Resumen

Objective: To prove the effectiveness and safety of fluoxetine enteric coated 90 mg, administered once weekly in the maintenance treatment of Major Depressive Disorder (MDD) in Latin American patients who had responded to an acute treatment with fluoxetine 20 mg/day. Methods: Open-label, prospective, multicentre, non -controlled study of 24 weeks in patients with MDD (DSM -IV criteria) who had responded to fluoxetine 20 mg/day for at least 8 weeks. A HAMD17 score ? 9, were the criteria for successful clinical response. The primary efficacy measure was the rate of relapse. Secondary efficacy measures were mean changes in HAM -D17 total score; anxiety/somatization sub -score extracted from HAM -D17 and Clinical Global Impression -Severity of illness (CGI -S) Spontaneous adverse events, vital signs and results of ECG and laboratory tests were also registered. Results: Ninety-eight patients were enrolled; 96% completed the study. None patient relapses during the 24 weeks of follow -up after switching. Two patients presented reappearance of mild and briefly depressive symptoms. Endpoint versus baseline analysis showed statistical differences in the HAMD17, CGI -S and anxiety/somatization sub score (p ? 0.001). The analysis of sleep items of HAMD17 (4 to 6) showed a significant improvement from baseline to endpoint (p < 0.001). The most frequent adverse events were: cephalea (41%), anxiety (37%), somnolence (21%), nausea (19%) and insomnia (17%); the severity was mild or moderate. Only one patient withdrew the study because adverse events: nausea and vomiting with increase of the level of TGP and TGO. No significantly changes in vital signs, lab exams or EGCs were registered during the study. Conclusions: The switching from Fluoxetine 20 mg/day to Fluoxetine 90 mg weekly is an effective and safety alternative for patients with MDD in long-term treatment.

Palabras clave: Major depressive disorder fluoxetine maintenance treatment.

2008-06-19   |   1,191 visitas   |   Evalua este artículo 0 valoraciones

Vol. 5 Núm.1. Enero 2004 Pags. Rev Avances 2004; 5(1)