Will Monoclonal Antibodies Overtake Statins As Cholesterol Drug of Choice?

by Colin Carmichael

Cholesterol-lowering statin drugs have been the #1 selling, most profitable drug for pharmaceutical companies for years.

And while these drugs are mostly effective at lowering cholesterol, even supporters have to admit they're not effective for up to 30-50% of high cholesterol patients.

Some simply cannot tolerate the miserable muscle pain. Others experience liver or kidney damage. And still others can't get their bad cholesterol down to suggested levels even on the highest recommended doses of the most potent versions of these drugs.

New Statin Alternatives…

That's why pharmaceutical companies have been looking into alternatives to statin drugs so they can improve their success rate and still tap into this mega-profitable segment of high cholesterol patients.

A new study, funded by Amgen and recently published in The Lancet, details some results with a new type of cholesterol-lowering drug that may be an alternative to statins in the future.

This new type of drug, known as monoclonal antibodies, is administered by injection and works by binding to the enzyme proprotein convertase subtilisin/kexin type 9 (or simply called PCSK9 for short) which plays a role in cholesterol synthesis.

Once the drugs bind to PCSK9, it prevents PCSK9 from attaching to LDL receptors. This then allows liver cells to absorb and remove excess LDL cholesterol in the bloodstream.

What Did the Study Show?

Amgen's study was done with 631 high cholesterol patients over a 12 week period. They did injections at both 2-week and 4-week intervals and used 3 different dosage amounts as well as a matching placebo.

The patients getting a bi-weekly injection had a 41.8 to 66.1% greater decrease in LDL compared to the placebo group.

Those receiving monthly injections experienced a 41.8 to 50.3% increased reduction in LDL cholesterol as compared to those administered a placebo.

What About the Safety of PCSK9 Inhibitors?

The next step is long-term testing on a much larger group of participants to test for safety and get FDA approval.

Amgen is set to start Phase 3 clinical trials on these compounds in 2013. Along with Amgen, Sanofi/Regeneron and Pfizer are also developing monoclonal antibodies. Sanofi and Regeneron have already announced they're starting a Phase 3 trial with 18,000 heart disease patients in order to get one step closer to FDA approval.

So, is it safe to block and inhibit these natural processes of the liver?

History has shown that methods like these which "trick" the body into an unnatural process always comes with side effects and risks.

Doesn't it makes more sense to find out how to lower cholesterol naturally vs. ways that force your body to function abnormally? If you agree with me on this, go ahead and signup for my daily email tips below and let me show you how it's done. (It's not as hard as you might think.)

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