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New review of the first oral PCSK9 drug, a needle-free option for high cholesterol

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New review of the first oral PCSK9 drug, a needle-free option for high cholesterol

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A new review from Binghamton University School of Pharmacy and Pharmaceutical Science explores how Lipfendra (enlicitide) can be beneficial for those who have intolerances to injectable medications. The review was recently published in Annals of Pharmacotherapy and was authored by clinical assistant professors Taylor Clark, Rachel Lucas and Mia Lussier, as well as assistant professor Azadeh Nasuhidehnavi.

The FDA's recent approval of enlicitide marks a significant advancement in cholesterol management. This once-daily pill is the first in the PCSK9 inhibitor class, which was previously limited to injectable forms.

Enlicitide effectively reduces LDL ("bad") cholesterol by approximately 57% to 65% in patients already on statins, matching the efficacy of injectable PCSK9 inhibitors. In comparative trials, it lowered LDL by about 65%, outperforming bempedoic acid (6%) and ezetimibe (28%).

Side effects are minimal, with diarrhea and dizziness occurring slightly more often than with a placebo. The recommended regimen involves taking the pill first thing in the morning on an empty stomach, followed by a 30-minute wait before consuming anything other than water, black coffee or plain tea. Enlicitide also serves as a cost-effective alternative to other injectable therapies, priced at $315 for a 30-day supply.

While enlicitide has not yet demonstrated a reduction in heart attacks or stroke, it provides a valuable option for patients who prefer oral medication or require additional LDL lowering beyond what other pills offer.


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