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Latest & greatest articles for duloxetine
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Osteoarthritis pain getting you down? Duloxetine July 13, 2020 Osteoarthritis pain getting you down? Duloxetine Clinical Question: Do Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), specifically duloxetine, improve pain in patients with osteoarthritis? Bottom Line: Duloxetine can meaningfully reduce osteoarthritis pain scores (by at least 30%) for ~60% of patients compared to ~40% on placebo. An average pain of ~6 (scale 0-10) will be reduced by ~2.5 points, compared to 1.7 on placebo (...) . Duloxetine adverse effects lead to withdrawal in 12% of patients versus 6% on placebo. Evidence: • Six systematic reviews with 2-7 randomized controlled trials (RCTs) and 487-2102 patients. 1-6 Duloxetine 60-120mg daily versus placebo, results statistically significant unless indicated. o Proportion of patients attaining a meaningful pain reduction (generally =30% reduction in pain score): ? Systematic review (6 RCTs, 2060 patients) 1 of hip or knee osteoarthritis, over 10-18 weeks: 64% taking duloxetine
Maternal and fetal outcomes following exposure to duloxetine in pregnancy: cohort study. To evaluate the risk of adverse maternal and infant outcomes following in utero exposure to duloxetine.Cohort study nested in the Medicaid Analytic eXtract for 2004-13.Publicly insured pregnancies in the United States.Pregnant women 18 to 55 years of age and their liveborn infants.Duloxetine exposure during the etiologically relevant time window, compared with no exposure to duloxetine, exposure (...) to selective serotonin reuptake inhibitors, exposure to venlafaxine, and exposure to duloxetine before but not during pregnancy.Congenital malformations overall, cardiac malformations, preterm birth, small for gestational age infant, pre-eclampsia, and postpartum hemorrhage.Cohort sizes ranged from 1.3 to 4.1 million, depending on the outcome. The number of women exposed to duloxetine varied by cohort and exposure contrast and was around 2500-3000 for early pregnancy exposure and 900-950 for late pregnancy
Duloxetine Reduces Pain and Improves Quality of Recovery Following Total Knee Arthroplasty in Centrally Sensitized Patients: A Prospective, Randomized Controlled Study Unexplained postoperative pain is one of the most feared complications of total knee arthroplasty (TKA). A persistent noxious peripheral stimulus, such as the pain of chronic knee osteoarthritis, can cause central sensitization in which the central nervous system becomes hyperexcitable, resulting in hypersensitivity to both (...) noxious and non-noxious stimuli. Patients with central sensitization may be more susceptible to unexplained pain after TKA. Duloxetine, a selective serotonin norepinephrine reuptake inhibitor (SNRI), can ameliorate the pain associated with central sensitization, and we aimed to determine whether it could reduce postoperative pain and improve quality of recovery after TKA in patients with central sensitization.Patients undergoing TKA were screened for central sensitization preoperatively with use
Clinical meaningfulness of duloxetine's effect in Chinese patients with chronic pain due to osteoarthritis: post hoc analyses of a phase 3 randomized trial. To evaluate the analgesic effect of duloxetine in Chinese patients with osteoarthritis (OA) of the knee/hip at individual patient level and report the relationship between pain intensity reduction, overall improvement, and physical functioning.Post hoc analysis of 13-week, phase 3, parallel-group, randomized, placebo-controlled study (...) of duloxetine in Chinese patients with OA pain. Patients were randomized (1:1, computer-generated, interactive web-response system) to duloxetine (60 mg once daily, n=202) or placebo (n=207). Patients, investigators, and study staff were blinded throughout the study. Duloxetine's efficacy was evaluated using the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) and the Osteoarthritis Research Society International and Outcome Measures in Rheumatology (OARSI-OMERACT
Comparison of Preoperative Administration of Pregabalin and Duloxetine on Cognitive Functions and Pain Management After Spinal Surgery: A Randomized, Double-blind, Placebo-controlled Study Surgical trauma is known to induce hyperalgesia, and if pain management is insufficient, it contributes to persistent pain in the postoperative period.In this study, our primary aims were to compare the effect of pregabalin and duloxetine on postoperative pain scores and cognitive functions. Our secondary aim (...) hours. The second group received duloxetine 60 mg orally 1 hour before the surgery. At the postoperative 12th hour, they received a placebo capsule, and, at the 24th hour, they received duloxetine 60 mg again. The third group received placebo capsules orally at all timepoints.Postoperative pain evaluation was conducted using a Visual Analogue Scale at the postoperative first minute, 30th minute, first hour, and the 12th, 24th, and 48th hours. The preoperative and postoperative sixth hour cognitive
Duloxetine Top results for duloxetine - Trip Database or use your Google+ account Turning Research Into Practice ALL of these words: Title only Anywhere in the document ANY of these words: Title only Anywhere in the document This EXACT phrase: Title only Anywhere in the document EXCLUDING words: Title only Anywhere in the document Timeframe: to: Combine searches by placing the search numbers in the top search box and pressing the search button. An example search might look like (#1 or #2 (...) ) and (#3 or #4) Loading history... Population: Intervention: Comparison: Outcome: Population: Intervention: Latest & greatest articles for duloxetine The Trip Database is a leading resource to help health professionals find trustworthy answers to their clinical questions. Users can access the latest research evidence and guidance to answer their clinical questions. We have a large collection of systematic reviews, clinical guidelines, regulatory guidance, clinical trials and many other forms
A randomized, double-blind, placebo-controlled Phase III trial of duloxetine in Japanese patients with knee pain due to osteoarthritis To examine the efficacy and safety of duloxetine in Japanese patients with knee pain due to osteoarthritis.Patients were randomized to receive duloxetine 60 mg/day or placebo for 14 weeks in a double-blind manner (ClinicalTrials.gov Identifier: NCT02248480). The primary efficacy endpoint was mean change in Brief Pain Inventory pain severity (BPI-Severity (...) ) average pain. Secondary endpoints included improvement in other BPI-Severity scales, Patient Global Impression of Improvement, Clinical Global Impressions of Severity, health-related quality of life (HRQoL) scales, range of motion of the knee joint, safety and tolerability, and structural changes on X-ray images.Of the 354 randomized patients, 161 in the duloxetine group and 162 in the placebo group completed the study. BPI-Severity average pain improved significantly with duloxetine vs. placebo
Randomized, Multicenter, Placebo-Controlled Clinical Trial of Duloxetine Versus Placebo for Aromatase Inhibitor-Associated Arthralgias in Early-Stage Breast Cancer: SWOG S1202 Purpose Adherence to aromatase inhibitor (AI) therapy for early-stage breast cancer is limited by AI-associated musculoskeletal symptoms (AIMSS). Duloxetine is US Food and Drug Administration approved for treatment of multiple chronic pain disorders. We hypothesized that treatment of AIMSS with duloxetine would improve (...) average joint pain compared with placebo. Methods This randomized, double-blind, phase III trial included AI-treated postmenopausal women with early-stage breast cancer and who had average joint pain score of ≥ 4 out of 10 that developed or worsened since AI therapy initiation. Patients were randomly assigned 1:1 to duloxetine or placebo for 13 weeks. The primary end point was average joint pain through 12 weeks, examined using multivariable linear mixed models, adjusted for stratification factors
The effect of pregabalin or duloxetine on arthritis pain: a clinical and mechanistic study in people with hand osteoarthritis Osteoarthritis (OA) is the most prevalent arthritis worldwide and is characterized by chronic pain and impaired physical function. We hypothesized that heightened pain in hand OA could be reduced with duloxetine or pregabalin. In this prospective, randomized clinical study, we recruited 65 participants, aged 40-75 years, with a Numerical Rating Scale (NRS) for pain (...) of at least 5. Participants were randomized to one of the following three groups: duloxetine, pregabalin, and placebo. The primary endpoint was the NRS pain score, and the secondary endpoints included the Australian and Canadian Hand Osteoarthritis Index (AUSCAN) pain, stiffness, and function scores and quantitative sensory testing by pain pressure algometry. After 13 weeks, compared to placebo, ANOVA found significant differences between the three groups (P=0.0078). In the intention-to-treat analysis
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 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
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