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Effect of darapladib on major coronary events after an acute coronary syndrome: the SOLID-TIMI 52 randomized clinical trial

Standard

Effect of darapladib on major coronary events after an acute coronary syndrome: the SOLID-TIMI 52 randomized clinical trial. / O'Donoghue, Michelle L; Braunwald, Eugene; White, Harvey D; Steen, Dylan P; Lukas, Mary Ann; Tarka, Elizabeth; Steg, P Gabriel; Hochman, Judith S; Bode, Christoph; Maggioni, Aldo P; Im, KyungAh; Shannon, Jennifer B; Davies, Richard Y; Murphy, Sabina A; Crugnale, Sharon E; Wiviott, Stephen D; Bonaca, Marc P; Watson, David F; Weaver, W Douglas; Serruys, Patrick W; Cannon, Christopher P; Steen, Dylan L; SOLID-TIMI 52 Investigators.

in: JAMA-J AM MED ASSOC, Jahrgang 312, Nr. 10, 10.09.2014, S. 1006-1015.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

O'Donoghue, ML, Braunwald, E, White, HD, Steen, DP, Lukas, MA, Tarka, E, Steg, PG, Hochman, JS, Bode, C, Maggioni, AP, Im, K, Shannon, JB, Davies, RY, Murphy, SA, Crugnale, SE, Wiviott, SD, Bonaca, MP, Watson, DF, Weaver, WD, Serruys, PW, Cannon, CP, Steen, DL & SOLID-TIMI 52 Investigators 2014, 'Effect of darapladib on major coronary events after an acute coronary syndrome: the SOLID-TIMI 52 randomized clinical trial', JAMA-J AM MED ASSOC, Jg. 312, Nr. 10, S. 1006-1015. https://doi.org/10.1001/jama.2014.11061

APA

O'Donoghue, M. L., Braunwald, E., White, H. D., Steen, D. P., Lukas, M. A., Tarka, E., Steg, P. G., Hochman, J. S., Bode, C., Maggioni, A. P., Im, K., Shannon, J. B., Davies, R. Y., Murphy, S. A., Crugnale, S. E., Wiviott, S. D., Bonaca, M. P., Watson, D. F., Weaver, W. D., ... SOLID-TIMI 52 Investigators (2014). Effect of darapladib on major coronary events after an acute coronary syndrome: the SOLID-TIMI 52 randomized clinical trial. JAMA-J AM MED ASSOC, 312(10), 1006-1015. https://doi.org/10.1001/jama.2014.11061

Vancouver

O'Donoghue ML, Braunwald E, White HD, Steen DP, Lukas MA, Tarka E et al. Effect of darapladib on major coronary events after an acute coronary syndrome: the SOLID-TIMI 52 randomized clinical trial. JAMA-J AM MED ASSOC. 2014 Sep 10;312(10):1006-1015. https://doi.org/10.1001/jama.2014.11061

Bibtex

@article{4e727dd2e1864fa99ede2ab5a2e7c81f,
title = "Effect of darapladib on major coronary events after an acute coronary syndrome: the SOLID-TIMI 52 randomized clinical trial",
abstract = "IMPORTANCE: Lipoprotein-associated phospholipase A2 (Lp-PLA2) has been hypothesized to be involved in atherogenesis through pathways related to inflammation. Darapladib is an oral, selective inhibitor of the Lp-PLA2 enzyme.OBJECTIVE: To evaluate the efficacy and safety of darapladib in patients after an acute coronary syndrome (ACS) event.DESIGN, SETTING, AND PARTICIPANTS: SOLID-TIMI 52 was a multinational, double-blind, placebo-controlled trial that randomized 13,026 participants within 30 days of hospitalization with an ACS (non-ST-elevation or ST-elevation myocardial infarction [MI]) at 868 sites in 36 countries.INTERVENTIONS: Patients were randomized to either once-daily darapladib (160 mg) or placebo on a background of guideline-recommended therapy. Patients were followed up for a median of 2.5 years between December 7, 2009, and December 6, 2013.MAIN OUTCOMES AND MEASURES: The primary end point (major coronary events) was the composite of coronary heart disease (CHD) death, MI, or urgent coronary revascularization for myocardial ischemia. Kaplan-Meier event rates are reported at 3 years.RESULTS: During a median duration of 2.5 years, the primary end point occurred in 903 patients in the darapladib group and 910 in the placebo group (16.3% vs 15.6% at 3 years; hazard ratio [HR], 1.00 [95% CI, 0.91-1.09]; P = .93). The composite of cardiovascular death, MI, or stroke occurred in 824 in the darapladib group and 838 in the placebo group (15.0% vs 15.0% at 3 years; HR, 0.99 [95% CI, 0.90-1.09]; P = .78). There were no differences between the treatment groups for additional secondary end points, for individual components of the primary end point, or in all-cause mortality (371 events in the darapladib group and 395 in the placebo group [7.3% vs 7.1% at 3 years; HR, 0.94 [95% CI, 0.82-1.08]; P = .40). Patients were more likely to report an odor-related concern in the darapladib group vs the placebo group (11.5% vs 2.5%) and also more likely to report diarrhea (10.6% vs 5.6%).CONCLUSIONS AND RELEVANCE: In patients who experienced an ACS event, direct inhibition of Lp-PLA2 with darapladib added to optimal medical therapy and initiated within 30 days of hospitalization did not reduce the risk of major coronary events.TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01000727.",
keywords = "Acute Coronary Syndrome/drug therapy, Aged, Benzaldehydes/adverse effects, Blood Proteins/adverse effects, Cardiovascular Diseases/mortality, Double-Blind Method, Female, Follow-Up Studies, Humans, Incidence, Kaplan-Meier Estimate, Male, Middle Aged, Myocardial Infarction/drug therapy, Myocardial Ischemia/epidemiology, Oximes/adverse effects, Secondary Prevention",
author = "O'Donoghue, {Michelle L} and Eugene Braunwald and White, {Harvey D} and Steen, {Dylan P} and Lukas, {Mary Ann} and Elizabeth Tarka and Steg, {P Gabriel} and Hochman, {Judith S} and Christoph Bode and Maggioni, {Aldo P} and KyungAh Im and Shannon, {Jennifer B} and Davies, {Richard Y} and Murphy, {Sabina A} and Crugnale, {Sharon E} and Wiviott, {Stephen D} and Bonaca, {Marc P} and Watson, {David F} and Weaver, {W Douglas} and Serruys, {Patrick W} and Cannon, {Christopher P} and Steen, {Dylan L} and {SOLID-TIMI 52 Investigators} and Karsten Sydow",
year = "2014",
month = sep,
day = "10",
doi = "10.1001/jama.2014.11061",
language = "English",
volume = "312",
pages = "1006--1015",
journal = "JAMA-J AM MED ASSOC",
issn = "0098-7484",
publisher = "American Medical Association",
number = "10",

}

RIS

TY - JOUR

T1 - Effect of darapladib on major coronary events after an acute coronary syndrome: the SOLID-TIMI 52 randomized clinical trial

AU - O'Donoghue, Michelle L

AU - Braunwald, Eugene

AU - White, Harvey D

AU - Steen, Dylan P

AU - Lukas, Mary Ann

AU - Tarka, Elizabeth

AU - Steg, P Gabriel

AU - Hochman, Judith S

AU - Bode, Christoph

AU - Maggioni, Aldo P

AU - Im, KyungAh

AU - Shannon, Jennifer B

AU - Davies, Richard Y

AU - Murphy, Sabina A

AU - Crugnale, Sharon E

AU - Wiviott, Stephen D

AU - Bonaca, Marc P

AU - Watson, David F

AU - Weaver, W Douglas

AU - Serruys, Patrick W

AU - Cannon, Christopher P

AU - Steen, Dylan L

AU - SOLID-TIMI 52 Investigators

AU - Sydow, Karsten

PY - 2014/9/10

Y1 - 2014/9/10

N2 - IMPORTANCE: Lipoprotein-associated phospholipase A2 (Lp-PLA2) has been hypothesized to be involved in atherogenesis through pathways related to inflammation. Darapladib is an oral, selective inhibitor of the Lp-PLA2 enzyme.OBJECTIVE: To evaluate the efficacy and safety of darapladib in patients after an acute coronary syndrome (ACS) event.DESIGN, SETTING, AND PARTICIPANTS: SOLID-TIMI 52 was a multinational, double-blind, placebo-controlled trial that randomized 13,026 participants within 30 days of hospitalization with an ACS (non-ST-elevation or ST-elevation myocardial infarction [MI]) at 868 sites in 36 countries.INTERVENTIONS: Patients were randomized to either once-daily darapladib (160 mg) or placebo on a background of guideline-recommended therapy. Patients were followed up for a median of 2.5 years between December 7, 2009, and December 6, 2013.MAIN OUTCOMES AND MEASURES: The primary end point (major coronary events) was the composite of coronary heart disease (CHD) death, MI, or urgent coronary revascularization for myocardial ischemia. Kaplan-Meier event rates are reported at 3 years.RESULTS: During a median duration of 2.5 years, the primary end point occurred in 903 patients in the darapladib group and 910 in the placebo group (16.3% vs 15.6% at 3 years; hazard ratio [HR], 1.00 [95% CI, 0.91-1.09]; P = .93). The composite of cardiovascular death, MI, or stroke occurred in 824 in the darapladib group and 838 in the placebo group (15.0% vs 15.0% at 3 years; HR, 0.99 [95% CI, 0.90-1.09]; P = .78). There were no differences between the treatment groups for additional secondary end points, for individual components of the primary end point, or in all-cause mortality (371 events in the darapladib group and 395 in the placebo group [7.3% vs 7.1% at 3 years; HR, 0.94 [95% CI, 0.82-1.08]; P = .40). Patients were more likely to report an odor-related concern in the darapladib group vs the placebo group (11.5% vs 2.5%) and also more likely to report diarrhea (10.6% vs 5.6%).CONCLUSIONS AND RELEVANCE: In patients who experienced an ACS event, direct inhibition of Lp-PLA2 with darapladib added to optimal medical therapy and initiated within 30 days of hospitalization did not reduce the risk of major coronary events.TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01000727.

AB - IMPORTANCE: Lipoprotein-associated phospholipase A2 (Lp-PLA2) has been hypothesized to be involved in atherogenesis through pathways related to inflammation. Darapladib is an oral, selective inhibitor of the Lp-PLA2 enzyme.OBJECTIVE: To evaluate the efficacy and safety of darapladib in patients after an acute coronary syndrome (ACS) event.DESIGN, SETTING, AND PARTICIPANTS: SOLID-TIMI 52 was a multinational, double-blind, placebo-controlled trial that randomized 13,026 participants within 30 days of hospitalization with an ACS (non-ST-elevation or ST-elevation myocardial infarction [MI]) at 868 sites in 36 countries.INTERVENTIONS: Patients were randomized to either once-daily darapladib (160 mg) or placebo on a background of guideline-recommended therapy. Patients were followed up for a median of 2.5 years between December 7, 2009, and December 6, 2013.MAIN OUTCOMES AND MEASURES: The primary end point (major coronary events) was the composite of coronary heart disease (CHD) death, MI, or urgent coronary revascularization for myocardial ischemia. Kaplan-Meier event rates are reported at 3 years.RESULTS: During a median duration of 2.5 years, the primary end point occurred in 903 patients in the darapladib group and 910 in the placebo group (16.3% vs 15.6% at 3 years; hazard ratio [HR], 1.00 [95% CI, 0.91-1.09]; P = .93). The composite of cardiovascular death, MI, or stroke occurred in 824 in the darapladib group and 838 in the placebo group (15.0% vs 15.0% at 3 years; HR, 0.99 [95% CI, 0.90-1.09]; P = .78). There were no differences between the treatment groups for additional secondary end points, for individual components of the primary end point, or in all-cause mortality (371 events in the darapladib group and 395 in the placebo group [7.3% vs 7.1% at 3 years; HR, 0.94 [95% CI, 0.82-1.08]; P = .40). Patients were more likely to report an odor-related concern in the darapladib group vs the placebo group (11.5% vs 2.5%) and also more likely to report diarrhea (10.6% vs 5.6%).CONCLUSIONS AND RELEVANCE: In patients who experienced an ACS event, direct inhibition of Lp-PLA2 with darapladib added to optimal medical therapy and initiated within 30 days of hospitalization did not reduce the risk of major coronary events.TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01000727.

KW - Acute Coronary Syndrome/drug therapy

KW - Aged

KW - Benzaldehydes/adverse effects

KW - Blood Proteins/adverse effects

KW - Cardiovascular Diseases/mortality

KW - Double-Blind Method

KW - Female

KW - Follow-Up Studies

KW - Humans

KW - Incidence

KW - Kaplan-Meier Estimate

KW - Male

KW - Middle Aged

KW - Myocardial Infarction/drug therapy

KW - Myocardial Ischemia/epidemiology

KW - Oximes/adverse effects

KW - Secondary Prevention

U2 - 10.1001/jama.2014.11061

DO - 10.1001/jama.2014.11061

M3 - SCORING: Journal article

C2 - 25173516

VL - 312

SP - 1006

EP - 1015

JO - JAMA-J AM MED ASSOC

JF - JAMA-J AM MED ASSOC

SN - 0098-7484

IS - 10

ER -