Study: New Cholesterol Drugs Effectively Lower LDL Levels

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People who have high cholesterol were given fresh hope this week that new, effective cholesterol-lowering drugs could be a reality in the near future. An experimental class of drugs known as PCSK9 inhibtors were presented over the weekend at the annual meeting of the American College of Cardiology, and The Wall Street Journal reported Sunday that they were shown to reduce LDL cholesterol levels by two-thirds across a number of different patient groups.

Currently, the most commonly used weapon against cardiovascular disease is a group of medicines called statins — drugs that went on the market more than 25 years ago — but statins have a number of complications. Now, both health experts and patients have hope that the new drugs will eventually be able to join the fight against high levels of LDL cholesterol, a risk factor for heart attack and stroke.

According to the Journal, Amgen (NASDAQ:AMGN) is the company that sponsored the phase 3 studies of PCSK9 inhibitors over the weekend, while Sanofi SA and Regeneron Pharmaceuticals (NASDAQ:REGN) also financed an additional phase 3 trial. Funds for phase 2 data came from Pfizer (NYSE:PFE). Each company is fighting for its own rights to the drugs that could potentially enter into a hungry pharmaceuticals market. The results over the weekend clearly showed that the new drugs really do have a significant effect on LDL cholesterol levels.

Steve Nissan, chairman of cardiovascular medicine at the Cleveland Clinic, explained to The Wall Street Journal that ”There’s not a shred of doubt that this is a very efficacious way to lower LDL.”

The results that recently came from the studies of PCSK9 inhibitors were consistent with what health professionals found earlier, and patients who followed the plan for as long as a year didn’t suffer any significant safety issues.

Still, questions surrounding the new drugs remain, and the studies that Amgen, Sanofi, and Regeneron launched to answer those questions aren’t expected to be completed until 2018, The Wall Street Journal reported Sunday. Among others, one thing health experts still have to determine is whether the dramatic reductions in LDL that the drugs furthered will actually facilitate significant reductions in heart attacks, strokes, and other consequences of cardiovascular disease. That much is still unknown, and until answers to questions such as those are uncovered, patients who have high cholesterol will continue taking statins, as long as they qualify.

In the meantime, PCSK9 inhibitors will continue to be tested, and more health professionals and patients are expected to take note of what the future of cholesterol medication could hold. The first step is education and understanding how these inhibitors differ from statins, currently the most widely used drugs ever developed by the pharmaceutical industry. According to the Journal, the medicines in question that are hoping to upset that reality are bioengineered antibodies that block PCSK9, a protein that interferes with the liver’s ability to remove cholesterol from the blood. In comparison, statins such as Lipitor, Zocor, and Crestor curb cholesterol production.

But if statins work so effectively, why can’t we just focus on those and use the research money elsewhere? Because many high cholesterol sufferers don’t qualify for statin therapy on account of the muscle pain or other side effects they suffer. The Wall Street Journal reports that while more than 50 million Americans qualify for statin therapy, more than 10 percent of patients are prevented from taking statins due to their muscle pain or inability to reach targets required for statin medication.

In order to qualify for statins, patients have to follow an aggressive diet and exercise regimen, but because some have genetically high levels of LDL, they are essentially disqualified them from ever being a statin-worthy candidate.

That’s where the new drugs and studies come in, and health experts are hopeful. According to The Wall Street Journal, in the 901-patient study funded by Amgen, those treated with a 420-milligram dose of a drug called Descartes had a 57 percent reduction in LDL compared with those who took a placebo. Other Amgen studies showed a lowering of LDL in patients with genetically high LDL and among those considered statin-intolerant, leading those studies to be published online by the New England Journal of Medicine.

It is still not absolutely clear what the future of cholesterol medication holds, but the studies over the weekend show that it might be a bright one.

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