Inhibitors - therapeutic use Male Medical sciences Membrane Proteins - antagonists & inhibitors Membrane Proteins - genetics Middle Aged Myocardial Infarction - genetics Myocardial Infarction - metabolism Myocardial Infarction - prevention & control Myocarditis. Cardiomyopathies Peroxidase - metabolism Polymorphism, Single Nucleotide Prospective Studies Proteins Quinolines - therapeutic use Risk Factors |
Title | Effects of a 5-Lipoxygenase–Activating Protein Inhibitor on Biomarkers Associated With Risk of Myocardial Infarction: A Randomized Trial |
URI | http://dx.doi.org/10.1001/jama.293.18.2245 https://www.ncbi.nlm.nih.gov/pubmed/15886380 https://www.proquest.com/docview/211356304/abstract/ https://search.proquest.com/docview/17575801 https://search.proquest.com/docview/67822304 |
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