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 After the needle is positioned properly in the plaque, the medication should be injected as the needle is being withdrawn to deposit the drug along the needle track.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.