Author + information
- Svend Aage Mortensen, MD, DMSc∗ ()
- ↵∗Heart Center, Copenhagen University Hospital, B 2141, Blegdamsvej 9, Copenhagen DK-2100, Denmark
Ezekowitz expressed in an editorial comment (1) his opinion about the Q-SYMBIO study (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]) (2) with the following conclusion: “Heart failure (HF) patients are spending a lot of energy trying to be normal. Let us help them.”
Yes. HF is a disabling disease with a poor prognosis despite significant advances in drug and device-based therapies. The results of the Q-SYMBIO study demonstrate that supplementation with coenzyme Q10 (CoQ10) in addition to conventional therapy: 1) improves symptoms; 2) improves survival; and 3) reduces hospitalization rate.
Yes. The investigators are encouraged about the study outcomes. The number of patients needed to treat (NNT) for 2 years to prevent 1 death is calculated to 10 based on the hazard ratio (in favor of CoQ10) and the survival rate at 2 years. This estimate of NNT is low compared with NNTs in other HF trials.
Yes. CoQ10 is necessary for the normal function of all cells, and supplementation with CoQ10 has been clinically tested in various disease states in more than 200 randomized controlled trials (RCT) as listed on Medline. None of these trials have reported serious adverse effects. A few incidences of mild gastrointestinal discomfort have been registered, probably due to the vegetable solvent in the capsule and not by CoQ10 per se. The 42% lower all-cause mortality in the CoQ10 group in the Q-SYMBIO study compared with placebo is indicative of the safety profile.
The preparation used in the Q-SYMBIO trial (Myoqinon) is a licensed medicinal product in Hungary, a European Union Member, for adjunctive treatment of HF, which further supports the safety of CoQ10.
Ezekowitz (1) questions whether the results of the Q-SYMBIO study would be replicable in a larger study. It is unlikely to be a large-scale trial, as funding is difficult when using a nonpatentable substance. A confirmatory trial with CoQ10 could be done, but then the important question would be, is it ethical to wait for the results of a new trial with the present survival data in Q-SYMBIO study?
RCTs with a similar size as the Q-SYMBIO study have been guideline changing in HF. The CONSENSUS I (Cooperative North Scandinavian Enalapril Survival Study) (3) from 1987 with enalapril of 253 patients changed clinical practice in HF. Also, the initial beta-blocker trials had fewer patients enrolled compared with the Q-SYMBIO study, for example, the PRECISE trial (4) with 278 patients.
CoQ10 was acknowledged in a previous American College of Cardiology/American Heart Association HF guidelines from 2005 (5) to have a possible effect in some studies, but supplementation was not recommended until more data were available. The positive survival data from the Q-SYMBIO study and the meta-analyses of RCTs regarding ejection fraction and/or New York Heart Association classification give us a more robust documentation for CoQ10 treatment in HF.
Unlike current pharmacological interventions, CoQ10 supplementation restores a deficiency state that may otherwise contribute to symptoms and reduced survival in patients with HF.
- American College of Cardiology Foundation
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- for the PRECISE Study Group
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