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The effect of coenzyme Q10 on morbidity and mortality in chronic heart failure: results from Q-SYMBIO: a randomized double-blind trial.

Abstract

OBJECTIVES

This randomized controlled multicenter trial evaluated coenzyme Q10 (CoQ10) as adjunctive treatment in chronic heart failure (HF).

BACKGROUND

CoQ10 is an essential cofactor for energy production and is also a powerful antioxidant. A low level of myocardial CoQ10 is related to the severity of HF. Previous randomized controlled trials of CoQ10 in HF were underpowered to address major clinical endpoints.

METHODS

Patients with moderate to severe HF were randomly assigned in a 2-year prospective trial to either CoQ10 100 mg 3 times daily or placebo, in addition to standard therapy. The primary short-term endpoints at 16 weeks were changes in New York Heart Association (NYHA) functional classification, 6-min walk test, and levels of N-terminal pro-B type natriuretic peptide. The primary long-term endpoint at 2 years was composite major adverse cardiovascular events as determined by a time to first event analysis.

RESULTS

A total of 420 patients were enrolled. There were no significant changes in short-term endpoints. The primary long-term endpoint was reached by 15% of the patients in the CoQ10 group versus 26% in the placebo group (hazard ratio: 0.50; 95% confidence interval: 0.32 to 0.80; p = 0.003) by intention-to-treat analysis. The following secondary endpoints were significantly lower in the CoQ10 group compared with the placebo group: cardiovascular mortality (9% vs. 16%, p = 0.026), all-cause mortality (10% vs. 18%, p = 0.018), and incidence of hospital stays for HF (p = 0.033). In addition, a significant improvement of NYHA class was found in the CoQ10 group after 2 years (p = 0.028).

CONCLUSIONS

Long-term CoQ10 treatment of patients with chronic HF is safe, improves symptoms, and reduces major adverse cardiovascular events. (Coenzyme Q10 as adjunctive treatment of chronic heart failure: a randomised, double-blind, multicentre trial with focus on SYMptoms, BIomarker status [Brain-Natriuretic Peptide (BNP)], and long-term Outcome [hospitalisations/mortality]; ISRCTN94506234).

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  • Authors+Show Affiliations

    ,

    Department of Cardiology, Heart Centre, Copenhagen University Hospital, Copenhagen, Denmark. Electronic address: doctormortensen@gmail.com.

    ,

    Cardiac Surgical Research Unit, Alfred Hospital, Monash University, Melbourne, Australia.

    ,

    Department of Cardiology, Government Medical College/G.N.D. Hospital, Amritsar, India.

    ,

    Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria.

    ,

    First Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.

    ,

    Medical Faculty of P.J. Safarik University, Kosice, Slovakia.

    ,

    University Hospital, Linköping, Sweden.

    ,

    Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria.

    ,

    Clinical and Dental Sciences, Biochemistry Section, Polytechnic University of The Marche, Ancona, Italy.

    Source

    JACC. Heart failure 2:6 2014 Dec pg 641-9

    MeSH

    Biomarkers
    Chronic Disease
    Death, Sudden, Cardiac
    Double-Blind Method
    Female
    Heart Failure
    Hospitalization
    Humans
    Male
    Middle Aged
    Natriuretic Peptide, Brain
    Peptide Fragments
    Prospective Studies
    Ubiquinone
    Vitamins

    Pub Type(s)

    Clinical Trial, Phase II
    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    25282031

    Citation

    Mortensen, Svend A., et al. "The Effect of Coenzyme Q10 On Morbidity and Mortality in Chronic Heart Failure: Results From Q-SYMBIO: a Randomized Double-blind Trial." JACC. Heart Failure, vol. 2, no. 6, 2014, pp. 641-9.
    Mortensen SA, Rosenfeldt F, Kumar A, et al. The effect of coenzyme Q10 on morbidity and mortality in chronic heart failure: results from Q-SYMBIO: a randomized double-blind trial. JACC Heart Fail. 2014;2(6):641-9.
    Mortensen, S. A., Rosenfeldt, F., Kumar, A., Dolliner, P., Filipiak, K. J., Pella, D., ... Littarru, G. P. (2014). The effect of coenzyme Q10 on morbidity and mortality in chronic heart failure: results from Q-SYMBIO: a randomized double-blind trial. JACC. Heart Failure, 2(6), pp. 641-9. doi:10.1016/j.jchf.2014.06.008.
    Mortensen SA, et al. The Effect of Coenzyme Q10 On Morbidity and Mortality in Chronic Heart Failure: Results From Q-SYMBIO: a Randomized Double-blind Trial. JACC Heart Fail. 2014;2(6):641-9. PubMed PMID: 25282031.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - The effect of coenzyme Q10 on morbidity and mortality in chronic heart failure: results from Q-SYMBIO: a randomized double-blind trial. AU - Mortensen,Svend A, AU - Rosenfeldt,Franklin, AU - Kumar,Adarsh, AU - Dolliner,Peter, AU - Filipiak,Krzysztof J, AU - Pella,Daniel, AU - Alehagen,Urban, AU - Steurer,Günter, AU - Littarru,Gian P, AU - ,, Y1 - 2014/10/01/ PY - 2014/04/21/received PY - 2014/05/31/revised PY - 2014/06/13/accepted PY - 2014/10/6/entrez PY - 2014/10/6/pubmed PY - 2015/11/17/medline KW - chronic heart failure KW - coenzyme Q(10) KW - metabolic therapy KW - randomized controlled trial KW - ubiquinone SP - 641 EP - 9 JF - JACC. Heart failure JO - JACC Heart Fail VL - 2 IS - 6 N2 - OBJECTIVES: This randomized controlled multicenter trial evaluated coenzyme Q10 (CoQ10) as adjunctive treatment in chronic heart failure (HF). BACKGROUND: CoQ10 is an essential cofactor for energy production and is also a powerful antioxidant. A low level of myocardial CoQ10 is related to the severity of HF. Previous randomized controlled trials of CoQ10 in HF were underpowered to address major clinical endpoints. METHODS: Patients with moderate to severe HF were randomly assigned in a 2-year prospective trial to either CoQ10 100 mg 3 times daily or placebo, in addition to standard therapy. The primary short-term endpoints at 16 weeks were changes in New York Heart Association (NYHA) functional classification, 6-min walk test, and levels of N-terminal pro-B type natriuretic peptide. The primary long-term endpoint at 2 years was composite major adverse cardiovascular events as determined by a time to first event analysis. RESULTS: A total of 420 patients were enrolled. There were no significant changes in short-term endpoints. The primary long-term endpoint was reached by 15% of the patients in the CoQ10 group versus 26% in the placebo group (hazard ratio: 0.50; 95% confidence interval: 0.32 to 0.80; p = 0.003) by intention-to-treat analysis. The following secondary endpoints were significantly lower in the CoQ10 group compared with the placebo group: cardiovascular mortality (9% vs. 16%, p = 0.026), all-cause mortality (10% vs. 18%, p = 0.018), and incidence of hospital stays for HF (p = 0.033). In addition, a significant improvement of NYHA class was found in the CoQ10 group after 2 years (p = 0.028). CONCLUSIONS: Long-term CoQ10 treatment of patients with chronic HF is safe, improves symptoms, and reduces major adverse cardiovascular events. (Coenzyme Q10 as adjunctive treatment of chronic heart failure: a randomised, double-blind, multicentre trial with focus on SYMptoms, BIomarker status [Brain-Natriuretic Peptide (BNP)], and long-term Outcome [hospitalisations/mortality]; ISRCTN94506234). SN - 2213-1787 UR - https://www.unboundmedicine.com/medline/citation/25282031/full_citation L2 - https://linkinghub.elsevier.com/retrieve/pii/S2213-1779(14)00336-9 DB - PRIME DP - Unbound Medicine ER -