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Auxilium AA4500 Trials Report.
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01/25/2008 22:28
Randy_H 
01/25/2008 22:28
Randy_H 

AA4500 Vs NA

The similarities between Collegenase and NA are so striking that Dr. Charles Eaton referred to the two as "competing" procedures. The only difference is in how an offending cord is broken. That's pretty much it. I don't think calling Collegenase "chemical NA" is an oversimplification. That's what it is. Here are the differences so far in my view, however:

1) NA takes more training, skill, expertise.
2) The cost of NA is labor driven while Collegenase's increased cost is in the injectable material.
3) NA is far more proven having been around for 35 years.
4) Collegenase *may* theoretically have lower recurrence rates.
5) American NA is typically performed at numerous points along a chord where Collegenase at fewer.

I have a guess as to why there is more trauma being reported with Collegenase. It sounds like the cord is more stretched than "snapped". When a cord cut by NA snaps the surgeon knows it. It breaks and releases. More backward pressure may be being applied to fingers with Collegenase because the MD doesn't have feedback as to his success. If the NA surgeon doesn't get results he simply works on the cord more. You don't have that immediacy with Collegenase.

02/19/2008 19:06
Collagenase interest

not registered

02/19/2008 19:06
Collagenase interest

not registered

Re: Auxilium AA4500 Trials Report.

Hi Collagenase trials have now started in the UK. There are three centres enrolling including the pulvertaft hand clinic in Derby.

02/21/2008 13:07
size15n 
02/21/2008 13:07
size15n 
Re: Auxilium AA4500 Trials Report.

I have just completed my series of injections and manipulations with Ausilium AA4500 and am very happy to announce that "IT WORKED". The only bad part was the fact that it took 3 injections drawn out over 90 days but it was worth it. Being that this was a trial, I also had to travel a considerable amount to the trial site. This made for some long days. As mentioned in earlier posts, the pain of the injection and tenderness during the first hours after injection were quite intense. I do believe that the pain and discomfort is infinitely less than that which would have been experienced as a result of surgery. Swelling and bruising were experienced after each injection. This subsided quickly and was completely gone within a week to 10 days. I went from 20+ degrees of deflection to <5. I can now put my palm flat and even raise my fingers off of the surface while doing it!

03/14/2008 03:53
moondanc 
03/14/2008 03:53
moondanc 
Re: Auxilium AA4500 Trials Report.

I just completed my 90 day evaluation in this study (I started with a 35-40 degree contraction, ring finger MCP). I was lucky enough to get the product rather than the placebo first time around. My finger straightened and has remained straight for 90 days. For the life of me, though, as someone who had NA with Dr. Eaton, I still cannot figure out any reasons why collagenase is preferable to NA-- the ONLY reasons might be-- less recurrence, not yet documented, and less scar tissue.

As far as I'm concerned collagenase has these drawbacks:
1) expense
2) 2 visits-- one for the injection, one to "break" the cord
3) pain of injections and subsequent pain with skin tethers
4) it only deals with the cord, not the lumps or skin tethers
5) potential-- at least in my case-- of stimulating the disease

AA4500 "softens" the cord allowing release and for a lot of people I guess getting the finger straight is the first priority. Also, since mine was MCP and not PIP, I don't know if it's more effective or easier than NA for PIP joints. However, for me to be left with the skin tethers--needing NA-- lumps in the palm and disease aggressively spreading it doesn't seem to be the miracle drug people are expecting.

03/14/2008 08:39
wach 

Administrator

03/14/2008 08:39
wach 

Administrator

Re: Auxilium AA4500 Trials Report.

Hi moondanc,

thank you four your thorough assessment! I am sorry to hear that you Dupuytren's became so aggressive. I had a similar effect (though probably for orther reasons) after surgery and opted for radiotherapy which stabilized the condition and made the development much less aggressive.

I agree with you that collagenase won't eb a mmircale drug but we hope it will give us an additional option. We'll see. At least it is great that the trial is on-going and not on hold anymore.

Wolfgang

03/14/2008 12:31
size15n 
03/14/2008 12:31
size15n 
Re: Auxilium AA4500 Trials Report.

I wanted t let you know that with the Collegenase treatment that the chords definately "Pop". During the manipulation by the doctor at the office visit 7 days after the injection a definite "pop" was heard and the release was immediate. Prior to the office visit I could not get my hand flat. After the manipulation, I could. As explaned to me, the Collegenase disolves the chord rather than NA's perforation/break.

03/14/2008 21:05
jim_h 
03/14/2008 21:05
jim_h 
flexible

It seems to me there's one huge difference between NA and Collagenase that's not being discussed.

Collagenase (Xiaflex) costs $1,000 a pop and insurance companies are going to set guidelines on how many injections they'll pay for. The MD injects, waits a couple of days, and maybe tries a second injection. But if that doesn't work, he says "sorry" and you're done.

NA is a purposeful, manual technique. The MD knows what he's cutting and can 'feel' it to some extent. And, he sees the immedate result. He will keep cutting, withing safe bounds, until he succeeds and the cord is severed or can be snapped. Insurance isn't going to cut you off after 10 minutes regardless of outcom.

Maybe Collagenase can get into places where the cutting needle can't; but in the long run I believe NA will prove superior.

03/14/2008 21:32
Randy_H 
03/14/2008 21:32
Randy_H 

Re: Auxilium AA4500 Trials Report.

Jim_h:

It would seem that there is now enough evidence to believe that Collegenase is eventually going to see the light of day :-)

"I believe NA will prove superior."

Let's suppose that NA and Collegenase just prove to be essentially equivalent in safety and effectiveness.

No question, NA will remain the better *value* but unless there are enough trained MDs doing the procedure you have to add travel and time expenses to the cost. NA looses some it it's edge right there.

Collegenase will be FDA approved and easier to Insure. Reimbursement for NA still remains a challenge.

Collegenase will have the marketing machine behind it. Already, having never done NA or Collegenase, the majority of CHS favor Collegenase. They don't have to cut what they can't see. Surgeons hate that. Forget the safety statistics on NA. A blind procedure is counterintuitive and against their training.

With an alternative to NA readily available I think most CHS will not buck the tide but just do Collegenase and call it a day. At that point there will be far less motication for the new patitent to seek out NA and it's growth may stop.

May of us are convinced of what NA's place in Dups treatment *should* be. Collegenase approval may change all that. Frankly I don't mind. An entry level noninvasive treatment option to OS is really all I've ever been concerned about. As I look back, I became a stanch NA advocate partly because Collegenase was simply not available. I wonder what I would have done had it been otherwise.

03/14/2008 22:05
moondanc 
03/14/2008 22:05
moondanc 
Re: Auxilium AA4500 Trials Report.

To size15n :

I'd been told earlier that Collegenase dissolves the cord but That's not consistent with some of the things I've read. I had a different, younger, study doc for my 90 day evaluation and I asked her directly and she said: "No, it does not dissolve, there's not enough of it, what it does is soften"

For other:
When looking at my left hand and my quickly advancing disease she advised me that with PIP contractures one shouldn't wait as long to get treatment as with MCP and then said--either surgery or NA. First time a "regular" OS has even allowed those words/initials out of his/her mouth!

Quote
After the manipulation, I could. As explaned to me, the Collegenase disolves the chord rather than NA's perforation/break.

03/15/2008 04:46
newman 
03/15/2008 04:46
newman 

PIP Contractures- "One shouldn't wait too long....."

Australia Calling Hi'
For those members with contracture in the pip joints ,I would recommend having a look at PhD Thesis presented by J.P.Moermans.M.D. on the web page http://www.dupuytren-online.info surgery ,techniques ,scroll to Segmental Aponeurectomy. Click on (Moermans) -Item 12 'Early results. '
The suggestion is that the optimun results for treatment were between 30 to 40 degrees.Worth reading.

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