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Cardiovascular mortality and N-terminal-proBNP reduced after combined selenium and coenzyme Q10 supplementation: a 5-year prospective randomized double-blind placebo-controlled trial among elderly Swedish citizens

Urban Alehagen, Peter Johansson, Mikael Björnstedt, Anders Rosén, Ulf Dahlström
International Journal of Cardiology 2013 167(5):1860-1866

Bibliography

PubMed
PMID 22626835
DOI
10.1016/j.ijcard.2012.04.156
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, Linköping University and the Swedish Research Council. Pharma Nord donated the selenium tablets, CoQ10 capsules and matching placebos.
Competing interests
The original publication reported that all authors completed ICMJE conflict-of-interest disclosures and no conflicts were reported. Manufacturer donation/funding remains relevant context.

Study snapshot

DesignProspective randomized double-blind placebo-controlled community trial; block randomization; intention-to-treat and per-protocol analyses; participants assessed every six months.
ModelCommunity-dwelling Swedish adults aged 70–88 years from a rural municipality with generally low selenium status.
Sample443 randomized: 221 active combination and 222 placebo. Across the 48-month intervention, 228 completed, 86 died and 129 (29.1%) withdrew before completion.
InterventionBio-Quinon CoQ10 100 mg twice daily (200 mg/day) plus SelenoPrecise organic selenium yeast 200 µg/day, both from Pharma Nord, versus matching placebo; added to usual medication.
Duration48 months of supplementation; cardiovascular mortality followed for a median approximately 5.2 years in the initial report.
EndpointsCardiovascular mortality; NT-proBNP at 48 months; Echocardiographic cardiac-function score; Intention-to-treat mortality analysis; Per-protocol analyses

What the study showed, in plain terms

KiSel-10 randomized 443 Swedish adults aged 70–88 to four years of combined selenium yeast 200 µg/day plus CoQ10 200 mg/day or matching placebo. The CoQ10 product was Bio-Quinon 100 mg twice daily and the selenium product was SelenoPrecise; both were supplied by Pharma Nord.

At a median follow-up of about 5.2 years, cardiovascular mortality was 5.9% in the active-combination group versus 12.6% with placebo (p=0.015). At 48 months, mean NT-proBNP was 214 ng/L versus 302 ng/L (p=0.014), and the echocardiographic cardiac-function score also favored active treatment (p=0.03).

The result is clinically interesting but must be labeled correctly: this was a selenium-plus-CoQ10 combination trial in an elderly population with low selenium exposure. It cannot tell us whether CoQ10 alone caused the mortality, biomarker or echocardiographic effects. Long intervention duration also produced major attrition: only 228 completed 48 months, 86 died during the intervention period and 129 withdrew.

Key findings

  • Cardiovascular mortality at ~5.2 years: 5.9% with selenium+CoQ10 vs 12.6% placebo; p=0.015.
  • NT-proBNP at 48 months: mean 214 ng/L active vs 302 ng/L placebo; p=0.014.
  • Echocardiographic cardiac-function score favored active combination treatment; p=0.03.
  • Intervention: Bio-Quinon CoQ10 200 mg/day + SelenoPrecise selenium yeast 200 µg/day; the two active ingredients were never separated into factorial monotherapy arms.
  • Attrition across 48 months was substantial: 228 completed, 86 died and 129 withdrew; the major withdrawal reason later reported was the burden of taking many tablets.

What this study can and cannot tell us

  • Combination intervention: there is no CoQ10-only arm and no selenium-only arm, so the independent contribution of CoQ10 cannot be estimated.
  • Small single-region cohort aged 70–88 with low selenium status; generalizability to selenium-replete populations, younger adults or other countries is uncertain.
  • Long intervention led to high attrition; the original authors described the study as underpowered/hypothesis-generating because of sample size and premature withdrawals.
  • Pharma Nord contributed funding and supplied active products/placebos, although the authors reported no conflicts and stated funders had no role in analysis or reporting.

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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