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Study adds to concerns about cardiovascular risk associated with testosterone therapy

Older men who are initiated on testosterone therapy are at an increased risk of myocardial infarction, a cohort study published online in PLOS One (29 January 2014) suggests. Younger men with pre-existing diagnosed heart disease were also found to be at increased risk.

The research was prompted by three recent studies that raised concerns about possible adverse cardiovascular outcomes associated with testosterone. Using a large healthcare database, the researchers observed that among men aged 65 years and older there was a two-fold increase in the risk of myocardial infarction (MI), regardless of cardiovascular disease history, in the 90 days after filling an initial testosterone therapy prescription (pre- and post-prescription rate ratio for MI [RR] 2.19, 95 per cent confidence interval 1.27–3.77). They also found that the risk declined to baseline in the 91 to 180 days after initial testosterone therapy among those who did not refill their prescription (RR 0.98, CI 0.43–2.23). The researchers say that the pattern of change in risk by supply of testosterone is consistent with an effect of the drug and underscores concerns raised by the other recent studies.

In the current study, among younger men with a history of heart disease, a two- to three-fold increased risk of MI was observed in the 90 days following an initial prescription for testosterone therapy (RR 2.90, CI 1.49–5.62). There was no excess risk in younger men without such a history (RR 0.90, CI 0.61–1.34).

Include cardiovascular complications in discussions about potential risks

The researchers say: “Further study is needed to examine the risk of a variety of specific serious adverse cardiovascular events in relation to testosterone therapy dose and duration, and to assess if the risks of testosterone therapy vary by level of serum testosterone and presence or absence of hypogonadal disease.” They add: “The observed excess MI risk in younger men with a history of heart disease is a particular public health concern, as about 10 per cent of the men in our study under age 65 years with a testosterone therapy prescription had a history of heart disease.”

The researchers advise clinicians to include serious cardiovascular events in their discussions with patients about potential risks, particularly for men with existing cardiovascular disease.

Following publication of the study, the US Food and Drug Administration announced that it will be investigating the risk of stroke, heart attack and death in men taking FDA-approved testosterone products.

A spokesman for the Medicines and Healthcare products Regulatory Agency told PJ Online: “In the UK, testosterone products are authorised for use as replacement therapy for men with confirmed hypogonadism. Some studies have observed an association between low testosterone levels and increased cardiovascular risk and diabetes; the effect of testosterone replacement on this risk is not clear. Product information includes a warning about its use in patients suffering from severe cardiac insufficiency or ischaemic heart disease.”

He added: “The MHRA will consider any important new evidence and take any appropriate action needed to further protect patients.”

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.11134119

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