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Pooled data from three randomized, double-blind, multicenter trials were analyzed, in which patients with MDD were treated for 8 weeks with either escitalopram (n = 462) or an SNRI (n = 467).
Pharmacotherapy was instituted for PTTN patients and was based on widely accepted protocols for neuropathic pain and conducted in an open fashion. Outcome was assessed by employing prospective diaries recording pain intensity measured with an 11-point (0 to 10) verbal pain score (VPS). Individual characteristics in the patients and their influence on outcome were analyzed. Treatment results in the PTTN patients were compared with those in classical trigeminal neuralgia (CTN) patients, who were used as a comparative cohort. Data were analyzed with a Pearson chi-square test for nominal variables and with an independent samples t test or analysis of variance for continuous variables.
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Duloxetine hydrochloride ((S)-N-methyl-3-(1-naphthalenyloxy)-2-thiophenepropanamine hydrochloride) has been found to react with polymer degradation products or residual free acids present in the enteric polymers hydroxypropyl methylcellulose acetate succinate (HPMCAS) and hydroxypropyl methylcellulose phthalate (HPMCP) in dosage formulations to form succinamide and phthalamide impurities, respectively. The rate of formation of the impurities is accelerated by heat and humidity. The structures were deduced using molecular weights obtained from LC-MS experiments and confirmed by comparison of UV spectra, HPLC retention times, and electrospray mass spectra to independently synthesized material. It is proposed that polymer-bound succinic and phthalic substituents can be cleaved from the polymer, resulting in the formation of either the free acids or the anhydrides. It is postulated that the reaction is enabled by migration of either (1) the free acid or anhydride or (2) the parent drug through the formulation. The formation of these impurities was minimized by increasing the thickness of the physical barrier separating the enteric coating from the drug.
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A total of 2,136 patients (1,785 pregabalin and 351 duloxetine) were identified. No significant differences in gender, age, or pre-index Quan-Charlson comorbidity score were observed between the two cohorts. No significant differences (pregabalin vs. duloxetine) in pre-index to post-index change in mean all-cause health care costs ($1,411 vs. $1,560, P = 0.93) or mean pDPN-related health care costs ($704 vs. -$240, P = 0.22) were found. The DiD models showed no significant difference in all-cause (mean) costs attributable to pregabalin vs. duloxetine therapy between pre-index and post-index periods (mean cost ratio = 0.97, 95% CI: 0.75 to 1.26), but showed that patients receiving pregabalin had a significantly higher increase in pDPN-related costs compared with patients receiving duloxetine (mean cost ratio = 2.35, 95% CI: 1.01 to 5.46). However, the difference (pre- to post-index) in pDPN-related costs attributable to pregabalin vs. duloxetine therapy was nonsignificant (mean cost ratio = 2.30, 95% CI: 0.93 to 5.68) in a sensitivity analysis in which patients with depression and GAD were excluded from both cohorts.
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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.
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In the medication of depression, the antidepressants such as selective 5-HT reuptake inhibitors (SSRIs) and a 5-HT and NA reuptake inhibitor (SNRI) are mainly in use in Japan. However, remission rates for SSRI or SNRI are 60% or less. This means that there are still many patients with treatment-resistant depression (TRD). Meanwhile it is considered that the DA nerve system plays an important role for recovery from troublesome feelings and a sense of aimlessness in life in patients with TRD. Recently, new generation antidepressants under development in Japan (escitalopram, duloxetine, mirtazapine, and bupropion) are expected as an option in the medical treatment of TRD. We introduce the pharmacological (focusing on the DA nerve system) and clinical data on these new antidepressants and their putative positioning of each antidepressant. Escitalopram is a stronger and safer SSRI with an earlier onset of action. The antidepressant effect of duloxetine is considered stronger than that of other SNRIs. Mirtazapine is an antagonist of alpha2, 5-HT2A, and 5-HT2C receptors and promotes releases of NA, 5-HT, and DA. Clinically, mirtazapine shows an earlier onset of action and a sedative effect. Bupropion is a DA and NA reuptake inhibitor, and is considered useful to activate DA neurons.
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75 adult patients with DSM-IV major depressive disorder, recruited from psychiatric wards, psychiatric specialist practices, or general medical practices between September 2005 and August 2008, were randomly assigned to a 9-week chronotherapeutic intervention using wake therapy, bright light therapy, and sleep time stabilization (n = 37) or a 9-week intervention using daily exercise (n = 38). Patients were evaluated at a psychiatric research unit. The study period had a 1-week run-in phase in which all patients began treatment with duloxetine. This phase was followed by a 1-week intervention phase in which patients in the wake therapy group did 3 wake therapies in combination with daily morning light therapy and sleep time stabilization and patients in the exercise group began daily exercise. This phase was followed by a 7-week continuation phase with daily light therapy and sleep time stabilization or daily exercise. The 17-item Hamilton Depression Rating Scale was the primary outcome measure, and the assessors were blinded to patients' treatment allocation.
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This post-hoc analysis was conducted to investigate if safety outcomes differed among race/ethnic subgroups of patients treated with duloxetine for chronic painful conditions.
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Our results (n = 19) show enhanced ventral striatal responses after duloxetine administration compared with placebo. Moreover, this increase in ventral striatal activity was positively correlated with duloxetine plasma levels.
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To determine the clinically relevant reference points for the Incontinence Quality of Life (I-QOL) questionnaire scores in women with stress urinary incontinence and compare them with the treatment effects observed with duloxetine and placebo.
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Fluoxetine was not statistically different in either tolerability or efficacy when compared with duloxetine. Venlafaxine was significantly superior to duloxetine in all analyses except dropout rate. In the absence of relevant data from head-to-head comparison trials, results suggest that venlafaxine is superior compared with duloxetine and that duloxetine does not differentiate from fluoxetine.
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For efficacy, randomized controlled trials (RCTs) comparing duloxetine with placebo or second-generation antidepressants were included. For safety, both experimental and observational studies were eligible.
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To evaluate the maintenance of effect of duloxetine 60 mg QD over 26 weeks in patients with diabetic peripheral neuropathic pain (DPNP).
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The epidemiology and treatment of mixed incontinence has received relatively little attention. However, mixed incontinence--defined as the combination of stress and urge incontinence accounts for approximately 33% of all cases of incontinence in women. The condition often responds poorly to treatment, either pharmacologic or surgical. Potential pharmacologic approaches for mixed incontinence include antimuscarinic agents, estrogen replacement therapy (for postmenopausal women), and dopamine, serotonin, or norepinephrine reuptake inhibitors. In a large-scale, multinational, placebo-controlled, clinical trial, the antimuscarinic agent tolterodine significantly reduced incontinence episodes in women with mixed symptoms. The benefits of tolterodine continued to increase during the 8 weeks of the trial and extended to additional end points, including frequency, urgency, and urge incontinence. A limited number of studies have examined the use of estrogen for mixed incontinence and have produced conflicting results. Duloxetine oxalate, a combined serotonin/norepinephrine reuptake inhibitor, has shown great promise in animal studies, as well as in phase 2 and 3 clinical trials. This agent is the first to demonstrate efficacy as a sole therapy for stress incontinence and has exhibited favorable effects on bladder capacity, suggesting possible benefits in mixed incontinence. Only five studies (two of which were conducted during the 1980s) have specifically examined the use of surgery for the treatment of mixed incontinence; the cure rates reported have varied. The current body of information supports use of an antimuscarinic agent as initial therapy for mixed incontinence, although long-term trials are needed to shed more light on the duration of benefit.
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Microspheres constitute an important part of oral drug delivery system by virtue of their small size and efficient carrier capacity. However, the success of these microspheres is limited due to their short residence time at the site of absorption.
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Selective literature review.
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To estimate the minimum clinically important difference (MCID) for several pain measures obtained from the Brief Pain Inventory (BPI) for patients with fibromyalgia.
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We selected all randomised or quasi-randomised trials of any formulation of duloxetine, used for the treatment of painful peripheral neuropathy or chronic pain in adult participants.
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The mean (SD) of baseline TSH serum levels was 1.55 (0.86) mIU/L (median: 1.35; interquartile range: [0.92-1.94]). No significant treatment-by-TSH quartile interaction was evidenced in change from baseline, response, nor remission, indicating that the magnitude of duloxetine's treatment effects did not differ significantly between TSH quartiles. No significant difference in time to response was evidenced between any of the quartiles.
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To evaluate the efficacy and safety of duloxetine 30 mg/d in adults with fibromyalgia.
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Disorders of oxidative phosphorylation affects 1/5000 individuals and present heterogeneous involvement of tissues highly dependent upon ATP production.
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Adults (N = 611) with MDD were randomized to 8 weeks of double-blind treatment with placebo, vortioxetine (2.5 or 5 mg) or active reference (duloxetine 60 mg). The primary measure was change from baseline in the 24-item Hamilton Depression Scale (HAM-D24). Secondary endpoints included responder rate, Clinical Global Impression Scale-Global Improvement scale (CGI-I), and remission rate. Participants were monitored for adverse events (AEs), and treatment-emergent sexual dysfunction using the Arizona Sexual Experiences (ASEX) scale.
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These distinct morphologic changes associated with nitrofurantoin have not been previously reported to our knowledge. Skin biopsy appears to be helpful in confirming the diagnosis in these patients.
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The purpose of this study has been to assess the efficacy of duloxetine, a selective inhibitor of serotonin and norepinephrine reuptake, in the treatment of stress urinary incontinence (SUI) in women.
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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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This study evaluated the pharmacodynamics and pharmacokinetics of once-daily dosing of warfarin at steady state when taken concomitantly with once-daily doses of duloxetine. Healthy subjects with a stable international normalized ratio (INR) of 1.5 to 2.0 on an individualized fixed dose of warfarin (2-9 mg) in period 1 received daily warfarin and duloxetine (60 mg for 14 days [n = 15] or 60 mg for 4 days, then 120 mg for 10 days [n = 15]) in period 2. Across the 14-day period when warfarin was coadministered with duloxetine, the least squares mean INR changes from baseline (warfarin alone) ranged from -0.05 to +0.07, and the 90% confidence intervals ranged from -0.12 to +0.14. Following coadministration of warfarin with 60 mg duloxetine, but not with 120 mg duloxetine, there was a statistically significant prolongation in bleeding time compared to warfarin alone. For both R- and S-warfarin, the 90% confidence interval for the geometric mean ratios of area under the curve (AUC(tau,ss)) and maximum plasma concentrations (C(max,ss)) between warfarin administered alone and with 60 or 120 mg duloxetine were contained within the bioequivalence limits of 0.8 to 1.25. In conclusion, duloxetine had no clinically or statistically significant effect on the pharmacodynamics or pharmacokinetics of warfarin at steady state.