Michelle DeSanti
Biology 22 (24556)
Professor Linder
4 May 2017
Clinical outcomes: Evolocumab use for Cardiovascular Disease High cholesterol, two words that can certainly ignite a fear in a patient who is newly diagnosed with this common issue. Which brings us to the question, what exactly is high cholesterol and what makes it so bad? Low-density lipoprotein cholesterol, also known as LDL cholesterol is what many consider to be the “bad cholesterol”. This is due to the fact that LDLs bring fat to the bodies cell. This fat then sits in the cell where it can build up in the vessels and cause cardiovascular events that pose a threat to ones’ health. Whereas their counterpart, High-density Lipoprotein (HDL) is often seen as good. HDL cholesterol is what many call “the good cholesterol” because it removes the excess fat from the cells. LDLs can become a dangerous factor in the overall health and well-being of the human body. If there is a large quantity of LDLs being produced, it increases the likelihood of developing various cardiovascular diseases. To combat these large amounts of lipoproteins, a PCSK9 inhibitor has been created to block the production of LDLs within the system. What exactly is the PCSK9 gene? According to the Journal of Lipid Research, PCSK9 is a gene that is coded to regulate LDL receptors which then help remove LDL particles in the plasma. However, if a mutation in the gene occurs it can lead to a decrease in LDL receptors, thus causing increased LDL cholesterol in the blood. This is where issues can occur in the body. Often times when someone is diagnosed with high cholesterol, it is referring to the buildup of LDL cholesterol in the arteries. This is especially dangerous because it can cause the arteries to harden; once the hardening has taken place, this is a condition known as atherosclerosis. The build of cholesterol is associated with myocardial infarction, commonly known as a heart attack. High LDL cholesterol can also lead to stroke and symptomatic peripheral artery disease, a condition in which the arteries most commonly found in the extremities become narrow and cause circulatory problems. Due to the dangers of high LDL cholesterol, researchers began funding trials to chemically inhibit the PCSK9 gene. …show more content…
In order to create a drug that could inhibit this particular gene, there was research conducted to determine what antibody to use. Evolocumab is a member of monoclonal antibodies that allow the inhibition of the PCSK9 gene (New England Journal of Medicine). One trial that was conducted was the Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk, also known as FOURIER. This trial was created to monitor the cardiovascular changes that may take place while taking Evolocumab as a part of a high cholesterol treatment regimen. Along with Evolocumab, patients were also being treated using statin therapy. Statin therapy involves the use of particular drugs that work inside of the body at the liver to prevent cholesterol from forming. According to the American Heart Association, statin therapy is the only class of medication that is strictly responsible for lowing the likelihood of stroke or heart attack occurrence. The process of this trial was rather simple. FOURIER was a double blind, randomized clinical trial that used multiple patients from various parts of the world. This trial was double blind; one group would receive the true drug, Evolocumab, while the other group received a placebo. The patients were randomly selected from a total of 1242 sites, within 49 different countries (New England Journal of Medicine). Multiple requirements were fulfilled during the trial. For example, the population ages for …show more content…
Each group received an injection right under the skin every two weeks. One group received an injection with the active ingredients, and the placebo group received an injection without. The efficacy end point, which tests whether the hypothesis is true or not, was determined by cardiovascular events. These events include cardiovascular death, angina or chest pain, a myocardial infarction, or coronary revascularization. Coronary revascularization is a procedure in which they bypass an artery to restore blood flow to the heart. Throughout the trial, those who were responsible in reading and monitoring the results were also double blind; they did not know whose results were the true experimental group and who were a part of the placebo
Biology 22 (24556)
Professor Linder
4 May 2017
Clinical outcomes: Evolocumab use for Cardiovascular Disease High cholesterol, two words that can certainly ignite a fear in a patient who is newly diagnosed with this common issue. Which brings us to the question, what exactly is high cholesterol and what makes it so bad? Low-density lipoprotein cholesterol, also known as LDL cholesterol is what many consider to be the “bad cholesterol”. This is due to the fact that LDLs bring fat to the bodies cell. This fat then sits in the cell where it can build up in the vessels and cause cardiovascular events that pose a threat to ones’ health. Whereas their counterpart, High-density Lipoprotein (HDL) is often seen as good. HDL cholesterol is what many call “the good cholesterol” because it removes the excess fat from the cells. LDLs can become a dangerous factor in the overall health and well-being of the human body. If there is a large quantity of LDLs being produced, it increases the likelihood of developing various cardiovascular diseases. To combat these large amounts of lipoproteins, a PCSK9 inhibitor has been created to block the production of LDLs within the system. What exactly is the PCSK9 gene? According to the Journal of Lipid Research, PCSK9 is a gene that is coded to regulate LDL receptors which then help remove LDL particles in the plasma. However, if a mutation in the gene occurs it can lead to a decrease in LDL receptors, thus causing increased LDL cholesterol in the blood. This is where issues can occur in the body. Often times when someone is diagnosed with high cholesterol, it is referring to the buildup of LDL cholesterol in the arteries. This is especially dangerous because it can cause the arteries to harden; once the hardening has taken place, this is a condition known as atherosclerosis. The build of cholesterol is associated with myocardial infarction, commonly known as a heart attack. High LDL cholesterol can also lead to stroke and symptomatic peripheral artery disease, a condition in which the arteries most commonly found in the extremities become narrow and cause circulatory problems. Due to the dangers of high LDL cholesterol, researchers began funding trials to chemically inhibit the PCSK9 gene. …show more content…
In order to create a drug that could inhibit this particular gene, there was research conducted to determine what antibody to use. Evolocumab is a member of monoclonal antibodies that allow the inhibition of the PCSK9 gene (New England Journal of Medicine). One trial that was conducted was the Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk, also known as FOURIER. This trial was created to monitor the cardiovascular changes that may take place while taking Evolocumab as a part of a high cholesterol treatment regimen. Along with Evolocumab, patients were also being treated using statin therapy. Statin therapy involves the use of particular drugs that work inside of the body at the liver to prevent cholesterol from forming. According to the American Heart Association, statin therapy is the only class of medication that is strictly responsible for lowing the likelihood of stroke or heart attack occurrence. The process of this trial was rather simple. FOURIER was a double blind, randomized clinical trial that used multiple patients from various parts of the world. This trial was double blind; one group would receive the true drug, Evolocumab, while the other group received a placebo. The patients were randomly selected from a total of 1242 sites, within 49 different countries (New England Journal of Medicine). Multiple requirements were fulfilled during the trial. For example, the population ages for …show more content…
Each group received an injection right under the skin every two weeks. One group received an injection with the active ingredients, and the placebo group received an injection without. The efficacy end point, which tests whether the hypothesis is true or not, was determined by cardiovascular events. These events include cardiovascular death, angina or chest pain, a myocardial infarction, or coronary revascularization. Coronary revascularization is a procedure in which they bypass an artery to restore blood flow to the heart. Throughout the trial, those who were responsible in reading and monitoring the results were also double blind; they did not know whose results were the true experimental group and who were a part of the placebo