The Q-SYMBIO trial, published in the Journal of the American College of Cardiology (JACC) Heart Failure, evaluated the effects of Coenzyme Q10 (CoQ10) supplementation on morbidity and mortality in patients with chronic heart failure (CHF). This randomized, double-blind, placebo-controlled multicenter trial aimed to assess the potential of CoQ10 as an adjunctive treatment in improving symptoms, reducing hospitalizations, and lowering mortality rates among CHF patients.
Study Design and Objectives
- Participants: 420 patients with moderate to severe CHF were enrolled from 17 centers across Europe, Asia, and Australia.
- Randomization: Patients were randomly assigned to receive either CoQ10 (100 mg, three times daily) or a placebo, in addition to standard heart failure therapy.
- Duration: The study spanned two years, with evaluations at 16 weeks (short-term) and 106 weeks (long-term).
- Endpoints:
- Primary Short-Term Endpoints: Changes in New York Heart Association (NYHA) class, 6-minute walk test (6MWT), and N-terminal pro-B-type natriuretic peptide (NT-proBNP).
- Primary Long-Term Endpoint: Composite of major adverse cardiovascular events (MACE), including hospitalization for worsening CHF, cardiovascular death, mechanical assist implantation, or urgent heart transplantation.
Key Baseline Characteristics
- Average Age: 62.3 years in both groups.
- Male/Female Ratio: 154/48 in the CoQ10 group, 151/67 in the placebo group.
- Ejection Fraction (EF): Mean baseline EF was approximately 31% in both groups.
- Heart Failure Duration: On average, patients had CHF for 3 years prior to enrollment.
Primary Outcomes and Statistical Findings
Morbidity and Mortality (Long-Term) at 106 Weeks:
- MACE occurred in 15% of the CoQ10 group compared to 26% of the placebo group (p = 0.003).
- The hazard ratio (HR) for the CoQ10 group was 0.50 (95% CI: 0.32 – 0.80), indicating a 50% reduction in the risk of major cardiovascular events.
- Cardiovascular mortality was significantly lower in the CoQ10 group (9%) compared to the placebo group (16%, p = 0.026).
- All-cause mortality was 10% in the CoQ10 group and 18% in the placebo group (p = 0.018).
Hospitalizations for Worsening Heart Failure:
- Hospital admissions for heart failure were 8% in the CoQ10 group versus 14% in the placebo group (p = 0.033).
- This corresponds to a hazard ratio of 0.51 (95% CI: 0.27 – 0.95).
Functional Improvement (NYHA Class):
- After two years, 58% of patients in the CoQ10 group experienced at least one NYHA class improvement, compared to 45% in the placebo group (p = 0.028).
Reduction in NT-proBNP (Heart Failure Biomarker):
- NT-proBNP levels decreased by 1,137 pg/ml (60%) in the CoQ10 group compared to 881 pg/ml (52%) in the placebo group, though the between-group difference was not statistically significant.
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Short-Term Outcomes at 16 Weeks
- NYHA Class and 6MWT: There were no statistically significant differences between groups at 16 weeks for NYHA class or 6MWT.
- NT-proBNP: Although there was a 20% reduction in NT-proBNP in the CoQ10 group compared to a 12% increase in the placebo group, this trend did not reach statistical significance (p > 0.05).
Safety and Tolerability
- Adverse Events:
- Adverse events occurred in 13% of the CoQ10 group versus 19% of the placebo group (p = 0.110).
- Gastrointestinal disturbances were more common in the placebo group (8% vs. 2%).
Subgroup Analyses
- CoQ10 consistently showed benefits across subgroups, including:
- Elderly patients (≥65 years).
- Patients with EF ≥30%.
- Patients with NT-proBNP ≥300 pg/ml.
- The effects were independent of baseline heart failure medications, including beta-blockers and ACE inhibitors.
Clinical Implications
- Reduction in Mortality and MACE:
- The 42-43% reduction in mortality and MACE highlights the potential of CoQ10 as a life-extending adjunctive therapy in CHF management.
- Improved Functional Status:
- CoQ10 improved symptoms and quality of life as evidenced by significant improvements in NYHA class.
- Safe and Well-Tolerated:
- CoQ10 showed an excellent safety profile with no serious adverse events reported.
Conclusion
The Q-SYMBIO trial demonstrated that CoQ10 supplementation significantly reduces the risk of major cardiovascular events and mortality in CHF patients. It improves symptoms and functional status, making it a valuable addition to standard heart failure therapies. Further large-scale studies are recommended to confirm these findings and explore CoQ10’s long-term benefits.
For full details, refer to the original article: https://pubmed.ncbi.nlm.nih.gov/25282031/