Latest & greatest articles for duloxetine

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Top results for duloxetine

21. Duloxetine Zentiva

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

2015 European Medicines Agency - EPARs

22. Benefits and harms in clinical trials of duloxetine for treatment of major depressive disorder: comparison of clinical study reports, trial registries, and publications. Full Text available with Trip Pro

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

2014 BMJ

23. Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder: descriptive study. Full Text available with Trip Pro

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

2014 BMJ

24. Health economic evaluation of venlafaxine, duloxetine, bupropion, and mirtazapine compared to further prescribable pharmaceutical treatments

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

2014 Health Technology Assessment (HTA) Database.

25. Duloxetine

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

2014 UK Teratology Information Service

26. Duloxetine Lilly

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

2014 European Medicines Agency - EPARs

27. Effect of duloxetine on pain, function, and quality of life among patients with chemotherapy-induced painful peripheral neuropathy: a randomized clinical trial. Full Text available with Trip Pro

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

2013 JAMA Controlled trial quality: predicted high

28. Health economic evaluation of venlafaxine, duloxetine, bupropion, and mirtazapine compared to further prescribable pharmaceutical treatments

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

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

29. Duloxetine for the management of pain in older adults with knee osteoarthritis: randomised placebo-controlled trial Full Text available with Trip Pro

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

2012 EvidenceUpdates Controlled trial quality: predicted high

30. 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 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

2012 NHS Economic Evaluation Database.

31. A systematic review of duloxetine and venlafaxine in major depression, including unpublished data

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.

2012 DARE.

32. 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 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

2012 NHS Economic Evaluation Database.

33. A Comparative Evaluation of Amitriptyline and Duloxetine in Painful Diabetic Neuropathy: A randomized, double-blind, cross-over clinical trial Full Text available with Trip Pro

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

2011 EvidenceUpdates Controlled trial quality: predicted high

34. Pain response profile of patients with fibromyalgia treated with duloxetine (Abstract)

Pain response profile of patients with fibromyalgia treated with duloxetine This study examined the time course for minimal clinically significant improvement in pain severity during the initial 12 weeks of treatment in patients with fibromyalgia taking duloxetine.Four double-blind, placebo-controlled trials of duloxetine were pooled. Patients received duloxetine 60 mg/d, 120 mg/d, or placebo. Clinically significant treatment response (>or=30% reduction in pain severity on the 24-hour average (...) pain severity of the Brief Pain Inventory scale) was assessed over 12 weeks.At endpoint, 46.9% of duloxetine 60-mg-, 48.6% of duloxetine 120-mg-, and 32.1% of placebo-treated patients (P<0.001 for both doses) had >or=30% improvement on average pain from baseline. The probabilities of achieving >or=30% response at Weeks 1, 2, 4, 8, and 12 among duloxetine 60-mg-treated patients were 27%, 44%, 45%, 47%, and 49%, respectively, and among duloxetine 120-mg-treated patients were 35%, 43%, 53%, 53

2010 EvidenceUpdates Controlled trial quality: uncertain

35. Cymbalta (duloxetine hydrochloride)

Cymbalta (duloxetine hydrochloride) Drug Approval Package: Cymbalta (duloxetine hydrochloride) NDA #022516 Drug Approval Package U.S. Food & Drug Administration Search FDA Drug Approval Package - Cymbalta (duloxetine hydrochloride), 20, 30, and 60 mg Capsules Company: Eli Lilly and Company Application No.: 022516 Approval Date: 11/04/2010 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF

2010 FDA - Drug Approval Package

36. Analytic model comparing the cost utility of TVT versus duloxetine in women with urinary stress incontinence

Analytic model comparing the cost utility of TVT versus duloxetine in women with urinary stress incontinence Analytic model comparing the cost utility of TVT versus duloxetine in women with urinary stress incontinence Analytic model comparing the cost utility of TVT versus duloxetine in women with urinary stress incontinence Jacklin P, Duckett J, Renganathan A 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 versus tension-free vaginal tape as the second-line treatment for urinary stress incontinence, using new data on drug discontinuation rates. The authors concluded that tension-free vaginal tape was more cost-effective than duloxetine and was below the recommended

2010 NHS Economic Evaluation Database.

37. Economic evaluation of duloxetine versus serotonin selective reuptake inhibitors and venlafaxine XR in treating major depressive disorder in Scotland

Economic evaluation of duloxetine versus serotonin selective reuptake inhibitors and venlafaxine XR in treating major depressive disorder in Scotland Economic evaluation of duloxetine versus serotonin selective reuptake inhibitors and venlafaxine XR in treating major depressive disorder in Scotland Economic evaluation of duloxetine versus serotonin selective reuptake inhibitors and venlafaxine XR in treating major depressive disorder in Scotland Benedict A, Arellano J, De Cock E, Baird J 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 examined the cost-utility of duloxetine, compared with selective serotonin re-uptake inhibitors (SSRIs), venlafaxine extended release, and mirtazapine, for the treatment of major

2010 NHS Economic Evaluation Database.

38. Pregabalin, the lidocaine plaster and duloxetine in patients with refractory neuropathic pain: a systematic review

Pregabalin, the lidocaine plaster and duloxetine in patients with refractory neuropathic pain: a systematic review 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.

2010 DARE.

39. Cost-effectiveness of duloxetine: the Stress Urinary Incontinence Treatment (SUIT) study Full Text available with Trip Pro

Cost-effectiveness of duloxetine: the Stress Urinary Incontinence Treatment (SUIT) study Cost-effectiveness of duloxetine: the Stress Urinary Incontinence Treatment (SUIT) study Cost-effectiveness of duloxetine: the Stress Urinary Incontinence Treatment (SUIT) study Mihaylova B, Pitman R, Tincello D, van der Vaart H, Tunn R, Timlin L, Quail D, Johns A, Sculpher M 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 assess the cost-effectiveness of duloxetine compared with conservative therapy for women with stress urinary incontinence. The authors concluded that, although there were limitations due to the use of observational data, duloxetine therapy seemed to be cost-effective. The methods were good

2010 NHS Economic Evaluation Database.

40. Duloxetine in acute major depression: review of comparisons to placebo and standard antidepressants using dissimilar methods

Duloxetine in acute major depression: review of comparisons to placebo and standard antidepressants using dissimilar methods Duloxetine in acute major depression: review of comparisons to placebo and standard antidepressants using dissimilar methods Duloxetine in acute major depression: review of comparisons to placebo and standard antidepressants using dissimilar methods Girardi P, Pompili M, Innamorati M, Mancini M, Serafini G, Mazzarini L, Del Casale A, Tatarelli R, Baldessarini RJ CRD (...) summary The review found that duloxetine appeared more effective than placebo for acute major depression in adults, and was comparable to selective serotonin-reuptake inhibitors, but that more research is needed. In view of poor reporting of review methods and adverse event outcomes, and lack of statistical evidence that the trials were suitable for pooling, the authors’ conclusions may not be reliable. Authors' objectives To evaluate the efficacy and tolerability of duloxetine for acute major

2009 DARE.