Is new cholesterol-lowering medication Nexletol a solution for those who can’t take statins?
Last month, a new kind of medication called bempedoic acid (Nexletol) was approved for use by the FDA as a novel way to lower cholesterol. Does this new medication add something special?
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Lowering cholesterol is one of the most important things that can be done to decrease the risk of developing coronary artery disease. Following a careful diet, exercising regularly, and dealing with stress are key components in this battle, but sometimes medication is needed.
Most people with high cholesterol need a drug called a statin, which includes the popular drugs called atorvastatin (Lipitor) and rosuvastatin (Crestor). Last month, a new kind of medication called bempedoic acid (Nexletol) was approved for use by the FDA as a novel way to lower cholesterol. Does this new medication add something special?
Statins, which are now generic and inexpensive, are usually the best way to lower cholesterol if you need a medication. Their Achilles’ heel: Anywhere from 5% to 20% of people taking them cannot tolerate the medication, as the main side effect of muscle aching can be severe. Almost half of people prescribed a statin will stop in the first year of use.
For years, the medical community’s response was to suggest trying another statin, or recommend that patients just put up with their discomfort. Pharmaceutical companies recognized an unmet need, both for statin intolerance and for cholesterol levels that remained too high despite being on statins, and the research has produced some fascinating results.
We have learned that lowering LDL cholesterol (so-called bad cholesterol) to levels that were previously thought to be too low is both safe and effective. And we learned that raising HDL (good cholesterol) with medication is bad for you. This was an expensive lesson for Pfizer, the company invested more than $800 million on a drug called torcetrapib, which harmed people even though it raised HDL levels. The same is true of niacin, which raises HDL but is unsafe when taken with a statin. The painful lesson: The best way to raise HDL is diet and exercise, and medications don’t work. We have also learned that triglycerides are important if you have heart disease and your cholesterol and triglyceride levels are elevated. In this case, a special kind of fish oil called Vascepa will further lower your risk.
But despite these advances, many patients still have problems tolerating statins.
The prescription alternatives for those who cannot tolerate a statin include Zetia (ezetimibe) — which works by preventing cholesterol absorption from the intestine — and the injectable, expensive PCSK-9 inhibitors (Repatha and Praluent). Taking Zetia alone does not lower your cholesterol that much, only 15% to 20%. The injectable drugs work but and are prohibitively expensive for many.
I have used red yeast rice (an inexpensive over-the-counter supplement) to treat statin intolerance for years with good success. It has not caught on for several reasons, mainly because of a lack of consistency among poorly regulated over-the-counter brands.
The development of another medication to help patients who cannot take a statin would help fight heart disease. This was the impetus for bempedoic acid. It seems to be just what the doctor ordered: a non-statin medication that can provide an alternative to help patients aching from statins.
But after reviewing the studies done on this new medication, unfortunately, it may be more hype than reality. The most important points:
Bempedoic acid is presently approved to take with a statin to further lower cholesterol, mainly for people with genetically high cholesterol.
When combined with Zetia, another non-statin, it lowered cholesterol 36%. Zetia alone lowered cholesterol 23%. This is from an average baseline cholesterol of 150 mg/dl.
It does not lower cholesterol much when taken alone — only by 17%.
Side-effects include an increased risk of gout, as it can raise uric acid levels, but it was otherwise well-tolerated. There has been minimal muscle aching reported.
It is priced at about $300 a month.
I doubt bempedoic acid will be the drug to help the majority of people who cannot take statins. It is expensive and is only moderately effective. Hopefully, further research will change this, but statin intolerance remains a problem in search of a solution.
David Becker is a frequent Inquirer contributor and a board-certified cardiologist with Chestnut Hill Temple Cardiology in Flourtown, Pa. He has been in practice for more than 25 years.