The Q-Symbio study was an international multi-center clinical trial that was reported in the Journal of the American College of Cardiology: Heart Failure in September 2014. Professor Mortensen and a team of researchers enrolled 420 patients with moderate to severe chronic heart failure. Half of the patients received a Coenzyme Q10 treatment of 100 milligrams three times daily for two years. The other half of the patients got inactive placebo capsules daily for two years. All of the patients continued their standard heart failure medications. Not until the end of the clinical trial did the researchers and the patients find out which patients were receiving the active Coenzyme Q10 treatment and which patients were receiving the placebo treatment. The patients in the Coenzyme Q10 treatment group had significantly reduced risk of heart disease death and death from all causes and significantly fewer hospital stays for heart failure complications. A later sub-analysis including only the European segment of the Q-Symbio Study showed that the Coenzyme Q10 therapy was also positively associated with a significant improvement in ejection fraction. The results of the Coenzyme Q10 treatment were even more impressive in the European sub-study. Treatment with Coenzyme Q10 300 milligrams per day in addition to conventional heart failure medications was safe, well tolerated, and effective at reducing symptoms and improving survival rates of chronic heart failure patients.
Purpose The Q-Symbio study was a multi-center randomized placebo-controlled double-blind clinical trial that was reported in the Journal of the American College of Cardiology: Heart Failure in September 2014. The purpose of the study was to assess the effect of the adjuvant therapy drug Coenzyme Q10 on several short-term and long-term endpoints in a total of 420 chronic heart failure patients enrolled in 17 cardiology centers in Europe, Asia, and Australia from 2003 to 2010. The trial name Q-SYMBIO reflects the focus on the following elements in the clinical trial: Q = Q10 and SYMBIO = SYMptoms, BIomarker status [Brain-Natriuretic Peptide], and long-term Outcome [hospitalizations/mortality]. Professor Mortensen and a team of researchers assigned 420 patients with moderate to severe chronic heart failure to Coenzyme Q10 100 milligrams three times daily or matching placebos in addition to the patients' standard heart failure therapies for two years. The patients in the Coenzyme Q10 adjunctive treatment group had significantly fewer major adverse cardiovascular events, significantly reduced risk of cardiovascular death and all-cause death, and significantly fewer hospital stays for heart failure complications.
Dosage The dosage of CoQ10 administered to the active treatment arm of the Q-SYMBIO trial was 100 milligrams three times daily, a dosage large enough to raise blood serum levels of Q10 significantly.
Patients The patients were selected for the Q-SYMBIO trial if they had chronic heart failure in New York Heart Association functional classes III (marked limitation of physical activity) or IV (unable to carry out any physical activity without discomfort). The age of the patients in years was 62.3 +/- 12. The ratio of male patients to female patients was roughly three to one. The mean duration of heart failure was around three years in both arms of the trial, and the baseline ejection fraction and six-minute-walking-time distances were equal between the groups. 90% of the patients in the study were receiving angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and 75% of the patients in the study were receiving beta-blockers. The dosages of the medications were only infrequently modified during the trial, so it is unlikely that minor changes in medication should have influenced the outcome of the trial.
Short-Term Effects (16 weeks of treatment) At week 16, there were improvements in NYHA classification, VAS score, and 6MWT (6-Minute Walk Test) in both treatment groups, but there were no significant differences between the groups. There was a trend with a 20% reduction of NT-proBNP in the CoQ10 group and a proportional rise of 12% in the placebo group. Retrospectively, at this time cardiovascular deaths were already significantly lower in the CoQ10 group, but this was not a pre-specified endpoint at week 16.
Long-Term Effects (106 weeks of treatment) Major Adverse Cardiovascular Events The number of Major Adverse Cardiovascular Events (MACE), which was the primary long-term endpoint in the trial, was statistically significantly fewer (p < 0.005) in the Q10 treatment arm (N = 30, 15%) than in the placebo arm (N = 57, 26%), corresponding to a 42.3% relative reduction in risk of MACE events. Cardiovascular Mortality The total number of cardiovascular deaths during the 106 weeks of the study was statistically significantly lower (p = 0.026) in the Q10 treatment arm (N = 18, 9%) than in the control arm (N = 34, 16%), a relative reduction of 43.8% in risk of cardiovascular death. All-cause Mortality Altogether, there were statistically significantly fewer (p = 0.018) deaths from all causes in the Q10 treatment arm (N = 21, 10%) than in the control arm (N = 39, 18%), a relative reduction of 44.4%. Hospital Stays for Heart Failure The number of hospital stays for heart failure during the 106 weeks was statistically significantly lower (p = 0.033) in the Q10 treatment arm (N = 17, 8%) as compared to the control arm (N = 31, 14%), a relative reduction of 42.8%.
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