MONDAY, Dec. 14 (HealthDay News) -- Older women who take antidepressants may have a small but statistically significant increased risk of stroke and death compared to women not on the medications, a new study finds.
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"But statistical significance can be different from clinical significance," stressed Dr. Jordan W. Smoller, an associate professor of psychiatry at Harvard Medical School, and lead author of a report in the Dec. 14 issue of Archives of Internal Medicine. "It is possible that a statistically detectable effect may not be a problem for most people."
The study compared six-year data on 5,500 postmenopausal women who began taking antidepressants after enrolling in the Women's Health Initiative trial to data on more than 130,000 who did not take the drugs.
It found that women on selective serotonin uptake inhibitors (SSRIs, which include Celexa, Paxil, Prozac and Zoloft) had a 45% increase in risk for stroke and a 32% increase in risk for death from any cause, compared to non-users. Similar results were found for women on tricyclic antidepressants.
But the overall risk for any one woman remained very small, the authors stressed.
"The annual risk [of stroke] was 0.3% for women who did not take antidepressants, and ranged from 0.4 to 0.5% for women who did," said Smoller, who is also assistant vice chairman of psychiatry at Massachusetts General Hospital. "In a sample this large, that is a statistically significant difference, but it means that by far, most women did not have a stroke."
No increased risk for other heart problems was found in the study.
So, the decision as to whether and when an older woman with depression should take an antidepressant remains, "an individualized matter between a patient and her physician," Smoller said. "This study provides one more piece of information when considering options for treating depression."
Those options can include psychotherapies such as cognitive behavioral therapy, which have been shown to benefit many persons with depression, Smoller said.
"There are many ways to treat depression," he said. "But for serious depression, medication is often part of the treatment. For most women with serious depression, the benefits of medication outweigh the risks."
Depression itself "is a very serious and often debilitating illness that has its own effects, such as heart disease," Smoller noted. And he added that the study was not a randomized, controlled trial, which makes it difficult to distinguish the effects of depression itself from those of antidepressant medications.
That point was echoed by Sylvia Wassertheil-Smoller, a professor of epidemiology and public health at Albert Einstein College of Medicine, and a member of the research team (and mother of Jordan W. Smoller).
"Women who are on antidepressants should pay particular attention to other cardiovascular risk factors," she said. "There is lots of stuff that we know is effective but don't do. We know that hypertension is a risk factor, yet only a third of hypertensives have it under control."
A woman's decision about taking an antidepressant "depends on how severe and how debilitating her condition is," Wassertheil-Smoller said. "You have to weigh the risk and the benefit. But that applies to any drug, even aspirin."
It would take a major controlled trial to establish the risk-benefit ratio for antidepressants, and such a trial is highly unlikely, she said. "It would have to be a long-term trial, and you couldn't ethically assign people not to take antidepressants if they need antidepressants," she explained.
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SOURCES: Jordan W. Smoller,M.D., associate professor, psychiatry, Harvard Medical School, vice chairman psychiatry, Massachusetts General Hospital, Boston; Sylvia Wassertheil-Smoller, Ph.D, professor, epidemiology and public health, Albert Einstein College of Medicine, New York City; Dec. 14, 2009, Archives of Internal Medicine