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Pcsk9 Inhibitor

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Lipfendra: the first daily oral PCSK9 inhibitor and how it compares with statins
cholesterol-and-cardiovascular27 days ago

Lipfendra: the first daily oral PCSK9 inhibitor and how it compares with statins

The FDA approved Lipfendra (enlicitide), the first oral PCSK9 inhibitor for high cholesterol and heterozygous familial hypercholesterolemia. In trials, Lipfendra lowered LDL cholesterol by about 56–59% versus placebo, mainly in patients already on statins, but there’s no head‑to‑head comparison with statins yet. It can be used alongside statins or other lipid drugs when LDL remains above goal, offering a pill alternative to injectable PCSK9 inhibitors. However, it’s approved only for adults, has a stringent morning-on-empty-stomach regimen, and more cardiovascular outcomes data are still being gathered, so doctors will tailor its use to patients who need additional LDL lowering beyond maximally tolerated statin therapy.

via Medical News Today|
#cholesterol#cholesterol-and-cardiovascular#ldl-cholesterol
Oral Lipfendra could redefine cholesterol management, doctors say
health1 month ago

Oral Lipfendra could redefine cholesterol management, doctors say

The FDA approved Lipfendra, an oral PCSK9 inhibitor, which when used with statins lowered LDL cholesterol by about 60% in a 24-week trial; doctors expect to prescribe it to a large share of patients with high cholesterol, potentially changing treatment for the roughly 86 million Americans affected. The pill costs about $315 per month and is seen as easier to manage than the injectable version, with side effects like dizziness and diarrhea similar to placebo in trials. Lowering cholesterol can promote plaque regression and reduce the risk of heart attack or stroke, especially when combined with lifestyle changes and statin therapy.

via The Spokesman-Review|
#cholesterol#fda-approval#health
Merck's Lipfendra lands FDA nod as oral PCSK9 cholesterol fighter
health1 month ago

Merck's Lipfendra lands FDA nod as oral PCSK9 cholesterol fighter

The FDA approved Lipfendra, Merck's oral cholesterol-lowering drug that blocks the PCSK9 protein, offering a non-injectable option to reduce LDL cholesterol by up to about 60% after 24 weeks in trials. It targets hypercholesterolemia (including familial forms) for patients often already on statins, expanding treatment beyond injectable PCSK9 inhibitors. Lipfendra is priced at $10.50 per day (about $315 for a 30‑day supply), with Merck signaling lower out‑of‑pocket costs. The approval aligns with evolving guidelines urging aggressive LDL targets to cut heart-disease and stroke risk.

via NBC News|
#health#hypercholesterolemia#ldl-cholesterol
FDA approves first oral PCSK9 inhibitor to slash LDL cholesterol
health1 month ago

FDA approves first oral PCSK9 inhibitor to slash LDL cholesterol

The FDA approved Lipfendra (enlicitide), the first oral PCSK9 inhibitor, to be used with diet and existing LDL-lowering therapies in adults with high cholesterol, including inherited forms. In phase 3 trials, Lipfendra reduced LDL cholesterol by about 56%–60% when added to statin therapy, roughly doubling the impact of many statin regimens. The pill offers a convenient alternative to injectable PCSK9 inhibitors and was generally well tolerated, with diarrhea and dizziness as common side effects and similar discontinuation rates to placebo. Merck noted that large cardiovascular-outcome data are still pending, with results expected in 2029.

via Fox News|
#cholesterol#fda-approval#health