Clinical trial NCT00194402: SLIM: Combined Effects of Slo-Niacin and Atorvastatin on Lipoproteins and Inflammatory Markers in Hyperlipidemia
Official title: SLIM: Combined Effects of Slo-Niacin and Atorvastatin on Lipoproteins and Inflammatory Markers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dyslipidemia
Keywords: cholesterol
dyslipidemia
hypercholesterolemia
C-reactive protein
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Upsher-Smith Laboratories
First posted: 2005-09-19
Enrollment: 64
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: LDL-C change for atorvastatin 10 mg, Slo-Niacin 1500 mg, and the two together.
timeFrame: Change from baseline to 12 weeks and end of intervention
Secondary outcomes:
measure: 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.
timeFrame: Change from baseline to end of 12 weeks and/or end of intervention
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Northwest Lipid Research Clinic, University of Washington
state: Washington
Study officials:
affiliation: Northwest Lipid Research Clinic, University of Washington
name: Robert H. Knopp, MD
role: PRINCIPAL_INVESTIGATOR
References: