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Selected research from leading health care experts whose findings have a direct bearing on public policies effecting medical progress. Research is chosen based on its quality and relevance by the Medical Progress Today editorial staff.

Selected Research

Risk of Death in Elderly Users of Conventional vs. Atypical Antipsychotic Medications
Philip S. Wang, M.D., New England Journal of Medicine, 12-1-05

New drug candidates must meet daunting safety standards from both industry and the FDA, standards that weren’t applied to drugs approved 20 or 30 years ago. New drugs are also much more scrutinized by the media and consumer groups, who rush to publicize every new potential side effect. As a result, the public and policymakers may assume that older drugs are safer because experience has already revealed everything we need to know about their safety profiles.

This study, however, calls that assumption into question. It uses an observational database to compare new psychiatric drugs called atypical antipsychotics to their older counterparts (typical antipsychotics). The researchers noted that

Recently, the Food and Drug Administration (FDA) issued an advisory stating that atypical antipsychotic medications increase mortality among elderly patients. However, the advisory did not apply to conventional antipsychotic medications; the risk of death with these older agents is not known.
We conducted a retrospective cohort study involving 22,890 patients 65 years of age or older who had drug insurance benefits in Pennsylvania and who began receiving a conventional or atypical antipsychotic medication between 1994 and 2003. Analyses of mortality rates and Cox proportional-hazards models were used to compare the risk of death within 180 days, less than 40 days, 40 to 79 days, and 80 to 180 days after the initiation of therapy with an antipsychotic medication. We controlled for potential confounding variables with the use of traditional multivariate Cox models, propensity-score adjustments, and an instrumental-variable analysis.

The researchers discovered that “conventional antipsychotic medications were associated with a significantly higher adjusted risk of death than were atypical antipsychotic medications at all intervals studied…and in all subgroups defined according to the presence or absence of dementia or nursing home residency.”

They concluded that “if confirmed, these results suggest that conventional antipsychotic medications are at least as likely as atypical agents to increase the risk of death among elderly persons and that conventional drugs should not be used to replace atypical agents discontinued in response to the FDA warning.”

More analysis of these drugs clearly needs to be done before any firm conclusions emerge. In the meantime, we should temper our bias that older treatments are de facto safer because they have been on the market longer. As the old saying goes, you don’t know what you don’t know.



Project FDA.
  
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