Assessment of omega-3 carboxylic acids in statin-treated patients with high levels of triglycerides and low levels of high-density lipoprotein cholesterol: Rationale and design of the STRENGTH trial

Stephen J. Nicholls, A. Michael Lincoff, Dianna Bash, Christie M. Ballantyne, Philip J. Barter, Michael H. Davidson, John J.P. Kastelein, Wolfgang Koenig, Darren K. McGuire, Dariush Mozaffarian, Terje R. Pedersen, Paul M. Ridker, Kausik Ray, Björn W. Karlson, Torbjörn Lundström, Kathy Wolski, Steven E. Nissen

Research output: Contribution to journalArticle

40 Citations (Scopus)

Abstract

It is uncertain whether omega-3 fatty acids are beneficial in statin-treated patients. Epanova is a mix of omega-3 free fatty acids, not requiring co-ingestion with food, which can lower triglycerides by up to 31%. STRENGTH will examine whether Epanova 4 g daily reduces the rate of cardiovascular events in statin-treated patients with hypertriglyceridemia and low levels of HDL-C at high risk for developing cardiovascular events. STRENGTH is a randomized, double-blind, placebo-controlled trial. Patients had a triglyceride level ≥ 180 to <500 mg/dL and HDL-C < 42 mg/dL (men) or < 47 mg/dL (women) in the presence of either (1) established atherosclerotic cardiovascular disease, (2) diabetes with one additional risk factor, or (3) were other high-risk primary prevention patients, based on age and risk factor assessment. Patients should be treated with a statin, for >4 weeks, and have LDL-C < 100 mg/dL, but were also eligible if LDL-C was ≥100 mg/dL while on maximum tolerated statin therapy. The study will extend from October 30, 2014 to October 30, 2019. 13 086 patients were randomized to Epanova 4 g or placebo daily in addition to standard medical therapy. The primary efficacy outcome is time to first event of cardiovascular death, myocardial infarction, stroke, coronary revascularization or hospitalization for unstable angina. The trial will continue until 1600 patients reach the primary endpoint, with a median duration of therapy of 3 years. STRENGTH will determine whether Epanova 4 g daily will reduce cardiovascular events in statin-treated high-risk patients with hypertriglyceridemia and low HDL-C levels.

LanguageEnglish
Pages1281-1288
Number of pages8
JournalClinical Cardiology
Volume41
Issue number10
DOIs
Publication statusPublished - 1 Oct 2018

Keywords

  • cardiovascular risk
  • clinical trials
  • non-HDL cholesterol
  • omega-3 fatty acids
  • triglycerides

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Nicholls, Stephen J. ; Lincoff, A. Michael ; Bash, Dianna ; Ballantyne, Christie M. ; Barter, Philip J. ; Davidson, Michael H. ; Kastelein, John J.P. ; Koenig, Wolfgang ; McGuire, Darren K. ; Mozaffarian, Dariush ; Pedersen, Terje R. ; Ridker, Paul M. ; Ray, Kausik ; Karlson, Björn W. ; Lundström, Torbjörn ; Wolski, Kathy ; Nissen, Steven E. / Assessment of omega-3 carboxylic acids in statin-treated patients with high levels of triglycerides and low levels of high-density lipoprotein cholesterol : Rationale and design of the STRENGTH trial. In: Clinical Cardiology. 2018 ; Vol. 41, No. 10. pp. 1281-1288.
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abstract = "It is uncertain whether omega-3 fatty acids are beneficial in statin-treated patients. Epanova is a mix of omega-3 free fatty acids, not requiring co-ingestion with food, which can lower triglycerides by up to 31{\%}. STRENGTH will examine whether Epanova 4 g daily reduces the rate of cardiovascular events in statin-treated patients with hypertriglyceridemia and low levels of HDL-C at high risk for developing cardiovascular events. STRENGTH is a randomized, double-blind, placebo-controlled trial. Patients had a triglyceride level ≥ 180 to <500 mg/dL and HDL-C < 42 mg/dL (men) or < 47 mg/dL (women) in the presence of either (1) established atherosclerotic cardiovascular disease, (2) diabetes with one additional risk factor, or (3) were other high-risk primary prevention patients, based on age and risk factor assessment. Patients should be treated with a statin, for >4 weeks, and have LDL-C < 100 mg/dL, but were also eligible if LDL-C was ≥100 mg/dL while on maximum tolerated statin therapy. The study will extend from October 30, 2014 to October 30, 2019. 13 086 patients were randomized to Epanova 4 g or placebo daily in addition to standard medical therapy. The primary efficacy outcome is time to first event of cardiovascular death, myocardial infarction, stroke, coronary revascularization or hospitalization for unstable angina. The trial will continue until 1600 patients reach the primary endpoint, with a median duration of therapy of 3 years. STRENGTH will determine whether Epanova 4 g daily will reduce cardiovascular events in statin-treated high-risk patients with hypertriglyceridemia and low HDL-C levels.",
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Nicholls, SJ, Lincoff, AM, Bash, D, Ballantyne, CM, Barter, PJ, Davidson, MH, Kastelein, JJP, Koenig, W, McGuire, DK, Mozaffarian, D, Pedersen, TR, Ridker, PM, Ray, K, Karlson, BW, Lundström, T, Wolski, K & Nissen, SE 2018, 'Assessment of omega-3 carboxylic acids in statin-treated patients with high levels of triglycerides and low levels of high-density lipoprotein cholesterol: Rationale and design of the STRENGTH trial', Clinical Cardiology, vol. 41, no. 10, pp. 1281-1288. https://doi.org/10.1002/clc.23055

Assessment of omega-3 carboxylic acids in statin-treated patients with high levels of triglycerides and low levels of high-density lipoprotein cholesterol : Rationale and design of the STRENGTH trial. / Nicholls, Stephen J.; Lincoff, A. Michael; Bash, Dianna; Ballantyne, Christie M.; Barter, Philip J.; Davidson, Michael H.; Kastelein, John J.P.; Koenig, Wolfgang; McGuire, Darren K.; Mozaffarian, Dariush; Pedersen, Terje R.; Ridker, Paul M.; Ray, Kausik; Karlson, Björn W.; Lundström, Torbjörn; Wolski, Kathy; Nissen, Steven E.

In: Clinical Cardiology, Vol. 41, No. 10, 01.10.2018, p. 1281-1288.

Research output: Contribution to journalArticle

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AU - Nicholls, Stephen J.

AU - Lincoff, A. Michael

AU - Bash, Dianna

AU - Ballantyne, Christie M.

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AU - Davidson, Michael H.

AU - Kastelein, John J.P.

AU - Koenig, Wolfgang

AU - McGuire, Darren K.

AU - Mozaffarian, Dariush

AU - Pedersen, Terje R.

AU - Ridker, Paul M.

AU - Ray, Kausik

AU - Karlson, Björn W.

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N2 - It is uncertain whether omega-3 fatty acids are beneficial in statin-treated patients. Epanova is a mix of omega-3 free fatty acids, not requiring co-ingestion with food, which can lower triglycerides by up to 31%. STRENGTH will examine whether Epanova 4 g daily reduces the rate of cardiovascular events in statin-treated patients with hypertriglyceridemia and low levels of HDL-C at high risk for developing cardiovascular events. STRENGTH is a randomized, double-blind, placebo-controlled trial. Patients had a triglyceride level ≥ 180 to <500 mg/dL and HDL-C < 42 mg/dL (men) or < 47 mg/dL (women) in the presence of either (1) established atherosclerotic cardiovascular disease, (2) diabetes with one additional risk factor, or (3) were other high-risk primary prevention patients, based on age and risk factor assessment. Patients should be treated with a statin, for >4 weeks, and have LDL-C < 100 mg/dL, but were also eligible if LDL-C was ≥100 mg/dL while on maximum tolerated statin therapy. The study will extend from October 30, 2014 to October 30, 2019. 13 086 patients were randomized to Epanova 4 g or placebo daily in addition to standard medical therapy. The primary efficacy outcome is time to first event of cardiovascular death, myocardial infarction, stroke, coronary revascularization or hospitalization for unstable angina. The trial will continue until 1600 patients reach the primary endpoint, with a median duration of therapy of 3 years. STRENGTH will determine whether Epanova 4 g daily will reduce cardiovascular events in statin-treated high-risk patients with hypertriglyceridemia and low HDL-C levels.

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