Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00194402
Status:
COMPLETED
Last Update Posted:
2008-08-21
First Post:
2005-09-12
Brief Title:
SLIM Combined Effects of Slo-Niacin and Atorvastatin on Lipoproteins and Inflammatory Markers in Hyperlipidemia
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
SLIM Combined Effects of Slo-Niacin and Atorvastatin on Lipoproteins and Inflammatory Markers
Status:
COMPLETED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 130mgdL 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 mgday 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 mgdL TG 187 LDL-C 171 HDL-C 39 Mean BMI was 326 KgM2 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 445 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
Methods Forty-four dyslipidemic men and women LDL-C 130mgdL 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 mgday 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 mgdL TG 187 LDL-C 171 HDL-C 39 Mean BMI was 326 KgM2 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 445 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None