Recently (June 17-18, 2023. P. A5), The Wall Street Journal ran a piece by Betsy McKay titled “Testosterone Therapy Shown Not to Increase Heart Risks.” At first blush, this does not appear to have much impact on those of us on Dialysis. But wait. The fifth paragraph states, “While the study found no risk of major cardiovascular events such as heart attacks, researchers did report a few cases of pulmonary embolism, or a blood clot affecting the lungs; atrial fibrillation, a heart-rhythm disorder; acute kidney injury; and small blood pressure increases among men who received testosterone treatment. (Emphasis provided.)
I am and have been for years on Testosterone Therapy and the “acute kidney injury” got my attention. What is this all about?
McKay’s article cited the study upon which her article was based as being published in the New England Journal of Medicine. It was based on a new clinical trial of about 5,200 men funded by AbbVie et al. With the information, I did a Google, found, and created the original report in searchable PDF format. I then searched for the word “kidney.” This is where things get interesting!
Buried in the body of the report is the following statement: “There were more cases of nonfatal arrhythmias warranting intervention, atrial fibrillation, and acute kidney injury among patients who received testosterone than among those who received placebo; these adverse events were not expected.“ (Again, emphasis provided.) And this is pretty much where it was left for this study – EXCEPT.
Refer to Figure 3 at the end, a screen capture from the report. To impart a little more understanding to what is shown, a little about “p” values in statistics is merited. In this study, it was assumed that there are no differences between the two groups of men, ie, those taking testosterone and those who do not. This is called a null hypothesis in statistical testing. The “p” value, or probability value, describes how likely the data support the null hypothesis, in this case, no difference between the groups. A “p” value of 0.05 or less is generally accepted as a strong indicator that, in this case, THERE IS A DIFFERENCE. 1-p is the inverse, that is, there is a difference rather than there is not. For acute kidney injury, 1-p=1-.04=96% probability that there is a difference in the groups. In layman’s terms, we can be 96% certain that the administration of testosterone therapy adversely affected those from a kidney perspective who took it compared to those who did not.
Like analysis holds true for Atrial Fibrillation, only even stronger, that is, the probability is 98% that those who were on testosterone therapy were adversely affected in this regard compared to those who were not on the therapy.
To me, these are stupendous findings. I recognize that the researchers were investigating therapy as related to cardio aspects, but to state “these adverse events were not expected” is a vast understatement and a disservice. You can see from the table below that 60 men on therapy suffered acute kidney injury compared to 40 not on therapy who did not. Let’s put this into perspective! Full 50% more men on therapy suffered acute kidney injury compared to the 40 men in the control group. That’s right, half again as many. Have your attention yet?
I didn’t stop here. I turned to my faithful AI subscription and asked, “What is the tie, if any, between testosterone-replacement therapy and acute kidney injury?”
The AI summarized findings thusly: “However, the evidence in humans is limited and somewhat mixed. Some observational studies have found higher testosterone associated with lower mortality in CKD patients and higher estimated glomerular filtration rate (eGFR), a measure of kidney function. However, a clinical case report showed testosterone therapy induced renal impairment, and a small randomized controlled trial in 48 men showed that 6-month testosterone treatment lowered eGFR. The lack of large-scale randomized controlled trials makes it difficult to assess the long-term effect of testosterone on CKD definitively​.”
So, I’m sitting here thinking, Oh crap, or stronger words, what’s next to crawl out from the woodwork?
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