SLIM: Combined Effects of Slo-Niacin and Atorvastatin on Lipoproteins and Inflammatory Markers in Hyperlipidemia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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SLIM: Combined Effects of Slo-Niacin and Atorvastatin on Lipoproteins and Inflammatory Markers

Conditions
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Dyslipidemia

Intervention / Treatment
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* Drug: Slo-Niacin, atorvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: LDL-C > 130 mg/dL HDL-C <= 45 mg/dL in men and <= 55 mg/dL in women Exclusion Criteria: history of hypersensitivity to any statin, niacin or aspirin diagnosis of diabetes or a fasting glucose > 125 mg/dL hyper or hypothyroidism (unless treatment stable) meet other health, medication, and logistical criteria

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Atorvastatin 10 mg for 12 weeks followed by Slo-Niacin (titrated from 500 to 1500 mg over 8 weeks) taken with atorvastatin 10 mg for an additional 12 weeks | Drug: Slo-Niacin, atorvastatin<br>* Atorvastatin 10 mg qd for 12 or 24 weeks. Time-released niacin 1500 mg qd (titrated from 500mg to 1000mg and then to 1500 mg at 4 week intervals) taken for 12 or 24 weeks.<br>* Other names: Slo-Niacin (R) (time-release niacin;|
| Active Comparator: 2<br>Slo-Niacin (titrated from 500 to 1500 mg over 8 weeks) for 12 weeks followed by atorvastatin 10 mg taken with Slo-Niacin 1500 mg for an additional 12 weeks | Drug: Slo-Niacin, atorvastatin<br>* Atorvastatin 10 mg qd for 12 or 24 weeks. Time-released niacin 1500 mg qd (titrated from 500mg to 1000mg and then to 1500 mg at 4 week intervals) taken for 12 or 24 weeks.<br>* Other names: Slo-Niacin (R) (time-release niacin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-C change for atorvastatin 10 mg, Slo-Niacin 1500 mg, and the two together. |  | Change from baseline to 12 weeks and end of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HDL-C, HDL2-C, HDL3-C, LDL-C:HDL-C, triglyceride, remnant lipoprotein, apoproteins A-I and B, LDL buoyancy, hsCRP, glucose, insulin, and SGOT. |  | Change from baseline to end of 12 weeks and/or end of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cholesterol, dyslipidemia, hypercholesterolemia, C-reactive protein