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Does amiodarone increase cancer risk?

Amiodarone may increase the risk of developing cancer, especially in men and people exposed to high amounts of the drug, according to a study1 published recently in Cancer.

Because amiodarone is fat-soluble and degrades very slowly, large amounts can accumulate in soft tissues after a long-term prescription. Previous studies have shown that amiodarone might increase the risk of certain cancers, but no large-scale study has looked at the issue.

Researchers led by Dr Vincent Yi-Fong Su (Taipei Veterans General Hospital, Taiwan) studied 6,418 individuals taking the drug, following them for an average of 2.57 years. A total of 280 participants developed cancer.

Patients who were male or who received high cumulative daily doses of amiodarone within the first year had an increased risk of developing cancer. Those with both factors were 46% more likely to develop cancer than those with neither factor. After taking age, sex, and illnesses into account, individuals taking a high amount of amiodarone had nearly twice the risk of developing cancer as those taking a low amount of the drug.

“We suggest that cancer events should be routinely reported in future amiodarone trials, and further observational research is necessary,” said Dr Su. “Also, when prescribing amiodarone, doctors need to keep in mind that this medication may increase cancer risk.”

Vincent

Dr Vincent Yi-Fong Su (Taipei Veterans General Hospital, Taiwan)

Speaking to theheart.org, another expert cautions that while we should pay attention to the findings of this study, “we need to take it with a grain of salt.” Dr James Marshall (Roswell Park Cancer Institute, Buffalo, NY), who wasn’t involved in the analysis, pointed out that it has a number of limitations.

It is based on the use of standard incidence ratios (SIR)s, he noted, which compare the number of observed cancer cases with the “expected” number of cases within a population or geographic area.

“There was only a 12% increase for the whole group, and that is a small increase,” Marshall said. “If this were a pristine study, it might mean something, but they are using standard incidence ratios, and those are notoriously difficult to interpret.”

The use of the cumulative defined daily dose is a little cleaner, he said. “They can then compare high exposure and low exposure.”

Marshall also noted that while the authors did adjust for age, gender, and comorbidities, they did not look at potential risk factors such as smoking, environmental exposure, family history of malignancy, alcohol use, and obesity.

“We do want to make note of these results,” he said, “And not just toss the data out. But I don’t think cardiologists are going to change treatment based on this one study alone. We need to be careful about coming to conclusions until we see some confirmation of this in other studies.”

Figure 1. On Kaplan-Meier analysis excluding the person-time and events occurring within the first year, the cumulative incidence among patients with low, intermediate, and high numbers of cumulative defined daily doses (cDDDs) (≤103, 103–253, and >253) of amiodarone was found to differ significantly (log-rank P = .023).

Figure 1. On Kaplan-Meier analysis excluding the person-time and events occurring within the first year, the cumulative incidence among patients with low, intermediate, and high numbers of cumulative defined daily doses (cDDDs) (≤103, 103–253, and >253) of amiodarone was found to differ significantly (log-rank P = .023).

References

1. Su VY, Hu Y-W, Chou K-T, et al. Amiodarone and the risk of cancer: a nationwide population-based study. Cancer 2013;119:1699–705. http://dx.doi.org/10.1002/cncr.27881

Published on: May 22, 2013

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