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By B. Hadley Wilson, MD

Every week, I see patients who can’t get their cholesterol down, even though they’re taking statins, exercising and eating a heart-healthy diet. Some of these patients have already had a heart attack or stroke and are worried their lives are in jeopardy. But I’ve never been able to offer these high-risk patients a proven treatment – until now.

In March 2018, the ODYSSEY Outcomes trial showed that a relatively new class of drug, called PCSK9 inhibitors, can significantly reduce cholesterol in high-risk patients, and make them less likely to suffer a life-threatening health event.

PCSK9 Inhibitors Improve Outcomes

PCSK9 inhibitors are monoclonal antibodies designed to deactivate the PCSK9 protein and, in turn, reduce LDL cholesterol. In 2017, the FOURIER study showed that these drugs reduced LDL levels by approximately 60 percent in patients who were taking statins and had stable cardiovascular disease.

But no one knew if PCSK9 inhibitors actually improved outcomes in patients who had already suffered an adverse cardiovascular event. That’s where ODYSSEY comes in.

ODYSSEY is an international study that enrolled nearly 19,000 participants who had suffered acute coronary syndrome, had elevated cholesterol levels (LDL-C ≥70 mg/dL) and were taking maximal statins. For the study, these participants added the PCSK9 inhibitor alirocumab. The results were significant.

ODYSSEY participants saw:

  • LDL-C levels fall by approximately 50 percent
  • A 15 percent reduction in risk of adverse cardiovascular events including coronary heart disease death, nonfatal heart attack, ischemic stroke or unstable angina requiring hospitalization
  • A 0.6 percent reduction in all-cause mortality compared to placebo

Participants who initially had the highest cholesterol (greater than 100 mg/dL) benefited the most. Many of these participants saw LDL cholesterol levels fall to around 25 mg/dl – well below the 70-100mg/dl target that we typically aim for. These participants also saw an even greater reduction in risk of adverse health events and early death.

Transforming Cholesterol Treatment

These results are already changing treatment at Sanger Heart & Vascular Institute, where we actively prescribe PCSK9 inhibitors for patients who don’t respond to statins. So far, we’ve seen the drugs significantly lower LDL cholesterol in hundreds of patients – with virtually no side effects. And almost all patients have easily embraced the habit of giving themselves biweekly, subcutaneous injections.

The biggest barrier has been cost. The annual cost of PCSK9 inhibitors has been as much as $14,000 per patient, and many insurers have declined to cover the drugs. But drug makers have started offering steep discounts that can reduce this price by 50 percent or more. We’re hopeful that this, combined with the ODYSSEY results, will spur more payers to cover the drugs in high-risk patients.

This will make PCSK9 inhibitors more accessible to patients who desperately need to bring their cholesterol down – and give them a better chance at leading longer, healthier lives.

For more information, or to make a referral, call 877-999-7484.

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