Experimental Cholesterol-Lowering Drug Effective, Study Reports

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An experimental antibody drug could prove effective at lowering LDL (“bad”) cholesterol levels for patients who have side effects with cholesterol-lowering statin medications.

That’s the conclusion of a clinical trial presented Monday at the American Heart Association annual meeting in Chicago.

The drug, alirocumab, outperformed the on-the-market medication that is currently the most widely used alternative to statins, Zetia, said lead researcher Dr. Patrick Moriarty, director of clinical pharmacology at the University of Kansas Medical Center. Researchers from the drug’s developers — Sanofi and Regeneron Pharmaceuticals — were also involved in the current study.

Patients taking alirocumab had a 45 percent decrease in their LDL cholesterol levels. Those taking Zetia went down by just 14.6 percent, Moriarty reported. One drawback to the new medication, however, is that it’s administered as an injection once every two weeks, according to the researchers. Zetia and statins are oral medications.

Still, the study’s findings are good news for patients who experience serious side effects from statins, most commonly muscle aches and pains, the researchers said.

Although previous studies have found as many as 25 percent of patients can’t tolerate statins, Moriarty said as many as half the patients in his practice have trouble taking the widely used cholesterol-busting drugs. Statins primarily cause muscle pain and stiffness as a side effect.

“It’s very heartwarming to me that we have a new class of medication that is well-tolerated by this complex and difficult patient population,” he said.

This trial’s finding that alirocumab was more effective at lowering LDL cholesterol than Zetia is particularly interesting given the results of another study — also presented Monday — on Zetia combined with a statin. That study found that particular drug combination (known as Vytorin) could reduce heart attacks and strokes by 14 percent among patients with clogged arteries.

Alirocumab is a genetically designed antibody. It improves the removal of LDL cholesterol from the bloodstream by blocking a protein that normally stops the body from getting rid of LDL, according to the researchers.

Zetia and statins both work differently. Zetia prevents absorption of LDL cholesterol in food by the intestines. Statins block cholesterol production by the liver.

In the clinical trial, 314 high-risk heart patients randomly received either alirocumab injections once every two weeks or daily Zetia or atorvastatin (Lipitor) pills for 24 weeks. At 12 weeks, the dose of alirocumab was doubled depending on cardiovascular risk and whether or not LDL goals had been met, according to the researchers.

Significantly more patients taking alirocumab achieved their cholesterol-lowering goal, the investigators found, about 42 percent compared with 4 percent taking Zetia.

Alirocumab also caused fewer muscle aches and pains than Zetia or atorvastatin. About 33 percent of alirocumab patients reported muscle side effects, compared with 46 percent of statin patients.

Overall, patients taking the statin were 63 percent more likely to experience side effects than those taking alirocumab, Moriarty said. Among patients who are completely unable to take statins, about 97 percent were able to tolerate alirocumab, according to Moriarty.

Dr. Karol Watson, associate professor of cardiology at UCLA’s David Geffen School of Medicine and co-director of the UCLA Program in Preventive Cardiology, said that the new drug “lowers LDL cholesterol impressively.”

However, Watson added that one of the study’s main takeaways is buried between the lines — the fact that “people who are labeled as statin-intolerant can, in fact, tolerate a statin.”

The trial asked patients considered statin-intolerant to take atorvastatin for 24 weeks, and during that period only 24 percent dropped out due to side effects, according to the study.

That means “75 percent successfully completed the study on a statin,” Watson said, which shows that some of these patients “may be able to be treated with a statin.”

Watson also noted that the results presented Monday did not show how alirocumab performed against statins, only that alirocumab outperformed the major non-statin drug Zetia.

Because the research was presented at a medical meeting, the findings should be considered preliminary until published in a peer-reviewed journal.

More information

For more about statins, visit the U.S. National Library of Medicine.

Source: HealthDay

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