Statins + niacin: no subgroup escapes adverse effects

  • Haynes R & al.
  • Clin Ther
  • 22 Aug 2019

  • International Clinical Digest
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Takeaway

  • Niacin as add-on to statins is linked to increased adverse event risk, even in those with low high-density lipoprotein (HDL) cholesterol and high triglycerides, who had been viewed as having less risk.
  • No subgroup in this trial (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events, or HPS2-THRIVE) stood out as having relatively less risk for such events.

Why this matters

  • These authors say clinicians should consider these risks when contemplating adding niacin to a statin regimen, especially given the lack of evidence for cardiovascular benefits from niacin.

Key results

  • The adverse events associated (HRs; 95% CIs) with niacin-laropiprant use included:
    • New-onset diabetes: 1.33 (1.16-1.52);
    • Disturbance in control of existing diabetes: 1.56 (1.35-1.80);
    • Serious bleeding (mostly intracranial or gastrointestinal): 1.38 (1.17-1.63);
    • About one-fifth of these bleeds were fatal; and
    • Serious infection (mostly respiratory, urinary tract): 1.22 (1.11-1.34).
  • Risks for most of these peaked in the first year of niacin use.

Study design

  • Randomised, double-blind trial comparing 2000/40 mg/day niacin-laropiprant vs placebo in 25,673 people with high vascular disease risk.
  • Trial enrolled from January 2007 to May 2010; median follow-up, 3.9 years.
  • Funding: Merck & Co., Inc., Kenilworth, NJ, USA.

Limitations

  • Trial design allowed for selection of participants with short-term tolerance.