Rationale and design of the dal-OUTCOMES trial: efficacy and safety of dalcetrapib in patients with recent acute coronary syndrome

Gregory G Schwartz, Anders G Olsson, Christie M Ballantyne, Phillip J Barter, Ingar M Holme, David Kallend, Lawrence A Leiter, Eran Leitersdorf, John J V McMurray, Prediman K Shah, Jean-Claude Tardif, Bernard R Chaitman, Regina Duttlinger-Maddux, John Mathieson, Kenneth Egstrup

Research output: Contribution to journalJournal articleResearchpeer-review

Abstract

BACKGROUND: Despite contemporary therapies for acute coronary syndrome (ACS), morbidity and mortality remain high. Low levels of high-density lipoprotein (HDL) cholesterol are common among patients with ACS and may contribute to ongoing risk. Strategies that raise levels of HDL cholesterol, such as inhibition of cholesterol ester transfer protein (CETP), might reduce risk after ACS. Dal-OUTCOMES is a multicenter, randomized, double-blind, placebo-controlled trial designed to test the hypothesis that CETP inhibition with dalcetrapib reduces cardiovascular morbidity and mortality in patients with recent ACS. DESIGN: The study will randomize approximately 15,600 patients to receive daily doses of dalcetrapib 600 mg or matching placebo, beginning 4 to 12 weeks after an index ACS event. There are no prespecified boundaries for HDL cholesterol levels at entry. Other elements of care, including management of low-density lipoprotein cholesterol, are to follow best evidence-based practice. The primary efficacy measure is time to first occurrence of coronary heart disease death, nonfatal acute myocardial infarction, unstable angina requiring hospital admission, resuscitated cardiac arrest, or atherothrombotic stroke. The trial will continue until 1,600 primary end point events have occurred, all evaluable subjects have been followed for at least 2 years, and 80% of evaluable subjects have been followed for at least 2.5 years. SUMMARY: Dal-OUTCOMES will determine whether CETP inhibition with dalcetrapib, added to current evidence-based care, reduces cardiovascular morbidity and mortality after ACS.
Original languageEnglish
JournalAmerican Heart Journal
Volume158
Issue number6
Pages (from-to)896-901.e3
ISSN0002-8703
DOIs
Publication statusPublished - 1. Dec 2009

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Acute Coronary Syndrome
Cholesterol Ester Transfer Proteins
Safety
HDL Cholesterol
Placebos
Evidence-Based Practice
LDL Cholesterol
dalcetrapib

Keywords

  • Acute Coronary Syndrome
  • Anticholesteremic Agents
  • Humans
  • Multicenter Studies as Topic
  • Randomized Controlled Trials as Topic
  • Research Design
  • Sulfhydryl Compounds

Cite this

Schwartz, Gregory G ; Olsson, Anders G ; Ballantyne, Christie M ; Barter, Phillip J ; Holme, Ingar M ; Kallend, David ; Leiter, Lawrence A ; Leitersdorf, Eran ; McMurray, John J V ; Shah, Prediman K ; Tardif, Jean-Claude ; Chaitman, Bernard R ; Duttlinger-Maddux, Regina ; Mathieson, John ; Egstrup, Kenneth. / Rationale and design of the dal-OUTCOMES trial: efficacy and safety of dalcetrapib in patients with recent acute coronary syndrome. In: American Heart Journal. 2009 ; Vol. 158, No. 6. pp. 896-901.e3.
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title = "Rationale and design of the dal-OUTCOMES trial: efficacy and safety of dalcetrapib in patients with recent acute coronary syndrome",
abstract = "BACKGROUND: Despite contemporary therapies for acute coronary syndrome (ACS), morbidity and mortality remain high. Low levels of high-density lipoprotein (HDL) cholesterol are common among patients with ACS and may contribute to ongoing risk. Strategies that raise levels of HDL cholesterol, such as inhibition of cholesterol ester transfer protein (CETP), might reduce risk after ACS. Dal-OUTCOMES is a multicenter, randomized, double-blind, placebo-controlled trial designed to test the hypothesis that CETP inhibition with dalcetrapib reduces cardiovascular morbidity and mortality in patients with recent ACS. DESIGN: The study will randomize approximately 15,600 patients to receive daily doses of dalcetrapib 600 mg or matching placebo, beginning 4 to 12 weeks after an index ACS event. There are no prespecified boundaries for HDL cholesterol levels at entry. Other elements of care, including management of low-density lipoprotein cholesterol, are to follow best evidence-based practice. The primary efficacy measure is time to first occurrence of coronary heart disease death, nonfatal acute myocardial infarction, unstable angina requiring hospital admission, resuscitated cardiac arrest, or atherothrombotic stroke. The trial will continue until 1,600 primary end point events have occurred, all evaluable subjects have been followed for at least 2 years, and 80{\%} of evaluable subjects have been followed for at least 2.5 years. SUMMARY: Dal-OUTCOMES will determine whether CETP inhibition with dalcetrapib, added to current evidence-based care, reduces cardiovascular morbidity and mortality after ACS.",
keywords = "Acute Coronary Syndrome, Anticholesteremic Agents, Humans, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Research Design, Sulfhydryl Compounds",
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Schwartz, GG, Olsson, AG, Ballantyne, CM, Barter, PJ, Holme, IM, Kallend, D, Leiter, LA, Leitersdorf, E, McMurray, JJV, Shah, PK, Tardif, J-C, Chaitman, BR, Duttlinger-Maddux, R, Mathieson, J & Egstrup, K 2009, 'Rationale and design of the dal-OUTCOMES trial: efficacy and safety of dalcetrapib in patients with recent acute coronary syndrome', American Heart Journal, vol. 158, no. 6, pp. 896-901.e3. https://doi.org/10.1016/j.ahj.2009.09.017

Rationale and design of the dal-OUTCOMES trial: efficacy and safety of dalcetrapib in patients with recent acute coronary syndrome. / Schwartz, Gregory G; Olsson, Anders G; Ballantyne, Christie M; Barter, Phillip J; Holme, Ingar M; Kallend, David; Leiter, Lawrence A; Leitersdorf, Eran; McMurray, John J V; Shah, Prediman K; Tardif, Jean-Claude; Chaitman, Bernard R; Duttlinger-Maddux, Regina; Mathieson, John; Egstrup, Kenneth.

In: American Heart Journal, Vol. 158, No. 6, 01.12.2009, p. 896-901.e3.

Research output: Contribution to journalJournal articleResearchpeer-review

TY - JOUR

T1 - Rationale and design of the dal-OUTCOMES trial: efficacy and safety of dalcetrapib in patients with recent acute coronary syndrome

AU - Schwartz, Gregory G

AU - Olsson, Anders G

AU - Ballantyne, Christie M

AU - Barter, Phillip J

AU - Holme, Ingar M

AU - Kallend, David

AU - Leiter, Lawrence A

AU - Leitersdorf, Eran

AU - McMurray, John J V

AU - Shah, Prediman K

AU - Tardif, Jean-Claude

AU - Chaitman, Bernard R

AU - Duttlinger-Maddux, Regina

AU - Mathieson, John

AU - Egstrup, Kenneth

N1 - Kenneth Egstrup var investigator på publikationen

PY - 2009/12/1

Y1 - 2009/12/1

N2 - BACKGROUND: Despite contemporary therapies for acute coronary syndrome (ACS), morbidity and mortality remain high. Low levels of high-density lipoprotein (HDL) cholesterol are common among patients with ACS and may contribute to ongoing risk. Strategies that raise levels of HDL cholesterol, such as inhibition of cholesterol ester transfer protein (CETP), might reduce risk after ACS. Dal-OUTCOMES is a multicenter, randomized, double-blind, placebo-controlled trial designed to test the hypothesis that CETP inhibition with dalcetrapib reduces cardiovascular morbidity and mortality in patients with recent ACS. DESIGN: The study will randomize approximately 15,600 patients to receive daily doses of dalcetrapib 600 mg or matching placebo, beginning 4 to 12 weeks after an index ACS event. There are no prespecified boundaries for HDL cholesterol levels at entry. Other elements of care, including management of low-density lipoprotein cholesterol, are to follow best evidence-based practice. The primary efficacy measure is time to first occurrence of coronary heart disease death, nonfatal acute myocardial infarction, unstable angina requiring hospital admission, resuscitated cardiac arrest, or atherothrombotic stroke. The trial will continue until 1,600 primary end point events have occurred, all evaluable subjects have been followed for at least 2 years, and 80% of evaluable subjects have been followed for at least 2.5 years. SUMMARY: Dal-OUTCOMES will determine whether CETP inhibition with dalcetrapib, added to current evidence-based care, reduces cardiovascular morbidity and mortality after ACS.

AB - BACKGROUND: Despite contemporary therapies for acute coronary syndrome (ACS), morbidity and mortality remain high. Low levels of high-density lipoprotein (HDL) cholesterol are common among patients with ACS and may contribute to ongoing risk. Strategies that raise levels of HDL cholesterol, such as inhibition of cholesterol ester transfer protein (CETP), might reduce risk after ACS. Dal-OUTCOMES is a multicenter, randomized, double-blind, placebo-controlled trial designed to test the hypothesis that CETP inhibition with dalcetrapib reduces cardiovascular morbidity and mortality in patients with recent ACS. DESIGN: The study will randomize approximately 15,600 patients to receive daily doses of dalcetrapib 600 mg or matching placebo, beginning 4 to 12 weeks after an index ACS event. There are no prespecified boundaries for HDL cholesterol levels at entry. Other elements of care, including management of low-density lipoprotein cholesterol, are to follow best evidence-based practice. The primary efficacy measure is time to first occurrence of coronary heart disease death, nonfatal acute myocardial infarction, unstable angina requiring hospital admission, resuscitated cardiac arrest, or atherothrombotic stroke. The trial will continue until 1,600 primary end point events have occurred, all evaluable subjects have been followed for at least 2 years, and 80% of evaluable subjects have been followed for at least 2.5 years. SUMMARY: Dal-OUTCOMES will determine whether CETP inhibition with dalcetrapib, added to current evidence-based care, reduces cardiovascular morbidity and mortality after ACS.

KW - Acute Coronary Syndrome

KW - Anticholesteremic Agents

KW - Humans

KW - Multicenter Studies as Topic

KW - Randomized Controlled Trials as Topic

KW - Research Design

KW - Sulfhydryl Compounds

U2 - 10.1016/j.ahj.2009.09.017

DO - 10.1016/j.ahj.2009.09.017

M3 - Journal article

C2 - 19958854

VL - 158

SP - 896-901.e3

JO - American Heart Journal

JF - American Heart Journal

SN - 0002-8703

IS - 6

ER -