| Summary: | Eiji Harada,1 Osamu Shirakawa,2 Yoichi Satoi,3 Lauren B Marangell,4 Rodrigo Escobar5 1Eli Lilly Japan K.K., Medicines Development Unit Japan, Medical Science, Kobe, 2Department of Neuropsychiatry, Kinki University Faculty of Medicine, Osakasayama, 3Eli Lilly Japan K.K., Medicines Development Unit Japan, Statistical Science, Kobe, Japan; 4The University of Texas Health Science Center School of Medicine, Houston, TX, 5Eli Lilly and Company, Neuroscience, Indianapolis, IN, USA Purpose: We sought to better understand how dose and titration with duloxetine treatment may impact tolerability and treatment discontinuation in patients with major depressive disorder.Patients and methods: We investigated Phase III duloxetine trials. Group 1 was a single placebo-controlled study with a 20 mg initial dose and a slow titration to 40 and 60 mg. Group 2 was a single study with a 40 mg initial dose and final “active” doses of 40 and 60 mg (5 mg control group), with 1-week titration. Group 3 consisted of eight placebo-controlled studies with starting doses of 40, 60, and 80 mg/day with minimal titration (final dose 40–120 mg/day). Tolerability was measured by rate of discontinuation due to adverse events (DCAE).Results: The DCAE in Group 1 were 3.6% in the 60 mg group, 3.3% in the 40 mg group, and 3.2% in the placebo group. In Group 2, the DCAE were 15.0% in the 60 mg group, 8.1% in the 40 mg group, and 4.9% in the 5 mg group. In Group 3, the DCAE were 9.7% and 4.2% in the duloxetine and placebo groups, respectively.Conclusion: This study suggests that starting dose and titration may have impacted tolerability and treatment discontinuation. A lower starting dose of duloxetine and slower titration may contribute to improving treatment tolerability for patients with major depressive disorder. Keywords: antidepressant, dose, duloxetine, major depressive disorder, titration
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