A groundbreaking oral medication could transform treatment for people battling genetically high cholesterol levels after slashing bad cholesterol by up to 60 per cent in patients with heterozygous familial hypercholesterolemia, a genetic condition that makes traditional treatments ineffective.
The research, published in JAMA on 9 November, offers hope to those whose cholesterol remains dangerously elevated despite taking statins and making lifestyle changes.
For these patients, existing options have been limited to injectable medications.
Enlicitide works as a PCSK9 inhibitor, boosting the body's ability to clear LDL cholesterol from the bloodstream.
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It's the first drug in this class available as a convenient daily pill rather than an injection.
The international trial recruited 303 participants from 59 sites across 17 countries, all of whom were already taking statins but still had elevated LDL cholesterol levels.
Researchers gave 202 participants enlicitide once daily for 52 weeks, while 101 received a placebo.
After 24 weeks, those taking enlicitide saw their LDL cholesterol plummet by an average of 58.2 per cent.
Those reluctant to have injections tend to be more consistent in taking a daily dose of pills
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The placebo group's levels actually rose by 2.6 per cent.
By the 52-week mark, the enlicitide group maintained impressive reductions averaging 55.3 per cent.
Meanwhile, the placebo group experienced an 8.7 per cent increase in their bad cholesterol levels.
These dramatic differences highlight enlicitide's potential for patients who've exhausted other treatment options, with benefits extending beyond LDL cholesterol.
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Non-HDL cholesterol dropped by 52.3 per cent in the enlicitide group compared to just 2.1per cent with placebo.
Apolipoprotein B, which carries bad cholesterol and signals heart disease risk, fell by 48.2 per cent versus 1.8 per cent.
Even lipoprotein(a), a stubborn genetic risk factor that resists diet and exercise, decreased by 24.7 per cent compared to 1.6 per cent in the placebo group.
"Individuals reluctant to have injections tend to be more consistent in taking a daily dose of pills.
"I tend to see an increase of adherence by approximately 20 per cent amongst individuals who switch," noted medical director at Medical Cert UK, Dr Maria Knöbel.
Scientists believe the drug could work beyond genetic cases
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The pill format could make this powerful treatment accessible to many more patients.
Lead author Dr Ann Marie Navar from the University of Texas Southwestern Medical Center noted that "daily enlicitide resulted in almost identical changes in LDL, non-HDL, and ApoB to those achieved with the injectable antibodies alirocumab and evolocumab".
Cardiologist Dr Yu-Ming Ni believes the drug could work beyond genetic cases.
"This medication is in the same drug class as other established injectable PCSK9 inhibitors and appears to have a similar overall effect on cholesterol levels.
"Therefore, I do expect that it has similar efficacy on cholesterol in patients without genetically driven high cholesterol."
However, he stressed that longer trials are needed to confirm whether these cholesterol reductions translate into fewer cardiovascular events over time.
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