The multiceNtre, open, uncontrolled sAfety and tolerability stUdy of a modified-release nicoTinic acId formuLation in sUbjects with dySlipidaemia and low HDL-cholesterol (NAUTILUS) trial was designed to evaluate the safety and tolerability of prolonged-release nicotinic acid (Niaspan®) in patients treated for dyslipidaemia in a usual care setting in Germany. The dyslipidaemia was inadequately controlled by diet, including low high-density lipoprotein cholesterol (HDL-C) (< 1.0 mmol/L [< 40 mg/dL] in men and < 1.2 mmol/L [<46 mg/dL] in women). This analysis focuses on the tolerability and safety of Niaspan® in patients with diabetes. Diabetic and non-diabetic subjects reported similar incidences of all-cause adverse events (AE; 59.9% vs. 60.8%, respectively), serious AE (SAE; 4.0% vs. 3.4%, respectively) and withdrawals for AE (17.6% vs. 16.4%). Flushing was the most common side effect, as expected (42% of patients in each group), but < 10% withdrew for flushing. There was no indication of hepatotoxicity or serious muscle toxicity in diabetic or non-diabetic subjects. Changes in glycaemic parameters were small (mean changes in diabetic subjects of +0.2% HbA1C and +0.4 mmol/L [+8 mg/dL] for fasting plasma glucose), despite marked reductions in the intensity of antidiabetic therapy in about one third of patients. Niaspan® was equally effective in diabetic or non-diabetic subjects in increasing HDL-C (+24% in each group) and decreasing triglycerides (-12% and -13%, respectively). Niaspan® was well tolerated in patients with type 2 diabetes and the results of NAUTILUS support its use for correction of low HDL-C in this population.
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