Tier 3 — preclinical

Reduced Cardiovascular Mortality 10 Years after Supplementation with Selenium and Coenzyme Q10 for Four Years: Follow-Up Results of a Prospective Randomized Double-Blind Placebo-Controlled Trial in Elderly Citizens

Urban Alehagen, Jan Aaseth, Peter Johansson
PLOS ONE 2015 10(12):e0141641

Bibliography

PubMed
PMID 26624886
PubMed Central
PMC4666408
DOI
10.1371/journal.pone.0141641
Trial registry
View on ClinicalTrials.gov Registered trial — results not yet published in a peer-reviewed journal.
Funding
Part of the analysis costs was supported by Pharma Nord A/S, the County Council of Östergötland and Linköping University. The funding organizations were reported to have no role in design, management, analysis, interpretation or manuscript preparation.
Competing interests
The authors declared no competing interests in the PLOS ONE publication. Pharma Nord's financial/product support of the parent KiSel-10 trial remains relevant context.

Study snapshot

DesignLong-term observational mortality follow-up preserving original randomized treatment assignment from a four-year double-blind placebo-controlled trial.
ModelOriginal 443 community-dwelling older Swedish adults from KiSel-10.
Sample443 original randomized participants: 221 active and 222 placebo; no participant was lost to mortality follow-up.
InterventionOriginal four-year assignment to Bio-Quinon CoQ10 200 mg/day + SelenoPrecise selenium 200 µg/day versus placebo; no trial supplementation after 48 months.
DurationFour-year intervention followed by mortality ascertainment for up to 10 years from baseline.
EndpointsCardiovascular mortality through 10 years; Multivariable Cox hazard ratio; Sex subgroup mortality; Diabetes subgroup; Ischemic heart disease subgroup; Functional-class subgroup

What the study showed, in plain terms

This paper followed the same KiSel-10 randomized cohort for up to 10 years, even though selenium-plus-CoQ10 supplementation stopped after four years. Mortality ascertainment was complete: no participant was lost to the long-term mortality follow-up.

Cardiovascular deaths were 46/221 in the group originally assigned to selenium+CoQ10 versus 86/222 in placebo (p<0.0001). The multivariable Cox model reported HR 0.51 (95% CI 0.36–0.74; p=0.0003). The paper also reported favorable subgroup estimates in both sexes and in participants with ischemic heart disease or diabetes.

The persistence of separation after supplementation ended is intriguing, but the authors explicitly called the finding hypothesis-generating. This is a follow-up of the same small combination trial—not a new independent randomized test and not evidence that CoQ10 alone halves cardiovascular mortality.

Key findings

  • 10-year cardiovascular mortality: 46/221 original active-assignment participants vs 86/222 placebo; p<0.0001.
  • Univariate Cox HR 0.52 (95% CI 0.36–0.74; p=0.0004).
  • Multivariable Cox HR 0.51 (95% CI 0.36–0.74; p=0.0003).
  • Male cardiovascular deaths: 34/115 active vs 49/110 placebo (p=0.02); female deaths: 12/106 vs 37/112 (p=0.004).
  • The intervention had ended six years before the 10-year endpoint; this is persistence of an original randomized-assignment association, not continued randomized exposure.

What this study can and cannot tell us

  • Same KiSel-10 cohort as the initial report; it should not be counted as an independent replication.
  • CoQ10 was always combined with selenium; no component-specific causal effect can be isolated.
  • Only 443 participants from one Swedish municipality; the authors called the long-term result hypothesis-generating.
  • After the four-year intervention ended, subsequent exposures were observational; persistent group separation cannot establish the biological mechanism.
  • Parent-trial attrition during intervention was substantial even though national-registry mortality follow-up was complete.

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Dr. Khaled Mahmoud, MBBChCritical Care Medicine, Longevity Science & Editorial Direction Dr. Amr Yasser, PhDCardiometabolic, Musculoskeletal, Gut & Bioavailability Dr. Abdulla Mostafa, PhDCellular Senescence, Neurological, Mitochondrial & Brain-Ageing Biology