Efficacy

The Depression Rating Scale
Study summary
Citation Brannan SK, et al. J Psychiatr Res 2005; 39(2): 161-72
Study Design Randomised, double-blind, placebo-controlled
Duration 9 weeks
Dose Duloxetine: 60 mg QD
N 512 patients
Results Median times to sustained improvements of 10% and 20% in the HAMD(17) total score among duloxetine-treated patients were 14 days and 21 days, respectively, compared with 34 days and 49 days, respectively, for placebo-treated patients (p<0.001 for both results). The median time to sustained 30% improvement in HAMD(17) total score was 35 days for duloxetine-treated patients, while the median time for placebo-treated patients was not estimable since less than half of the patients met this criterion by the end of the trial. For duloxetine-treated patients, median times to sustained 10%, 20%, and 30% improvements on the Maier subscale of the HAMD(17) were the same as those for the HAMD(17) total score: 14, 21, and 35 days, respectively. However, in other analyses, changes in core emotional symptoms as measured by subscales of the HAMD(17) were somewhat faster than changes in overall symptomatology. The probabilities of achieving a sustained 30% improvement (Maier subscale) at Week 1 for duloxetine- and placebo-treated patients were 16.2% vs. 4.8%, respectively (p<0.001). The corresponding probabilities of sustained improvement at Weeks 2 and 3 for duloxetine were 32.5% and 45.4%, respectively, compared to 12.8% and 21.4% for placebo ((p<0.001 for both comparisons).
Cymbalta
Study summary
Citation Shelton RC, et al. Int J Clin Pract 2007; 61(8): 1337-48
Study Design Double-blind, placebo-controlled studies to determine whether baseline severity of depression influenced the efficacy of duloxetine
Duration 8-9 weeks
Dose Duloxetine: 60 mg/d
N Study 1: duloxetine - 123, placebo - 122; Study 2: duloxetine - 128, placebo - 139; Study 3: duloxetine - 273, placebo - 137; Study 4: duloxetine - 207, placebo - 104 patients with MDD
Results Duloxetine produced significantly greater baseline-to-end-point improvement vs placebo (p<0.05) on the HAMD17 total score, Maier and retardation subscales, HAMD17 items 1 (depressed mood), 7 (work and activities) and 10 (psychic anxiety) in all three patient cohorts. The largest effect sizes were observed in assessments of core emotional depressive symptoms. A significant improvement for duloxetine vs placebo was not observed for sleep-related symptoms at end-point or genital symptoms at any time point during acute treatment. With respect to the time course of depressive symptom improvement, the data show that regardless of baseline severity, the most rapid and consistent improvement for duloxetine compared with placebo was observed in the core symptoms of MDD.
Cymbalta
Study summary
Citation Brecht S, et al. J Clin Psychiatry 2007; 68: 1707-1716
Study Design Double-blind, randomised, placebo-controlled study of duloxetine in the treatment of pain in MDD patients
Duration 8 weeks
Dose Duloxetine: 60 mg once daily
N Placebo: N=165; duloxetine: N=162 outpatients presenting with MDD (DSM-IV; Montgomery-Asberg Depression Rating Scale [MADRS] score ≥20), moderate pain (Brief Pain Inventory-Short Form [BPI-SF] average pain score ≥3), and Clinical Global Impressions-Severity of Illness scale (CGI-S) score ≥4.
Results Duloxetine, compared with placebo, significantly reduced pain and improved depression with significant mean changes at endpoint in both BPI-SF average pain scores (-2.57 vs -1.64, p<0.001) and in MADRS total scores (-16.69 vs -11.31, p<0.001)
Cymbalta
Study summary
Citation Perahia DG, et al. J Clin Psychiatry 2009; 70(5): 706-716.
Study Design Multicentre, randomised, double-blind, placebo-controlled study to assess the efficacy of duloxetine
Duration to 34 weeks open label treatment followed by up to 52 weeks of double-blind maintenance treatment
Dose Duloxetine: 60-120 mg/d
N Outpatients with at least 3 episodes of MDD (DSM-IV diagnosis) in the past 5 years. Patients meeting response criteria were eligible to enter the continuation phase of the study (n=413). Those that continued to meet response criteria after 24 weeks were eligible for entry into the double-blind maintenance phase (n=288).
Results Patients entering the maintenance phase on duloxetine had previously experienced an average of 4.4 episodes of depression with the average duration being 6.9 months. Time to a depressive recurrence was significantly longer in duloxetine-treated patients compared with placebo-treated patients (p<0.001). During the double-blind maintenance phase, 33.1% of placebo-treated patients experienced a depressive recurrence compared with 14.4% of duloxetine-treated patients (p<0.001)
Treatment of Patients in GAD
Study summary
Citation Koponen H, et al. Prim Care Companion J Clin Psychiatry 2007; 9(2): 100-107
Study Design Multicenter, randomised, double-blind, fixed-dose, placebo-controlled, parallel-group study to examine the efficacy and tolerability of duloxetine in patients with GAD.
Duration 9 weeks
Dose Duloxetine: 60-120 mg/d
N 513 patients with a primary diagnosis of DSM-IV-defined GAD
Results Both groups of duloxetine-treated patients demonstrated significantly greater improvements in anxiety symptom severity compared with placebo-treated patients as measured by HAM-A total score and HAM-A psychic and somatic anxiety factor scores (p values ranged from ≤0.01 to ≤0.001). Duloxetine-treated patients had greater functional improvements in Sheehan Disability Scale global and specific domain scores (p ≤0.001) than placebo-treated patients. Both duloxetine doses also resulted in significantly greater HAM-A response, remission, and sustained improvement rates compared with placebo (p values ranged from ≤0.01 to ≤0.001). The rate of study discontinuation due to adverse events was 11.3% for duloxetine 60 mg and 15.3% for duloxetine 120 mg vs 2.3% for placebo (p ≤0.001).
Study summary
Citation Rynn M, et al. Depress Anxiety 2008; 25(3): 182-9
Study Design Double-blind, progressive-titration, flexible-dose trial to study the efficacy and safety of duloxetine in the treatment of GAD
Duration 10 weeks.
Dose Duloxetine: 30-120 mg/d
N 327 adult outpatients with a DSM-IV-defined GAD diagnosis
Results Patients who received duloxetine treatment demonstrated significantly greater improvement in HAMA total scores (p=0.02); a higher response rate (p=0.03), and greater improvement (p=0.04) than patients who received placebo. Duloxetine-treated patients were also significantly more improved than placebo-treated patients on SDS global functional (p<0.01) and work, social, and family/home impairment scores (p<0.05). The rate of discontinuation due to adverse events (AEs) was higher for the duloxetine group compared with the placebo group (p=0.002). The AEs most frequently associated with duloxetine were nausea, dizziness, and somnolence.
Study summary
Citation Hartford J, et al. Int Clin Psychopharmacol 2007; 22(3): 167-74
Study Design Multicenter, randomised, double-blind, flexible-dose, placebo and active-controlled trial to examine the efficacy and tolerability of duloxetine for the treatment of patients with GAD.
Duration 10 weeks.
Dose Duloxetine: 60-120 mg/d; venlafaxine XR: 75-225 mg/d
N 487 patients with DSM-IV-defined GAD
Results Significantly greater improvement on the Hamilton Anxiety Rating Scale total score occurred in the duloxetine (p=0.007) and venlafaxine XR (p<0.001) groups compared with the placebo group. Overall discontinuation rates did not differ among the three groups, but adverse event-related discontinuation was significantly higher in the duloxetine (14.2%, p<0.001) and venlafaxine XR (11.0%, p=0.001) groups than in the placebo group (1.9%). During the 2-week drug-tapering phase, discontinuation-emergent adverse events were significantly greater in the venlafaxine XR group (26.9%, p=0.04), but not in the duloxetine group (19.4%, p=0.448) compared with placebo (15.8%).
Treatment of Patients to Relieve Pain Rapidly

There is no evidence that higher doses confer additional benefit, even in patients who do not respond to a 60 mg dose, and higher doses are associated with a higher rate of adverse events.

Study summary
Citation Goldstein DJ, et al. Pain 2005; 116(1-2): 109-18
Study Design Multicenter, double-blind study of duloxetine vs placebo.
Duration 12 weeks
Dose Duloxetine: 20 mg/d (20 mg QD), 60 mg/d (60 mg QD), 120 mg/d (60 mg BID) .
N 457 patients experiencing pain due to polyneuropathy caused by Type 1 or Type 2 diabetes mellitus
Results Duloxetine 60 and 120 mg/d demonstrated statistically significant greater improvement compared with placebo on the 24-h Average Pain Score, beginning 1 week after randomisation and continuing through the 12-week trial. Duloxetine also separated from placebo on nearly all the secondary measures including health-related outcome measures. Significantly more patients in all three active-treatment groups achieved a 50% reduction in the 24-h Average Pain Score compared with placebo. Duloxetine treatment was considered to be safe and well tolerated with less than 20 percent discontinuation due to adverse events.

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There is no evidence that higher doses confer additional benefit, even in patients who do not respond to a 60 mg dose, and higher doses are associated with a higher rate of adverse events.

Cymbalta

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HKGCYM2015-09-29T13_34_49




Last Update: 12 Oct 15

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