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

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

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.


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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

Resource links provided by the National Library of Medicine


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




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 ]


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00194402


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

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Responsible Party: Robert H. Knopp, MD, Professor of Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT00194402     History of Changes
Other Study ID Numbers: 03-6262-A
First Posted: September 19, 2005    Key Record Dates
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:
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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
Nutrients
Growth Substances
Physiological Effects of Drugs