NEJM: Is Testosterone-Replacement Therapy Safe?

Background: There were concerns that TRT might increase the risk of cardiovascular events like heart attacks and strokes in men already at risk for these problems. This study aimed to address those concerns.

How the study worked:

• Participants: Over 5,000 men aged 45 to 80 with low testosterone ("hypogonadism") and pre-existing heart disease or high risk factors were enrolled.
• Treatment: Participants were randomly assigned to receive either testosterone gel or a placebo gel daily. The testosterone dose was adjusted to keep levels within a normal range.
• Follow-up: Researchers tracked the men for an average of almost 3 years to see if they experienced any cardiovascular problems.
• Main Measurement: The primary outcome was the combined rate of death from cardiovascular causes, non-fatal heart attack, or non-fatal stroke.

What they found:

• No increased risk: The rates of major adverse cardiac events were essentially the same in both the testosterone and placebo groups. This means TRT did not appear to increase the risk of heart problems.
• Some concerns: There was a slightly higher incidence of atrial fibrillation (irregular heartbeat), acute kidney injury, and pulmonary embolism (blood clot in the lung) in the testosterone group.

Conclusion:

• For middle-aged and older men with low testosterone who are at risk for heart disease, TRT appears to be safe in terms of major cardiac events. However, there may be a small increased risk of other complications.

Important note: This study was funded by AbbVie, a pharmaceutical company that manufactures testosterone products. While the study followed rigorous methods, it's important to be aware of potential conflicts of interest.

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