madman
Super Moderator
* “[The label change] does not give a clean slate to [health care professionals] who are giving testosterone treatment to people who do not have low testosterone,” Dhindsa said. “[Some clinics] are overtreating men, and then they [need] a phlebotomy to deal with the effects of excessive testosterone on hemoglobin. We don’t know whether [overtreatment] is CV-safe or not.”
* The FDA removed the CV risk warning from testosterone products based on TRAVERSE, but Nissen said the trial only assessed a testosterone gel and not injectable products.
* Nissen said he would like to see another trial examining CV risk with an injectable testosterone product to validate TRAVERSE’s findings, but acknowledged it is unlikely another trial will take place.
“Companies will never do a study to determine if there are harms,” Nissen said. “This was done because FDA demanded it, and I don’t think they’re going to demand a big CV outcome trial with injectable products.”
Key Takeaways
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Moving Forward
With the CV risk warning removed from testosterone labels, Dhindsa said he believes that testosterone therapy research will begin to shift. With the TRAVERSE substudies raising several new questions about testosterone replacement, more trials examining the therapy’s effect on a wide range of outcomes and conditions should be pursued, Dhindsa said.
“We should invest more in studying effects of testosterone on bone, inflammation and our ability to deal with infections,” Dhindsa said.
Nissen said he would like to see another trial examining CV risk with an injectable testosterone product to validate TRAVERSE’s findings, but acknowledged it is unlikely another trial will take place.
“Companies will never do a study to determine if there are harms,” Nissen said. “This was done because FDA demanded it, and I don’t think they’re going to demand a big CV outcome trial with injectable products.”
Dobs agreed that randomized controlled trials remain the “gold standard” in research, but conducting such trials in which a large sample size is required is challenging with testosterone therapy.
“As electronic health records become better, we might be able to obtain more registry-oriented data,” Dobs said. “I think there are other ways we can still be looking at these [questions].”
Dhindsa said he is uncertain whether testosterone therapy use will change after the removal of the box warning. A research letter published in JAMA in 2018 estimated that the proportion of men aged 30 years and older using testosterone therapy in the U.S. increased from 0.52% in 2002 to 3.2% in 2013 before dropping to 1.67% in 2016. Dhindsa said prescription rates never returned to the levels seen before the CV risk warning was added and said he believes that some patients will continue to have concerns even with the warning removed.
“I think there might be a small increase [in testosterone therapy use],” Dhindsa said. “I don’t think it will result in a great change.”
Morgentaler is uncertain whether health care professionals will be more eager to prescribe testosterone therapy even after the FDA’s labeling changes. He said testosterone therapy has not been accepted by some physicians due to safety concerns and health care professionals should be open to learning more about the therapy.
“I would encourage physicians, especially in primary care and endocrinology, who have been uncertain about this topic, based on their prior training and their own perceptions, to be open to [testosterone therapy],” Morgentaler said. “Try treating a few patients. Most of us who are in this field tried it in a few patients and we learned from our patients about the kinds of benefits it can have in their lives.”
* The FDA removed the CV risk warning from testosterone products based on TRAVERSE, but Nissen said the trial only assessed a testosterone gel and not injectable products.
* Nissen said he would like to see another trial examining CV risk with an injectable testosterone product to validate TRAVERSE’s findings, but acknowledged it is unlikely another trial will take place.
“Companies will never do a study to determine if there are harms,” Nissen said. “This was done because FDA demanded it, and I don’t think they’re going to demand a big CV outcome trial with injectable products.”
Key Takeaways
- The FDA removed a warning about CV risk from testosterone product labels after a randomized trial showed no link.
- Use of testosterone therapy may rise, but more research is needed about other potential risks.
Removal of boxed warning clears testosterone of heart-related risk, but concerns remain
Results from a randomized controlled trial led the FDA to make a major change to testosterone replacement therapy labeling in February.The FDA announced it would remove language about increased risk for adverse cardiovascular events from the label of all testosterone replacement products...
www.healio.com
Moving Forward
With the CV risk warning removed from testosterone labels, Dhindsa said he believes that testosterone therapy research will begin to shift. With the TRAVERSE substudies raising several new questions about testosterone replacement, more trials examining the therapy’s effect on a wide range of outcomes and conditions should be pursued, Dhindsa said.
“We should invest more in studying effects of testosterone on bone, inflammation and our ability to deal with infections,” Dhindsa said.
Nissen said he would like to see another trial examining CV risk with an injectable testosterone product to validate TRAVERSE’s findings, but acknowledged it is unlikely another trial will take place.
“Companies will never do a study to determine if there are harms,” Nissen said. “This was done because FDA demanded it, and I don’t think they’re going to demand a big CV outcome trial with injectable products.”
Dobs agreed that randomized controlled trials remain the “gold standard” in research, but conducting such trials in which a large sample size is required is challenging with testosterone therapy.
“As electronic health records become better, we might be able to obtain more registry-oriented data,” Dobs said. “I think there are other ways we can still be looking at these [questions].”
Dhindsa said he is uncertain whether testosterone therapy use will change after the removal of the box warning. A research letter published in JAMA in 2018 estimated that the proportion of men aged 30 years and older using testosterone therapy in the U.S. increased from 0.52% in 2002 to 3.2% in 2013 before dropping to 1.67% in 2016. Dhindsa said prescription rates never returned to the levels seen before the CV risk warning was added and said he believes that some patients will continue to have concerns even with the warning removed.
“I think there might be a small increase [in testosterone therapy use],” Dhindsa said. “I don’t think it will result in a great change.”
Morgentaler is uncertain whether health care professionals will be more eager to prescribe testosterone therapy even after the FDA’s labeling changes. He said testosterone therapy has not been accepted by some physicians due to safety concerns and health care professionals should be open to learning more about the therapy.
“I would encourage physicians, especially in primary care and endocrinology, who have been uncertain about this topic, based on their prior training and their own perceptions, to be open to [testosterone therapy],” Morgentaler said. “Try treating a few patients. Most of us who are in this field tried it in a few patients and we learned from our patients about the kinds of benefits it can have in their lives.”
