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XIAFLEX

ABOUT TIME OR WASTE OF TIME
Xiaflex group - 61% of men achieved at least a 25% decrease
in penile curvature as compared to 25% of men in the
placebo group.  This is not a typo - 1/4 of the men who
received the placebo had their curvature decreasd by at least
25%. One lucky man had a 50% improvement in his curvature
with Xiaflex.   

  • Remember- when improvement is discussed, it is  
    measured in terms of percentage of curvature
    improvement.  It does not refer to an absolute number of
    degrees.  For example, if a man had a 50 degree
    curvature and it states he had a 20% improvement, the
    improvement was 10 degrees.  Based on my reader
    feedback, it seems that men are so anxious to
    experience an improvement, they overlook this fact.   

  • On average, including the entire universe of men in the
    trial, subjects who received the placebo (saline solution)
    and those who received Xiaflex showed significant
    curvature reduction. Those who received Xiaflex
    demonstrated the most improvement. Authors of the
    medical journal article were at a loss to explain this
    outcome, but speculated that a significant number of
    men in the placebo group had PD for a relatively short
    period of time.  This may offer some reason for this
    surprising outcome. I am adding to this speculation that
    this clinical trial had a small number of men and this
    unexpected improvement with the placebo may not be
    statistically significant. The take away is no one really
    can explain this outcome. If you have been diagnosed
    with PD within the last 2 years and decide against
    Xiaflex, you may want to point these findings out to your
    urologist and ask him if he would be willing to give you
    a series of placebo (saline solution) injections.

  • The overwhelmingly percentage of subjects did not recall
    any trauma preceding development of PD.

  • Authors of the Journal of Urology article point out (no
    pun intended) that the needle should be placed in the
    plaque at the point of maximum curvature.  After the
    needle is positioned properly in the plaque, the
    medication should be injected as the needle is being
    withdrawn to deposit the drug along the needle track.  
    Read this point a number of times, in fact, memorize it .  
    As you will read later, any deviation from this protocol
    can spell trouble!  Further, this injection protocol that is
    noted in the Journal of Urology article is not even
    mentioned in the phase IIb protocol.  Was it omitted from
    the initial paperwork, but somehow communicated with
    the clinical trial urologists? This  discrepancy must be
    resolved.  As the injection placement and procedure are
    absolutely critical.  

  • When there was a decrease in penile curvature, it was
    noticed in the first 6 weeks.  If you decide to get the
    Xiaflex treatment and do not notice any improvement in
    6 weeks, then you may not improve-if this finding holds
    correct.

  • Subjects who received Xiaflex has had small mean
    decreases in plaque length, width and area.  It would
    have been interesting to know if decreased plaque
    dimensions corresponded closely to penile improvement.

  • Xiaflex resulted in a small increase in penile length.

  • All subjects completed an International Index of Erectile
    Function questionnaire. This is a very detailed
    questionnaire about penile sexual function.  There was
    no statistical difference between the Xiaflex and placebo
    group. This forms measures just about everything
    relating to sex and penile function.  What does this
    outcome mean? Click Here for information about this
    assessment.

  • Auxilium developed an additional questionnaire and
    Xiaflex treated subjects appeared less bothered about
    their PD symptoms than the placebo group. However,
    there was no statistical difference between the Xiaflex
    and placebo group when it came penile pain and
    intercourse discomfort and constraint.

  • The responses to the questionnaires seem odd and
    somewhat disturbing. You would think that men who
    improved would be jumping for joy and making up for
    lost time.

  • Adverse events were only mild to moderate and resolved
    without medical intervention.  As you will see later on in
    my discussion of Xiaflex, this definition is somewhat
    misleading and understates what can go wrong.

NEWS FLASH UPDATE - 02/01/2013 AUXILIUM PRESS
RELEASE ANNOUNCED THE UNCORRECTRED JOURNAL OF
UROLOGY ARTICLE HAS BEEN MADE
AVAILABLE ONLINE
WHICH INCLUDES PHASE III RESULTS OF THE XIAFLEX
PEYRONIES STUDY.  MEN WHO RECEIVED XIAFLEX
SHOWED A MEAN 34% IMPROVEMENT VS AN 18% MEAN
IMPROVEMENT FOR THE PLACEBO GROUP.  THE RESULTS
WILL APPEAR IN PRINT IN THE JULY 2013 JOURNAL OF
UROLOGY. THREE MEN IN THE STUDY REQUIRED  
HOSPITALIZATION FOR SURGICAL CORRECTION OF A
PENILE FRACTURE. These results are in line with what I
reported on concerning the phase IIb study.  Greater
improvement in the Xiaflex group, but also a surprising
percentage improvement in the placebo group.