The FOURIER study (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk) was a large, randomized controlled trial that evaluated the effectiveness of a cholesterol-lowering medication called evolocumab in reducing the risk of cardiovascular events in people with high cholesterol levels and a history of cardiovascular disease. The study found that the medication, when added to statin therapy, significantly reduced the risk of heart attacks, strokes, and other cardiovascular events by 15-20% compared to statin therapy alone.
The study also found that evolocumab treatment led to a significant reduction in LDL cholesterol levels, with a median reduction of 59% compared to the placebo group. Additionally, the study found that the risk of cardiovascular events decreased as LDL cholesterol levels decreased, with a 20% reduction in risk for every 39 mg/dL reduction in LDL cholesterol.
The FOURIER study provides strong evidence that lowering LDL cholesterol levels with a PCSK9 inhibitor like evolocumab can have a significant impact on reducing the risk of cardiovascular events in people with high cholesterol and a history of cardiovascular disease. These findings support the idea that lower cholesterol levels may be beneficial in reducing the risk of heart disease and that using a drug like evolocumab can achieve lower levels.
It’s worth noting that the FOURIER study used a cholesterol-lowering medication that targets a specific protein (PCSK9) to lower LDL cholesterol levels. This is different from the studies that use statins, as these drugs work in a different way, by inhibiting an enzyme that is responsible for the production of cholesterol in the liver. Moreover, the FOURIER study population had a history of cardiovascular disease, and the findings may not be generalizable to people without a history of cardiovascular disease.
The FOURIER study specifically evaluated the use of evolocumab in combination with statin therapy in people with high cholesterol levels and a history of cardiovascular disease, such as a previous heart attack or stroke. The study found that evolocumab, when added to statin therapy, significantly reduced the risk of cardiovascular events in this population.
Based on these findings, the US Food and Drug Administration (FDA) has approved evolocumab for use in combination with statin therapy in people with high cholesterol levels who have been diagnosed with one of the following: -heterozygous familial hypercholesterolemia (HeFH) -homozygous familial hypercholesterolemia (HoFH) -clinical atherosclerotic cardiovascular disease (ASCVD) -primary hyperlipidemia as an adjunct to diet when response to diet and maximally tolerated statin therapy is inadequate.
It’s important to note that evolocumab is not recommended for use in people without a history of cardiovascular disease or high cholesterol, and that the decision to use evolocumab in combination with statin therapy should be made on an individual basis, taking into account the patient’s specific risk factors and medical history. It’s also important to note that the use of evolocumab may not be appropriate for all patients, as it may not be cost-effective or affordable for some. Patients should always consult with their healthcare provider to determine the best treatment plan for them.
The National Lipid Association (NLA) recommends the use of PCSK9 inhibitors, such as evolocumab, in addition to statin therapy for patients who have a history of cardiovascular disease and LDL cholesterol levels that remain above 70 mg/dL despite maximally tolerated statin therapy.
It’s important to note that the decision to use evolocumab in combination with statin therapy should be made on an individual basis, taking into account the patient’s specific risk factors and medical history, as well as the cost-effectiveness and affordability of the medication. Patients should always consult with their healthcare provider to determine the best treatment plan for them.
