New England Journal of Medicine study terminated after testosterone gel is associated with increased risk of cardiovascular adverse events

For four years beginning in September 2005, doctors in Boston studied the effects of Auxilium Pharmaceuticals’ Testim testosterone gel on 209 older men with limited mobility. One group of men in the study was given a placebo and the other group was given testosterone gel. In the testosterone group, there were “significantly more adverse events” as compared with the placebo group.

While only five men in the placebo group reported cardiovascular events, 23 men in the testosterone group reported such health problems. Seven men in the testosterone group reported atherosclerosis events and only one reported such an issue in the placebo group.

Men in the testosterone group reported needing procedures and serious health problems including:

  • Cardiovascular-related events
  • Peripheral edema
  • Elevated blood pressure
  • Arrhythmia
  • Electrocardiographic changes
  • Stroke and syncope
  • Atherosclerosis-related events
  • Myocardial infarction
  • Sudden death
  • Angioplasty
  • Coronary-artery bypass surgery
  • Respiratory, thoracic, and mediastinal disorders
  • Skin and subcutaneous tissue disorders

Even after adjusting for age, body mass index (BMI), smokers, diabetes, high-density lipoprotein cholesterol level, hypertension, and hyperlipidemia, the risk of cardiovascular problems “remained significantly greater” among men who took Testim testosterone gel in the study. Men taking testosterone gel in the study experienced a greater frequency of cardiovascular, respiratory, and dermatologic problems. As the study notes, testosterone causes salt and water retention, especially in older men, and this retention may have contributed to edema, congestive heart failure, and hypertension.

The New England Journal of Medicine testosterone study notes that there are several limitations that constrict generalizations of the study’s data. First, cardiovascular events were not structurally evaluated. Second, the sample size was relatively small. Third, the men who took part in the trial were older, had a mean age of 74 years old, had mobility limitations, and were more likely to have cardiovascular disease than those who do not have mobility limitations.

The testosterone gel study was published in the New England Journal of Medicine on July 8, 2010. The New England Journal of Medicine testosterone study was followed by two later low-T medical studies: a 2013 study in the Journal of the American Medical Association and a 2014 study in the PLOS ONE medical journal.

The study concluded that the application of Testim testosterone gel was “associated with an increased risk of cardiovascular adverse events.” Due to these safety concerns about testosterone therapy, the study was terminated before its completion.

If you took a low-T testosterone replacement therapy drug and experienced negative side effects, please contact The Cochran Firm, D.C. Our attorneys are actively investigating claims related to low-T drugs.

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