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Testosterone therapy not associated with myocardial infarction, stroke
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LAS VEGAS — Testosterone therapy did not increase the risk of myocardial infarction or stroke and may provide a cardioprotective factor, a presenter at the AACE 23rd Annual Scientific & Clinical Congress said.
“We were concerned about our patients so we were actually looking for an internal quality management program to see what’s happening with those patients [who] were treated with testosterone in our centers,” Robert S. Tan, MD, MBA, of the Low T Institute in Dallas, Texas, professor of family and community medicine at University of Texas and associate professor of medicine in geriatrics at Baylor College of Medicine, said during his presentation. “Our study showed that perhaps carefully monitored testosterone replacement therapy may actually protect from heart attacks and stroke.”
Tan presented data on 39,937 patients were seen between years 2009-2014, of whom approximately 50% met criteria for treatment.
Of those treated with mainly injected testosterone, researchers saw four non-fatal MI and two probable fatal MI, in which there was no verification that death was due to MI. Tan explained that they also interviewed families of patients who had fatal MI. He estimated their rate of new MI was 30 per 100,000. Additionally, there were 46 patients who suffered MI prior to engaging in testosterone therapy. None had adverse outcomes after testosterone therapy.
Of the patients undergoing testosterone therapy, there were two cases of stroke, with a rate of new stroke at 10 per 100,000 patients. There were 12 patients who suffered strokes prior to testosterone therapy and none had adverse outcomes after testosterone therapy.
Tan compared their study to the JAMA article that raised concerns about cardiovascular adverse events in patients taking testosterone, explaining that the cohort in the original article mean total testosterone level was 332 ng/dl, while his study cohort had a level of 543 ng/dl.
“By definition, in the JAMA paper’s patients, many of them were close to hypogonadal,” he said.
In addition, the JAMA cohort was older and had less follow-up, according to Tan.
As this was not a randomized controlled trial, Tan explained that the risks for new MI and stroke were compared to the Kaiser Permanente and Northern Manhattan Registry, which were 208 per 100,000 and 93 per 100,000 respectively. Rate ratio for MI in patients treated with testosterone was 0.14 (P<0.0001) or seven times less likely than the Kaiser data, whereas stroke ratio was 0.107 (P<0.0001) or nine times less likely than the Manhattan Registry.
“At least from our experience, there was no worsening of heart attacks or strokes in patients treated with testosterone,” Tan said. “I don’t think we’re alone in saying that testosterone is cardioprotective.
“A long-term randomized controlled trial is desperately needed,” he added. “Perhaps there is more to be learned about testosterone particularly in respect to cardiometabolic safety.”
For more information: Tan R. Abstract 1353. Presented at: AACE 23rd Annual Scientific & Clinical Congress; May 13-18, 2014; Las Vegas, Nevada.
Disclosures: Endocrine Today could not confirm disclosures at the time of press.
Perspective
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George Grunberger, MD, FACP, FACE
As endocrinologists, we are very practical. If it’s low, you stimulate it; if it’s high, you suppress it. There’s nothing more logical in medicine than endocrinology. But then there’s a cottage industry encouraging testosterone therapy. You have an additional “Low T” commercial push and, lately, media frenzy about testosterone therapy and possible increase in cardiovascular events.
In a way, the FDA saying there is a possible connection between testosterone therapy and cardiovascular events is good. But, at the same time, the last thing you want is “legitimate” patients that have low testosterone to get scared and stop taking that hormone.
I was glad this study showed up because, at least hopefully, we’ll lay to rest this idea that testosterone increases risk of MI and stroke. Tan even found that the risk of stroke and MIs was decreased significantly, but then the question becomes is testosterone cardioprotective?
A concern is: What is his control? There was no control population. This was not a prospective trial. The bottom line should be the bottom line: the gold standard is a randomized, controlled trial. You need a truly, high-level, classy randomized trial to make definitive conclusions, but that would cost us hundreds of millions of dollars.
But these were very encouraging results.
There were tens of thousands of patients, so the fact that you have something that is fairly civilized, should maybe take away some of the element of fear. The last thing you want is appropriate patients who are doing well to stop treatment because of some stupid headline.
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