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

Phase 4CompletedNCT00194402

University of Washington64 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dyslipidemia

Interventions

Slo-Niacin, atorvastatinDRUG

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.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Northwest Lipid Research Clinic, University of Washington

Seattle, Washington, United States

Outcomes

Primary Outcomes

LDL-C change for atorvastatin 10 mg, Slo-Niacin 1500 mg, and the two together.

Time frame: Change from baseline to 12 weeks and end of intervention

Secondary Outcomes

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.

Time frame: Change from baseline to end of 12 weeks and/or end of intervention

Data from ClinicalTrials.gov

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