MedicalResearch.com Interview with:
David Charytan, MD MSc
Chief, Nephrology Division
NYU Langone Medical Center
New York, NY 10010
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Cardiovascular events are much more frequent in patients with impaired kidney function (chronic kidney disease), and cardiovascular disease is the most common cause of death in advanced chronic kidney disease. This risk remains high despite the use of standard medical therapies including statins, the most commonly used cholesterol lowering agents.
The PCSK9 inhibitor evolocumab is a new class of highly potent cholesterol lowering medications that can further reduce the risk of cardiovascular events in patients already taking statins. We analyzed data from the FOURIER trial, which randomized study patients with clinically evident atherosclerosis and an LDL cholesterol level >=70 mg/dL or HDL cholesterol level >= while on a statin, to assess the safety and efficacy of evolocumab, a PCSK9 inhibitor, compared with placebo in individuals with mild to moderate chronic kidney disease.
There were several major findings
- a) evolocumab appears to be equally safe in individuals with preserved and mild to moderately impaired kidney function
- b) evolocumab appears to have preserved efficacy at preventing cardiovascular events as kidney function declines.
- c) We were unable to detect any significant impact on kidney function.
- In addition, because the baseline risk of cardiovascular events is much higher in individuals with chronic kidney disease, the absolute benefits of treatment with evolocumab appear to be magnified as kidney function declines.
MedicalResearch.com: What should readers take away from your report?
Response: The addition of the PCSK9 inhibitor evolocumab to background statin therapy, is safe and effectively lowers the risk of cardiovascular events in individuals with atherosclerosis and impaired kidney function. The absolute benefits of therapy may be enhanced in the setting of chronic kidney disease.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: There were very few individuals with advanced kidney disease in the FOURIER trial and it is unclear if our results apply to this population. Dedicated studies of Evolocumab in individuals with advanced chronic kidney disease are needed, particularly in patients on maintenance dialysis—a group with extremely high risks of cardiovascular events that was not included in FOURIER. Whether Evolocumab would benefit chronic kidney patients not a statin or those without baseline atherosclerosis is also uncertain.
David Charytan has consulted to Amgen, the manufacturer of Evolocumab, Janssen, Astra Zeneca, Merck, and Allena Pharmaceuticals. He has received research support from Janssen Pharm, and has pending research support or research support under consideration from Amgen, Gilead, and NovNordisc.
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