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

Information source: University of Washington
ClinicalTrials.gov processed this data on August 23, 2015
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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
Last updated: August 20, 2008

Page last updated: August 23, 2015

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