| Think Xiaflex is safe? Read this |
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09/22/2009 23:40
bstenman 
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09/22/2009 23:40
bstenman
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Re: Think Xiaflex is safe? Read this
The risk with a fasciectomy is for both permanent nerve damage and loss of motor function, largely due to the use of a tourniquet for 90 minutes or longer during the operation. This risk is not present with NA.
Collegenase has been used superficially with such small groups of people and with no double blind process in place so the results are not statistically valid and ones you can rely on for better or for worse. With ALL drugs there are side effects and until these are fully known and a patient can accurately weigh the risks against the benefits, they are really human guinea pigs and should accept the risks involved.
Early cancer treatments with X-ray and drugs were quite crude initially and the success rate was lower and the side effects much more pronounced than they are at the present time. But this took decades and billions of dollars to achieve. With Dupuytren's XRT and NA are two relatively low tech and low risk treatments that are available.
I was surprised to read that someone paid $3000 for a NA procedure. I had both hands treated in 2007 by Dr. Denkler in California and the bill was $1100.
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09/23/2009 23:23
user714not registered
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09/23/2009 23:23
user714not registered
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Re: Think Xiaflex is safe? Read this
The doctor in Seattle is charging $8000-$10,000 to do NA.. very concerned to find out if you have insurance beforehand. This is not right!
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09/23/2009 23:34
Randy_H
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09/23/2009 23:34
Randy_H
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Re: Think Xiaflex is safe? Read this
Doctors can charge anything they like. Auto mechanics can also charge $7,000 for a tune up if they want, but no one in their right mind will pay for that. Fly down and take a little vacation in San Fran for the weekend, spend an hour with Denkler and keep the change.
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09/24/2009 02:58
flojo
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09/24/2009 02:58
flojo
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Re: Think Xiaflex is safe? Read this
RE: Varying charges for NA. One more thing this site is doing for all of us - comparison of charges for the same procedures. Some stepped out on the cutting edge (more accurately, the non-cutting edge), clearly for best interest of their patients (Eaton, Denkler and a few others in the USA), and their prices and motives are still in patients' best interest. Are others getting on board now because of $ or for the best interest of their patients?
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09/24/2009 05:06
moondanc
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09/24/2009 05:06
moondanc
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Re: Think Xiaflex is safe? Read this
Quote:
Collegenase has been used superficially with such small groups of people and with no double blind process in place so the results are not statistically valid and ones you can rely on for better or for worse. With ALL drugs there are side effects and until these are fully known and a patient can accurately weigh the risks against the benefits, they are really human guinea pigs and should accept the risks involved.
XRT and NA are two relatively low tech and low risk treatments that are available.
While I agree with your remark about "human guinea pigs" the Stage III FDA trials (Cord I study) were double-blinded (I believe the Stage II trials also were). You're also right about the small number of patients-- in the US probably fewer than 500 in the 3 trials over the years and, of course, no followup after 1 year.
From the Auxilium website:
"The CORD I study was designed to assess the safety and efficacy of XIAFLEX therapy in Dupuytren's contracture with MP or PIP joint contractures greater than or equal to 20° at baseline. In the 3-month double-blind portion of the study, 308 patients with Dupuytren's contractures (stratified 2:1, MP joint to PIP joint) were initially randomized to receive up to 3 once-monthly doses of XIAFLEX (0.58 mg) or placebo. There were 203 patients randomized to receive XIAFLEX and 103 patients randomized to receive placebo that had primary joints able to be evaluated."
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11/13/2009 17:09
Guestnot registered
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11/13/2009 17:09
Guestnot registered
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Re: Think Xiaflex is safe? Read this
I participated in the Phase III xiaflex study and there seems to be quite a bit of misinformation and paranoia about this treatment.
First off, the phase III study WAS double blind. (although it becomes quite obvious in a few days who got the "real" treatment.) I was lucky: got the actual drug.
There were also several phase II studies that had a much longer time period to assess recurrence of symptoms. The general consensus is that xiaflex provides a more permanent result than other treatments. That has been the case for me. No reoccurances. My Dupuytren's has stabilized.
Treatment with xiaflex is no different than surgery or NA. The success rate is dependent on the skill of your doctor. Get a bad one, and you should expect a bad result. Luckily, my doctor was excellent and had excellent results.
The pain is significant but short lived. But remember, this was a phase III study. Doctors were prevented from using any pain medication whatsoever since it might skew the results of the study. This will not be the case in actual use. A short lived painkiller the morning of the "release" would be all that is needed, although an injection of painkiller is another option.
I am very happy with my result and look forward to having xiaflex available for possible "tuning" at a later date. (due to study restrictions, I did not qualify for additional injections that would have eliminated all lesions, so I have a few lumps remaining)
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01/02/2010 17:46
Dodienot registered
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01/02/2010 17:46
Dodienot registered
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Re: Think Xiaflex is safe? Read this
11/13/09 care to disclose your doctor's name. I am awaiting approval of Xiaflex to have it administered. Did not know about the clinicals
until it was too late.
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06/23/2010 11:56
dave tnot registered
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06/23/2010 11:56
dave tnot registered
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Re: Think Xiaflex is safe? Read this
I had NA a year ago in Memphis and the contracture returned to the affected fingers within 10 months. I am having the first xiaflex injection and manipulation over the next two days. I will let you know how it turns out. I will contact anyone off-line for a conversation about the procedure if you post how to reach you.-Dave
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