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Cymbalta (Duloxetine) Demonstrates High Tolerability, Safety In Long-Term Study One-year data shows high likelihood of remission from depression TORONTO, ON -- November 20, 2003 -- Duloxetine (proposed brand name Cymbalta(TM) was safe and well tolerated in a 52-week open-label study of 1,279 patients with major depressive disorder, and patients in the study who responded to treatment with Cymbalta had a high probability of achieving remission. These findings are published in the current issue of the Journal of Clinical Psychiatry. Patients who tolerated Cymbalta during the early period of the trial were likely to tolerate long-term dosing; there were no significant tolerability issues attributable to chronic vs. acute use of the investigational agent Cymbalta. Of the patients in the study, 520 remained on Cymbalta for at least 360 days, yielding approximately 808 patient-years of total exposure. There were 142 Canadian patients from 11 sites included in the trial. "Long-term tolerability is important for antidepressant effectiveness in the complete treatment of depression. The higher-than-expected completion rate in this open-label study implies that Cymbalta was well-tolerated in these patients and was effective in helping them relieve their depressive illness," said Joel Raskin, MD, Lilly senior clinical research physician and lead author of the study. Remission rates at 52 weeks in this study were close to response rates (81.8 per cent and 89.1 per cent, respectively), implying that patients who responded had a high probability of achieving complete resolution of their depressive symptoms. "Remission is the gold standard for anti-depressant treatment. The fact that over 80% of patients in this study who responded to Cymbalta were still taking it after one year and were virtually free of symptoms is very encouraging." said Sidney Kennedy, MD, Psychiatrist-in-Chief, University Health Network, Toronto, Ontario. Study Highlights · Cymbalta was well-tolerated in long-term treatment, despite higher dosages than those used in most other Cymbalta studies. · Most treatment-emergent adverse events were either mild or moderate and occurred early in the study. · Efficacy was demonstrated on all assessed measures, both clinician- and patient-rated. Furthermore, discontinuation due to adverse events over the entire 52-week study was 17 per cent - a favorable rate given the long duration of the study. Methods Data were gathered from a 52-week, open-label, multinational study of 1,279 adult outpatients who met the criteria for major depressive disorder. Patients were administered duloxetine 80 to 120 mg/day as two equal doses of 40 mg or 60 mg. Efficacy was assessed using the Clinical Global Impression-Severity (CGI-Severity) scale, the Hamilton Depression Rating Scale (HAMD17), the Beck Depression Inventory-II and the Patient Global Impression-Improvement (PGI-Improvement) scale. Patient-rated quality was evaluated with the Sheehan Disability Scale. Response was defined as a 50 per cent decrease from baseline on the HAMD17 total score and remission was defined as a HAMD17 total score of < 7. Tolerability/Safety Discontinuation due to adverse events over the entire 52-week study was 17 per cent - a favorable rate given the long duration of the study. The most common reasons for discontinuation included adverse event (17 per cent), personal conflict/other reasons (10.2 per cent), and lost to follow-up (9.3 per cent). The most common treatment-emergent adverse events in the study included nausea (34 per cent), somnolence (29.8 per cent), insomnia (31.3 per cent), headache (30.4 per cent), dry mouth (23.5 per cent), constipation (21.3 per cent) and dizziness (23.3 per cent). Most side effects occurred early in the study and generally dissipated over time. Only one side effect (headache) occurred in more than 10 per cent of patients in weeks 9-52 of the study. Efficacy/Remission Efficacy was demonstrated on all assessed measures, both clinician-and patient-rated. The high rates of improvement at week one and two, while difficult to define and assess, were consistent with results from double-blind, placebo-controlled studies. Accumulating evidence suggests complete resolution of disease symptoms, or remission, rather than simple treatment response, should be the primary goal of depression treatment. Current medical literature suggests that patients who respond to current treatment options often experience lingering symptoms, such as persistent unexplained pain, putting them at a higher risk for relapse or recurrence.4 Although interpreting results in an open-label study can be problematic, the remission rates in this 52-week study were high, implying Cymbalta was effective in relieving the symptoms of major depression in these patients. Cymbalta Cymbalta is a new investigational therapy developed by Eli Lilly and Company that has been submitted to Health Canada. References: 1. Detke MJ, Lu Y, Goldstein DJ, et al. Duloxetine 60 mg once daily, for major depressive order: a randomized double-blind placebo-controlled trial. J Clin Psychiatry 2002:63: 308-315 2. Detke MJ, Goldstein DJ, et al. Duloxetine 60 mg once daily dosing versus placebo in the acute treatment of major depression. J Psychiatry Res 2002;36: 383-390 3. Goldstein DJ, Mallinckrodt C, Lu Y, et al. Duloxetine in the treatment of major depressive disorder: a double-blind clinical trial. J Clin Psychiatry 2002;63: 225-231 4. Paykel ES, Ramana R, Cooper Z, et al. Residual symptoms after partial remission: an important outcome in depression. Psychol Med 1995;25: 1171-1180 SOURCE: Eli Lilly Canada Inc. E-mail this page to a friend or colleague! To print, use this version