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Can’t Tolerate Statins? New PCSK9 Inhibitor Drugs Hitting the Market

Three years ago we posed the question: “Can we wipe out heart attacks?” on our blog and made a case why the answer could be “yes.” At the time, we were learning more about the impact of the Dallas Heart Study on genetics and coronary atherosclerosis. Researchers determined from a pool of more than 6,000 people, that if you have very low LDL (bad cholesterol), you are unlikely to develop cardiovascular heart disease. Bottom line – 80 to 90 percent of all heart attacks could be eliminated (wiped out) altogether. Furthermore, what fueled this discovery – the existence of a gene mutation called PCSK9 – set ablaze to the research and development of a new class of cholesterol-lowering drugs showing promise in studies to lower LDL to target (under 60) 100 percent of the time. Essentially, the race to market with these new PCSK9 inhibitor drugs began and to date of publishing this blog, one has already crossed the finish line with another one close behind.

July 24, 2014 the FDA approved the first PCSK9 inhibitor, Praluent (alirocumab) injection. The first-of-its-kind drug is approved for those with heterozygous familial hypercholesterolemia (HeFH) or for patients with “clinical atherosclerotic cardiovascular disease such as heart attacks or strokes, who require additional lowering of LDL cholesterol,” along with diet and statin therapy as tolerated, the FDA said in a press release. Praluent works by making the protein, PCSK9, less effective at its job. PCSK9 reduces the number of receptors in the liver that remove LDL. Therefore, with a PCSK9 inhibitor in place, more receptors are available to remove LDL cholesterol from the blood. In five clinical trials, Praluent reduced LDL cholesterol 36 to 59 percent, according to the FDA. Later this month, Amgen is expected to have FDA approval of their PCSK9 inhibitor, Repatha, after winning EU (European Union) approval in July.

For the estimated 10 million Americans with high cholesterol who are either unable to manage it with statin therapy or cannot tolerate the side effects of statins, which can include muscles aches and weakness, dizziness, headaches and nausea, PCSK9 inhibitors offer promising results from the worldwide ODYSSEY clinical trial.