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[A naturalistic study comparing two initial duloxetine dosing strategies in a clinical "real world" setting].

UNLABELLED
AIMS. To compare, in a "real world" setting, the efficacy and tolerability of two initial duloxetine starting doses: 30 mg once daily (q.d.) for 1 week, followed by escalation to 60 mg q.d. versus 60 mg q.d. without titolation, evaluating expecially the effects on sexual dysfunction.


METHODS
The sample is constituted by outpatients meeting diagnostic criteria for mild-severe (HAMD17 > or =24 and CGI-S > or =4) Major Depressive Episode as defined by DSM-IV-TR (Diagnostic and Statistic Manual for Mental Disorder, Fourth Edition-Text Revision), based on the Structured Clinical Interview for DSM-IV-TR (Mini International Neuropsychiatric Interview, MINI). The study design planned an initial evaluation and 4 follow-up visits; at each visit the following scales were administered: Hamilton Rating Scale for Depression (HAMD17) and Anxiety (HAMA), Clinical Global Impression Severity Scale (CGI-S) for severity evaluation and Arizona Sexual Experience Scale (ASEX) for sexual disfunction evaluation.


RESULTS
Both of the groups showed 90% of response (> or = 50% reduction in a patient's HAMD17 total score from baseline) within 2 months of follow-up. 50% of patients receiving a 30 mg q.d. starting dose achieved a HAMD17 total score < or =7 versus 40% of 60 mg q.d. treating group. None showed relapses during the study. After the first treatment month, the 60 mg q.d. receiving group showed a statistical significative amelioration of sexual function (Mann-Whitney test: p=0,02).


CONCLUSIONS
Our naturalistic "real world" study results confirm previous duloxetine tolerability and efficacy findings suggesting a 60 mg q.d. after meal duloxetine somministration without titolation.