Phase 3
Completed N=193
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)
Hyperlipidemia · Mixed Dyslipidemia
Source: ClinicalTrials.gov NCT00465088 ↗
Enrolled (actual)
193
Serious AEs
—
Results posted
May 2009
Primary outcomePrimary: Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 12 — 30.1; 9.4 percent change — p=<0.001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 12 |
30.1; 9.4 | <0.001 sig |
| SECONDARY Percent Change in HDL-C From Baseline to Week 8 |
26.7; 1.4 | — |
| SECONDARY Percent Change in Non-HDL-C From Baseline to Week 8 |
-45.0; -44.3 | — |
| SECONDARY Percent Change in Non-HDL-C From Baseline to Week 12 |
-43.4; -43.3 | — |
| SECONDARY Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 12 |
-43.8; -46.0 | — |
| SECONDARY Percent Change in Triglycerides From Baseline to Week 12 |
-44.0; -37.0 | — |
| SECONDARY Percent Change in LDL-C:HDL-C Ratio |
-54.5; -50.5 | — |
| SECONDARY Percent Change in Total Cholesterol From Baseline to Week 12 |
-31.3; -35.1 | — |
| SECONDARY Percent Change in Total Cholesterol:HDL-C Ratio |
-45.2; -40.3 | — |
| SECONDARY Percent Change in Lipoprotein A From Baseline to Week 12 |
-15.8; 16.0 | — |
| SECONDARY Percentage of Subjects Meeting With HDL-C >/= 40 mg/dL at Week 12 |
78; 28 | — |
| SECONDARY Percentage of Subjects Meeting National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III Goal for LDL-C at Week 12 |
78; 84 | — |
| SECONDARY Percentage of Subjects With Triglycerides < 150 mg/dL at Week 12 |
79; 70 | — |
| SECONDARY Percentage of Subjects With HDL-C >/= 40 mg/dL, LDL-C Meeting NCEP ATP III Goal, and Triglycerides < 150 mg/dL at Week 12 |
65; 34 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00465088). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.