madman
Super Moderator
* He added, “It is my hope that the AUA will, in short order, go back and change that statement, so that we now have guideline-based instructions to physicians that will say, you are now allowed to say to patients that testosterone therapy is not associated with major adverse cardiovascular events.”
www.urologytimes.com
Later, the FDA mandated the conducting of the TRAVERSE study to investigate testosterone therapy and MACE. The study, Mulhall, said, “was powered to answer the question: Is testosterone therapy associated with major adverse cardiovascular events?”
“In 5200 men, very clearly, definitively, irrefutably, it has been shown that testosterone therapy is not associated with MACE over the course of the 12 to 24 months after commencement of testosterone therapy,” Mulhall said.
He added, “It is my hope that the AUA will, in short order, go back and change that statement, so that we now have guideline-based instructions to physicians that will say, you are now allowed to say to patients that testosterone therapy is not associated with major adverse cardiovascular events.”
John P. Mulhall, MD, shares his reaction to the FDA’s testosterone labeling changes
“In 5200 men, very clearly, definitively, irrefutably, it has been shown that testosterone therapy is not associated with MACE over the course of the 12 to 24 months after commencement of testosterone therapy," says John P. Mulhall, MD.
Later, the FDA mandated the conducting of the TRAVERSE study to investigate testosterone therapy and MACE. The study, Mulhall, said, “was powered to answer the question: Is testosterone therapy associated with major adverse cardiovascular events?”
“In 5200 men, very clearly, definitively, irrefutably, it has been shown that testosterone therapy is not associated with MACE over the course of the 12 to 24 months after commencement of testosterone therapy,” Mulhall said.
He added, “It is my hope that the AUA will, in short order, go back and change that statement, so that we now have guideline-based instructions to physicians that will say, you are now allowed to say to patients that testosterone therapy is not associated with major adverse cardiovascular events.”
