New Cholesterol Drug Examined by FDA

7/2/2015

A new drug could significantly cut bad LDL cholesterol levels down to size. This new potent drug may be soon available as it goes under review by the Food and Drug Administration (FDA). This new brand of cholesterol medication is known as PCSK9 inhibitors. Recently, and FDA advisory panel suggested that both new drugs alirocumab (Praluent) and evolocumab (Repatha) be approved. And while the FDA usually adheres to the suggestion(s) of its advisory panels, it will determine whether to give the green light to both new drugs sometime this summer.

PSK9 drugs have been a significant help for those with a family history of high cholesterol, in addition to those who cannot handle the popularly prescribed satin drugs.

“Satins work by reducing the production of cholesterol in the liver. These drugs work by pulling cholesterol out of the bloodstream more effectively. More specifically these drugs allow the molecules that sweep up your bad cholesterol to keep working longer and harder than they would normally,” said physician nutrition specialist, Melina Jampolis, MD.

Jampolis also notes that nearly 20 percent of people on statins cease from taking them due to complaints of muscles aches, memory loss, and flu-like symptoms, in addition to noticeable changes in liver function. This translates into PCSK9 inhibitors to be the best option for them.

“Also some people with genetically high cholesterol are unable to get their numbers down with statins alone. They face an incredibly high risk of heart disease and might benefit greatly from these drugs,” added Jampolis.

Professor of cardiology at Harvard Medical School and co-author of the study, Christopher Cannon, MD, also sees the potential of these new drugs, citing that people could bring their cholesterol levels down to the levels they were born with. They could also be utilized alongside statins to achieve maximum benefits.

“They can reduce cholesterol, and the bad cholesterol in particular, by 50 percent more, and that’s on top of statin medications,” said Cannon.

Furthermore, unlike statins, PCSK9 inhibitors come in the form of shots rather than pills. The advantage of this is that shots only need to be administered every 2-4 weeks, which may be better for those who don’t always remember to take their statin pills.

“Many of us have thought, ‘Well, who would want to take an injection when you could take a pill?’ On the other hand, if you do that every 2 weeks, or sometimes every 4 weeks, maybe that’s easier, and you don’t have to worry about taking your pulls every day,” said Cannon.

Jampolis also mentioned that the drugs have been tested in over 6,000 patients and so far no major signs of side effects have cropped up. However, Cannon is still looking for any signs of possible dangers, noting that while there have been no major setbacks patients have reported feeling headache, limb pain, and confusion during the clinical trials. And due to the medication being injected there could be other side effects to consider such as swelling, redness, or skin irritation when injected on-site. Yet, it still stands the new drug has a lot to offer.

“This is a really exciting new area in cardiovascular medicine, and I think it has a tremendous amount of potential for some patients,” said Jampolis.

The only real drawback is the cost of the new drug as reports of $7,000 to $12,000 for a year’s worth of supply may be the asking price. It is also unclear whether such medication will be covered by insurance agencies.

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