Dutasteride Phase 3 study for treatment of Androgenetic Alopecia complete!

[bbbeeeppp2]

https://clinicaltrials.gov/ct2/show/results/NCT01831791

http://www.ncbi.nlm.nih.gov/pubmed/26893187

> As a potential future treatment option for male androgenetic alopecia, dutasteride 0.5 mg exhibited long-term safety, tolerability and efficacy within this study population.

Will the FDA now be likely to approve 0.5mg dutasteride for Androgenetic Alopecia? I've been using it off-label for a while, but this is really good news for people who can't get a prescription but want to try it.

 

[br1]

I don't understand how they call 1 year, "long term". Specially considering a drug that ppl would have to take it forever.

 

[hwezdarik]

It is 2016 FFS, when we have 4k TVs, VR sets, Tesla Model 3 and in the world of hairloss we have dutasteride soon to be approved for Androgenetic Alopecia ... I don't know but it seems to be that scientists or pharma companies do not wanna be rich... Looking at the number of men balding they would be into 10 digits each year.... Androgenetic Alopecia should have been a thing of the past since 2011.....

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GSK is the sponsor of that study. It makes me wanna cry that such a top-tier pharma company is not looking into other safer and better hairloss solutions... They can have all the money/loans/grants they want for their research.

 

[Giiizmo]

This phase 3 study is useless and the probable, subsequent FDA approval is even more useless.

The study just proves that it works and that it doesn't give you cancer - hooray, we already knew that. People are already using dutasteride off-label to try and treat hair loss - some will have sexual side effects and some lucky others won't.

Just to put things in perspective, it's been almost 25 years since finasteride hit the market (Proscar). Everyone thinks it's time we get something else than 5-aR which is the hormonal equivalent of shooting a mosquito with a bazooka. As it stands, marketing dutasteride as a hair loss drug is just a way for big pharma to make more bucks off of an old molecule.

So f-ck you GSK, I hope you lose more money on your dumb studies than you'll ever make off of this garbage drug. Oh, and get sued into oblivion for making people's dick fall off.

 

[otis]

Why would they go for FDA aprovel now that Avodart went generic.The wouldn't sell it for less than the generic. I am buying 60 tablets at Costco for under thirty bucks. No one would pay the high price for there name brand any more.

 

[Rockinlove]

Indeed.

However, since this establishes the safety efficacy profile of the drug then this grants me some measure of solace.

I am a dutasteride user. In certain genetic phenotypes dutasteride is far more effective than finasteride. Even the sides are tolerated better.

Yeah, I don't see the point in going forward with it for them. People have been using it off-label since it became available back in the '00's, and it doesn't seem to be any more effective than finasteride. I took it for about a year and noticed no benefit, so I switched back to finasteride as it was cheaper. I've also seen a study that said it only blocked an additional 5% more of DHT than finasteride (I don't have a link, but it's frequently referenced on the forums).

One advantage for the company is that it's a liqui-gel pill, which means it can't be quartered like Proscar. More money for them, I guess.

 

[Afro_Vacancy]

How can the sides possibly be better on dutasteride?

 

[Rockinlove]

How can the sides possibly be better on dutasteride?

Unlike finasteride, dutasteride has given me an increased sex drive and even my erections are better.

It is also pretty much akin to that of a steroid if you are working out.

However, the shedding phase is far more severe and a tad bit terrifying.

 

[Afro_Vacancy]

Unlike finasteride, dutasteride has given me an increased sex drive and even my erections are better.

It is also pretty much akin to that of a steroid if you are working out.

However, the shedding phase is far more severe and a tad bit terrifying.

How can that be?

dutasteride is a stronger version of finasteride, the sides should be worse.

 

[buckthorn]

Unlike finasteride, dutasteride has given me an increased sex drive and even my erections are better.

It is also pretty much akin to that of a steroid if you are working out.

However, the shedding phase is far more severe and a tad bit terrifying.

Yup, both finasteride and dutasteride did the exact same thing to me. My libido is STILL through the roof - then all my hair started rapidly falling out. I hope it works for you man, but at the first sign of bad scalp inflammation, I would read the warning signs!

 

[Rockinlove]

In theory, yes. It may have something to with dutasteride increasing T levels more than finasteride does. Perhaps a Doctor might be able to provide a better explanation.

How can that be?

dutasteride is a stronger version of finasteride, the sides should be worse.

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Did you recover?

Yup, both finasteride and dutasteride did the exact same thing to me. My libido is STILL through the roof - then all my hair started rapidly falling out. I hope it works for you man, but at the first sign of bad scalp inflammation, I would read the warning signs!

 

[Mach]

It's been approved for Androgenetic Alopecia in Japan under the name Zagallo sense last year.

 

[kiwipilu]

How can that be?

dutasteride is a stronger version of finasteride, the sides should be worse.

If there are 2 options you better try both. obv this not the same molecule. for those who have serious SE with finasteride, they should at least try dutasteride.

 

[Dolph]

I don't understand why it's saying it exhibited long-term safety when over 50% of the participants experienced an adverse event. Can someone help explain?

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2.5% stopped the drug due to suicidality? Jesus. Especially when all of the participants were Japanese, where suicide is very different culturally, a huge dishonor to one's family...

I think I'm convinced -- inhibiting the production of DHT just isn't an option. Killing DHT at some other part of the process (CB?) might be interesting. But stopping its production just seems like utter **** for brain health. I am so glad I'm off finasteride.

 

[lickawrist]

In theory, yes. It may have something to with dutasteride increasing T levels more than finasteride does. Perhaps a Doctor might be able to provide a better explanation.





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Did you recover?

dutasteride inhibits all three of the 5a-reductase enzyme, finasteride only inhibits type I and II. Consequently, this "raises" t-levels moreso than finasteride because there is more free-t floating around that isn't being metabolized by the enzymes. I use quotations because your total testosterone doesn't change; only the ratio between T/DHT is altered. That's how these antigens mitigate the balding process. I'm not a doctor or a biophysicist, so I may be wrong.

 

[Dench57]

In certain genetic phenotypes dutasteride is far more effective than finasteride. Even the sides are tolerated better.

Do you have any studies or evidence regarding this theory that certain genotypes respond differently to finasteride or dutasteride? I've seen people reference it but never seen any evidence for it myself.
I do know of several people who felt better on dutasteride than on finasteride, however I also know more people who were fine on finasteride and got sides on dutasteride. Since dutasteride lowers everything that finasteride does to a greater extent, but increases Test more than finasteride does - I can only speculate that the extra T boost is what makes some people, who do not "need" DHT, benefit more from the extra T. From what I understand, DHT is primarily an "amplifier" of testosterone in local tissue.

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People have been using it off-label since it became available back in the '00's, and it doesn't seem to be any more effective than finasteride.

I don't think there can be any question that dutasteride is more effective than finasteride. I've yet to see a study where dutasteride did not outperform finasteride, but if you know one I'd be interested.

 

[Rockinlove]

As far as I know there have been no empirical studies conducted in this regard. However, take into consideration those on forums who have documented their results with dutasteride as well as finasteride. Some reported no sexual sides after switching to dutasteride.

In my case, I have been on finasteride for 3 years before switching to dutasteride recently. I did have a few sexual sides on finasteride such as weaker erections but nothing that was cause for much consternation. With dutasteride I find that at least there have been no sexual sides. If anything; my libido is better than it was before.

I wondered why and this was the only tenable explanation that I could come up with. It is perhaps why some people are good responders to certain medications and others are not. It is why the medical fraternity considers precision medicine as being the way of the future. Since there are variations in how every individual responds to a treatment. Biological factors such as age, race, weight and height do make a difference. Also, it would not be far fetched to state that our genetic makeup has a discernible impact on the efficacy of treatments.

We also have to consider that they are different molecules. dutasteride is not a stronger version of finasteride since that would be proscar but an entirely different drug.

Do you have any studies or evidence regarding this theory that certain genotypes respond differently to finasteride or dutasteride? I've seen people reference it but never seen any evidence for it myself.
I do know of several people who felt better on dutasteride than on finasteride, however I also know more people who were fine on finasteride and got sides on dutasteride. Since dutasteride lowers everything that finasteride does to a greater extent, but increases Test more than finasteride does - I can only speculate that the extra T boost is what makes some people, who do not "need" DHT, benefit more from the extra T. From what I understand, DHT is primarily an "amplifier" of testosterone in local tissue.

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I don't think there can be any question that dutasteride is more effective than finasteride. I've yet to see a study where dutasteride did not outperform finasteride, but if you know one I'd be interested.

 

[Pavi]

I just don't get why they invested the time and money for this.... We all know the potential and disastrous effects of DHT suppression; also, "new era" treatments are not focusing on DHT and people don't want to suppress their most potent male hormone

 

[Rockinlove]

That's a highly myopic view. Since this grants dutasteride users some measure of solace and it would also pave the way for a topical solution that includes dutasteride.

I just don't get why they invested the time and money for this.... We all know the potential and disastrous effects of DHT suppression; also, "new era" treatments are not focusing on DHT and people don't want to suppress their most potent male hormone

 

[whatevr]

Yeah, why bother with finasteride / dutasteride when you have all these NEW ERA treatments that have been proven to work and that you can get right now? c: