INTRODUCTION: The aim of this study was to relate drug concentrations in serum and clinical effects in patients treated with the new antidepressant duloxetine. METHODS: Data were obtained from a newly established therapeutic drug monitoring (TDM) survey. Duloxetine was measured using HPLC with UV detection and clinical effects by the clinical global impressions (CGI) scale for improvement. RESULTS: The study included 103 depressed inpatients (69% female). Patients under duloxetine monotherapy who were very much improved according to CGI had significantly (p<0.05) higher serum levels than patients with moderate, minimal or lacking improvement (mean+/-SD and range, 93+/-53 ng/mL and 30-182 ng/mL and 47+/-39 ng/mL and 5-178 ng/mL, respectively). Daily doses were similar in the two groups (76+/-27 vs. 83+/-27 mg/d). Receiver operating characteristics (ROC) curve analysis revealed significant predictive properties of duloxetine serum levels (p=0.011) for improvement with a lower threshold concentration of duloxetine of 58 ng/mL. DISCUSSION: The findings indicate that therapeutic drug monitoring of duloxetine and titration to steady state serum concentrations above 58 ng/mL is useful for treatment optimization. Georg Thieme Verlag KG Stuttgart - New York.
INTRODUCTION: The aim of this study was to relate drug concentrations in serum and clinical effects in patients treated with the new antidepressant duloxetine. METHODS: Data were obtained from a newly established therapeutic drug monitoring (TDM) survey. Duloxetine was measured using HPLC with UV detection and clinical effects by the clinical global impressions (CGI) scale for improvement. RESULTS: The study included 103 depressed inpatients (69% female). Patients under duloxetine monotherapy who were very much improved according to CGI had significantly (p<0.05) higher serum levels than patients with moderate, minimal or lacking improvement (mean+/-SD and range, 93+/-53 ng/mL and 30-182 ng/mL and 47+/-39 ng/mL and 5-178 ng/mL, respectively). Daily doses were similar in the two groups (76+/-27 vs. 83+/-27 mg/d). Receiver operating characteristics (ROC) curve analysis revealed significant predictive properties of duloxetine serum levels (p=0.011) for improvement with a lower threshold concentration of duloxetine of 58 ng/mL. DISCUSSION: The findings indicate that therapeutic drug monitoring of duloxetine and titration to steady state serum concentrations above 58 ng/mL is useful for treatment optimization. Georg Thieme Verlag KG Stuttgart - New York.
Authors: Dara J Sakolsky; James M Perel; Graham J Emslie; Gregory N Clarke; Karen Dineen Wagner; Benedetto Vitiello; Martin B Keller; Boris Birmaher; Joan Rosenbaum Asarnow; Neal D Ryan; James T McCracken; Michael J Strober; Satish Iyengar; Giovanna Porta; David A Brent Journal: J Clin Psychopharmacol Date: 2011-02 Impact factor: 3.153