SLIM: Combined Effects of Slo-Niacin and Atorvastatin on Lipoproteins and Inflammatory Markers in Hyperlipidemia
Information source: University of Washington
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dyslipidemia
Intervention: Slo-Niacin, atorvastatin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Washington Official(s) and/or principal investigator(s):
Robert H. Knopp, MD, Principal Investigator, Affiliation: Northwest Lipid Research Clinic, University of Washington
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.
Clinical Details
Official title: SLIM: Combined Effects of Slo-Niacin and Atorvastatin on Lipoproteins and Inflammatory Markers
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Primary outcome: LDL-C change for atorvastatin 10 mg, Slo-Niacin 1500 mg, and the two together.
Secondary outcome: 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.
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.
Eligibility
Minimum age: 21 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Northwest Lipid Research Clinic, University of Washington, Seattle, Washington 98104, United States
Additional Information
Starting date: August 2003
Ending date: January 2006
Last updated: February 12, 2008
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