Rejuvenate Biomed’s drug combination (metformin & galantamine) shows promise in sarcopenia in Phase 1b trial

FYI: Accuracy of Labeling of Galantamine Generic Drugs and Dietary Supplements | Clinical Pharmacy and Pharmacology | JAMA | JAMA Network

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Good to know.
I guess I will rely on Indian generics for this rather than Amazon.
Though I have taken galantamine from Amazon on and off for years with no undesirable effects.

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Haven’t looked that much as this, but cost wise looks like 60 x 12 tablets are less than $60 also in the U.S.

See eg Walgreens

https://www.goodrx.com/galantamine?

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Begs the question on how careful we might have to be with supplements in general.

Results

Ten brands of galantamine supplements and 11 brands of generic galantamine medications were included. Generic drugs were labeled as containing 4, 8, and 12 mg of galantamine per tablet or capsule. The actual content of galantamine in the generic drugs ranged from 97.5% to 104.2% of the labeled content (Table 1). No generic drugs were contaminated with microorganisms.

Dietary supplements were labeled as containing 4, 6, 8, and 12 mg of galantamine per serving. The actual quantity of galantamine in the dietary supplements ranged from less than 2% to 110% of the labeled quantity.

**Three supplements (30%) were contaminated with Bacillus cereus sensu stricto–encoding enterotoxin genes associated with diarrheal illness **(Table 2). The contaminated supplements contained 60%, 62%, and 75% of the labeled quantity of galantamine. All 11 generic drugs (100%) and 1 supplement (10%) contained a quantity of galantamine that was within 10% of the quantity declared on the label.

Discussion

Galantamine sold as generic drugs was accurately labeled and free of contamination, in contrast to galantamine sold as dietary supplements. The detected quantities of B cereus ss may suggest lack of appropriate quality control during manufacturing. However, adverse health effects would not be expected with these quantities of bacteria. For patients with Alzheimer disease, use of galantamine supplements instead of generic galantamine may adversely affect their care. Furthermore, the sale of inaccurately labeled galantamine supplements promoted for nonspecific memory and other cognitive problems is concerning given the lack of proven efficacy, potential drug-drug interactions, and adverse effects, including nausea, vomiting, dizziness, bradycardia, and syncope.6

The study has limitations. First, products were purchased at only 1 time point and the results may not be generalizable to galantamine supplements currently available given that manufacturers can introduce, reformulate, or withdraw supplement products without notifying the FDA. Second, whether the results are generalizable to other supplement ingredients, such as niacin, potassium, and iron, which are also available as either dietary supplements or generic drugs, is unknown.

The laws regulating dietary supplements should be reformed such that the FDA has enforcement mechanisms to ensure that dietary supplement labels accurately reflect their contents. Meanwhile, clinicians should query patients with memory concerns about the use of dietary supplements and advise patients not to use galantamine supplements.

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Exactly! @AnUser has pointed this out many times… drugs are safer than supplements simply because you know (generally) what you are getting. They have better manufacturing processes, and are regulated closely (especially if manufactured in the US).

The chance you aren’t getting at all what you expect in supplements is much higher; especially as you go away from the top brands.

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Drugs have also done all the safety studies. If you look at an EMA assessment report, they do toxicology studies in mice for range of different conditions including cancer. FDA might force companies to human safety studies as well, like was the case for SGLT2i and heart failure because of other diabetes drugs being harmful for that condition.

So you know a lot more about drugs.
You don’t have to worry about contamination if you buy from a supplement company like nootropicsdepot and probably thorne.

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You just have to be more diligent in researching supplements to make sure that you are getting a quality product from a reputable company (like Thorne) that does continuous 3rd Party testing and will provide a Certificate of Analysis (COA).
The more problematic issue for both drugs and supplements is the corruption of the science (the studies) by the profit motive. Take that away and the results would be much more clear.

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My traditional bias in favor of supplements and against pharmaceuticals is based on a distrust of the medical establishment and big pharma. Their focus on the quick fix and narrow focus on isolated problems without looking at the big picture (wholistic) certainly made it appear profit-centric. However as the supplement industry has been increasingly taken over by the big multinational corporations (like everything else) they no longer hold any ethical high ground.

https://drnealsmoller.com/rant/the-14-mega-corporations-that-own-your-supplement-brand/

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Is the trial being done in Europe? If the trial works, any clue when their drug might appear in the US market?

I think for galantamine you need to watch out for potential negative effects like tolerance.

Potential to up regulate enzyme acetylcholinesterase side effects may not be desirable.

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All I have to say is this is an important discovery as it moots the primary concern for chronically taking metformin — muscle weakness or impaired response to exercise. If that negative can be flipped into a positive it changes much for metformin.

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So if we are already using a diabetes drug - acarbose - to pair with our rapamycin, we wouldn’t want to add metformin on top of that. In theory acarbose combined with the galantamine should work just as well? Pio might also be a contender.

3 posts were split to a new topic: Rejuvenate Biomed’s drug combination (metformin & galantamine) Personal Results