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

• ClinicalTrials.gov Identifier: NCT00194402
• Recruitment Status: Completed
• First Posted: September 19, 2005
• Last Update Posted: August 21, 2008
• Sponsor: University of Washington
• Collaborator: Upsher-Smith Laboratories
• Information provided by: University of Washington

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Dyslipidemia	Drug: Slo-Niacin, atorvastatin	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: SLIM: Combined Effects of Slo-Niacin and Atorvastatin on Lipoproteins and Inflammatory Markers
• Study Start Date: August 2003
• Actual Primary Completion Date: January 2006
• Actual Study Completion Date: January 2006

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1; 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; 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.; Other Names: Lipitor (R) (Atorvastatin); Slo-Niacin (R) (time-release niacin
Active Comparator: 2; 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; 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.; Other Names: Lipitor (R) (Atorvastatin); Slo-Niacin (R) (time-release niacin

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Washington

Northwest Lipid Research Clinic, University of Washington

Seattle, Washington, United States, 98104

Sponsors and Collaborators

University of Washington

Upsher-Smith Laboratories

Investigators

• Principal Investigator: Robert H. Knopp, MD; Northwest Lipid Research Clinic, University of Washington

More Information

• Responsible Party: Robert H. Knopp, MD, Professor of Medicine, University of Washington
• ClinicalTrials.gov Identifier: NCT00194402
• Other Study ID Numbers: 03-6262-A
• First Posted: September 19, 2005
• Last Update Posted: August 21, 2008
• Last Verified: August 2008

Keywords provided by University of Washington:

cholesterol; dyslipidemia; hypercholesterolemia; C-reactive protein

Additional relevant MeSH terms:

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Niacin; Niacinamide; Nicotinic Acids; Atorvastatin; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enzyme Inhibitors; Vasodilator Agents; Vitamin B Complex; Vitamins; Micronutrients; Physiological Effects of Drugs