Presentación hecha para colegas del hospital donde trabajo ante un comunicado del Ministerio de Salud en el que se "contraindicaba" el uso de atípicos en pacientes con Demencia (año 2005).

1. Antipsicóticos atípicos y demencias Comunicado de la FDA

5. 1. Comunicado de la FDA

6. Comunicado de la FDA FDA Issues Public Health Advisory for Antipsychotic Drugs used for Treatment of Behavioral Disorders in Elderly Patients The Food and Drug Administration (FDA) today issued a public health advisory to alert health care providers , patients, and patient caregivers to new safety information concerning an unapproved (i.e., “off-label”) use of certain drugs called “atypical antipsychotic drugs.” These drugs are approved for the treatment of schizophrenia and mania, but clinical studies of these drugs to treat behavioral disorders in elderly patients with dementia have shown a higher death rate associated with their use compared to patients receiving a placebo (sugar pill). Today’s advisory applies to such antipsychotic drugs as Abilify (aripiprazole), Zyprexa (olanzapine), Seroquel (quetiapine), Risperdal (risperidone), Clozaril (clozapine) and Geodon (ziprasidone). Symbyax, which is approved for treatment of depressive episodes associated with bipolar disorder is also included in the agency’s advisory.

7. Comunicado de la FDA II FDA Public Health Advisory Deaths with Antipsychotics in Elderly Patients with Behavioral Disturbances The Food and Drug Administration has determined that the treatment of behavioral disorders in elderly patients with dementia with atypical (second generation) antipsychotic medications is associated with increased mortality . Of a total of seventeen placebo controlled trials performed with olanzapine (Zyprexa), aripiprazole (Abilify), risperidone (Risperdal), or quetiapine (Seroquel) in elderly demented patients with behavioral disorders, fifteen showed numerical increases in mortality in the drug-treated group compared to the placebo-treated patients. These studies enrolled a total of 5106 patients , and several analyses have demonstrated an approximately 1.6-1.7 fold increase in mortality in these studies. Examination of the specific causes of these deaths revealed that most were either due to heart related events (e.g., heart failure, sudden death) or infections (mostly pneumonia).

11. Prospectos II

12. 2. Evidencias de la FDA 1. Comunicado de la FDA

17. 3. Evidencia de eficacia de los fármacos 2. Evidencias de la FDA 1. Comunicado de la FDA

19. Estudios doble ciego, controlados con placebo de antipsicóticos para tratamientos de síntomas psiquiátricos en demencias Clive et al. “The Relationship Betweeen Antipsychotic Treatment and Quality of Life…”. J Clin Psych 2004;65 Suppl 11. 65 / 57 / 43 / 36 Olanzapina 5, 10, 15 206 Street, 2000 72 / 69 / 61 Risperidona/Halo 344 De Deyn, 1999 68 / 61 Risperidona 435 Katz, 1999 Sin diferencias Olanzapina 238 Satterlee, 1995 32 / 31 Haloperidol 149 Teri, 2000 59 / 47 Tioridazina 53 Barnes, 1982 65 / 36 Haloperidol 61 Petrie, 1982 89 / 67 Haloperidol 18 Sugarmann, 1964 Sin diferencias Cloropromazina 32 Abse et al, 1960 %Med/%Placebo Medicación N Estudio