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Posted

I read today that Merck has received approval from the FDA to start selling a new pill that will lower LDL, the bad cholesterol, dramatically. It will offer an bc alternative to patients now taking statins.

As for myself, I have done well on statins but not everyone does, including bothersome side effects. Nice to know there is an alternative if that were to change.

Posted

I'm very dubious about anything coming from the current FDA.  What do the European, British, Canadian, Japanese and other international health ministries say about this new treatment?  Since I've moved to Japan, I've found a New Zealand doctor licensed and working in Japan.  I will seek his opinion on changing from my current Lipitor prescription.  I'll share what he tells me.

Posted (edited)
8 hours ago, Petris Sage said:

I'm very dubious about anything coming from the current FDA.  What do the European, British, Canadian, Japanese and other international health ministries say about this new treatment?  Since I've moved to Japan, I've found a New Zealand doctor licensed and working in Japan.  I will seek his opinion on changing from my current Lipitor prescription.  I'll share what he tells me.

The current FDA evaluates drugs no differently than previously. Lipfendra has been undergoing trials since 2020 with the Phase 3 trial ending in July 2025. While novel as a pill, it uses the same biological target as injectables like Repatha, Praluent, and Leqvio, so it's very likely to be approved by other countries within a year.

Edited by Lotus-eater
Posted (edited)

The rigour of gold-standard clinical trials exists not because cynicism is always justified, but because it is inevitable. The methodology is designed to withstand scrutiny regardless of where the skepticism originates. Many astute eyes, other than regulatory entities, critically appraise research findings. Next up: tracking of impact on major adverse cardiovascular events occurrence over longer periods. 

Edited by SirBillybob
Posted (edited)
On 7/16/2026 at 5:00 PM, Luv2play said:

I read today that Merck has received approval from the FDA to start selling a new pill that will lower LDL, the bad cholesterol, dramatically. It will offer an alternative to patients now taking statins.

Actually the most common application will be augmentation not substitution, other than alternative to its injectable formulation or statins not tolerated. The research placebo groups continued their previous treatment, not solely the usual inactive agent that we think of as characterizing placebo. Therefore, the purported benefit of Lipfendra is additive to pre-existing standard of care, wasn’t head-to-head comparison with total withholding of LDL-targeted agents.

Edited by SirBillybob

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