By Peter A. McCullough, MD, MPH
It has been several years since the introduction of a new oral drug to lower cholesterol. However, the injectable market has become crowded with more choices for those needing cholesterol-lowering. Merck’s new drug will almost certainly be disruptive in the marketplace.
💊 Merck’s Lipfendra: The First Oral PCSK9 Inhibitor Arrives — Mixed News for Statin Haters
The FDA dropped a bombshell on July 17, 2026, approving Lipfendra (enlicitide) — Merck’s once-daily oral PCSK9 inhibitor. This isn’t just another cholesterol drug. It’s the first pill capable of doing what previously required a needle, and it slashes LDL-C by 56–59% on top of maximally tolerated statins. For millions of Americans who’ve been waged war on generic statins, this changes the calculus entirely.
🔬 Side Effects: Lipfendra vs. Statins — No Contest
Let’s be blunt about what statins actually do to people. In ~15% of people, there are well-documented muscle pain, weakness—the problem is that 100% of the general public has these complaints as well.
Now look at Lipfendra’s side effect profile from the two pivotal trials across 3,207 patients:
In the larger ASCVD trial, adverse reactions were similar between Lipfendra and placebo — meaning the drug was essentially indistinguishable from a sugar pill in side effect burden. The HeFH trial showed mild upticks in diarrhea and dizziness, but nothing approaching the metabolic and muscular devastation statins routinely inflict.
The fasting requirement — eight hours overnight, take it 30 minutes before breakfast — is annoying, but Merck appears to have dosed at 20 mg to build in a compliance buffer. Compared to waking up every morning feeling like you got hit by a truck on atorvastatin, an empty stomach is a trivial inconvenience.
IPAK-EDU is grateful to FOCAL POINTS (Courageous Discourse™) as this piece was originally published there and is included in this news feed with mutual agreement. Read More
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