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Sept. 16, 2003 — Patients with bipolar disorder who take divalproex, the most commonly prescribed mood- stabilizinger drug in the United States, have about a 2.5 times higher risk of suicide death, than if they take lithium, according to an article in the Sept. 17 issue of The Journal of the American Medical Association.
Bipolar disorder (a psychiatric disorder characterized by extreme mood swings, ranging between episodes of elevated mood and severe depression) is a major public health problem, in any given year affecting approximately 1.3 percent to 1.5 percent of the U.S. population, according to background information in the article. In the World Health Organization's Global Burden of Disease study, bipolar disorder ranked sixth among all medical disorders in years of life lost to death or disability. Estimates of the lifetime risk of suicide in patients with bipolar disorder range from 8 percent to 20 percent, which is 10 to 20 times that in the U.S. general population.
Several studies have suggested that lithium treatment reduces risk of suicide in bipolar disorder, but no research has examined suicide risk during treatment with divalproex. Frederick K. Goodwin, M.D., of George Washington University Medical Center, Washington, D.C., and colleagues compared the risk of suicide attempt and completed suicide death during periods of treatment with lithium to that during periods of treatment with divalproex.
The study included a population-based sample of 20,638 people from two large integrated health plans in California and Washington, aged 14 years or older who had at least one outpatient diagnosis of bipolar disorder and at least one filled prescription for lithium, divalproex, or carbamazepine between January 1, 1994, and December 31, 2001. Follow-up for each individual began with first qualifying prescription and ended with death, disenrollment from the health plan, or end of the study period.
"In both health plans, unadjusted rates were greater during treatment with divalproex than during treatment with lithium for emergency department suicide attempt (31.3 vs. 10.8 per 1000 person-years), hospitalized suicide attempt resulting in hospitalization (10.5 vs. 4.2 per 1000 person-years), and suicide death (1.7 vs. 0.7 per 1000 person-years)," the authors write. "After adjustment for age, gender, health plan, year of diagnosis, comorbid medical or psychiatric conditions, and concomitant use of other psychotropic drugs, risk of completed suicide death was 2.7 times higher during treatment with divalproex than during treatment with lithium."
The researchers found that patients taking divalproex had a 70 percent increased risk for attempts resulting in hospitalization and an 80 percent increased risk for attempts diagnosed in the emergency department, compared to patients taking lithium.
Editor's Note: This study was supported by a research grant from Solvay Pharmaceuticals to Best Practice LLC based on a proposal developed by the study investigators. For the financial disclosures of the authors, please see the JAMA article.
Editorial: Suicide Risk and Treatment for Patients with Bipolar Disorder
In an accompanying editorial, Ross J. Baldessarini, M.D., and Leonardo Tondo, M.D., of Harvard Medical School, Boston, write that the study by Goodwin et al not only has merits in its methods and findings but also represents a significant contribution to a newly emerging interest in suicide as a major unsolved medical problem.
"Not until this year has the Food and Drug Administration approved any treatment to prevent suicidal behavior, with the recent approval of clozapine for such purposes among patients with schizophrenia or schizoaffective disorder. This approval was supported by a prospective randomized study showing about 32 percent lower risk of nonlethal suicidal behaviors with clozapine than with olanzapine, which may also reduce risk of suicide. Hopefully, such renewed interest in the potentially treatment-modifiable lethality of major mental disorders will be sustained and increasingly successful," they conclude.