SLIM: Combined Effects of Slo-Niacin and Atorvastatin on Lipoproteins and Inflammatory Markers in Hyperlipidemia
NCT ID: NCT00194402
Last Updated: 2008-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
64 participants
INTERVENTIONAL
2003-08-31
2006-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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.
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
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HDL-C \<= 45 mg/dL in men and \<= 55 mg/dL in women
Exclusion Criteria
* diagnosis of diabetes or a fasting glucose \> 125 mg/dL
* hyper or hypothyroidism (unless treatment stable)
* meet other health, medication, and logistical criteria
21 Years
75 Years
ALL
No
Sponsors
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Upsher-Smith Laboratories
INDUSTRY
University of Washington
OTHER
Responsible Party
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University of Washington
Principal Investigators
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Robert H. Knopp, MD
Role: PRINCIPAL_INVESTIGATOR
Northwest Lipid Research Clinic, University of Washington
Locations
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Northwest Lipid Research Clinic, University of Washington
Seattle, Washington, United States
Countries
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Other Identifiers
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03-6262-A
Identifier Type: -
Identifier Source: org_study_id