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Approximately 50% of postmenopausal women with hormone receptor-positive early stage breast cancer treated with an aromatase inhibitor (AI) develop musculoskeletal symptoms. Standard analgesics are relatively ineffective. Duloxetine is a serotonin norepinephrine reuptake inhibitor with proven efficacy for treatment of multiple chronic pain states. The authors investigated the hypothesis that duloxetine is efficacious for treatment of AI-associated musculoskeletal symptoms.
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Data were obtained from 8 trials evaluating 1754 patients for efficacy and 1791 patients for discontinuation/safety. Venlafaxine-XR rates were 17.8% (95% CI 9.0 to 26.5) and 24.4% (95% CI 15.0 to 37.7) greater than those with placebo for remission and response compared with 14.2% (95% CI 8.9 to 26.5) and 18.6% (95% CI 13.0 to 24.2) for duloxetine. Although numerically higher for venlafaxine-XR, no statistically significant differences were found between the drugs; however, both demonstrated overall remission and response rates significantly higher than the rates achieved with placebo (p < 0.001). Reported adverse events were comparable between drugs.
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A simple and rapid HPLC method is developed for the determination of two serotonin-norepinephrine-reuptake inhibitors (duloxetine and venlaflaxine) and two selective serotonin-reuptake inhibitors (fluoxetine and paroxetine) in human biofluids. Separation was performed on an Inertsil ODS-3 column (250 x 4.0 mm, 5 µm) with acetonitrile-ammonium acetate (0.05 M, 41:59 v/v) at 235 nm, within 7 min. SPE on Oasis(®) HLB cartridges was applied for the isolation of analytes from biofluids. The developed methodology was validated in terms of sensitivity, linearity, accuracy, precision, stability and selectivity. Relative standard deviation was less than 10.4%. Limit of detection was 0.2-0.6 ng/µl in blood plasma and 0.1-0.8 ng/µl in urine. The method was successfully applied to biofluids from a patient under duloxetine treatment.
This analysis is based on 10 placebo-controlled, randomized, double-blind trials of duloxetine (40-60mg/day) for treatment of MDD from baseline up to week 8. Remission was defined as a HAM-D17 total score ≤7 at week 8 (last observation carried forward). Trajectories of HAM-D17 items were assessed by mixed model repeated measures analysis for treatment and remitter-nonremitter comparisons. Grouping of the trajectories was performed by factor analysis. Predictor analysis using HAM-D17 items was conducted by logistic regression.
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A total of 55 AS patients with concurrent depression disorders were randomized into treatment and control groups. Both were given conventional therapy of AS while duloxetine was administered in treatment group. Bath ankylosing spondylitis disease activity index (BASDAI), functional Index (BASFI) and metrology Index (BASMI), spinal pain, self-rating anxiety scale (SAS), self-rating depression scale (SDS) and Hamilton depression scale (HAMD) were recorded before and Weeks 4 and 8 weeks post-treatment.
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Frequency/discontinuations due to treatment-emergent adverse events (TEAEs).
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The aim of this study was to examine the association between duloxetine adherence/persistence and hospital utilization. In a managed care claims database, 8521 patients with a major depressive disorder diagnosis were initiated on duloxetine in 2006. Patients had no active duloxetine prescription for 6 months before initiation and had continuous enrollment for 12 months preinitiation and postinitiation. Adherence was defined as medication possession ratio of 0.8 or more, and persistence was defined as the duration of therapy without exceeding a 30-day gap. Logistic regression and negative binominal regression were conducted. Overall, 55.8% of patients were adherent and the average duration of duloxetine therapy was 118.4 days within 6 months after initiation. Adherent patients had significantly lower rates of hospitalization (19.7 vs. 23.4%, P<0.0001) and emergency room visits (30.6 vs. 36.9%, P<0.0001) than nonadherent patients. Hospitalization and emergency room visits were significantly reduced with treatment persistence (P<0.0001). After adjustment for demographics, comorbidities, and prior hospitalization, adherence was associated with reduced hospitalization (odds ratio=0.86) and emergency room visits (odds ratio=0.80). Patients on duloxetine of more than 90 days, compared with less than 31 days, were 16% less likely to be hospitalized and 22% less likely to have emergency room visits. Duloxetine adherence and persistence appear to be associated with reduced hospital utilization in the 1-year follow-up period.
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To identify, from the Mexican Public Health System perspective, which would be the most cost-effective treatment for patients with Fibromyalgia (FM).
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To review the use of duloxetine, a new selective serotonin and norepinephrine reuptake inhibitor (SNRI), and other antidepressants in the treatment of patients with fibromyalgia.
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This study was aimed at determining the effect of duloxetine (a serotonin-norepinephrine reuptake inhibitor) on pudendal inhibition of bladder overactivity. Cystometrograms were performed on 15 cats under α-chloralose anesthesia by infusing saline and then 0.25% acetic acid (AA) to induce bladder overactivity. To inhibit bladder overactivity, pudendal nerve stimulation (PNS) at 5 Hz was applied to the right pudendal nerve at two and four times the threshold (T) intensity for inducing anal twitch. Duloxetine (0.03-3 mg/kg) was administered intravenously to determine the effect on PNS inhibition. AA irritation significantly (P < 0.01) reduced bladder capacity to 27.9 ± 4.6% of saline control capacity. PNS alone at both 2T and 4T significantly (P < 0.01) inhibited bladder overactivity and increased bladder capacity to 83.6 ± 7.6% and 87.5 ± 7.7% of saline control, respectively. Duloxetine at low doses (0.03-0.3 mg/kg) caused a significant reduction in PNS inhibition without changing bladder capacity. However, at high doses (1-3 mg/kg) duloxetine significantly increased bladder capacity but still failed to enhance PNS inhibition. WAY100635 (N-[2-[4-(2-methoxyphenyl)-1-piperazinyl]ethyl]-N-(2-pyridyl)cyclohexanecarboxamide; a 5-HT1A receptor antagonist, 0.5-1 mg/kg i.v.) reversed the suppressive effect of duloxetine on PNS inhibition and significantly (P < 0.05) increased the inhibitory effect of duloxetine on bladder overactivity but did not enhance the effect of PNS. These results indicate that activation of 5-HT1A autoreceptors on the serotonergic neurons in the raphe nucleus may suppress duloxetine and PNS inhibition, suggesting that the coadministration of a 5-HT1A antagonist drug might be useful in enhancing the efficacy of duloxetine alone and/or the additive effect of PNS-duloxetine combination for the treatment of overactive bladder symptoms.
Higher levels of pain severity and depressive symptoms and a US geographical location were significant predictors of relapse in patients with MDD.
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Antidepressants may have an impact on the course of eye dryness. The aim of this study was to investigate the effects of commonly used new antidepressants on eye wetting. Fifty-four patients using new antidepressants and 57 controls were recruited. The Beck Depression Scale and Beck Anxiety Scale questionnaires were completed by the patients, and drug use time and dosages were recorded. The Schirmer test was performed without prior instillation of topical anesthesia to the ocular surface, and the wetting result was recorded for each eye. Escitalopram, duloxetine, and venlafaxine were used by 27, 13, and 14 patients, respectively. The Schirmer test results in the patients were significantly lower than in the controls (P < 0.001). The patients using selective serotonin reuptake inhibitors (SSRIs) displayed lower wetting measurements (≤5 mm) compared with those using serotonin-norepinephrine reuptake inhibitors, which was independent of the duration of antidepressant usage (P < 0.05). Although SSRIs do not have anticholinergic adverse effects except paroxetine, we found that both SSRIs and serotonin-norepinephrine reuptake inhibitors increased the risk for eye dryness. The lower Schirmer test results of the SSRIs may be associated with a mechanism other than the anticholinergic system. An awareness of the drugs that contribute to dry eye will allow ophthalmologists, optometrists, and other physicians to better manage patients who have this problem.
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To provide detailed information on the adverse events associated with duloxetine and to identify differences in the adverse event profile between treatment indications and patient demographic subgroups.
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This article examines the time course for minimal clinically significant improvement in pain severity in duloxetine-treated patients with fibromyalgia. It provides information about continued treatment in patients who do not initially respond to duloxetine. This information could potentially help physicians facing clinical decisions about management of fibromyalgia with duloxetine.
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The Arizona Sexual Experience Scale (ASEX) was used to assess sexual functioning.
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65 subjects were enrolled, of whom 57 began medication. They ranged in age from 19 to 70 years (mean ± SD = 41.63 ± 11.22) and included 24 women and 33 men. Baseline 24-item HDRS score (mean ± SD) for both groups was 20.75 ± 4.92. After 10 weeks, duloxetine-treated subjects had significantly lower 24-item HDRS scores than placebo-treated subjects (time-by-drug group effect on analysis of variance: F1,55 = 9.43, P = .003). Responder and remitter analyses significantly favored duloxetine treatment. The response rate was 65.5% for duloxetine versus 25.0% for placebo (χ(2)(1) = 9.43, P = .003); and the remitter rate was 55.2% for duloxetine versus 14.3% for placebo (χ(2)(1) = 10.46, P = .002). After 10 weeks, duloxetine-treated subjects did not differ significantly better from placebo-treated subjects on the SAS (time-by-drug group effect on analysis of variance: F(1,46) = 0.35, P = .555) or on the GAF (time-by-drug group effect on analysis of variance: F(1,51) = .01, P = .922).
Duloxetine increased the maximum plasma concentration of desipramine 1.7-fold and the area under the concentration-time curve 2.9-fold. Paroxetine increased the maximum plasma concentration of duloxetine and the area under the concentration-time curve at steady state 1.6-fold. Reports of adverse events were similar whether duloxetine was administered alone or in combination with desipramine or paroxetine.
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Response data for TCAs are limited to 30% improvement levels, reported trials are small, and have low placebo response rates. The model necessarily assumes that response rates are independent of placement in the treatment sequence.
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Twenty-three patients with PD with painful phenomena were treated with duloxetine for 6 weeks in an open-label design. Assessments were performed before and at treatment completion and consisted of a Visual Analogue Scale, the Brief Pain Inventory, Short-Form McGill Pain Questionnaire, Parkinson Disease Quality of Life Questionnaire-39-item version, and motor part of the Unified Parkinson Disease Rating Scale. Pain threshold was assessed by quantitative sensory tests.
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Duloxetine hydrochloride (1) is an important antidepressant that acts as a serotonin and noradrenaline reuptake inhibitor that has only recently been characterized by single-crystal X-ray diffraction. This study describes an investigation into polymorphism of duloxetine hydrochloride, discusses the challenges of characterizing new structures, and reports a new metastable solvate (1(acetone)) where acetone is trapped in a duloxetine hydrochloride host lattice. In view of the importance of formulation processing and bioavailability characteristics of the crystalline forms of 1, a comprehensive structural study of 1(acetone) was carried out using single-crystal and powder X-ray diffraction, infrared and Raman spectroscopies, and solid-state NMR spectroscopy. The rapid desolvation from 1(acetone) to the stable unsolvated form was investigated, and the structures of free and solvated forms are discussed in terms of the noncovalent intermolecular interactions.
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Duloxetine was more effective but less well-tolerated than vortioxetine in MDD. Considering the potential limitations of this meta-analysis, more large-scale RCTs are needed to confirm these findings.
Because of lower costs, CBT is the most cost-effective treatment for adult FM patients. Implementation in routine medical care would require policymakers to develop more-widespread public access to trained and experienced therapists in group-based forms of CBT.
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Ipsilateral SC injections (2 mg/0.4 mL) of R-duloxetine and N-methyl duloxetine reduced both postoperative allodynia and hyperalgesia by approximately 89% to 99% in the area under the curve of skin responses next to incision over 5 days. Systemic intraperitoneal injections at a higher dosage (10 mg) had smaller analgesic effects (reduced by approximately 53%-69%), whereas contralateral SC injections (10 mg) were ineffective. Both R-duloxetine and N-methyl duloxetine blocked neuronal Na⁺ currents, with a higher affinity for the inactivated than the resting states. In addition, both drugs elicited significant use-dependent block of Na currents when stimulated at 5 Hz.
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Mean Q(max) values increased from baseline in escitalopram-treated subjects and decreased in duloxetine-treated subjects. The maximum difference in treatment effect was observed after 2 days of treatment and was statistically significant (4.27 mL/sec, 95% CI 1.14-7.39, p = 0.009). Similar results were obtained with TQ(max). There were no significant differences between treatments in other urinary flow measures or urinary symptoms. Urinary flow measures reverted towards baseline values after stopping treatment. There were no treatment-related adverse events.
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To outline, deriving them from the literature review, the SUI therapeutic implications of SNRI (serotonin-noradrenaline reuptake inhibitors) particularly of the duloxetine, though displaying its full therapeutic dose (40 mg twice/day)-related side effects and, therefore, highlighting recent issues concerning novel drug administration modalities to avoid such adverse events. EMERGING KNOWLEDGES: Intriguing studies in SUI animal models have shown that co-administration of duloxetine low dose with α 2-adrenoceptor antagonists - given the α 2-adrenoceptor inhibition-induced enhancement of duloxetine effectiveness on the urethral rhabdospincter-can avoid the duloxetine-related adverse events though perspectively reaching, in perspective translational clinical applications, the awaited beneficial effects for women suffering from intrinsic rhabdosphincter deficiency-based mild-to-moderate SUI as well as, in men, to treat post-prostatectomy mild SUI.
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Although frequently used in antidepressant trials, the analysis and reporting of results is virtually non-existent. It remains unclear if QoL measurement, as currently used, gives any information that is not already captured by more formal depression rating scales. The question then remains whether QoL measurement in antidepressant trials has any added value and, if so, whether this is just a story of missed opportunities.
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Single-nucleotide and diplotype associations with 17-item Hamilton Depression Rating Scale (HAMD(17)) total score changes were examined, based on catechol-O-methyltransferase (COMT) rs165599 status in duloxetine-treated, self-identified white patients with major depressive disorder. COMT rs165737 and a diplotype containing COMT rs165599 and COMT rs165737 were associated with HAMD(17) total score changes.
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The purpose of our study was to examine dosing patterns and pretreatment predictors of high-dose duloxetine therapy for patients with MDD in the usual clinical setting.
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Higher performance in alertness and divided attention at baseline correlated with less severe depression at week 6. During the first week of treatment, a greater increase in sBDNF was associated with a greater improvement in alertness at week 6.