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Latest & greatest articles for duloxetine
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Duloxetine and Subacute Pain after Knee Arthroplasty when Added to a Multimodal Analgesic Regimen: A Randomized, Placebo-controlled, Triple-blinded Trial Duloxetine is effective for chronic musculoskeletal and neuropathic pain, but there are insufficient data to recommend the use of antidepressants for postoperative pain. The authors hypothesized that administration of duloxetine for 15 days would reduce pain with ambulation at 2 weeks after total knee arthroplasty.In this triple-blinded (...) , randomized, placebo-controlled trial, patients received either duloxetine or placebo for 15 days, starting from the day of surgery. Patients also received a comprehensive multimodal analgesic regimen including neuraxial anesthesia, epidural analgesia, an adductor canal block, meloxicam, and oxycodone/acetaminophen as needed. The primary outcome was the pain score (0 to 10 numeric rating scale) with ambulation on postoperative day 14.One hundred six patients were randomized and analyzed. On day 14
Perioperative Duloxetine to Improve Postoperative Recovery After Abdominal Hysterectomy: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Study Postsurgical quality of recovery is worse in female than that in male patients. Duloxetine has been used successfully for the treatment of chronic pain conditions, but its use for preventing acute postoperative pain has been limited to a single previous study. More importantly, the effect of preoperative duloxetine on global postoperative (...) quality of recovery has yet to be evaluated. The main objective of the current investigation was to evaluate the effect of perioperative duloxetine on postoperative quality of recovery in women undergoing abdominal hysterectomy.The study was a prospective, randomized, placebo-controlled, double-blinded trial. Female patients undergoing abdominal hysterectomy were randomized to receive duloxetine (60 mg orally 2 hours before surgery and 24 hours after surgery) or an identical placebo pill. The primary
Duloxetine Mylan 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/contact 23 April 2015 EMA/CHMP/238550/2015 Committee for Medicinal Products for Human Use (CHMP) Assessment report Duloxetine Mylan International non-proprietary name: duloxetine Procedure No. EMEA/H/C/003981 Note Assessment report as adopted by the CHMP with all (...) /2015 Page 4/24 1. Background information on the procedure 1.1. Submission of the dossier The applicant Generics (UK) Limited submitted on 18 August 2014 an application for Marketing Authorisation to the European Medicines Agency (EMA) for Duloxetine Mylan, through the centralised procedure under Article 3 (3) of Regulation (EC) No. 726/2004– ‘Generic of a centrally authorised product’. The eligibility to the centralised procedure was agreed upon by the EMA/CHMP on 20 March 2014 The application
Duloxetine Zentiva 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/contact 25 June 2015 EMA/CHMP/373461/2015 Committee for Medicinal Products for Human Use (CHMP) Assessment report Duloxetine Zentiva International non-proprietary name: duloxetine Procedure No. EMEA/H/C/003935/0000 Note Assessment report as adopted by the CHMP with all (...) 2014 an application for Marketing Authorisation to the European Medicines Agency (EMA) for Duloxetine Zentiva, through the centralised procedure under Article 3 (3) of Regulation (EC) No. 726/2004– ‘Generic of a Centrally authorised product’. The eligibility to the centralised procedure was agreed upon by the EMA/CHMP on 23-01-2014. The application concerns a generic medicinal product as defined in Article 10(2)(b) of Directive 2001/83/EC and refers to a reference product for which a Marketing
Benefits and harms in clinical trials of duloxetine for treatment of major depressive disorder: comparison of clinical study reports, trial registries, and publications. To determine, using research on duloxetine for major depressive disorder as an example, if there are inconsistencies between protocols, clinical study reports, and main publicly available sources (journal articles and trial registries), and within clinical study reports themselves, with respect to benefits and major harms.Data (...) on primary efficacy analysis and major harms extracted from each data source and compared.Nine randomised placebo controlled trials of duloxetine (total 2878 patients) submitted to the European Medicines Agency (EMA) for marketing approval for major depressive disorder.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
Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder: descriptive study. To assess the effects of coding and coding conventions on summaries and tabulations of adverse events data on suicidality within clinical study reports.Systematic electronic search for adverse events of suicidality in tables, narratives, and listings of adverse events in individual patients within clinical study reports. Where possible, for each (...) event we extracted the original term reported by the investigator, the term as coded by the medical coding dictionary, medical coding dictionary used, and the patient's trial identification number. Using the patient's trial identification number, we attempted to reconcile data on the same event between the different formats for presenting data on adverse events within the clinical study report.9 randomised placebo controlled trials of duloxetine for major depressive disorder submitted
Health economic evaluation of venlafaxine, duloxetine, bupropion, and mirtazapine compared to further prescribable pharmaceutical treatments Kosten-nutzen-bewertung von venlafaxin, duloxetin, bupropion und mirtazapin im vergleich zu weiteren verordnungsfähigen medika-mentösen behandlungen [Health economic evaluation of venlafaxine, duloxetine, bupropion, and mirtazapine compared to further prescribable pharmaceutical treatments] Kosten-nutzen-bewertung von venlafaxin, duloxetin, bupropion und (...) mirtazapin im vergleich zu weiteren verordnungsfähigen medika-mentösen behandlungen [Health economic evaluation of venlafaxine, duloxetine, bupropion, and mirtazapine compared to further prescribable pharmaceutical treatments] IQWiG Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation IQWiG. Kosten-nutzen-bewertung von venlafaxin, duloxetin, bupropion
Duloxetine for treating painful neuropathy, chronic pain or fibromyalgia. Duloxetine is a balanced serotonin and noradrenaline reuptake inhibitor licensed for the treatment of major depressive disorders, urinary stress incontinence and the management of neuropathic pain associated with diabetic peripheral neuropathy. A number of trials have been conducted to investigate the use of duloxetine in neuropathic and nociceptive painful conditions. This is the first update of a review first published (...) in 2010.To assess the benefits and harms of duloxetine for treating painful neuropathy and different types of chronic pain.On 19th November 2013, we searched The Cochrane Neuromuscular Group Specialized Register, CENTRAL, DARE, HTA, NHSEED, MEDLINE, and EMBASE. We searched ClinicalTrials.gov for ongoing trials in April 2013. We also searched the reference lists of identified publications for trials of duloxetine for the treatment of painful peripheral neuropathy or chronic pain.We selected all
Duloxetine USE OF DULOXETINE IN PREGNANCY 0344 892 0909 USE OF DULOXETINE IN PREGNANCY (Date of issue: March 2018 , Version: 3 ) This is a UKTIS monograph for use by health care professionals. For case-specific advice please contact UKTIS on 0344 892 0909. To report an exposure please download and complete a . Please encourage all women to complete an . A corresponding patient information leaflet on is available at . Summary Duloxetine is a serotonin noradrenaline re-uptake inhibitor (SNRI (...) ) indicated for the treatment of major depressive disorder, diabetic peripheral neuropathic pain, generalised anxiety disorder, and also for the treatment of moderate to severe urinary stress incontinence. There are limited data available on the use of duloxetine in pregnancy, therefore its use would not be routinely recommended. However, where duloxetine is being used effectively prior to conception in the treatment of a maternal psychiatric condition, the risks of destabilisation and maternal relapse
Duloxetine Lilly 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/contact 23 October 2014 EMA/753230/2014 Committee for Medicinal Products for Human Use (CHMP) Duloxetine Lilly duloxetine Procedure No. EMEA/H/C/004000 Applicant: Eli Lilly Nederland B.V. Assessment report for an initial marketing authorisation application Assessment (...) report as adopted by the CHMP with all commercially confidential information deleted Duloxetine Lilly EMA/753230/2014 Page 2/13 Table of contents 1. Background information on the procedure 4 1.1. Submission of the dossier 4 1.2. Manufacturers 4 1.3. Steps taken for the assessment of the product 5 2. Scientific discussion 5 2.1. Introduction 5 2.2. Quality aspects 6 2.3. Non-clinical aspects 6 2.4. Clinical aspects 7 2.5. Pharmacovigilance 7 2.6. Risk Management Plan 7 2.7. Product information 11
Effect of duloxetine on pain, function, and quality of life among patients with chemotherapy-induced painful peripheral neuropathy: a randomized clinical trial. There are no known effective treatments for painful chemotherapy-induced peripheral neuropathy.To determine the effect of duloxetine, 60 mg daily, on average pain severity.Randomized, double-blind, placebo-controlled crossover trial at 8 National Cancer Institute (NCI)-funded cooperative research networks that enrolled 231 patients who (...) were 25 years or older being treated at community and academic settings between April 2008 and March 2011. Study follow-up was completed July 2012. Stratified by chemotherapeutic drug and comorbid pain risk, patients were randomized to receive either duloxetine followed by placebo or placebo followed by duloxetine. Eligibility required that patients have grade 1 or higher sensory neuropathy according to the NCI Common Terminology Criteria for Adverse Events and at least 4 on a scale of 0 to 10
Health economic evaluation of venlafaxine, duloxetine, bupropion, and mirtazapine compared to further prescribable pharmaceutical treatments Executive Summary 1 Translation of the executive summary of the final report “Kosten-Nutzen-Bewertung von Venlafaxin, Duloxetin, Bupropion und Mirtazapin im Vergleich zu weiteren verordnungsfähigen medikamentösen Behandlungen” (Version 1.0; Status: 3 September 2013). Please note: This translation is provided as a service by IQWiG to English-language (...) readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. G09-01 Health economic evaluation of venlafaxine, duloxetine, bupropion, and mirtazapine compared to further prescribable pharmaceutical treatments 1 Executive summary of final report G09-01 Version 1.0 Health economic evaluation of venlafaxine, duloxetine, bupropion, mirtazapine 3 Sep 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details
Duloxetine for the management of pain in older adults with knee osteoarthritis: randomised placebo-controlled trial pain is the leading symptom of osteoarthritis (OA) and is often chronic in nature, leading to significant morbidity and decreased quality of life. Duloxetine, a selective serotonin norepinephrine reuptake inhibitor has been demonstrated to have a centrally acting analgesic effect.the aim of the present study was to investigate the efficacy of duloxetine in reducing pain in older (...) adults with knee OA.totally, 288 patients aged 65 years and above with primary knee OA were enrolled in this study. Patients were randomised 1:1. Totally, 144 received 60 mg/day of duloxetine HCL and 144 received placebo for 16 weeks. Outcome measures included pain reduction and improvement in physical functioning scores. Pain was assessed using the visual analogue pain scale (VAS; 0-100 mm). The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores were used to assess
Cost effectiveness of duloxetine in the treatment of fibromyalgia in the United States Cost effectiveness of duloxetine in the treatment of fibromyalgia in the United States Cost effectiveness of duloxetine in the treatment of fibromyalgia in the United States Beard SM, Roskell N, Le TK, Zhao Y, Coleman A, Ang D, Lawson K Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods (...) , the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. CRD summary This study assessed the cost-effectiveness of duloxetine for the treatment of moderate-to-severe pain from fibromyalgia. It focused on the best position for duloxetine in the treatment sequence. The authors concluded that adding duloxetine to the treatment sequence for fibromyalgia was cost-effective, particularly when it was the second-line treatment after
A systematic review of duloxetine and venlafaxine in major depression, including unpublished data Untitled Document The CRD Databases will not be available from 08:00 BST on Friday 4th October until 08:00 BST on Monday 7th October for essential maintenance. We apologise for any inconvenience.
Economic evaluation of duloxetine as a first-line treatment for painful diabetic peripheral neuropathy in Mexico Economic evaluation of duloxetine as a first-line treatment for painful diabetic peripheral neuropathy in Mexico Economic evaluation of duloxetine as a first-line treatment for painful diabetic peripheral neuropathy in Mexico Carlos F, Ramirez-Gamez J, Duenas H, Galindo-Suarez RM, Ramos E Record Status This is a critical abstract of an economic evaluation that meets the criteria (...) for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. CRD summary The objective was to evaluate the cost-effectiveness of duloxetine as a first treatment for adults with diabetic peripheral neuropathy and moderate-to-severe pain. The authors concluded that duloxetine was a cost-effective intervention, in Mexico. Overall, the study was adequate
A Comparative Evaluation of Amitriptyline and Duloxetine in Painful Diabetic Neuropathy: A randomized, double-blind, cross-over clinical trial To compare the efficacy and safety of duloxetine and amitriptyline in painful diabetic neuropathy (PDN).In this randomized, double-blind, cross-over, active-control trial, 58 patients received amitriptyline and duloxetine orally once daily at bedtime, each for 6 weeks with optional dose uptitration fortnightly. Single-blinded placebo washout was given (...) improvement in pain with both treatments compared with their baseline values (P < 0.001 for both). Good, moderate, and mild pain relief was achieved in 55, 24, and 15% of patients, respectively, on amitriptyline and 59, 21, and 9% of patients, respectively, on duloxetine. There were no significant differences in various other outcome measures between the groups. Of the reported adverse events, dry mouth was significantly more common with amitriptyline than duloxetine (55 vs. 24%; P < 0.01). Although
Comparative efficacy and acceptability of amitriptyline, duloxetine and milnacipran in fibromyalgia syndrome: a systematic review with meta-analysis To evaluate and compare the efficacy and acceptability of the antidepressants amitriptyline (AMT), duloxetine (DLX) and milnacipran (MLN) for FM syndrome (FMS).Cochrane Library, MEDLINE, SCOPUS, www.clinicalstudyresults.org and www.clinicalTrials.gov were searched for randomized pharmacological placebo-controlled trials until 30 May 2010. Outcomes