- Mark SanfordAffiliated withWolters Kluwer Health ¦ AdisWolters Kluwer Health Email author
- , Monique P. CurranAffiliated withWolters Kluwer Health ¦ AdisWolters Kluwer Health
Rent the article at a discountRent now
* Final gross prices may vary according to local VAT.Get Access
▲ Niacin extended-release (ER)/simvastatin is a once-daily, fixed-dose combination of the HMG-CoA reductase inhibitor simvastatin and an ER formulation of niacin (a B-complex vitamin).
▲ In healthy volunteers who were given niacin ER/simvastatin 2000 mg/40 mg, niacin exposure was similar to that with niacin ER 2000 mg, while simvastatin exposure was increased compared to that with simvastatin 40 mg.
▲ In patients with elevated non-high-density lipoprotein cholesterol (non-HDL-C) but with low-density lipoprotein cholesterol (LDL-C) at or below the National Cholesterol Education Program (NCEP) goal after a ≥2-week simvastatin 20 mg/day run-in period (SEACOAST I), 24 weeks of niacin ER/simvastatin 1000 mg/20 mg or 2000 mg/20 mg per day reduced median plasma non-HDL-C levels to a significantly greater extent than simvastatin 20 mg/day.
▲ In patients with elevated non-HDL-C and LDL-C at any level after a ≥2-week simvastatin 40 mg/day run-in period (SEACOAST II), 24 weeks of niacin ER/simvastatin 1000 mg/40 mg or 2000 mg/40 mg per day was noninferior to simvastatin 80 mg/day in reducing median plasma non-HDL-C levels.
▲ Compared with simvastatin monotherapy, there was no significant difference in reduction in plasma LDL-C levels with niacin ER/simvastatin in SEACOAST I, and the noninferiority criterion for LDL-C was not met in SEACOAST II. However, plasma HDL-C levels increased more and triglyceride levels were lowered more than with simvastatin monotherapy (SEACOAST I and II).
▲ Niacin ER/simvastatin was generally well tolerated, with flushing being the most common adverse reaction.
- Niacin Extended-Release/Simvastatin
Volume 68, Issue 16 , pp 2373-2386
- Cover Date
- Print ISSN
- Online ISSN
- Springer International Publishing
- Additional Links
- Industry Sectors