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Summary: The AHA names the PCSK9 inhibitor evolocumab as one of the top 10 heart disease and stroke advances of 2017 in its annual list published on February 8. However, this novel cholesterol-lowering drug carries a big price tag. [This article first appeared on LongevityFacts. Author: Brady Hartman. ]

The AHA named the cholesterol-lowering drug evolocumab in its annual top 10 lists of major advances in heart disease and stroke research, published on February 8. Evolocumab belongs to a class of cholesterol-lowering drugs called PCSK9 inhibitors and is injectable drug marketed by Amgen under the brand name Repatha. The two-year FOURIER study reported that evolocumab reduced high cholesterol levels and had few adverse effects.

FOURIER Study on Evolocumab

The FOURIER study, published in the New England Journal of Medicine, found that evolocumab can significantly reduce heart attacks and strokes among high-risk patients. The study included more than 27,000 patients who were randomized into taking evolocumab or a placebo, and showed that the new drug has a clear benefit over statins in reducing LDL, the bad cholesterol in patients. FOURIER showed that the new medication cut the risk of having a heart attack, stroke or other cardiovascular events by 20% when added to intensive statin therapy. The study was paid for by Amgen and reported that evolocumab lowered LDL by about 60%, to a median of 30 mg/dL.

PCSK9 inhibitors are a new class of drugs called humanized monoclonal antibodies. Evolocumab isn’t the only game in town. The pharma firm Regeneron Pharmaceuticals / Sanofi released another PCSK9 inhibitor called alirocumab (tradename Praluent). PCSK9 inhibitors work by binding to LDL receptors in the bloodstream, removing LDL from circulation.

Cholesterol

Cholesterol is a fat-like substance that’s found naturally in the blood. High cholesterol levels increase the risk of heart attack, stroke, kidney disease, and death. Cholesterol builds up on the insides of blood vessels, clogging the arteries that feed the kidneys, heart, and brain.

Also known as a lipid, cholesterol is vital for normal functioning of the body. The human body manufactures nearly all of the cholesterol it needs and uses it as a feedstock to make vital substances, such as hormones. We also obtain cholesterol in our diet through foods such as cheese, egg yolks, and fatty meats, and cheese.

High cholesterol levels lead to a build of plaque on the walls of arteries, a condition alternately referred to as atherosclerosis or hardening of the arteries. Atherosclerosis is a disease in which this plaque – made up of cholesterol, fat, calcium, among other things – builds up on the inner walls of the arteries. Over time, the plaque hardens and narrows the arteries, limiting the flow of oxygen-rich blood to the organs, especially the brain and heart. People with atherosclerosis also have a substantially increased risk of clots forming, and when a clot breaks off and lodges in a vessel leading to the brain or heart, it can cause a stroke or heart attack.

Moreover, these plaques increase the level of inflammation in the blood vessels as white blood cells congregate at the site of plaques. Inflammation is emerging as a significant trigger of heart attacks, and the recent CANTOS trial showed that the inflammation-lowering drug Canakinumab reduced the incidence of heart attacks by around 25% and cancer by about 50%.

Health Effects of Ultra-low Cholesterol

The interesting thing about FOURIER is that it found that extremely low cholesterol levels conferred a lower risk of cardiovascular deaths. In fact, the researchers found that the risk declined steadily as LDL cholesterol levels fell. FOURIER investigators monitored many safety indicators and found no adverse effects associated with these ultra-low cholesterol levels, including no negative impact on cognitive ability, cataracts, nor an increased risk of diabetes.

And even though the study suggests that lower cholesterol is better, the trial was only two years in length. The long-term health effects of extremely low cholesterol levels haven’t been fully explored. Moreover, the FOURIER trial participants were a special group – the trial recruited patients with established vascular disease. One in three patients were taking moderate-intensity statins before the trial began and the remaining two-thirds were already on high-intensity statins.

Bottom Line on Evolocumab

While the FOURIER study reported that PCSK9 inhibitors work well in those with extremely high cholesterol, they are expensive and cost more than $14,000 per patient per year. Doctors find that low-cost statins work well for most people with high cholesterol. However, PCSK9 inhibitors are a lifesaver for patients with very high LDL levels.

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References

Cover photo credit: Getty Images(iStock).

AHA names top heart disease and stroke research advances of 2017. American Heart Association. February 8, 2018. Link to AHA press release in MedicalXpress.

Marc S. Sabatine, Robert P. Giugliano, Anthony C. Keech, et al. “Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease.” The New England Journal of Medicine. 2017 May 4;376(18):1713-1722. doi: 10.1056/NEJMoa1615664. Epub 2017 Mar 17. Link to article in NEJM.

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