Low T Or High Risk? Testosterone Treatments And Heart Attacks
Maybe ‘Low T’ is something men may want to live with, after all. A new study finds that treatments for boosting low testosterone levels – which pervasive marketing warns can interfere with sex drive, moods and energy – may increase the risk of heart attacks in large swathes of men.
Specifically, the risk doubled during the first three months after starting therapy in men younger than 65 years old who had a history of heart disease. Similarly, the risk also doubled for all men older than 65 – those with or without heart disease – shortly after beginning treatment, according the study published in PLOS One.
At first blush, this may not seem to be heart-stopping news. Previous studies have suggested such therapies – including the widely touted AndroGel that is sold by AbbVie ABBV 0% – can increase cardiovascular risk. In fact, a small study published in The New England Journal of Medicine three years ago reached such a conclusion.
But the latest study is different and, consequently, may have the potential to change the conversation about the extent to which using testosterone treatments is desirable. And the results are prompting calls for the FDA to update product labeling in order to flag cardiovascular concerns.
Why? Unlike earlier efforts, the latest study examined a large population. The researchers culled records of 55,593 men who had been prescribed testosterone treatments, including 48,539 who were younger than 65 years old. The data was obtained from Truven Health Analytics, which aggregates patient records.
“Due to the size of our study, we were able to examine heart attacks, as opposed to a variety of cardiovascular conditions, and we were able to examine excess risk in the short term,” says William Finkle, the lead author and an epidemiologist at Consolidated Research, a statistics and software development firm. “Our study is also the first to include a substantial number of men under 65″ (here is the study).
An AbbVie spokesman did not respond to a request for comment.
The researchers also compared patients given testosterone treatments – which include the Axiron solution sold by Eli Lilly and the Androderm patch marketed by Actavis ACT -2.79% – with those given the Viagra and Cialis erectile dysfunction pills, since these are similarly prescribed for enhancing sexual performance.
Here, they found that men younger than 65 who were given testosterone boosters and had a history of heart disease were twice as likely to suffer a heart attack, relative to the impotence pills. The implication is that the increase in cardiovascular risk is due to the treatments, not the sexual behavior.
The findings come amid years of aggressive promotion of testosterone treatments. A study published last fall in the Journal of the American Medical Association noted that annual prescriptions for these elixirs rose more than five-fold from 2000 to 2011, reaching 5.3 million prescriptions. Sales totaled nearly $2 billion in 2012, according to IMS Health, the research firm.
The marketing has sometimes been controversial. Four years ago, a study in The New England Journal of Medicine found only 2 percent of men aged 40 to 80 suffered from ‘Low T,’ which is sometimes called male menopause, but the web site run by Abbott Laboratories ABT -0.03% (and now by AbbVie) was criticized for overstating the case.
And two years ago, a group of physicians and academics complained to the independent Pharmaceutical Advertising Advisory Board in Canada that an AndroGel campaign harmed public health by promoting unapproved uses and implying exaggerated effectiveness.
Consequently, the PLOS authors recommend further studies that can “assess the range of benefits and risks.” Although Sid Wolfe of Public Citizen Health Research Group believes the FDA should not wait to update the product labeling to reflect the risk of heart attacks.
“This study adds an enormous amount to what is known about the risks,” he argues. “It’s an important breakthrough and the implications are sobering, but unfortunately, there is nothing in the current labeling or the med guides for patients.”
Published in Forbes by Contributor Ed Silverman 1/29/2014