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The Journal of Neuropsychiatry and... 2012
Topics: Antidepressive Agents; Duloxetine Hydrochloride; Female; Humans; Liver Failure, Acute; Middle Aged; Thiophenes
PubMed: 22772703
DOI: 10.1176/appi.neuropsych.11060132 -
Neurological Research Apr 2019Previous studies showed the existence of a relationship between epilepsy and depression. Duloxetine is a potent and selective inhibitor of serotonin and norepinephrine...
AIM
Previous studies showed the existence of a relationship between epilepsy and depression. Duloxetine is a potent and selective inhibitor of serotonin and norepinephrine reuptake (SNRI) used in the treatment of the major depressive disorder. The aim of the present study was to investigate the effect of duloxetine on penicillin-induced epileptiform activity in an experimental rat model of acute partial epilepsy.
METHOD
In this study, 35 male rats weighing 200-240 g were used. Under urethane anesthesia, tripolar electrodes were placed for electrocorticography (ECoG) recording. Duloxetine, at 1, 5, 10 or 30 mg/kg rates, was administered intraperitoneally 30 minutes after intracortical penicillin (500 IU) injection.
RESULTS
Duloxetine administrations of 1, 5, 10 and 30 mg/kg increased the mean frequency of epileptiform activity 10 minutes after Duloxetine injection compared to the control group (p < 0.05) without changing amplitude in all groups (p > 0.05).
CONCLUSION
The results showed proconvulsant effect of duloxetine in penicillin-induced epileptiform activity and indicated that it could pose complications risk for people with partial epilepsy.
Topics: Analysis of Variance; Animals; Brain Waves; Disease Models, Animal; Dopamine Agents; Dose-Response Relationship, Drug; Duloxetine Hydrochloride; Electrocardiography; Epilepsy; Male; Penicillins; Rats; Rats, Wistar; Time Factors
PubMed: 30582741
DOI: 10.1080/01616412.2018.1560642 -
Prescrire International Oct 2013
Topics: Duloxetine Hydrochloride; Humans; Selective Serotonin Reuptake Inhibitors; Substance Withdrawal Syndrome; Thiophenes
PubMed: 24298592
DOI: No ID Found -
CMAJ : Canadian Medical Association... Mar 2017
Topics: Duloxetine Hydrochloride; Humans; Marketing; Selective Serotonin Reuptake Inhibitors; Thiophenes; Urinary Incontinence
PubMed: 28280069
DOI: 10.1503/cmaj.732561 -
Journal of Pharmaceutical and... Mar 2016Duloxetine HCl was subjected to forced degradation under conditions of hydrolysis (neutral, acidic and alkaline), oxidation, photolysis and thermal stress, as suggested...
Duloxetine HCl was subjected to forced degradation under conditions of hydrolysis (neutral, acidic and alkaline), oxidation, photolysis and thermal stress, as suggested in the ICH guideline Q1A(R2). The drug showed significant degradation under acidic, alkaline and aqueous hydrolytic as well as photolytic conditions. The drug remained stable under thermal and oxidative stress conditions. In total, seventeen degradation products (I-XVII) were formed under varied conditions, which could be separated by chromatography of respective degraded solutions on C18 (250 mm×4.6 mm; 5 μ, Nulceodur) column using isocratic elution method. Detection wavelength was selected as 290 nm. MS/TOF accurate mass studies were carried out to establish the complete fragmentation pathway of the drug and degradation products, which, in turn, was utilized in characterization of the products. The degradation pathway of the drug leading to generation of fifteen products I-X, XII-XIII, XV-XVII was postulated and this has not been reported so far.
Topics: Chromatography, Liquid; Drug Stability; Duloxetine Hydrochloride; Hydrolysis; Oxidation-Reduction; Pharmaceutical Preparations; Photolysis; Solutions; Spectrometry, Mass, Electrospray Ionization; Spectrophotometry, Ultraviolet
PubMed: 26775018
DOI: 10.1016/j.jpba.2016.01.002 -
Acta Psychiatrica Scandinavica Jun 2018Our analysis aimed at comparing the placebo effect sizes from randomized controlled trials (RCTs) of two widely prescribed antidepressants, namely duloxetine and... (Comparative Study)
Comparative Study Meta-Analysis
OBJECTIVE
Our analysis aimed at comparing the placebo effect sizes from randomized controlled trials (RCTs) of two widely prescribed antidepressants, namely duloxetine and venlafaxine, and at analysing a potential influence of the investigated drugs on the placebo response.
METHOD
We conducted a comprehensive systematic review and meta-analysis of placebo-controlled, double-blind RCTs, which examined the efficacy of duloxetine and venlafaxine in the acute treatment of major depressive disorder.
RESULTS
We included 71 studies (29 duloxetine trials and 43 venlafaxine trials; one study provided data for the duloxetine and the venlafaxine data set). The placebo effect sizes, defined as pre-postscore change divided by baseline standard deviation, differed significantly between venlafaxine and duloxetine studies (-2.51 vs. -2.09; test for subgroup differences P = 0.028; high heterogeneity). The analysis of effect modifiers and the metaregression analyses confirmed the drug, next to baseline depression severity and publication status, as the most influential independent predictor.
CONCLUSION
Our analyses show a significant difference in the placebo response between venlafaxine and duloxetine trials and suggest that the investigated drug has an influence on the placebo response that is not related to baseline severity, changes over the years or other variables we included.
Topics: Depressive Disorder, Major; Duloxetine Hydrochloride; Humans; Placebo Effect; Serotonin and Noradrenaline Reuptake Inhibitors; Venlafaxine Hydrochloride
PubMed: 29603140
DOI: 10.1111/acps.12881 -
Anesthesiology Sep 2016
Topics: Arthroplasty, Replacement, Knee; Duloxetine Hydrochloride; Humans; Pain Measurement; Pain, Postoperative
PubMed: 27387352
DOI: 10.1097/ALN.0000000000001229 -
Osteoarthritis and Cartilage Jan 2021Establish the impact of pain severity on the cost-effectiveness of generic duloxetine for knee osteoarthritis (OA) in the United States.
OBJECTIVE
Establish the impact of pain severity on the cost-effectiveness of generic duloxetine for knee osteoarthritis (OA) in the United States.
DESIGN
We used a validated computer simulation of knee OA to compare usual care (UC) - intra-articular injections, opioids, and total knee replacement (TKR) - to UC preceded by duloxetine in those no longer achieving pain relief from non-steroidal anti-inflammatory drugs (NSAIDs). Outcomes included quality-adjusted life years (QALYs), lifetime medical costs, and incremental cost-effectiveness ratios (ICERs). We considered cohorts with mean ages 57-75 years and Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain 25-55 (0-100, 100-worst). We derived inputs from published data. We discounted costs and benefits 3% annually. We conducted sensitivity analyses of duloxetine efficacy, duration of pain relief, toxicity, and costs.
RESULTS
Among younger subjects with severe pain (WOMAC pain = 55), duloxetine led to an additional 9.6 QALYs per 1,000 subjects (ICER = $88,500/QALY). The likelihood of duloxetine being cost-effective at willingness-to-pay (WTP) thresholds of $50,000/QALY and $100,000/QALY was 40% and 54%. Offering duloxetine to older patients with severe pain led to ICERs >$150,000/QALY. Offering duloxetine to subjects with moderate pain (pain = 25) led to ICERs <$50,000/QALY, regardless of age. Among knee OA subjects with severe pain (pain = 55) who are unwilling or unable to undergo TKR, ICERs were <$50,600/QALY, regardless of age.
CONCLUSIONS
Duloxetine is a cost-effective addition to knee OA UC for subjects with moderate pain or those with severe pain unable or unwilling to undergo TKR. Among younger subjects with severe pain, duloxetine is cost-effective at WTP thresholds >$88,500/QALY.
Topics: Aged; Analgesics; Analgesics, Opioid; Arthroplasty, Replacement, Knee; Computer Simulation; Cost-Benefit Analysis; Duloxetine Hydrochloride; Glucocorticoids; Humans; Injections, Intra-Articular; Middle Aged; Osteoarthritis, Knee; Pain Measurement; Quality-Adjusted Life Years
PubMed: 33171315
DOI: 10.1016/j.joca.2020.10.001 -
BMJ (Clinical Research Ed.) Apr 2023The studyTesfaye S, Sloan G, Petrie J, et al. Comparison of amitriptyline supplemented with pregabalin, pregabalin supplemented with amitriptyline, and duloxetine... (Randomized Controlled Trial)
Randomized Controlled Trial
The studyTesfaye S, Sloan G, Petrie J, et al. Comparison of amitriptyline supplemented with pregabalin, pregabalin supplemented with amitriptyline, and duloxetine supplemented with pregabalin for the treatment of diabetic peripheral neuropathic pain (OPTION-DM): a multicentre, double-blind, randomised crossover trial. 2022;400:680-90.To read the full NIHR Alert, go to: https://evidence.nihr.ac.uk/alert/combination-therapy-for-painful-diabetic-neuropathy-is-safe-and-effective/.
Topics: Humans; Diabetic Neuropathies; Pregabalin; Analgesics; Amitriptyline; Duloxetine Hydrochloride; Treatment Outcome; Double-Blind Method; Diabetes Mellitus
PubMed: 37085164
DOI: 10.1136/bmj.p866 -
F1000Research 2023Treatment of neuropathic pain is challenging. Pregabalin and duloxetine are used as first-line therapy. Various international guidelines recommend a combination of... (Randomized Controlled Trial)
Randomized Controlled Trial
Treatment of neuropathic pain is challenging. Pregabalin and duloxetine are used as first-line therapy. Various international guidelines recommend a combination of first-line agents for the management of neuropathic pain. The objective of this study was to evaluate the efficacy and safety of a fixed-dose combination (FDC) of low-dose pregabalin and duloxetine compared to pregabalin monotherapy at week 7 in patients with moderate to severe neuropathic pain. This was a phase 3, randomized, double-blind, double-dummy parallel-group non-inferiority study conducted at 17 sites across India. Three hundred and twenty-eight adult patients with moderate to severe neuropathic pain were randomized in a ratio of 1:1 to receive a FDC of pregabalin and duloxetine or pregabalin monotherapy for 7 weeks followed by a one-week follow-up. The pregabalin-duloxetine combination was initiated at 50 plus 20 mg per day and gradually titrated to a maximum of 75mg plus 30mg twice daily. Pregabalin was initiated at 75mg/day and gradually titrated to a maximum of 150mg twice daily. The main efficacy outcome was a mean change in pain intensity at the end of 7 weeks. Two hundred and ninety-eight patients completed the study, 148 in the pregabalin-duloxetine group and 150 in the pregabalin group. The mean change in daily pain at 7 weeks was as follows: -4.49 with FDC and -4.66 with pregabalin (p<0.0001). The non-inferiority of a low-dose FDC compared to pregabalin monotherapy was demonstrated at the end of the study. The incidence of dizziness and somnolence was comparable between both treatments. A higher frequency of peripheral oedema was observed with pregabalin monotherapy than in the FDC group (p>0.05). A FDC of low doses of pregabalin and duloxetine and high dose of pregabalin monotherapy achieved similar analgesia with dizziness, and somnolence as the most frequent adverse event. CTRI/2020/09/027555.
Topics: Adult; Humans; Dizziness; Duloxetine Hydrochloride; Neuralgia; Pregabalin; Sleepiness; Double-Blind Method
PubMed: 38618021
DOI: 10.12688/f1000research.130345.1