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Long-term use of androgen deprivation therapy (ADT) dramatically elevated the risk of heart failure over the course of 1 year follow-up in men with prostate cancer, compared with non-ADT users, although short-term use did not, a large study of Asian men indicated.

In the full, slightly mismatched cohort, the incidence of heart failure was 72% higher among ADT users compared with non-users, at an adjusted hazard ratio of 1.72 (95% CI 1.08-2.73), reported Yu-Ching Chow, PhD, of the National Defense Medical Center in Taipei City, Taiwan, and colleagues in the .

In a propensity-matched cohort, the risk of heart failure was even higher at 92% for men who took ADT compared with men who did not (adjusted HR 1.92, 95% CI 1.15-3.18), researchers added. "To our best knowledge, this is the first Asian population-based study aimed at exploring the connection between androgen deprivation therapy usage and subsequent risk of heart failure," the authors observed.

"We recommend that clinicians ... counsel their patients regarding modifiable heart failure risk factors ... and further provide relevant cardiovascular examination for prostate cancer patients receiving androgen deprivation therapy," they stated.

The Taiwan Longitudinal Health Insurance Database 2005 was used to identify 1,244 prostate cancer patients who had been treated with ADT, and another 1,806 who had not.

Men who had received ADT for >6 months were considered long-term users while all others who had filled a prescription for ADT were considered short-term users. The mean age of the ADT-using cohort was 73.3 while the mean age of controls was 67.2 (P<0.001).

There were also significant differences between the two groups in the proportion of men who lived in urban areas, in monthly income, and in the incidence of hypertension (P<0.001 for all), as well as coronary heart disease (CHD, P=0.033). Because of this bias, the authors carried out a propensity score-matched analysis after which no significant differences remained between the two groups.

Over the course of a 12-month follow-up, the incidence of heart failure was 4.00 per 100 person-years (95% CI 2.95-5.30) for men who had been treated with long-term ADT compared with 1.89 per 100 person-years for non-ADT treated men (95% CI 1.30-2.66).

Investigators also noted that valvular heart disease was significantly associated with heart failure (HR 2.51, 95% CI 1.34-4.69), suggesting that physicians should consider the risk-benefit ratio of treating men with ADT who also have valvular heart disease, and chose another option which does not aggravate heart failure risk, the authors noted.

They also tracked both cohorts for an additional 2 years from the initiation of ADT and found that the risk of heart failure slightly declined over time. For example, in the full cohort, ADT users had the same risk of developing heart failure at 2 years (adjusted HR 1.72, 95% CI 1.20-2.47) while at 3 years, the same group had a 53% higher risk of heart failure (adjusted HR 1.53, 95% CI 1.12-2.10) compared with non-ADT users.

For the propensity-matched cohort, the risk of heart failure for ADT users at 2 years was 87% higher compared with non-users (adjusted HR 1.87, 95% CI 1.27-2.77) while at 3 years, the risk of heart failure was 63% higher in men who received ADT compared with those who did not (adjusted HR 1.63, 95% CI 1.15-2.30).

"According to the findings in our study, we suggest that physicians should be alerted to the adverse cardiovascular effects [of ADT] if their patients need to receive long-term androgen deprivation therapy," the authors concluded.

The study had limitations, such as the fact that the database did not include information on BMI, cigarette smoking, alcohol consumption, and genetic factors.

Timothy Gilligan. MD, of the Cleveland Clinic, noted that the results of this study are supported by earlier studies that have also reported an increased risk of cardiovascular disease (CVD) in general, and heart failure specifically, in men with prostate cancer treated with ADT.

On the other hand, "ADT has been shown to prolong survival of men with prostate cancer in some settings [so] if the goal is to live longer, then treatment with ADT is often the best option for men with prostate cancer despite the risks of such treatment," Gilligan, who was not involved in the study, stated in an email.

He emphasized that it is important to be both cautious and thoughtful about the use of ADT in settings where it has not been shown to prolong survival, for example, in men who have a rising prostatic specific antigen (PSA) level after local treatment, but who have no evidence of metastatic disease on imaging.

"Such men often receive ADT and there is no persuasive evidence that such treatment prolongs survival or improves quality of life," Gilligan argued.

The evidence is most persuasive in supporting a survival advantage for ADT among men with metastatic disease and for those with high-risk localized disease receiving radiation therapy.

"In the future, we may be able to individualize therapy better and identify some men for whom the risk of ADT outweighs any benefit," Gilligan suggested. In the meantime, "this study provides additional evidence of a link between ADT and CVD, and it will further encourage us to be thoughtful about when to recommend and prescribe ADT, although I do not think it will change practice."

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