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Aug 03, 2009
 |  BioCentury  |  Regulation

Challenge to atypical thinking

Clozapine, a second generation (atypical) antipsychotic, has been restricted to third-line use in conjunction with a stringent risk management program due to its side effect profile. But new data showing a mortality benefit from its use raises the question of whether the drug should be prescribed more often, as well as whether that should be accomplished by changing the risk management program or the third-line indication.

The study's authors, who were led by Jari Tiihonen, professor and chair of forensic psychiatry at the University of Kuopio, suggest that the risk management program be relaxed in order to encourage more use.

But while physicians contacted by BioCentury agreed that clozapine should be used more often, they also suggested it may be the risk management program itself that has led to better outcomes compared to other drugs, rather than any differential in terms of efficacy.

Nor is the third-line indication likely to be changed, as the drug is generic and Novartis AG thus has little incentive to run new trial.

The course of the least resistance thus may turn out to be leaving things as they are, given that physicians who see the new data are free to provide the drug to their patients off label.

More generally, the new data, published in The Lancet, have revived the long-running controversy over the relative safety of atypical antipsychotics - which were first introduced in the 1990s - compared to older schizophrenia treatments. The new study seems to run counter to other studies that have suggested the increased use of atypicals has been associated with increased mortality.

The researchers conducted an observational study (FIN11) using data from nationwide registers in Finland to compare mortality in 66,881 schizophrenic outpatients with the country's population of 5.2 million between 1996 and 2006. The results showed that the gap in life expectancy between schizophrenics and the general population improved from 25 years in 1996 to 22.5 years in 2006, while proportional use of second generation antipsychotics rose from 13% to 64%.

Physicians contacted by BioCentury were unanimous in their belief that the study's most important takeaway message is the overall success of drug treatment.

"The...

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