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Scooped by Seth Bilazarian, MD
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Powerful new cholesterol drugs (PCSK9 inhibitors) offer hope - Should FDA approve?

Powerful new cholesterol drugs (PCSK9 inhibitors) offer hope - Should FDA approve? | Heart and Vascular Health | Scoop.it

More than 30 million Americans take statins to lower their cholesterol, according to estimates. But these popular drugs don't work for everyone. Now the FDA may be poised to approve two drugs in this new class.

Seth Bilazarian, MD's insight:

Drs. Harlan Krumholz and Steven Nissen do a good job summarizing the difficult task the FDA faces, regarding whether to approve these new drugs called PCSK9 inhibitors.

These powerful cholesterol lowering drugs have been shown to be safe in trials of 1 -2 years duration and can lower cholesterol by 50 -60% (compared to statins that lower cholesterol by 35 - 50%) without the side effect of muscle aches seen with statins.

Should the FDA wait 2 - 3 more years for trials to be completed or allow use earlier for patients with marked cholesterol elevation?

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Scooped by Seth Bilazarian, MD
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New Drug lowers LDL: PCSK9i might be the next stains

New Drug lowers LDL: PCSK9i might be the next stains | Heart and Vascular Health | Scoop.it

A new injectable drug can further knock down cholesterol levels in people who take cholesterol-busting statin medications, according to the results of a global trial.

People taking the new therapy alongside statins enjoyed a 63 - 75% decrease in their "bad" (LDL) cholesterol levels, on top of the reduction caused by the traditional statin medications. This drug enhances the body's natural way of reducing LDL levels in the bloodstream. Cells primarily located in the liver contain receptors that target LDL cholesterol and remove it from the bloodstream. But the liver also produces a regulatory protein called PCSK9 that binds to and breaks down these receptors, The antibodies in the tested drug, evolocumab are designed to intercept PCSK9, preventing the protein from breaking down the cells' LDL receptors, which allows them to stay in circulation longer to remove LDL cholesterol.

Seth Bilazarian, MD's insight:

We have good evidence of this drugs safety and effectiveness in lowering LDL for short term, but we do not yet have data on longer term safety or the more important effectiveness measurement of preventing heart attack, strokes and death.  The large triail called FOURIER is enrolling to assess this.  Check out http://fourierstudy.com for info.

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