Dyslipidemia Clinical Trial
Official title:
SLIM: Combined Effects of Slo-Niacin and Atorvastatin on Lipoproteins and Inflammatory Markers
Slo-Niacin and atorvastatin (Lipitor) are both drugs that lower cholesterol. In this research, we will compare the effectiveness of Slo-Niacin and atorvastatin taken alone and together. This study will help show how the individual benefits of the two drugs taken separately can be combined when taken together.
Combined niacin and a statin treatment has greater potential value than either agent alone
for the dyslipidemia of insulin resistance, obesity and the metabolic syndrome. The efficacy
of Slo-Niacin and atorvastatin has not been formally examined in this setting.
Methods: Forty-four dyslipidemic men and women (LDL-C >130mg/dL and below average HDL-C (<55
in women and <45 in men) were randomized to a 3 month course of atorvastatin 10 mg or
Slo-Niacin increased monthly at doses of 500, 1000 and 1500 mg/day. The alternate drug was
added in the second 3-month segment. Lipid profiles and transaminase measurements were
obtained monthly and full lipoprotein quantifications, apoproteins, remnant like
lipoproteins (RLP), LDL buoyancy, glucose, insulin, and C-reactive protein were measured at
the end of each 3-month sequence. Results: Mean entry lipids were (mg/dL) TG 187, LDL-C 171,
HDL-C 39. Mean BMI was 32.6 Kg/M2. When Slo-Niacin and atorvastatin were given alone,
respective decreases in triglyceride (TG) were 18% and 10%, LDL-C 12% and 36% and non-HDL-C
15% and 36%. HDL-C increased 8% and 6%, respectively. Combined therapy decreased median TG
33% and mean LDL-C 43% and increased mean HDL-C 10%. Mean hs CRP decreased 23% and RLP 44.5%
in the combined groups. Conclusions: Slo-Niacin with atorvastatin improves all lipoprotein
fractions, RLP and hsCRP in combined hyperlipidemia. The reduction of LDL with the drug
combination is equivalent to that obtained with 20-80 mg of atorvastatin alone.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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