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The SLIM study: Slo-Niacin and atorvastatin treatment of lipoproteins and inflammatory markers in combined hyperlipidemia
Journal of Clinical Lipidology, 06/24/09
Knopp RH et al. – Nonprescription time-release niacin (Slo-Niacin) 1.5 g/day with atorvastatin 10 mg/day improved lipoprotein lipids, apoproteins, and inflammation markers without hepatotoxicity, pending further study as a cost-effective treatment of hyperlipidemia.
Methods- Study of Slo-Niacin and atorvastatin, singly and together, to determine efficacy for combined abnormalities of triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C)
- Subjetcs: 42 men and women with LDL-C >130 mg/dL and HDL-C <45 mg/dL (men) or <55 mg/dL (women)
- Randomization to 3 mo of atorvastatin 10 mg/d or incremental doses of Slo-Niacin to 1500 mg/d
- Addition of alternate drug in next 3-mo segment
- Measurement of lipid profiles and transaminases monthly
- Other measures at baseline and end of each treatment sequence
- Mean entry lipids (in mg/dL) follows: TG 187, LDL-C 171, and HDL-C 39
- Mean body mass index: 32.6kg/m2
- Slo-Niacin monotherapy decreased median TG 15%, mean LDL-C 12%, and non-HDL-C 15% and increased HDL-C 8%
- Atorvastatin decreased median TG 26%, mean LDL-C 36%, and non-HDL-C 36% and increased HDL-C 6%
- Combined therapy decreased median TG 33% and mean LDL-C and non-HDL-C each 43%. HDL-C increased 10%
- Median remnant-like lipoprotein-C decreased 55%, mean apo-B 40%, median high-sensitivity C-reactive protein 23%, tumor necrosis factor alpha 12%, and no change in interleukin-6
- Mean LDL buoyancy increased 15%, apo-A-I 5%, and median HDL2-C 20%
- ALT decreased with Slo-Niacin treatment alone vs atorvastatin and decreased with Slo-Niacin added to atorvastatin
- Study discontinuation by 6 subjects, 3 due to niacin-related symptoms
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