An Open-Label Study to Compare the Lipid Effects of Niacin ER and Simvastatin (NS) to Atorvastatin in Subjects With Hyperlipidemia or Mixed Dyslipidemia (SUPREME)

Abbott199 enrolled

Overview

To demonstrate that niacin ER and simvastatin (NS) tablets, when compared to atorvastatin (Lipitor®; Pfizer, Inc.), has superior high-density lipoprotein cholesterol (HDL-C) elevating effects at Week 12 in subjects with type II hyperlipidemia or mixed dyslipidemia who are currently off lipid-modifying therapy. This was a prospective, randomized, open-label, blinded endpoint (PROBE) study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

199

Conditions

Hyperlipidemia Mixed Dyslipidemia

Interventions

Niacin ER/Simvastatin TabletsDRUG

Up to 2000 mg/40 mg at bedtime

atorvastatinDRUG

40 mg at bedtime

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects must meet all of the following laboratory criteria: * HDL-C \<40 mg/dL for men and \<50 mg/dL for women. * LDL-C ≥130 mg/dL but \<250 mg/dL. * TG \<350 mg/dL. * Creatine phosphokinase (CPK) \< 3 x upper limit of normal (ULN). * Alanine aminotransferase (ALT); serum glutamic pyruvic transaminase \[SGPT\] and aspartate aminotransferase (AST); serum glutamic oxaloacetic transaminase \[SGOT\] \< 1.3 x ULN. * Subjects must also be reasonably compliant with the Therapeutic Lifestyle Changes (TLC) diet during the 4 to 5 week Screening Period prior to randomization (and be willing to comply for the duration of the study). Exclusion Criteria: * Subjects who have a history of any important medical conditions or abnormalities (as specified in the protocol) that would preclude study inclusion

Locations (46)

Outcomes

Primary Outcomes

Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 12

(Week 12 HDL-C minus baseline HDL-C) x 100/baseline HDL-C

Time frame: From baseline to Week 12

Secondary Outcomes

Percent Change in HDL-C From Baseline to Week 8

(Week 8 HDL-C minus baseline HDL-C) x 100/baseline HDL-C

Time frame: From baseline to Week 8

Percent Change in Non-HDL-C From Baseline to Week 8

(Week 8 non-HDL-C minus baseline non-HDL-C) x 100/baseline non-HDL-C

Time frame: From baseline to Week 8

Percent Change in Non-HDL-C From Baseline to Week 12

(Week 12 non-HDL-C minus baseline non-HDL-C) x 100/baseline non-HDL-C

Time frame: From baseline to Week 12

Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 12

(Week 12 LDL-C minus baseline LDL-C) x 100/baseline LDL-C

Time frame: From baseline to Week 12

Percent Change in Triglycerides From Baseline to Week 12

(Week 12 triglycerides minus baseline triglycerides) x 100/baseline triglycerides

Time frame: From baseline to Week 12

Percent Change in LDL-C:HDL-C Ratio

(Week 12 LDL-C:HDL-C ratio minus baseline LDL-C:HDL-C ratio) x 100/baseline LDL-C:HDL-C ratio

Time frame: From baseline to Week 12

Percent Change in Total Cholesterol From Baseline to Week 12

Data from ClinicalTrials.gov

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Unnamed facility

Anaheim, California, United States

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Huntington Park, California, United States

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Long Beach, California, United States

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Sacramento, California, United States

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Walnut Creek, California, United States

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Brooksville, Florida, United States

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Daytona Beach, Florida, United States

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Gainesville, Florida, United States

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Largo, Florida, United States

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Merritt Island, Florida, United States

...and 36 more locations

(Week 12 total cholesterol minus baseline total cholesterol) x 100/baseline total cholesterol

Time frame: From baseline to Week 12

Percent Change in Total Cholesterol:HDL-C Ratio

(Week 12 total cholesterol:HDL-C ratio minus baseline total cholesterol:HDL-C ratio) x 100/baseline total cholesterol:HDL-C ratio

Time frame: From baseline to Week 12

Percent Change in Lipoprotein A From Baseline to Week 12

(Week 12 lipoprotein A minus baseline lipoprotein A) x 100/baseline lipoprotein A

Time frame: From baseline to Week 12

Percentage of Subjects Meeting With HDL-C >/= 40 mg/dL at Week 12

Time frame: 12 weeks

Percentage of Subjects Meeting National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III Goal for LDL-C at Week 12

For high-risk patients (coronary heart disease or equivalent), LDL-C \< 100 mg/dL and non-HDL-C \< 130 mg/dL; for moderate risk patients (having 2 risk factors), LDL-C \< 130 mg/dL and non-HDL-C \< 160 mg/dL; for low-risk patients (having 0 or 1 risk factor): LDL-C \< 160 mg/dL and non-HDL-C \< 190 mg/dL.

Time frame: 12 weeks

Percentage of Subjects With Triglycerides < 150 mg/dL at Week 12

Time frame: 12 weeks

Percentage of Subjects With HDL-C >/= 40 mg/dL, LDL-C Meeting NCEP ATP III Goal, and Triglycerides < 150 mg/dL at Week 12

NCEP ATP III goals for LDL-C are as follows: For high-risk patients, LDL-C \< 100 mg/dL; for moderate risk patients, LDL-C \< 130 mg/dL; for low-risk patients: LDL-C \< 160 mg/dL. High-risk means coronary heart disease or risk equivalents; moderate risk means having at least 2 risk factors; low-risk means having no or 1 risk factor.

Time frame: 12 weeks