Volume 13, Number 4, July-August 2006

Safety and tolerability of prolonged-release nicotinic acid in patients aged > 65 years enrolled in NAUTILUS
Anja Vogt, Ursula Kassner, Ulrike Hostalek, Elisabeth Steinhagen-Thiessen, on behalf of the NAUTILUS Study Group

Older patients are often at high risk for cardiovascular disease. Low high-density lipoprotein (HDL) cholesterol is an independent risk factor for cardiovascular disease. Prolonged-release nicotinic acid (Niaspan^®) is a once-daily formulation of nicotinic acid with improved tolerability compared with the immediate-release formulation. It may be used to correct low levels of HDL cholesterol. NAUTILUS (the multiceNtre, open, uncontrolled sAfety and tolerability stUdy of a modified release nicoTinic acId formuLation in sUbjects with dySlipidaemia and low HDL cholesterol) evaluated prolonged-release nicotinic acid at doses of up to 2,000 mg/day once daily in 566 patients, of whom 33.6% were aged > 65 years.
A similar incidence of adverse events (AE) was observed following 15 weeks of prolonged-release nicotinic acid treatment in older vs. younger patients for all-cause AE (55.3% vs. 63.3%) and for treatment-related AE (46.3% vs. 52.1%). Most AE were related to flushing, which also occurred at similar frequency in older and younger patients (39.5% vs. 43.4%).
Gastrointestinal AE were the most common AE apart from flushing, and occurred in 12.1% of older patients and 14.4% of younger patients. Serious AE were uncommon. There was no hepatotoxicity or serious muscle toxicity. Marked improvements in indices of atherogenic dyslipidaemia were observed (increases from baseline in HDL cholesterol of 26% in older and 21% in younger patients and decreases in triglycerides of 16% and 9%, respectively).
Prolonged-release nicotinic acid is well tolerated and effective in older patients, and is suitable for correction of low HDL cholesterol in this population.

Br J Cardiol 2006;13:278-282.

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