Dutasteride

[duhh]

Its cause the hairloss world is stagnant at this time. Bryan spends some time over at Hairsite on the duta. thread arguing with S.Foote and occasionally calibus, rocky?, troymaclure? I think alot of people including myself are temporarily switching to a more theoretical type of thought until something else comes out that we can actually comment on its effectiveness. This thread will be flooded at the end of this year when we got duta and start growing some hair. I have spent alot of time on the hairmultiplication thread at hairsite, and there is alot of buzz about upcoming developments. It is going to be really really soon when a hairloss treatment/cure comes out that will put our hairloss worries to rest once and for all. Ex. Bioamide's new patent on injectable dp cells (I think they were dp cells) that has the ability to create New Follicles! Absolutely amazing, quick easy uses own cells matches HLA and color and texture and unlimited density. Only possible weak point - a smooth natural looking hairline from an injectable mast of cells. Be a little patient and unfortunately for Kevin this site will have No One on it! Unless it is a "Former Hair Loss Sufferers Reintegration Into the Hair Sculpturing Society of America" website.

 

[Troymaclure]

we spent a good 9 months anticipating and excitedly debating the arrival of dutasteride, then it's dragged on for another year or so, so i think now it's time to just wait and see what happens...it's been discussed to death i reckon so best thing is to just wait for it now and gauge its results

 

[Webbie]

Duhh,

Those are some very interesting developments you write of. I haven't heard anything about them. Would you mind pointing out some links for me (and the rest of us) to follow to learn more?

Thanks a lot!

 

[Webbie]

Holy crap, it's Troy!

 

[Troymaclure]

lol webbie...you so crazy...i've been here since the dawn of time

 

[frankb]

Wake up you dummies!!!!!!..........Avodart(dutasteride) has been approved!!!!!......check out hairsite.com or go the FDA website(forgot what it was).......THAT IS GREAT NEWS!!!!

 

[Itchy]

Yep, dutasteride has been approved, check out http://www.gsk.com/press_archive/press_10102002.htm for all the latest info!

This is great news guys!!! :lol: :lol: :lol: :lol: :lol:

 

[Norris]

Bring it on, Bring it on :lol: :lol: :lol:

 

[Webbie]

Here's the FDA PDF file:

http://www.fda.gov/cder/foi/label/2002/21-319s1lbl.pdf

This is great news, but did anyone else notice in the PR that they've decreased the supposed amount of DHT inhibition from upwards of 97% to 90%???

 

[Webbie]

After reading through the prescribing information (see link in my last post above), there seems to be a much larger attention given towards the possible negative affects of Duta on a male fetus. Yet, after reading the entire document, there was not caution mentioned about a woman becoming pregnant from a male taking Duta, yet there were all kinds of precautions stating that a pregnant woman should not touch or handle a capsule of Duta. In addition, it is cautioned several times that men should wait 6 months after taking their final dose of Duta before donating blood b/c of the risk that the donated blood could be given to a pregnant women, thus possibly causing abnormal development of the fetus. Wouldn't we thus conclude that the same precaution should be made about intercourse, and that Duta can be spread through our ejaculate? Yet it is not mentioned anywhere in the document!! :evil:

 

[Gizmo]

Webbie,

thats a good question.
take it to hairlosshelp.com experts, or anyone else that you think might know.

 

[Itchy]

I doubt it, I mean if it were a problem, it must be stated, and there were over 4,000 men in the BPH trials, as well as a few hundred in the male pattern baldness trials, surely at least a handful have conceived, even if off the drug, traces are found in the blood at 6 months, so surely there is not a problem.

 

[Bryan]

There might be a few of you who haven't yet seen this information about dutasteride side-effects that I've posted on some other sites....here's a simple cut-and-paste of the whole thing:

I got that dutasteride for BPH study last night (the first and so far, the ONLY published study using dutasteride in humans), and it's interesting to see that the reported incidence of side-effects of ALL kinds from using the standard 0.5 mg dose of dutasteride for a full 2 years is quite nominal.

Once again, I'm talking about: "Efficacy and Safety of a Dual Inhibitor of 5-Alpha-Reductase Types 1 and 2 (Dutasteride) In Men With Benign Prostatic Hyperplasia", Roehrborn et al, Urology 60:434-441, 2002.

Here's all their text comments about side effects, followed by a table at the end which shows all the data...I've tried to make the columns of numbers line-up reasonably well:


Tolerability
Dutasteride was well tolerated. Overall, 75% of the placebo-treated versus 77% of the dutasteride-treated patients experienced an adverse event (AE) in the course of the 24-month study. The most common AEs were ear-nose-throat infections, musculoskeletal pain, and upper respiratory infections. Drug-related AEs were seen in 14% and 19% of placebo-treated and dutasteride-treated patients, respectively, with sexually related AEs the most common in both groups. Impotence, reduced libido, ejaculation disorders, and gynecomastia occurred more frequently in dutasteride-treated patients (Table III). Additionally, the diagnosed prostate cancer incidence was 42 (1.9%) of 2158 for the placebo group and 24 (1.1%) of 2167 for the dutasteride group during the 24 months. [...] The majority of AEs reported in the present study were not drug related in the judgement of the investigators. Of those considered to be related to the drug, sexually related AEs were the most common. More patients exposed to dutasteride than placebo experienced impotence, decreased libido, ejaculation disorders, and gynecomastia in the course of the 24-month study. However, most of these effects were transient, and the incidence of new occurrences of each event decreased in the second year. Additionally, discontinuation because of AEs was rare. These results compare favorably with the AE profile of the existing type II 5-alpha-reductase, demonstrating that the more pronounced reduction in DHT by the dual inhibitor of 5ARI does not lead to an increase in the number or severity of AEs.

TABLE III. Drug-related adverse events

Study............................................Placebo.........Dutasteride
Period.........Sexual Adverse Event....(n=2158)....(0.5 mg/day; n=2167)

Entire study
.....................Impotence.................86 (4.0).........158 (7.3)
.....................Decreased libido.........46 (2.1)..........91 (4.2)
.....................Gynecomastia...........16 (0.7)..........50 (2.3)
.....................Ejaculation disorder...17 (0.79)..........48 (2.2)

0-1 yr............................................n=2158............n=2167
.....................Impotence.................65 (3.0).........130 (6.0)
.....................Decreased libido........41 (1.9)..........80 (3.7)
.....................Gynecomastia...........11 (0.5)..........28 (1.3)
.....................Ejaculation disorder...15 (0.7)..........40 (1.79)

1-2 yr............................................n=1736............n=1744
.....................Impotence.................21 (1.2)..........29 (1.7)
.....................Decreased libido..........6 (0.3)..........11 (0.6)
.....................Gynecomastia.............5 (0.3)..........23 (1.3)
.....................Ejaculation disorder......2 (0.1)...........9 (0.5)

(Data presented as the number of patients, with the percentage in parentheses)

 

[Webbie]

Thanks for the info, Bryan. I'm confused as to why the approval of Dutasteride has gotten so little attention here. No news articles, very little to no discussion here on the boards...the drug isn't out yet and for some of us it may be a while before we're willing to try AvoDart, but I mean come on, this is what we have been arguing about for over a year now!

 

[Gizmo]

Thanks VERY MUCH for that info Bryan.

I just wish the guys on the trial were 18-40... so the sexual side effects could actually mean something.

but besides that, this looks great.
this really could give us a long-year stop to our hair loss....at least I want to believe that....until the next thing comes.....this will be it...!

Webbie,

I think the thing is, we don't know for sure about the sexual side effects, and I think this drug scares people a bit.

I think it's worth a try....

I REALLY REALLY REALLY REALLY REALLY REALLY REALLY REALLY REALLY REALLY REALLY REALLY REALLY REALLY REALLY REALLY REALLY REALLY REALLY REALLY REALLY REALLY REALLY REALLY REALLY REALLY REALLY REALLY REALLY REALLY REALLY hope this stuff will work.
really.

I had just about enough of this hair loss crap... I'm tired and don't have the strength to fight on, if this "big" thing called Dutasteride doesn't work
I've wasted years looking for info, talking on boards, reading the articles...
such a stupid this to waste so much life time...

 

[Friskies]

Ok, so its approved

When are we going to see this stuff for sale? Im anxious to make the switch from fina to dutasteride.

 

[Troymaclure]

anytime between now and January is my guess - depends what happens production-wise now it's been approved...just keep searching everyday online pharmacies and such, keep yourself updated :wink:

 

[austin powers]

The word that I have been hearing on the web is that it will be available in December 2002.

However, GSK doesn't even comment about it in their press release about Avodart's FDA approval. Yet, with other recently approved GSK drugs, GSK specifically states the anticipated availability timetable (eg, for their diabetic combination drug approved on October 11, "Avandamet will be commercially available in the U.S. in approximately one month.")

Why do you think they publicly haven't stated so (or have I missed it)?

 

[Itchy]

I have also read early-mid December 2002. That is not from GSK, but from other press releases.

I hope it is sooner...

 

[Axon]

I called Rite-aid in NYC today. They told me Nov/December. More than that they didn't know.