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

摘要

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~R, is little studied alone and not at all with atorvastatin. We studied Slo-Niacin~R 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 > 130 mg/dL and HDL-C <45 mg/dL (men) or <55 mg/dL (women) were randomized to 3 months of atorvastatin 10 mg/d or incremental doses of Slo-Niacin~R to 1500 mg/d. The alternate drug was added in the next 3-month segment. Lipid profiles and trans-aminases 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 32.6 kg/m2. Monotherapy with Slo-Niacin~R 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% andmean 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 a 12%,and no change in interleukin-6. Mean LDL buoyancy increased 15%, apo-A-I 5%, and median HDL_2-C 20% (all P < .05). ALT decreased with Slo-Niacin~R treatment alone compared with atorvastatin and also decreased when Slo-Niacin~R was added to atorvastatin. Six subjects dropped out of the study, 3 for niacin-related symptoms. CONCLUSIONS: Slo-Niacin~R 1.5 g/d with atorvastatin 10 mg/d improved lipoprotein lipids, apopro-teins, and inflammation markers without hepatotoxicity. Slo-Niacin~R deserves further study as a cost-effective treatment of hyperlipidemia. (ClinicalTrials.gov Identifier: NCT00194402)