Testosterone Replacement Therapy Not Linked With Cardiovascular Risks, Study Finds

The debate over the effectiveness and safety of testosterone replacement therapy (TRT) now has another study to contend with.

Hcplive.com reports that on March 7th, a team of researchers in the United States and the United Kingdom released a study on the potential link between TRT and cardiovascular illness. Presenting at the Endocrine Society’s 97th Annual Meeting and Expo (commonly referred to as EXPO 2015) in San Diego, California, the team found no definite link between cardiovascular conditions such as heart disease and stroke and the popular treatment for low testosterone.

The team openly admits that prior studies and literature reviews have lead to conflicting conclusions regarding the link. They add that their study is no different. The uncertainly, they feel, has been “heightened by recent retrospective analyses of observational data. Prior studies, including relatively small prospective clinical trials of hypogonadal men, have yielded conflicting results.”

Dr. Salim Janmohamed, head of the research team, and his colleagues reviewed data from two large, placebo-controlled clinical trials conducted in different countries that studied the effect of darapladib, an inhibitor used to treat atherosclerosis. The trials included adults of both genders with a history of either stable coronary heart disease or recent acute coronary syndrome. The subjects of the student underwent treatment for cardiovascular risk factors. Specially, the researchers focused on three major cardiovascular events, also called MACE: cardiovascular death, heat attacks, and strokes.

The team found that ultimately darapladib “did not significantly reduce the risk of CV events.” They studied the risk of MACE in men who underwent testosterone replacement therapy for both less than a year and more than a year, and compared them to men who did not undergo the therapy from both trials. Factors such as age, body mass index (BMI), weight, height, cholesterol, blood pressure, diabetes, medication use, smoking, glomerular filtration rate (GFR), and geographic region.

Although Dr. Janmohamed and his team stressed that only a small number of the test subjects underwent TRT and that most of them were American men, they found no discernible link between the therapy and risk of MACE.

The team writes that their findings “suggest that TRT [testosterone replacement therapy] is not associated with an increased risk of MACE in men with well-characterized coronary heart disease. The incidence of MACE was 11.1% in non-testosterone treated males and 7.9% in males on TRT.” They also noted that the data does not “corroborate recent observational reports that testosterone therapy is associated with increased CV risk.”

The report comes at a time when TRT is hotly contested as an effective method of treating low testosterone. If left untreated or diagnosed, low testosterone can lead to weight gain, chronic fatigue, reduced muscle mass, low libido, and other medical conditions. Pharmaceutical companies offer synthetic testosterone as a form of TRT.

Critics claim that the therapy is unnecessary and can increase the risk of cardiovascular illnesses, among other things. Some critics sight recent studies and data that demonstrate these risks, although there are other studies, such as Dr. Janmohamed’s, that find the opposite to be true.

Regardless, the studies have not stopped pharmaceutical companies from churning out TRT drugs due to increasing demand. Most recently, pharmaceutical giant Endo International released a new TRT called Natesto on March 16th.

As reported by the Philadelphia Business Journal, Endo claims that the new drug is the first and only nasal spray product on the market approved by the Food and Drug Administration (FDA). The FDA approved Natesto in May of last year.

It should be noted that Dr. Janmohamed’s study was composed of authors employed by GlaxoSmithKline, a pharmaceutical company known to produce and distribute TRT drugs.

Low testosterone is a serious medical condition that can lead to high blood pressure, weight gain, loss of muscle, low libido, and depression. Studies have shown that men with low testosterone have a 33% greater risk of dying during the next 18 years of their lives compared to men who have normal testosterone levels.

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