Efficacy, safety and tolerability of duloxetine 60 mg once daily in major depression.

BACKGROUND: Major depressive disorders (MDD) present a significant public health problem, in terms of burden for individual sufferers, their families and society as a whole. Recently, dualacting antidepressants, which block both serotonin (5-HT) and noradrenaline (NA) reuptake, have been developed with the hope of improving depression treatment outcomes. Duloxetine is a dual reuptake inhibitor of 5-HT and NA that has recently been licensed in the USA for the treatment of MDD. OBJECTIVE: This paper summarises efficacy and tolerability data for duloxetine with particular reference to the dose recommended for clinical use -- 60 mg once daily. Papers relating to duloxetine 60 mg once daily were identified through Medline searches and the publication databases at Eli Lilly/Boehringer Ingelheim. FINDINGS: Randomised, placebo-controlled studies have demonstrated the efficacy of duloxetine 60 mg once daily for the treatment of depression in the short and long term. Thus, duloxetine 60 mg once daily was superior to placebo in reducing once daily was superior to placebo in reducing MDD symptoms according to the primary efficacy MDD symptoms according to the primary efficacy measure -- the 17-item Hamilton Depression Rating Scale (HAMD(17)). Significantly greater improvements in subfactors of HAMD(17) and quality of life measures were also seen. In addition, duloxetine has been shown significantly to reduce the general aches and pains that frequently accompany MDD. A recent placebo-controlled study demonstrated that duloxetine improved cognition and depression measures in depressed elderly patients. Duloxetine appears to have an acceptable tolerance. The most frequently observed adverse events with duloxetine were nausea, dry mouth and somnolence. Importantly, duloxetine did not appear to have a clinically significant effect on blood pressure. CONCLUSION: In summary, duloxetine 60 mg once daily is effective for the treatment of core depressive symptoms, as well as general aches and pains associated with depression.