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Efficacy and safety of combination therapy with niacin extended-release and simvastatin versus atorvastatin in patients with dyslipidemia: The SUPREME Study
Journal of Clinical Lipidology, 03/25/09
Insull, W Jr et al. – Compared with atorvastatin, niacin extended-release and simvastatin (NER/S) provided superior improvements in high-density lipoprotein cholesterol (HDL-C), triglycerides (TG), and Lp(a) and comparable improvements in non-HDL-C and low density lipoprotein cholesterol (LDL-C). Treatment with NER/S should be considered for pts with dyslipidemia requiring comprehensive lipid control.
Methods- Comparison of efficacy and safety of proprietary NER/S combination vs atorvastatin monotherapy in multicenter, prospective, randomized (3:2), open-label, blinded endpoint (PROBE) study
- Assessment of 193 pts with dyslipidemia
- After &ge 4 wks without lipid-modifying therapies, treatment with NER/S (114 pts; 1000/40 mg/day, wks 1-4; 2000/40 mg/day weeks 5-12) or atorvastatin (79 pts; 40 mg/day, wks 1-12)
- Compared with atorvastatin, NER/S had a larger beneficial effect on HDL-C (primary end point), TG, and lipoprotein(a), and similar effects on LDL-C and non–HDL-C
- Two-thirds of NER/S pts concurrently attained LDL-C (cardiovascular risk-adjusted goals), HDL-C (≥40 mg/dL), and TG (<150 mg/dL) targets vs one-third of atorvastatin pts
- Flushing was most common treatment-emergent adverse event (TEAE) (67.5% NER/S vs 10.1% atorvastatin)
- Of all flushing episodes, 75% were mild to moderate
- More patients treated with NER/S discontinued due to TEAEs, most commonly flushing
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