To investigate whether propiverine has a noradrenaline re-uptake inhibitor and whether it acts on the lumbosacral cord or the urethral wall. In addition, we aimed to examine the effect of propiverine on leak point pressure in rats.
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Using as reference the work of the First Consultation on Incontinence (Montecarlo, 1999), the previous and later publications about T.A. have been reviewed, including experimental (isometric and "in vivo" studies) and clinical studies, investigating on pharmacological evidences, mechanism of action, tolerance and other effects of T.A.
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Overall, duloxetine 60 mg/day demonstrated significantly greater improvement compared with placebo for the composite cognitive score, GDS and HAMD17 total scores, CGI-Severity, HAMD17 response and remission rates, and some of the SF-36 and VAS measures. There were few significant treatment-by-comorbidity subgroup interactions for these efficacy variables, or for adverse events reported as the reason for discontinuation and common TEAEs.
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To evaluate the effectiveness and safety of duloxetine for the treatment of African-American and Hispanic women with stress urinary incontinence.
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High prolactin hormone level in the blood is known as hyperprolactinemia. The most common symptom of hyperprolactinemia is galactorrhea, in which spontaneous milky discharge is seen from all ducts of the 2 mammary glands. Galactorrhea occurs due to different medical conditions, including the use of antidepressant medications. Herein we report a hyperprolactinemia case with galactorrhea due to duloxetine treatment for depression.
Clinical study reports, including protocols as appendices (total 13,729 pages), were obtained from the EMA in May 2011. Journal articles were identified through relevant literature databases and contacting the manufacturer, Eli Lilly. Clinicaltrials.gov and the manufacturer's online clinical trial registry were searched for trial results.
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Double-blind, placebo-controlled clinical trials have evaluated and demonstrated the efficacy of duloxetine as an antidepressant in patients with major depressive disorders. The drug has been noted to be well tolerated and effective in the control of depressive symptoms. In addition, duloxetine has been shown to be better than placebo and as effective as paroxetine as an antidepressant and also better than placebo for reducing pain in both experimental models and patients. Duloxetine is a safe and well-tolerated new treatment option for depression including anxiety and painful physical symptoms. Furthermore, duloxetine has proven robust efficacy in stress urinary incontinence.
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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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Manic switching during antidepressant treatment has been reported with every class of antidepressant drugs. Serotonin-noradrenaline reuptake inhibitors (SNRIs) have been increasingly used for the treatment of unipolar and bipolar depression and are well tolerated and sufficiently effective because of their dual mechanism of action. A case of duloxetine-induced hypomania in a non-bipolar patient is presented, and a brief review of all cases of SNRIs' induced mania and hypomania has been carried out. The available data suggest that SNRIs, especially venlafaxine, can induce mood switching in patients with bipolar depression and in certain patients with unipolar depression, but the potential of duloxetine and milnacipran to induce manic or hypomanic symptoms cannot be disregarded. Switching appears to be dose-related and treatment initiation with lower doses and upward titration when needed may be preferable in selected cases and may help minimizing the risk of mood switching.
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Duloxetine is feasible in treating chronic OIPN with tolerable toxicity at a daily dose of 60 mg/day.
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The electronic medical and pharmacy records from January 2004 to December 2008 were requested from the Veterans Integrated Service Network 16 data warehouse. All select patients received either duloxetine or other treatments [tricyclic antidepressants (TCAs), venlafaxine, gabapentin, and pregabalin] over the study period, with the first dispense date of the index agent as the index date. All patients must have 1(+) prior DPNP diagnosis (ICD-9-CM: 250.6x or 357.2), but no diagnoses of prior depression (ICD-9-CM: 296.2, 296.3, 300.4, 309.1, or 311.0), fibromyalgia (ICD-9-CM: 729.1), or neuralgia (ICD-9-CM: 729.2). Logistic regression was used to examine the predictors of receiving duloxetine versus other treatments, controlling for demographics, comorbidities, prior pain level, prior use of other medications, and opioid use.
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The study sample was selected from a US privately insured claims database (2004-8). Selected patients were aged 18-64 years, and had a low back pain (LBP) diagnosis (per Healthcare Effectiveness Data and Information Set [HEDIS] specifications) with a subsequent CLBP-qualifying diagnosis recorded ≥90 days after the initial LBP diagnosis. Duloxetine-treated patients had ≥1 duloxetine prescription within 6 months after CLBP diagnosis, no prior duloxetine claim, and continuous eligibility ≥12 months before first LBP diagnosis and ≥6 months after index duloxetine prescription (study period). Because duloxetine patients had higher rates of co-morbidities, 553 duloxetine-treated patients were matched to 553 control patients who initiated another non-surgical LBP treatment based on propensity score and time from first LBP diagnosis to treatment initiation. A subset (n = 103 each) of matched employees with disability data was also analysed to assess work loss. Main outcomes measures included study period treatment rates and direct (medical and drug) costs from a third-party payer perspective and employee indirect (work-loss) costs. McNemar tests were used to compare LBP treatment rates. Bias-corrected bootstrapping t-tests were used to compare costs.
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Employees (18-64 years old) with a DPN diagnosis and at least one pDPN-related pain medication claim were identified using the MarketScan Commercial Database (2005-2008). Propensity scored matched pregabalin and duloxetine new starts were evaluated in the 6-month pre- and 6-month post-initiation periods. Study outcomes including imputed medically-related work loss, prescription and healthcare utilization, and associated expenditures were analyzed using univariate statistics and multivariate models in a difference-in-difference approach.
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Duloxetine has an acceptable safety profile. Dose escalation combined with patient counselling on the intensity and transient nature of adverse effects may help to further improve the benefit/tolerability ratio of duloxetine in the treatment of SUI.
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Clinicians should be aware of the possibility of clinically significant tachycardia in patients receiving duloxetine, even in low doses.
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Dysfunction of the serotonergic system is implicated in the etiology of many psychiatric disorders, including major depression. Major vulnerability genes for mood disorders are also related to the serotonergic system: one of these genes encodes for the serotonin transporter (SERT), which represent a major target for the action of antidepressant drugs. We have demonstrated recently that SERT knockout (KO) rats, generated by N-ethyl-N-nitrosourea-induced mutagenesis, show reduced expression of the neurotrophin brain-derived neurotrophic factor (BDNF) in the hippocampus and prefrontal cortex, suggesting that depression vulnerability can be associated with impaired neuronal plasticity. In the present study, we demonstrate that chronic treatment with the antidepressant duloxetine (DLX) was able to normalize the expression of BDNF mRNA-coding exon (IX) in the hippocampus and prefrontal cortex of SERT KO rats through the modulation of selected neurotrophin transcripts, whose expression was up-regulated by DLX only in SERT KO rats. On the other hand, the modulation of BDNF protein by DLX in frontal cortex was abolished in mutant rats. These data suggest that animals with a genetic defect of the serotonin transporter maintain the ability to show neuroplastic changes in response to antidepressant drugs. Because these animals show depression-like behavior, the region and isoform-specific increase of BDNF levels may be a mechanism activated by long-term antidepressant treatment to restore normal plasticity that is defective under genetic dysfunction of the serotonin transporter.
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Duloxetine is a selective serotonin-noradrenaline reuptake inhibitor approved for treatment of major depressive disorder. So far, duloxetine has been found to be well tolerated and reported cardiac side effects were negligible. However, pharmacological effects on cardiac hERG channels have not been properly addressed yet. hERG channels were expressed in Xenopus oocytes and a human embryonic kidney (HEK) cell line. Currents were measured using voltage clamp and patch clamp techniques. Channel surface expression was quantified using Western blot analysis. We found that duloxetine inhibits heterologously expressed hERG channels in a concentration-dependent manner, yielding an IC50 of 142.8 μM in Xenopus oocytes. Inhibitory effects were even more pronounced when using a mammalian cell line resulting in a 34 or 59% current decrease by 10 or 30 μM duloxetine, respectively. Duloxetine did not affect channel activation or inactivation kinetics. However, channel deactivation was accelerated by duloxetine. We further showed that inhibition occurs in the open and inactivated, but not closed, states. There was no frequency dependence of block. However, effects of duloxetine were significantly attenuated when using the hERG pore mutants Y652A and F656A. Subacute effects of duloxetine on hERG channel expression were analyzed using the Western blot technique. We found that incubation with duloxetine results in a concentration-dependent decrease of channel surface expression. Whereas inhibitory effects of duloxetine seem negligible under therapeutically relevant concentrations, hERG block should be considered in cases of duloxetine overdose and when administering duloxetine to patients susceptible to drug-induced QT prolongation.
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Comparative effectiveness study.
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The mean baseline IEF was 18.4/week; 55% of patients had a baseline IEF of > or = 14. There was a significantly greater median decrease in IEF with duloxetine with placebo (54% vs 40%, P = 0.05), with comparable significant improvements in quality of life (I-QOL score increases of 10.3 vs 6.4, P = 0.007). The improvements with duloxetine were associated with significantly greater increases in voiding intervals than with placebo (20.4 vs 8.5 min, P < 0.001). The placebo response was 10.7% and 12.5% higher than those reported in two European and North American phase 3 trials. This may have been related to more patients being naïve for incontinence management in the current trial. Discontinuation rates for adverse events were 1.7% for placebo and 17.2% for duloxetine (P < 0.001), with nausea being the most common reason for discontinuation (3.1%); it was the most common adverse event with duloxetine, but was mild or moderate in most (81%), did not worsen in any patient and resolved within 7 days in 60% and within 1 month in 86% of continuing patients; 88% of women who experienced nausea while taking duloxetine completed the trial.
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A cost-utility analysis was performed enhancing the Markov model from the 2008 OA guidelines of the National Institute for Health and Clinical Excellence (NICE). The NICE model was extended to include opioid and antidepressant comparators, adding titration, discontinuation, and relevant adverse events (AEs). Comparators included duloxetine, celecoxib, diclofenac, naproxen, hydromorphone, and oxycodone extended release (oxycodone). AEs included gastrointestinal and cardiovascular events associated with nonsteroidal antiinflammatory drugs (NSAIDs), as well as fracture, opioid abuse, and constipation, among others. Costs and incremental cost-effectiveness ratios (ICERs) were estimated in 2011 Canadian dollars. The base case modeled a cohort of 55-year-old patients with OA for a 12-month period of treatment, followed by treatment from a basket of post-discontinuation oral therapies until death. Sensitivity analyses (one-way and probabilistic) were conducted.
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While emotional symptoms such as depressed mood and loss of interest have traditionally been considered to constitute the core symptoms of major depressive disorder (MDD), the prevalence and importance of painful physical symptoms such as back pain, abdominal pain, and musculoskeletal pain is becoming increasingly appreciated. Antidepressants possessing dual serotonin/norepinephrine (5-HT/NE) reuptake inhibition may demonstrate greater efficacy in the alleviation of pain. The efficacy of duloxetine, a balanced and potent dual reuptake inhibitor of 5-HT and NE, was evaluated within a cohort of depressed patients with associated painful physical symptoms.
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A total of 524 patients randomly received duloxetine 60/120 mg/day (N = 264) or placebo (N = 260). In total, 74% of the patients completed the study. Mean age was 61 years (SD 9.2), 57% were female, and 81% were white. Duloxetine-treated patients had significantly greater pain reduction at week 8 (p < 0.001) than placebo-treated patients. In addition, relative to placebo at week 8, duloxetine-treated patients had significant improvements in physical function as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (p < 0.001), and Patient Global Impression of Improvement (p < 0.001). Compared to placebo, significantly more nausea, dry mouth, constipation, fatigue and decreased appetite were reported by patients taking duloxetine (each p < 0.05). Discontinuation due to adverse events occurred more commonly in the duloxetine group than the placebo group (p = 0.03).
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The clinical and EEG data of a 49-year-old man with myoclonic and generalized tonic-clonic seizures resulting from early childhood encephalitis are described. He experienced no tonic-clonic seizure for 10 years before brief exposure first to 60 mg/day duloxetine and then to 20mg/day paroxetine for depressive symptoms. These drugs were separately prescribed at a 9-month interval, and after beginning each drug, the patient experienced tonic-clonic seizures of worsening intensity and myoclonus of increasing frequency. Clinical features correlated with subcontinuous, generalized spike-wave discharges on the EEG. Discontinuation of antidepressant treatment resulted in rapid disappearance of clinical and electrophysiological manifestations of myoclonic status. We suggest care must be taken when using serotonin-noradrenaline reuptake inhibitors (SNRIs) or selective serotonin reuptake inhibitors (SSRIs), as these drugs pose the risk of complications in the specific population of people with myoclonic seizures.