Internationally, February is dedicated to heart health. Whether asAmerican Heart Month in the USA or as "Red February" in other countries, the message is clear: cardiovascular diseases remain the leading cause of death worldwide.
Cardiovascular diseases include, among others:
- Coronary heart disease (including heart attack)
- stroke
- Heart failure
- High blood pressure-related heart disease
- Peripheral arterial occlusive disease
According to the World Health Organization (WHO), around 20.5 million people worldwide die each year from cardiovascular diseases – this corresponds to about one-third of all deaths (WHO, 2023) . The situation in Germany remains clear: According to the Federal Statistical Office, cardiovascular diseases were responsible for around 34% of all deaths most recently. Coronary artery disease and heart attacks are particularly common.
This topic is particularly relevant for men, as they develop cardiovascular diseases on average several years earlier than women. In Germany, men are more likely to die from heart attacks than women, especially in middle age. Additionally, epidemiological data show that men are more likely to exhibit classic risk factors:
- Visceral abdominal fat
- High blood pressure
- Dyslipidemia (elevated LDL, lower HDL)
- Insulin resistance
- Metabolic syndrome
At the same time, men are less likely to undergo preventive examinations and, on average, seek medical help later.
Against this background, one topic has long been the subject of controversial debate: What role does testosterone play – and is testosterone therapy (TRT) a risk to the heart?
For years, uncertainty prevailed. Individual observational studies had suggested a possible increased cardiovascular risk with testosterone therapy. This resulted in warnings, patient anxiety, and reluctance to prescribe. Today – in 2026 – the evidence base has significantly evolved. And that is precisely what makes Red February particularly relevant this year.
Testosterone & Heart 2026 - Why the assessment has fundamentally changed
For many years, the cardiovascular effects of testosterone therapy were controversial. This was triggered by several observational studies between 2013 and 2014, which suggested a possible increased risk of heart attack and stroke in men undergoing testosterone therapy. Analyses by Vigen et al. (2013) and Finkle et al. (2014) , which evaluated retrospective insurance and registry data, were particularly frequently cited.
These studies had methodological weaknesses - including:
- No randomized allocation
- Incomplete adjustment of relevant risk factors
- Heterogeneous patient groups
- Partial statistical inconsistencies
Nevertheless, they attracted considerable public and regulatory attention.
What happened in 2015?
In March 2015, the US Food and Drug Administration (FDA) – the American drug regulatory agency – responded with an official safety notice. The FDA demanded:
- An adjustment of the product information for testosterone preparations
- A warning about a possible increased risk of heart attack and stroke
- The restriction of the indication to clearly diagnosed hypogonadism
This announcement caused international uncertainty – among both doctors and patients. In many countries, testosterone was prescribed much more cautiously, and public perception shifted: testosterone was increasingly seen as potentially "harmful to the heart".
Why this assessment is being re-evaluated today
The crucial point: The warnings at the time were not based on randomized, controlled long-term studies, but on observational data. Randomized controlled trials (RCTs), however, are considered the gold standard when it comes to causal statements about the safety of a drug. Sufficient data on this topic was simply not available in 2015.
The turning point: The TRAVERSE study
This changed with the TRAVERSE study , published in 2023 in the New England Journal of Medicine (N Engl J Med 2023; 389: 1183-1195).
Study design
- Over 5,200 men
- Ages 45-80 years
- Symptomatic hypogonadism
- Existing or increased cardiovascular risk
- Randomized: Testosterone gel vs. placebo
- Median observation period: 22 months
The central question was whether medically supervised testosterone therapy increases the risk of heart attack, stroke or cardiovascular death.
Result
The study showed no significantly increased risk of serious cardiovascular events with testosterone therapy compared to placebo. The primary safety endpoint was met. TRT was non-inferior to placebo in this high-risk population. Even in men with elevated cardiac risk, no additional risk was observed with properly supervised therapy.
2026: The new position paper
In January 2026, an updated position paper was published summarizing the TRAVERSE data, new meta-analyses of randomized trials, real-world data and pharmacovigilant registry data.
The conclusion is formulated more clearly than ever before:
With correctly diagnosed hypogonadism and adequate monitoring, testosterone therapy is considered safe from a cardiovascular point of view.
The potential benefits may outweigh the risks.
This reassessment also supports the recent adjustments to FDA labeling, which put the blanket perception of risk into perspective.
The prerequisite for any responsible therapy is a clear diagnosis. This includes a comprehensive test that considers not only the total testosterone level but also relevant accompanying parameters, such as the premium testosterone test .
Why this is relevant for men
Low testosterone is itself associated with metabolic risk factors:
- Increased visceral fat
- Insulin resistance
- Dyslipidemia
- Inflammatory markers
- Increased overall mortality
Untreated hypogonadism can therefore itself be part of a cardiometabolic risk profile. The discussion has thus shifted. Previously, the question was: "Is testosterone dangerous for the heart?" Today it is: "What does it mean for the heart and metabolism if a significant hormone deficiency remains untreated?"
Anyone wanting to know their hormone levels shouldn't speculate, but rather get tested. Structured laboratory diagnostics provide clarity – especially if metabolic risk factors are already present. Click here for the premium testosterone test .
And what does that have to do with Adon Health?
The crucial message from current evidence is not: testosterone is harmless. Rather: testosterone is safe – when used correctly from a medical perspective.
That means:
- Clear indication
- Objective laboratory diagnostics
- Risk stratification
- Regular follow-up examinations
- Monitoring of hematocrit, lipids, blood pressure and PSA
This structured approach forms the basis of our medical processes. Red February stands for heart health, and modern men's health means not considering hormonal and cardiometabolic connections separately. The evidence is more robust today than ever before and allows for a nuanced, objective assessment.
