Those individuals who ingested bempedoic acid on a daily basis experienced a significant reduction in low-density lipoprotein (LDL) cholesterol levels, averaging 30.2 mg/dL or 21.3%, over the course of approximately three years. Elevated levels of LDL cholesterol can contribute to the formation of cholesterol plaques, which can narrow blood vessels as depicted in the accompanying 3D rendering. (Photo: Getty) If you have elevated levels of “bad cholesterol” and are at a higher risk of suffering a heart attack or stroke, it is common for doctors to prescribe statins. However, what happens if you are among the 15% of people who cannot tolerate these cholesterol-lowering medications, finding yourself “stranded on a statin island,” so to speak? Well, a recent clinical trial has revealed promising findings about bempedoic acid, offering a potential alternative to statins. In this trial, participants who took bempedoic acid once a day experienced an average reduction of 30.2 mg/dL or 21.3% in LDL cholesterol levels over a period of approximately three years. These findings were published in JAMA on June 24. Additionally, compared to those who took a placebo, individuals taking bempedoic acid had a 39% lower risk of heart attacks, a 39% lower risk of death from heart disease, and a 36% lower risk of death from either a heart attack or stroke. These results provide encouraging news for those who cannot tolerate statins. However, it is important to approach these results with caution, as they represent only one study. And as we know, one study is just that – one study. Statin intolerance does not refer to insulting or belittling statins; rather, it describes the situation whereby an individual cannot continue taking these medications, such as atorvastatin (generic for Lipitor), rosuvastatin (Crestor), or simvastatin (Zocor), due to significant side effects. Muscle-related issues are the most common reason for discontinuing statins, with some individuals experiencing muscle aches, pains, weakness, or cramps that become intolerable, or elevated levels of creatine kinase, indicating muscle injury. Another reason to discontinue statin use is if blood tests show elevated liver enzymes, suggesting possible liver damage. Statin intolerance poses a real challenge in lowering elevated LDL cholesterol levels. LDL is the “bad” type of cholesterol that can obstruct arteries responsible for supplying blood to the heart and brain – two of the body’s most vital organs, depending on personal priorities. When LDL levels are elevated, doctors typically recommend lifestyle changes, such as reducing saturated fat intake, consuming foods rich in omega-3 fatty acids, increasing fiber consumption, incorporating whey protein into the diet, reducing physical inactivity, striving for weight loss, quitting smoking, and decreasing alcohol intake. Lifestyle modifications are the first line of therapy for high cholesterol. (Photo: Getty) When multiple attempts at lifestyle modifications have not been fruitful, doctors often prescribe statins to assist in lowering cholesterol. Statins function by inhibiting an enzyme in the liver called HMG-CoA reductase, which is involved in cholesterol production. They can also aid the liver in removing cholesterol from the blood and reducing inflammation in the walls of arteries. According to a meta-analysis published in The Lancet, studies have demonstrated that for every 1.0-mmol/L (39-mg/dL) reduction in LDL achieved through statin use, the risk of major cardiovascular problems can decrease by 20% to 25%. Bempedoic acid serves as an intriguing alternative for individuals with statin intolerance. In early 2020, the U.S. Food and Drug Administration (FDA) approved Nexletor, Esperion Therapeutics, Inc’s version of bempedoic acid, marking the first oral, non-statin LDL-lowering medication to receive approval since 2002. Bempedoic acid works via a different mechanism, inhibiting an enzyme called adenosine triphosphate-citrate lyase (ACL) in the liver, earlier in the cholesterol production process. Additionally, it promotes increased expression of LDL receptors, enhancing the removal of LDL from the bloodstream. Recognizing this alternative possibility, a research team comprising members from the Cleveland Clinic, Monash University, Brigham and Women’s Hospital, Imperial College London, the University of Amsterdam Academic Medical Center, and Esperion Therapeutics, Inc. conducted a study involving 4,206 individuals considered statin-intolerant. These individuals were part of a subset of 13,970 statin-intolerant patients enrolled in a clinical trial running from December 2016 to August 2019 at 1,250 centers across 32 countries. Among this subset, 2,100 were randomly assigned to receive 180 mg of bempedoic acid orally once a day, while 2,106 were assigned to receive a placebo. The study participants began with an average LDL level of 142.5 mg/dL, which falls within the borderline high range of 130 to 159 mg/dL. Ideally, LDL levels should be below 100 mg/dL. Participants also began the study with an average high-density lipoprotein (HDL) cholesterol level of 51.0 mg/dL and a median triglyceride level of 161.8 mg/dL. Nearly 59% of the participants were female, and close to 66% had diabetes. The average age of the participants was 68 years. The research team followed the participants for an average of 39.9 months. Muscle pain can be a side effect of statin use. (Photo: Getty) As mentioned previously, the study findings suggested that bempedoic acid could effectively lower LDL levels and decrease the risk of adverse cardiovascular events. Ultimately, 112 individuals, or 5.3% of those in the bempedoic group, experienced death from cardiovascular causes, heart attacks, strokes, coronary revascularization, or hospitalization for unstable angina. This figure was 31% lower than the 164 patients, or 7.8%, in the placebo group. Additionally, those taking bempedoic acid experienced an average decrease in high-sensitivity C-reactive protein levels of 0.56 mg/L or 21.5%, from an initial median level of 2.4 mg/L. Furthermore, individuals in the bempedoic acid group had a 27% lower risk of all-cause mortality. However, it is essential to consider the potential side effects when taking a medication daily. Although no adverse events merited the discontinuation of bempedoic acid, the research team did observe differences between the bempedoic acid and placebo groups. A higher proportion of participants in the bempedoic acid group experienced gout (2.6% vs. 2.0%), gallstones (2.5% vs. 1.1%), and increases in creatinine, uric acid, and hepatic enzyme levels compared to the placebo group. It is crucial to remember that this study represents only one piece of the puzzle. As we know, one study is often insufficient, whether we are discussing scientific research or rolls of toilet paper. Furthermore, this was not the largest clinical study conducted, as the number 4,206 may seem significant when contemplating tea parties or ferrets, but it fails to capture the full diversity of the general population. More research is required to determine whether bempedoic acid can genuinely serve as an alternative to statins. Nevertheless, the results from this study are promising, suggesting that bempedoic acid could fill an important gap. After all, you may desire a statin, but what if you cannot tolerate it? Until now, there have been limited medication alternatives to statins, with fibrates, bile acid-binding resins like cholestyramine, and niacin presenting their own limitations. Therefore, bempedoic acid has the potential to emerge as a leading alternative to statins. However, it is not necessarily the first medication to consider for cholesterol-lowering, particularly if you can tolerate statins without issue. Nonetheless, bempedoic acid…
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Jessica Irvine is a tech enthusiast specializing in gadgets. From smart home devices to cutting-edge electronics, Jessica explores the world of consumer tech, offering readers comprehensive reviews, hands-on experiences, and expert insights into the coolest and most innovative gadgets on the market.
