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HPS2-THRIVE published: Niacin did not benefit patients with vascular disease
Confirming findings presented at the American College of Cardiology 2013 Scientific Sessions, the HPS2-THRIVE data published in The New England Journal of Medicine indicate that the addition of niacin to statin-based therapy did not benefit patients with vascular disease and increased risk for adverse events.
Jane Armitage, FRCP, FFPH, from the University of Oxford, United Kingdom, and colleagues randomly assigned 25,673 adults with vascular disease taking statin-based therapy to 2 g extended-release niacin and 40 mg laropiprant or placebo daily. Median follow-up was 3.9 years.
As presented previously, the primary outcome, a composite of CV death, nonfatal MI, stroke and arterial revascularization, occurred in 13.2% of the niacin-laropiprant group vs. 13.7% of the placebo group (rate ratio=0.96; 95% CI, 0.9-1.03).
Assignment to niacin-laropiprant was also associated with the following: increased serious disturbances in diabetes control (absolute excess, 3.7 percentage points; P<.001), increased incidence of diabetes diagnosis (absolute excess, 1.3 percentage points; P<.001), increased gastrointestinal serious adverse events (absolute excess, 1 percentage point; P<.001), increased musculoskeletal system serious adverse events (absolute excess, 0.7 percentage points; P<.001), increased skin-related serious adverse events (absolute excess, 0.3 percentage points; P=.003), increased infection (absolute excess, 1.4 percentage points, P<.001) and increased bleeding (absolute excess, 0.7 percentage points; P<.001).
Donald M. Lloyd-Jones
In a related editorial published in NEJM, Donald M. Lloyd-Jones, MD, noted that niacin was believed to be beneficial because it raises HDL, but the HPS2-THRIVE trial failed to show that raising HDL reduced the risk for CHD or CVD. This trial and previous studies “seriously undermine the hypothesis that HDL cholesterol is a causal risk factor,” he wrote.
Adverse events reported in the niacin-laropiprant group, including a 9% increase in the risk for death (number needed to harm=200; P=.08), are “worrisome,” and previous studies of niacin alone “suggest that niacin is the major problem,” Lloyd-Jones, from the departments of preventive medicine and cardiology at Northwestern University Feinberg School of Medicine, wrote.
“Niacin must be considered to have an unacceptable toxicity profile for the majority of patients, and it should not be used routinely,” he wrote.
For more information:
Lloyd-Jones DM. N Engl J Med. 2014;371:271-273.
The HPS2-THRIVE Collaborative Group. N Engl J Med. 2014;371:203-212.
Disclosure: The study was funded by the British Heart Foundation, Cancer Research UK, Merck and the UK Medical Research Council. Several researchers report receiving grant support from Merck. Lloyd-Jones reports no relevant financial disclosures.