- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
Evolocumab Shows Promise in Long-Term Cholesterol Study
Monoclonal antibody reduces LDL-C levels (December 19)
The phase III DESCARTES (Durable Effect of PCSK9 Antibody CompARed wiTh PlacEbo Study) trial evaluating the long-term safety and efficacy of evolocumab (Amgen) for the treatment of high cholesterol has met its primary endpoint of percent reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at week 52.
Evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver’s ability to remove LDL-C from the blood.
The DESCARTES study evaluated the efficacy, safety, and tolerability of evolocumab in 901 patients with high LDL-C levels and a range of cardiovascular risks. Background lipid-lowering therapy was optimized to one of four treatment groups (diet alone; diet plus atorvastatin 10 mg; diet plus atorvastatin 80 mg; or diet plus atorvastatin 80 mg plus ezetimibe 10 mg) for individual patients, based on their LDL-C levels and cardiovascular risk. Patients with fasting LDL-C ≥ 75 mg/dL were then randomly assigned to receive monthly subcutaneous evolocumab 420 mg or placebo in combination with background lipid-lowering therapy.
Evolocumab significantly reduced LDL-C from baseline at week 52 compared with placebo. LDL-C reduction at week 12 was consistent with the drug’s long-term efficacy at week 52.
The most common adverse events associated with evolocumab included nasopharyngitis, upper respiratory tract infection, influenza, and back pain.
Source: Amgen; December 19, 2013.