The cholesterol-lowering drug alirocumab was linked to a 15% lower risk of death, and an equivalent reduction of cardiovascular events, such as heart attack and stroke, according to a new study.
It’s the first time a cholesterol-lowering drug has reduced deaths since statins such as Crestor and Lipitor came out decades ago.
The benefit was even higher among people with stubbornly high LDL cholesterol levels, above 100 mg/dL. Those people saw a 29% reduction in death from any cause after taking Alirocumab for two years.
Alirocumab is one of the called PCSK9 inhibitors that lower ‘bad’ or LDL cholesterol significantly more than statins alone. The new injectable medication is marketed by Regeneron Pharmaceuticals/Sanofi under the tradename Praluent.
Philippe Gabriel Steg, MD chief of cardiology at Hopital Bichat in Paris and co-chair of the study, says
“Now that we have two trials that consistently show benefits from PCSK9 inhibitors, and given the mortality benefit that we are reporting here for the first time, I think these results may change the equation for these drugs.” adding “We’re not just talking about preventing nonfatal events such as heart attacks but actually preserving life.”
PCSK9 inhibitors are a new class of medications called humanized monoclonal antibodies and work by binding to LDL receptors in the bloodstream, removing the bad cholesterol from circulation. Research has shown that PCSK9 inhibitors may work even better than statins, which are the traditional treatment for high cholesterol.
Last year, researchers reported similar results for another PCSK9 inhibitor called Repatha (evolocumab), named by the AHA as one of the top research advances in heart disease and stroke of 2017. The FOURIER trial showed that evolocumab reduced the risk of heart attack, stroke, and hospitalization due to blocked arteries by 15%.
High cholesterol is a crucial factor in heart attack, stroke, and kidney disease. Moreover, cardiovascular disease is the number one killer of men and women on the planet, according to the World Health Organization. Cholesterol combines with other fats and builds up as plaque on the insides of blood vessels, blocking the arteries that feed the brain, heart, and kidneys. Over time, the plaque hardens and narrows the arteries, limiting the flow of nourishing blood to these organs. People with this condition, called atherosclerosis or hardening of the arteries, also have a substantially increased risk of clots forming. When a clot breaks off and lodges in an artery feeding the heart or brain, it can cause a heart attack or stroke.
Moreover, the plaques raise the level of inflammation in the blood vessels and researchers have linked increased inflammation to a higher chance of a second heart attack. In fact, the recent CANTOS trial showed that heart attack patients taking the inflammation-lowering drug Canakinumab saw a nearly 25% decrease in second heart attacks and an about a 50% decrease in cancer.
The authors of the study presented their findings at the March 10 American College of Cardiology conference in Orlando, Florida. The results were based on a clinical trial of nearly 19,000 people in 57 countries, randomly assigned to take either alirocumab or a placebo. The study participants were over 40, and many had been treated with the maximum amount of statin drugs possible but were still unable to reduce their cholesterol to acceptable levels. The trial included patients on statins with LDL cholesterol at 70 mg/dL or above, and non-HDL cholesterol 100 mg/dL or above.
The researchers followed the study participants for up to five years, and 44% participated for three years or more.
Treatment with statins is inexpensive and straightforward, yet sometimes do not sufficiently reduce cholesterol levels. However, PCSK9 inhibitors have not achieved significant commercial success due to their hefty annual price tags of more than $14,000 for each patient. The high cost and small benefit have deterred many physicians from prescribing the drugs. For example, 167 people would need to use Alirocumab for nearly three years to prevent a single death.
Low-cost statins work well for most patients. However, PCSK9 inhibitors are a lifesaver for patients who are already on the maximum statin dose. Mount Sinai Medical Hospital’s physician-in-chief, Valentin Fuster, who was not involved in the research, says
“I believe this study is going to change practice,”
However, Fuster cautioned that the drugs’ high price remains an obstacle, as he pointed out during a press briefing,
“Up until now, the feasibility and affordability of using these types of drugs has been extremely difficult,” adding “I hope this particular study really is a trigger, is a catalyzer, for making these drugs much more available today in people who need it.”
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Cover Photo: lionvision (adapted) / Getty Images.
Kerry Sheridan. “Anti-cholesterol drug Praluent cuts death risk.” AFP. March 10, 2018. Link to the press release in MedicalXpress.
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