Efficacy and safety findings from naturalistic fluoxetine drug treatment in adolescent and young adult patients

This article reports on the efficacy and safety of the selective serotonin reuptake inhibitor, fluoxetine, in 213 patients (ages 11-23 years) treated by psychiatrists/neurologists (PN) or general practitioners/internists (GPI ). Data were derived from naturalistic drug utilization observation (DUO) s tudies with fluoxetine (n = 18,759 patients). Data collection-at the start and the end of the observation period (less than or equal to 6 weeks)-inclu ded patient characteristics, diagnoses, medication, co-medication, efficacy , and adverse events (AEs). Nonparametric statistics and descriptive p valu es (two-tailed) were used. Analyses revealed various differences between PN (n = 56) and GPI (n = 157) samples as to patient and treatment characteris tics (p < 0.001-0.08). Based on both Clinical Global Impression (CGI; all p < 0.001) and self-assessment (total n = 47; Zung SDS, all p less than or e qual to 0.003), both PN and GPI patients showed improvements in their sympt omatology over time, including suicidality tall p < 0.001; there were no gr oup differences). Overall AE rates were higher in PN patients (p < 0.01; 17 .9% vs. 4.5%); the frequency and type of AEs in both subgroups were typical for fluoxetine and the total DUO samples. In fact, AE rates were lower com pared to controlled trials. Findings suggest that PN patients were more sev erely ill at observation start and suffered a more complicated treatment co urse. However, clinical efficacy showed highly significant improvements in both subgroups; AE rates were low in both-although higher in PN patients. T hus, results support a positive benefit/risk ratio of fluoxetine use for th is young patient population.