New drugs used for heart attack prevention may change the treatment of the disease forever. An FDA panel voted 13-3 recently to approve new drugs for heart attacks. The drugs, injectable medicines called alirocumab (trade name Praluent) and evolocumab (trade name Repatha), work to lower LDL levels, commonly called “the bad cholesterol.” Unlike statins such as Lipitor, which are taken daily in pill form, these drugs are injected every two weeks.
Dr. Joshua W. Knowles, a cardiologist at Stanford, claimed that the drugs were “a triumph of the modern genetic revolution.” The principal idea for the drugs came from a genetic mutation known as PCSK9. The mutation offers a protective effect against heart attack and other forms of heart disease, including in smokers and those with high blood pressure. The drugs mimic the mutation by allowing the liver to produce more LDL receptors. The drugs can lower LDL levels as much as 65 percent in those treated, occasionally dropping them to levels normally seen in infants.
While clinical trials are still ongoing, the panel voted to approve their use in three cases: those who have high LDL levels and cannot take statin drugs, those who are already at risk from prior heart attacks or diabetes, and those whose LDL levels cannot be lowered to safe levels even with statin drugs. The panel also voted to offer the drugs to patients suffering from an inherited condition, familial hypercholesterolemia. The condition can be inherited from both parents or one, but the form inherited from one parent is common, while the form inherited from both is considered a rare disease. Cholesterol is considered a risk for heart attacks because it can clog arteries and leave them more vunerable to disease. The CDC currently reports that 735,000 people in the United States will have a heart attack this year. Fifteen percent of those will die. High blood cholesterol is one of the primary risk factors in heart attack instance and death. Other risk factors include smoking, high blood pressure, and diabetes.
A final study, which recently finished enrollment, is expected to finish in 2017 or 2018. Called the Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk (FOURIER) study, it has enrolled 27,000 individuals. The study will measure the total and relative percentages of heart attacks, stroke, and death by cardiac event. The final trial will determine whether the drugs will be approved for a larger portion of the population and study any possible side effects not recorded in prior ones.
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