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)
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.
Timeline
- Start
- 2007-04
- Primary completion
- 2008-02
- Completion
- —
Outcome
Met primary endpoint
registry LEAST_SQUARES_MEAN Niacin Extended-release Plus Simvastatin: 30.1 (25.6 to 34.6) percent change NCT00465088 ↗
registry LEAST_SQUARES_MEAN Atorvastatin: 9.4 (4.3 to 14.4) percent change NCT00465088 ↗
registry analysis (superiority or other test); Niacin Extended-release Plus Simvastatin vs Atorvastatin; p <0.001; Mixed Models Analysis NCT00465088 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atorvastatin | Small molecule | 40 mg | — |
| Subject | Niacin | Small molecule | 2000 mg | — |
| Subject | Simvastatin | Small molecule | 40 mg | — |