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| |  Clozaril Reduces the Rate of Suicide in People With Schizophrenia EAST HANOVER, NJ -- October 27, 1997 -- New research published in the most recent issue of the journal Epidemiology reveals current users of Clozaril(R) (clozapine) -- a drug prescribed for patients with treatment-resistant schizophrenia -- experience much lower rates of suicide while taking the drug. Conclusions of this epidemiological study indicate among current users of Clozaril, as many as four out of five suicide deaths may be prevented. Unlike clinical studies, which base their findings on actual observation and treatment of patients, epidemiological studies are retrospective analyses seeking to define relationships among data gathered over a long period of time. Previous research has investigated the effect of Clozaril on rates of suicide in people with schizophrenia. Results of a clinical study published in 1995 in The American Journal of Psychiatry demonstrated people with schizophrenia experienced an 86.4 percent reduction in suicide attempts when using Clozaril. "The incidence of suicide was dramatically lower during periods of current use of clozapine than periods of recent or past use," said Kenneth Rothman, Dr.PH., senior scientist, Epidemiology Resources, Inc. (ERI), Newton Lower Falls, Massachusetts. "As many as half of all deaths among schizophrenics can be suicides and the rate of suicide in schizophrenics may be up to 50 times greater than in the general population." Researchers linked data about various causes of death in 67,072 current and former users of Clozaril registered in the Clozaril National Registry, a database of relevant information on all Clozaril recipients, with death certificates from the National Death Index, a United States Government file kept to aid mortality analyses. Because people with schizophrenia have generally higher death rates than the general population, researchers compared the death rates of people being treated with Clozaril at the time of death with death rates among people previously treated with Clozaril. Death rates calculated in the study were standardized by age, sex and race. Results show mortality from suicide was decreased during Clozaril use when compared to periods of non-use. The risk of suicide in patients who discontinued Clozaril for medical reasons (i.e., low white blood cell counts) increased after discontinuation, to the same extent it did in those who discontinued for other reasons, including resistance to Clozaril therapy. The period just after discontinuation was considered separately in the analysis because of the individuals who may have discontinued for medical reasons. Data demonstrate the advantage of Clozaril therapy to current users was not attributable to a transient increase in suicide risk immediately upon discontinuation of therapy. In addition to the principal finding of this study, a striking reduction in suicide in current users of Clozaril, some unfavorable effects were also reported. Deaths due to pulmonary embolism and to respiratory disorders were more common in Clozaril users than in non-users. However, data show that deaths from these causes were rare and far outweighed by the sharp reductions in deaths due to suicide. Although Clozaril causes fewer extrapyramidal side effects than other antipsychotic medications, it is associated with an increase in the risk of developing agranulocytosis, a generally reversible adverse effect known to occur with Clozaril in which the recipients' white blood cell (WBC) count drops to dangerously low levels and their absolute neutrophil counts (ANC) drop to 500 cc/mm3 or below. Current data show a less than one percent (.38 percent) risk of agranulocytosis associated with taking Clozaril. Additionally, Clozaril recipients undergo mandatory white blood cell (WBC) count testing for early diagnosis of this condition. "The monitoring of clozapine patients requires weekly contact with a health professional, which may provide additional benefits of both surveillance and human contact," Dr. Rothman explained. Introduced in the U.S. in February 1990, Clozaril has proven to be highly effective and is indicated for the management of people with treatment-resistant schizophrenia -- approximately 10 to 15 percent of the schizophrenia population. Clozaril should only be used in patients who have failed to respond adequately to treatment with appropriate courses of two standard antipsychotic drugs. Currently, Clozaril is available in more than 30 countries around the world through Novartis Pharmaceuticals Corporation under the brand names Leponex(R) and Clozaril(R).
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