The SLIM study: Slo-Niacin® and Atorvastatin Treatment of Lipoproteins and Inflammatory Markers in Combined Hyperlipidemia.

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) [Copyright &y& Elsevier]