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Darapladib for preventing ischemic events in stable coronary heart disease.

Publication ,  Journal Article
STABILITY Investigators, ; White, HD; Held, C; Stewart, R; Tarka, E; Brown, R; Davies, RY; Budaj, A; Harrington, RA; Steg, PG; Ardissino, D ...
Published in: N Engl J Med
May 1, 2014

BACKGROUND: Elevated lipoprotein-associated phospholipase A2 activity promotes the development of vulnerable atherosclerotic plaques, and elevated plasma levels of this enzyme are associated with an increased risk of coronary events. Darapladib is a selective oral inhibitor of lipoprotein-associated phospholipase A2. METHODS: In a double-blind trial, we randomly assigned 15,828 patients with stable coronary heart disease to receive either once-daily darapladib (at a dose of 160 mg) or placebo. The primary end point was a composite of cardiovascular death, myocardial infarction, or stroke. Secondary end points included the components of the primary end point as well as major coronary events (death from coronary heart disease, myocardial infarction, or urgent coronary revascularization for myocardial ischemia) and total coronary events (death from coronary heart disease, myocardial infarction, hospitalization for unstable angina, or any coronary revascularization). RESULTS: During a median follow-up period of 3.7 years, the primary end point occurred in 769 of 7924 patients (9.7%) in the darapladib group and 819 of 7904 patients (10.4%) in the placebo group (hazard ratio in the darapladib group, 0.94; 95% confidence interval [CI], 0.85 to 1.03; P=0.20). There were also no significant between-group differences in the rates of the individual components of the primary end point or in all-cause mortality. Darapladib, as compared with placebo, reduced the rate of major coronary events (9.3% vs. 10.3%; hazard ratio, 0.90; 95% CI, 0.82 to 1.00; P=0.045) and total coronary events (14.6% vs. 16.1%; hazard ratio, 0.91; 95% CI, 0.84 to 0.98; P=0.02). CONCLUSIONS: In patients with stable coronary heart disease, darapladib did not significantly reduce the risk of the primary composite end point of cardiovascular death, myocardial infarction, or stroke. (Funded by GlaxoSmithKline; STABILITY ClinicalTrials.gov number, NCT00799903.).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

May 1, 2014

Volume

370

Issue

18

Start / End Page

1702 / 1711

Location

United States

Related Subject Headings

  • Treatment Failure
  • Stroke
  • Phospholipase A2 Inhibitors
  • Oximes
  • Myocardial Infarction
  • Middle Aged
  • Male
  • Kaplan-Meier Estimate
  • Humans
  • General & Internal Medicine
 

Citation

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STABILITY Investigators, ., White, H. D., Held, C., Stewart, R., Tarka, E., Brown, R., … Wallentin, L. (2014). Darapladib for preventing ischemic events in stable coronary heart disease. N Engl J Med, 370(18), 1702–1711. https://doi.org/10.1056/NEJMoa1315878
STABILITY Investigators, Lars, Harvey D. White, Claes Held, Ralph Stewart, Elizabeth Tarka, Rebekkah Brown, Richard Y. Davies, et al. “Darapladib for preventing ischemic events in stable coronary heart disease.N Engl J Med 370, no. 18 (May 1, 2014): 1702–11. https://doi.org/10.1056/NEJMoa1315878.
STABILITY Investigators, White HD, Held C, Stewart R, Tarka E, Brown R, et al. Darapladib for preventing ischemic events in stable coronary heart disease. N Engl J Med. 2014 May 1;370(18):1702–11.
STABILITY Investigators, Lars, et al. “Darapladib for preventing ischemic events in stable coronary heart disease.N Engl J Med, vol. 370, no. 18, May 2014, pp. 1702–11. Pubmed, doi:10.1056/NEJMoa1315878.
STABILITY Investigators, White HD, Held C, Stewart R, Tarka E, Brown R, Davies RY, Budaj A, Harrington RA, Steg PG, Ardissino D, Armstrong PW, Avezum A, Aylward PE, Bryce A, Chen H, Chen M-F, Corbalan R, Dalby AJ, Danchin N, De Winter RJ, Denchev S, Diaz R, Elisaf M, Flather MD, Goudev AR, Granger CB, Grinfeld L, Hochman JS, Husted S, Kim H-S, Koenig W, Linhart A, Lonn E, López-Sendón J, Manolis AJ, Mohler ER, Nicolau JC, Pais P, Parkhomenko A, Pedersen TR, Pella D, Ramos-Corrales MA, Ruda M, Sereg M, Siddique S, Sinnaeve P, Smith P, Sritara P, Swart HP, Sy RG, Teramoto T, Tse H-F, Watson D, Weaver WD, Weiss R, Viigimaa M, Vinereanu D, Zhu J, Cannon CP, Wallentin L. Darapladib for preventing ischemic events in stable coronary heart disease. N Engl J Med. 2014 May 1;370(18):1702–1711.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

May 1, 2014

Volume

370

Issue

18

Start / End Page

1702 / 1711

Location

United States

Related Subject Headings

  • Treatment Failure
  • Stroke
  • Phospholipase A2 Inhibitors
  • Oximes
  • Myocardial Infarction
  • Middle Aged
  • Male
  • Kaplan-Meier Estimate
  • Humans
  • General & Internal Medicine