No…
No it doesn’t!
There is a lot of negative information floating around out there about testosterone supplementation and possible negative effects of testosterone replacement with recent attention on cardiovascular disease and heart attacks.
I hope to clear up some of this information in this post.
A recent study publish by Finkle showed an increased risk of heart attacks in older men after starting testosterone. I’ve previously discussed several problems with this study in Does Testosterone Cause Heart Attacks.
The FDA has noticed the information about testosterone and cardiovascular disease and issued a warning about the possible cardiovascular effects of testosterone replacement therapy in March, 2015.(1) However, the European stance on testosterone is quite different. The Coordination Group for Mutual Recognition and Decentralized Procedures–Human (CMDh) stated that there is “no consistent evidence” of an increase in heart related problems associated with testosterone replacement.(2)
In one of the most profound statements I’ve seen in a while, the FDA stated “Patients using testosterone should seek medical attention immediately if symptoms of a heart attack or stroke are present, such as chest pain, shortness of breath or trouble breathing, weakness in one part or one side of the body, or slurred speech.”(2)
Seriously?
I’m pretty sure that ANYONE experiencing “symptoms of a heart attack or stroke are present, such as chest pain, shortness of breath or trouble breathing, weakness in one part or one side of the body, or slurred speech” should seek medical attention immediately. Did they really need to make that statement?
All of this represents an issue that I believe is far too common… a rush to judgement on the weakest bits of evidence possible.
I wish they would apply the same level of scrutiny to prolotherapy. Maybe then it would be a covered benefit for most patients.
All of this concern about testosterone replacement causing heart attacks started with an article published in 2013 in JAMA.(4) 8709 men in the VA system with low testosterone and had undergone coronary angiography were followed for 3 years. The researchers noted the absolute rate of stroke, heart attack, and death to be 25.7% in patients who had been prescribed testosterone. However, they reported the rate of 19.9% (5.8% lower) in patients who hadn’t received a testosterone prescription.
Sounds like a big deal…
There was a lot of media attention about this data. The problem is that these numbers are inaccurate.
The correct absolute rate of events (number of events divided by the number of patients) was over 50% less in the testosterone treated group (10.1% vs 21.2%).(5)
JAMA has published 2 follow up articles attempting to discuss and correct errors in the data. Interestingly, the “all-male” population of the study actually contained almost 10% women.(6) At least 29 medical societies have stated that the data has lost credibility and called for a retraction of the article.(7)
In regards to the Finkle study mentioned earlier… Let’s just say that there were so many methodological concerns in how they analyzed the data that the FDA stated “…it is difficult to attribute the increased risk for non-fatal MI seen in the Finkle study to testosterone alone…”(8)
There are lots of studies on testosterone. But there are only 4 which suggest an increased risk of cardiovascular disease associated with testosterone replacement. These results are inconclusive and intermixed with a number of problems.
On the other hand, there are lots of studies that show benefit.
- There is an increased risk of mortality, atherosclerosis, and coronary artery disease in patients with low testosterone.
- Men treated with testosterone have a 50% reduced mortality when compared with men not treated with testosterone.
- In men with known heart disease exercise capacity increased with with testosterone replacement vs placebo
- Cardiovascular disease risk factors such as fat mass, waist circumference, and insulin resistance improve uniformly with testosterone replacement vs placebo.(9)
Despite this evidence there is a negative view on the use of testosterone. You may have seen the lawyer advertisements asking men who have suffered a stroke or heart attack and been on testosterone to contact them.
Many patients have stopped taking testosterone and many physicians have stopped prescribing it. Those who continue to prescribe may be viewed negatively by their peers.
In a recent article by Abraham Morgentaler, MD it was reported that testosterone replacement therapy had level 1 evidence supporting its use for improving libido, erection, mood, increased muscle mass, increased bone density, and reduced fat mass.(3)
There are numerous benefits (sexual and non-sexual) to testosterone replacement that are well validated in the literature. Testosterone replacement not only improves symptoms but also improves overall health. There is no clear evidence that testosterone replacement is associated with increased risk of prostate cancer or cardiovascular disease.
Known risks of testosterone replacement include: gynecomastia, erythrocytosis, acne, peripheral edema, reduced fertility, and reduced testicular size.
In most cases, the risks of testosterone replacement therapy are far outweighed by the benefits. However, this is a very individual decision between you and your doctor.
If you think you have symptoms of low testosterone then call us today to schedule your appointment.
References:
- http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm436280.htm
- http://www.medscape.com/viewarticle/840811
- http://www.medscape.com/viewarticle/845705
- Vigen R, O’Donnell CI, Barón AE, et al. Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels. JAMA. 2013;310;1829-1836.
- Traish AM, Guay AT, Morgentaler A. Death by testosterone? We think not! J Sex Med. 2014;11:624-629.
- Correction. Incorrect number of excluded patients reported in the text and figure. JAMA. 2014;311:967. http://jama.jamanetwork.com/article.aspx?articleid=1835478 Accessed May 29, 2015.
- Morgentaler A, Lunenfeld B. Testosterone and cardiovascular risk: world’s experts take unprecedented action to correct misinformation. Aging Male. 2014;17:63-65.
- US Food and Drug Administration. Citizen petition denial response from FDA CDER to public citizen. July 16, 2014. http://www.regulations.gov/#!documentDetail;D=FDA-2014-P-0258-0003 Accessed August 31, 2014.
- Morgentaler A, Miner MM, Caliber M, Guay AT, Khera M, Traish AM. Testosterone therapy and cardiovascular risk: advances and controversies. Mayo Clin Proc. 2015;90:224-251.
