Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3
Summary
The primary objective of this study was to evaluate the effect of 24 weeks of evolocumab administered subcutaneously (SC) every month, compared with ezetimibe, on low-density lipoprotein cholesterol (LDL-C) levels in adults with high cholesterol who are unable to tolerate an effective dose of a statin due to muscle-related side effects (MRSE).
Timeline
- Start
- 2013-12-10
- Primary completion
- 2015-11-10
- Completion
- 2017-11-21
Outcome
Met primary endpoint
registry LEAST_SQUARES_MEAN Ezetimibe: -16.70 (Standard Error 1.91) percent change NCT01984424 ↗
registry LEAST_SQUARES_MEAN Evolocumab: -54.50 (Standard Error 1.39) percent change NCT01984424 ↗
registry analysis (superiority test); Ezetimibe vs Evolocumab; p <0.0001; LS Mean Treatment Difference -37.79 (95% CI -42.31 to -33.28); Repeated Measures Model NCT01984424 ↗
registry LEAST_SQUARES_MEAN Ezetimibe: -16.69 (Standard Error 2.11) percent change NCT01984424 ↗
registry LEAST_SQUARES_MEAN Evolocumab: -52.76 (Standard Error 1.52) percent change NCT01984424 ↗
registry analysis (superiority test); Ezetimibe vs Evolocumab; p <0.0001; LS Mean Treatment Difference -36.07 (95% CI -41.07 to -31.08); Repeated Measures Model NCT01984424 ↗
Publications
- Background Cho L, Dent R, Stroes ESG, Stein EA, Sullivan D, Ruzza A, Flower A, Somaratne R, Rosenson RS. Persistent Safety and Efficacy of Evolocumab in Patients with Statin Intolerance: a Subset Analysis of the OSLER Open-Label Extension Studies. Cardiovasc Drugs Ther. 2018 Aug;32(4):365-372. doi: 10.1007/s10557-018-6817-7.
- Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD011748. doi: 10.1002/14651858.CD011748.pub3.
- Nissen SE, Stroes E, Dent-Acosta RE, Rosenson RS, Lehman SJ, Sattar N, Preiss D, Bruckert E, Ceska R, Lepor N, Ballantyne CM, Gouni-Berthold I, Elliott M, Brennan DM, Wasserman SM, Somaratne R, Scott R, Stein EA; GAUSS-3 Investigators. Efficacy and Tolerability of Evolocumab vs Ezetimibe in Patients With Muscle-Related Statin Intolerance: The GAUSS-3 Randomized Clinical Trial. JAMA. 2016 Apr 19;315(15):1580-90. doi: 10.1001/jama.2016.3608.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atorvastatin | Small molecule | 20 mg | Oral |
| Subject | Evolocumab | Monoclonal antibody | 140 mg | Subcutaneous |
| Subject | Evolocumab | Monoclonal antibody | 420 mg | Subcutaneous |
| Comparator | Ezetimibe | Unknown | 10 mg | Oral |