The SLIM study: Slo-Niacin® and Atorvastatin Treatment of Lipoproteins and Inflammatory Markers in Combined Hyperlipidemia
Received 23 April 2009; accepted 26 April 2009. published online 05 May 2009.
Background
The combination of niacin and statin has proven value in the management of hyperlipidemia and prevention of heart disease. However, the efficacy of the nonprescription time-release niacin, Slo-Niacin®, is little studied alone and not at all with atorvastatin. We studied Slo-Niacin® and atorvastatin, singly and together, to determine efficacy on the combined abnormalities of triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C).
Methods
A total of 42 men and women with LDL-C >130mg/dL and HDL-C <45mg/dL (men) or <55mg/dL (women) were randomized to 3 months of atorvastatin 10mg/d or incremental doses of Slo-Niacin® to 1500mg/d. The alternate drug was added in the next 3-month segment. Lipid profiles and transaminases were measured monthly and other measures at baseline and the end of each treatment sequence.
Results
Mean entry lipids (in mg/dL) were as follows: TG 187, LDL-C 171, and HDL-C 39. Mean body mass index was 32.6kg/m2. Monotherapy with Slo-Niacin® 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% (all P < .001). Median remnant-like lipoprotein-C decreased 55%, mean apo-B 40%, median high-sensitivity C-reactive protein 23% (all P < .05), tumor necrosis factor α 12%, and no change in interleukin-6. Mean LDL buoyancy increased 15%, apo-A-I 5%, and median HDL2-C 20% (all P < .05). ALT decreased with Slo-Niacin® treatment alone compared with atorvastatin and also decreased when Slo-Niacin® was added to atorvastatin. Six subjects dropped out of the study, 3 for niacin-related symptoms.
Conclusions
Slo-Niacin® 1.5g/d with atorvastatin 10mg/d improved lipoprotein lipids, apoproteins, and inflammation markers without hepatotoxicity. Slo–Niacin® deserves further study as a cost-effective treatment of hyperlipidemia. (ClinicalTrials.gov Identifier: NCT00194402)
aDepartment of Medicine, Northwest Lipid Research Clinic, Division of Metabolism, Endocrinology and Nutrition, University of Washington, Seattle, Washington, USA
bDepartment of Medicine, Division of Cardiology, University of Washington School of Medicine, Seattle, Washington, USA
ABSTRACT