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Dose Consideration May Be Needed for Psychotic Patients With Cardiovascular Disease
December 13, 2001 — Patients prescribed moderate doses of antipsychotic medication are at increased risk of sudden cardiac death, according to an article in the December issue of the Archives of General Psychiatry, a journal of the American Medical Association.
Wayne A. Ray, Ph.D., from Vanderbilt University School of Medicine in Nashville, and colleagues conducted a large retrospective cohort study of the risk of sudden cardiac death among antipsychotic users. The study was conducted in a Medicaid population, which included many patients who were prescribed antipsychotic medications, consisting of 481,744 persons with 1,282,996 person-years of follow-up. This included 26,749 person-years for current moderate-dose antipsychotic use, 31,864 person-years for current low-dose antipsychotic use, 37,881 person-years for use in the past year only and 1,186,501 person-years for no use. The cohort had 1,487 confirmed sudden cardiac deaths. This study included only antipsychotics in use before 1994. The new, atypical antipsychotics risperidone, olanzapine and quetiapine were not included.
"In this large epidemiologic study, patients using antipsychotics in doses of more than 100 mg of thioridazine or its equivalent had a 2.4-fold increase in the rate of sudden cardiac death. The relative and absolute rates were increased among moderate-dose antipsychotic users who also had severe cardiovascular disease; consequently, these patients had an additional 367 sudden cardiac deaths per 10,000 person-years of follow-up," the authors write.
According to background information in the article, antipsychotic agents, the primary treatment for schizophrenia and other psychoses, are thought to increase the risk of serious heart rhythm abnormalities and, consequently, sudden cardiac death
The authors note that although their data suggest that antipsychotic medications might increase the risk of sudden cardiac death, this question has not been addressed in controlled epidemiologic studies before.
Editor's Note: This study was supported in part by a contract from Janssen Pharmaceutica, Titusville, N.J.,
Commentary: Sudden Death May Have Multifactorial Origins
In an accompanying commentary, Carlos A. Zarate, Jr., M.D., from the Mood Disorders Research Unit, National Institute of Mental Health in Bethesda, Md., states, "Ray and colleagues have done laudable work to help discern the link between the use of conventional antipsychotic drugs and the risk of sudden death," adding, " ... some issues deserve further discussion."
The issues in question, according to Dr. Zarate, are the dose of antipsychotic agents used for the assignment of patients into low- and moderate-dose groups (most patients are prescribed higher doses than the 100 mg daily of thioridazine or its equivalent used for assignment in the study). Would patients receiving the higher doses usually prescribed have the same outcome, or should physicians aim for prescribing lower doses?
Another issue to be addressed, according to Dr. Zarate, is the established relationship between major depression and mortality in psychiatric patients — although Ray et al. controlled for the effect of major depression on death rates, "Several studies suggest that depression in patients with coronary artery disease is rarely diagnosed by primary care physicians and cardiologists," Dr. Zarate states, " ... depression predicts future cardiac events and hastens mortality [in such patients]."
Finally, according to Dr. Zarate, Ray et al. did not take into account certain other medications patients may have been taking that could have contributed to an increase in mortality.
"Clearly the topic of sudden death is complex and will probably be identified as multifactorial and/or multietiological [having many causes] in origin," Dr. Zarate concludes, "However, we urgently need studies to determine not only the drug-related risks of sudden death but the non-drug risk factors that may predispose patients to cardiac adverse events."