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

Phase 4

Completed

• Conditions: Dyslipidemia
• Interventions: Drug: Slo-Niacin, atorvastatin

• Registration Number: NCT00194402
• Lead Sponsor: University of Washington

Brief Summary

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

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.

Study Timeline

• Study Start: 2003-08
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Primary Completion: 2006-01
• Study Completion: 2006-01
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-20
• Last Update Posted: 2008-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• LDL-C > 130 mg/dL
• HDL-C <= 45 mg/dL in men and <= 55 mg/dL in women

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Slo-Niacin, atorvastatin	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
1	Slo-Niacin, atorvastatin	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Northwest Lipid Research Clinic, University of Washington; 🇺🇸 Seattle, Washington, United States