http://www.theheart.org/article/1545585.do
In a study bound to be scrutinized when it is finally published, the Q-SYMBIO randomized, controlled, double-blind clinical trial garnered a fair deal of attention this past week when investigators reported excellent clinical outcomes in chronic heart failure patients treated with coenzyme Q10 (CoQ10).
Metabolic
modulation and energetic manipulation in the failing heart is the next
frontier of heart-failure management. I want this stuff to work.
Presenting the study at Heart Failure Congress 2013 of the European Society of Cardiology Heart Failure Association, lead investigator Dr Svend Aage Mortensen (Copenhagen
University Hospital, Denmark) reported that, at two years, major
adverse cardiovascular events (MACE), a composite of unplanned
hospitalization due to worsening heart failure, cardiovascular death,
and the need for urgent cardiac transplantation and mechanical support,
occurred in 14% of patients treated with CoQ10 compared with 25% of
patients who received a placebo, a statistically significant difference
(p=0.003). All-cause mortality was also significantly lower in the
CoQ10-treated patients, with 9% dying compared with 17% in the placebo
arm (p=0.01).
In addition to these outcomes, the Q-SYMBIO
investigators reported that cardiovascular mortality and admissions for
heart failure were significantly lower in those who received CoQ10. In
their conclusions, the researchers stated that "CoQ10 should be
considered as a part of the maintenance therapy of patients with chronic
heart failure."
Yellow light: Go slow, caution urged
Some, however, considered the recommendations
to alter clinical practice on the basis of this 420-patient clinical
trial premature. Dr Sanjay Kaul (Cedars-Sinai Medical Center, Los
Angeles), for example, said he wants to reserve judgment on the data
until they have stood up against the scrutiny of the peer-review
process. He noted that the mortality data were first presented at the
meeting of the International Coenzyme Q10 Association last November, but these are yet to be published.
"Clinicians should view implausibly large
treatment effects observed in small underpowered trials with skepticism,
as they are seldom replicated in subsequently conducted large
controlled trials," Kaul told heartwire. "The examples of vesnarinone
in heart failure, [glucose-insulin-potassium] GIK post-STEMI, and
perioperative beta-blockers in high-risk vascular surgery quickly come
to mind. None of the impressive preliminary results could be replicated.
If a finding appears to be 'too good to be true,' it usually is."
One curiosity that also needs to be addressed,
added Kaul, is why the Q-SYMBIO trial took more than 10 years to
complete. The trial design was first published in 2003. heartwire
asked Mortensen to comment on the study and the results, but he
declined, saying he wants to wait until after the study is published to
discuss the findings.
More at link.
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