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Objective:To compare the effects of combination niacin extended-release + simvastatin (NER/S) versus atorvastatin alone on apolipoproteins and lipid fractions in a post hoc analysis from SUPREME, a study which compared the lipid effects of niacin extended-release + simvastatin and atorvastatin in patients with hyperlipidemia or mixed dyslipidemia.Patients and methods:Patients (n = 137) with dyslipidemia (not previously receiving statin therapy or having discontinued any lipid-altering treatment 4–5 weeks prior to the study) received NER/S (1000/40 mg/day for four weeks, then 2000/40 mg/day for eight weeks) or atorvastatin 40 mg/day for 12 weeks. Median percent changes in apolipoprotein (apo) A-1, apo B, and the apo B:A-I ratio, and nuclear magnetic resonance lipoprotein subclasses from baseline to week 12 were compared using the Wilcoxon rank-sum test and Fisher’s exact test.Results:NER/S treatment produced significantly greater percent changes in apo A-I and apo B:A-I, and, at the final visit, apo B < 80 mg/dL was attained by 59% versus 33% of patients, compared with atorvastatin treatment (P = 0.003). NER/S treatment resulted in greater percent reductions in calculated particle numbers for low-density lipoprotein (LDL, 52% versus 43%; P = 0.022), small LDL (55% versus 45%; P = 0.011), very low-density lipoprotein (VLDL) and total chylomicrons (63% versus 39%; P < 0.001), and greater increases in particle size for LDL (2.7% versus 1.0%; P = 0.007) and VLDL (9.3% versus 0.1%; P < 0.001), compared with atorvastatin.Conclusion:NER/S treatment significantly improved apo A-I levels and the apo B:A-I ratio, significantly lowered the number of atherogenic LDL particles and VLDL and chylomicron particles, and increased the mean size of LDL and VLDL particles, compared with atorvastatin.

Background: Flushing related to niacin therapy is typically short-lived, occurring primarily during initiation of therapy. Aspirin significantly reduces flushing incidence and severity. We evaluated flushing-related troublesomeness, impact of flushing on usual daily activities, and sleep. Methods: Double-blinded treatments: 325 mg aspirin (ASA) or PBO 30 minutes prior to niacin extended release (NER) 500 mg/d (wk 1), 1000 mg/d (wk 2), and 2000 mg/d (wks 3-6), (NER+ASA or NER+PBO, respectively); or placebo for both NER and ASA (PBO+PBO) for 6 wks. Patients who flushed rated severity and troublesomeness, 0 (none) - 10 (very severe), daily and flushing's impact on usual daily activities and sleep, 0 (none) - 3 (severely), weekly. Mean scores were compared between treatment groups among patients who flushed using repeated measures mixed-effect model. Results: Of 269 patients randomized, 68 (76%) in the NER+ASA group, 78 (87%) in the NER+PBO group, and 56 (63%) in the PBO+PBO group reported at least 1 flushing episode. Ratings of flushing severity were significantly correlated with troublesomeness, impact on daily activities, and sleep (p < 0.001). Mean scores in the NER+ASA and PBO+PBO groups were similar for troublesomeness (figure). Results for impact on daily activities and sleep were similar to those for troublesomeness (data not shown). Conclusion: Aspirin reduces the burden of niacin-induced flushing by improving quality of life measures to a level similar to that of niacin placebo.

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