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https://www.readbyqxmd.com/read/27881925/efficacy-and-tolerability-balance-of-oxycodone-naloxone-and-tapentadol-in-chronic-low-back-pain-with-a-neuropathic-component-a-blinded-end-point-analysis-of-randomly-selected-routine-data-from-12-week-prospective-open-label-observations
#1
Michael A Ueberall, Gerhard H H Mueller-Schwefe
OBJECTIVE: To evaluate the benefit-risk profile (BRP) of oxycodone/naloxone (OXN) and tapentadol (TAP) in patients with chronic low back pain (cLBP) with a neuropathic component (NC) in routine clinical practice. METHODS: This was a blinded end point analysis of randomly selected 12-week routine/open-label data of the German Pain Registry on adult patients with cLBP-NC who initiated an index treatment in compliance with the current German prescribing information between 1st January and 31st October 2015 (OXN/TAP, n=128/133)...
2016: Journal of Pain Research
https://www.readbyqxmd.com/read/27867511/is-tapentadol-different-from-classical-opioids-a-review-of-the-evidence
#2
Richard M Langford, Roger Knaggs, Paul Farquhar-Smith, Anthony H Dickenson
Tapentadol is a single molecule able to deliver analgesia by two distinct mechanisms, a feature which differentiates it from many other analgesics. Pre-clinical data demonstrate two mechanisms of action: mu-opioid receptor agonist activity and noradrenaline re-uptake inhibition. From these, one may predict that tapentadol would be applicable across a broad spectrum of pain from nociceptive to neuropathic. The evidence in animal models suggests that norepinephrine re-uptake inhibition (NRI) is a key mechanism and may even predominate over opioid actions in chronic (and especially neuropathic) pain states, reinforcing that tapentadol is different to classical opioids and may, therefore, be an a priori choice for the treatment of neuropathic and mixed pain...
November 2016: British Journal of Pain
https://www.readbyqxmd.com/read/27853999/quantifying-the-exposure-of-tapentadol-extended-release-in-japanese-patients-with-cancer-pain-and-bridging-tapentadol-pharmacokinetics-across-populations-using-a-modeling-approach
#3
Liping Zhang, Xiaoyu Yan, Sayori Nobe, Peter Zannikos, Mila Etropolski, Partha Nandy
BACKGROUND AND OBJECTIVES: Tapentadol extended release (ER) is approved for the management of chronic and acute pain in adults. There has been no report of tapentadol ER pharmacokinetics in subjects with cancer pain. This analysis investigated tapentadol ER pharmacokinetics in Japanese patients with cancer pain and bridged it with the pharmacokinetics in Japanese healthy subjects and Caucasian patients with cancer pain. METHODS: Nonlinear mixed-effect pharmacokinetic modeling was conducted based on pooled tapentadol ER concentration data collected in five Phase 1 studies from 138 Japanese and Korean healthy subjects and in two Phase 3 studies from 215 Japanese and Korean subjects with cancer pain...
November 17, 2016: Clinical Drug Investigation
https://www.readbyqxmd.com/read/27844472/patient-relevant-outcomes-and-health-related-quality-of-life-in-patients-with-chronic-severe-noncancer-pain-treated-with-tapentadol-prolonged-release-using-criteria-of-health-technology-assessment
#4
Johannes Fx Hofmann, Arun Lal, Maike Steffens, Robert Boettger
OBJECTIVE: To perform a systematic comparison of tapentadol prolonged release (PR) and oxycodone controlled release (CR) using patient-relevant endpoints of efficacy, safety, and health-related quality of life (HRQoL) according to criteria used in health technology assessment. To derive a minimal important difference (MID) for the EQ-5D from three pivotal trials to measure patient-relevant changes in HRQoL. DESIGN: Randomized, double-blind, placebo and active controlled...
September 2016: Journal of Opioid Management
https://www.readbyqxmd.com/read/27807793/opioids-and-gi-motility-friend-or-foe
#5
REVIEW
Allen A Lee, William L Hasler
The use of opioids for the treatment of chronic non-cancer pain is growing at an alarming rate. Opioid-induced bowel dysfunction (OBD) is a common adverse effect of long-term opioid treatment manifesting as constipation, nausea, and vomiting. These effects are primarily mediated by peripheral μ-opioid receptors with resultant altered GI motility and function. As a result, patients may present with opioid-induced constipation (OIC), opioid-induced nausea and vomiting (OINV), and/or narcotic bowel syndrome (NBS)...
November 2, 2016: Current Treatment Options in Gastroenterology
https://www.readbyqxmd.com/read/27611642/tapentadol-prolonged-release-for-chronic-pain-a-review-of-clinical-trials-and-5-years-of-routine-clinical-practice-data
#6
Ralf Baron, Leopold Eberhart, Kai-Uwe Kern, Stefan Regner, Roman Rolke, Christian Simanski, Thomas Tölle
Tapentadol prolonged release (PR) for the treatment of moderate to severe chronic pain combines 2 modes of action. These are μ-opioid receptor agonism and noradrenaline reuptake inhibition in a single molecule that allows higher analgesic potency through modulation of different pharmacological targets within the pain transmitting systems. At the same time, this can also serve as a clue for modulation of different pain-generating mechanisms according to nociceptive, neuropathic, or mixed pain conditions. Tapentadol PR has now been on the market for 5 years, with over 2...
September 9, 2016: Pain Practice: the Official Journal of World Institute of Pain
https://www.readbyqxmd.com/read/27580162/comparative-metabolism-of-tramadol-and-tapentadol-a-toxicological-perspective
#7
Joana Barbosa, Juliana Faria, Odília Queirós, Roxana Moreira, Félix Carvalho, Ricardo Jorge Dinis-Oliveira
Tramadol and tapentadol are centrally acting, synthetic opioid analgesics used in the treatment of moderate to severe pain. Main metabolic patterns for these drugs in humans are well characterized. Tramadol is mainly metabolized by cytochrome P450 CYP2D6 to O-desmethyltramadol (M1), its main active metabolite. M1 and tapentadol undergo mainly glucuronidation reactions. On the other hand, the pharmacokinetics of tramadol and tapentadol are dependent on multiple factors, such as the route of administration, genetic variability in pharmacokinetic components and concurrent consumption of other drugs...
November 2016: Drug Metabolism Reviews
https://www.readbyqxmd.com/read/27568082/a-tapentadol-related-fatality-case-report-with-postmortem-concentrations
#8
F Lee Cantrell, Phyllis Mallett, Lenore Aldridge, Kimi Verilhac, Iain M McIntyre
Tapentadol (TAP) is an analgesic agent indicated for the management of different types of pain. It has a novel mechanism of action in that it induces analgesia via both μ-opioid receptor agonism and norepinephrine reuptake inhibition. Although deaths associated with TAP use have been reported, there is a paucity of published literature regarding TAP concentrations in biological samples obtained from TAP-associated fatalities. We report a case of TAP toxicity resulting in death with postmortem peripheral and central blood concentrations, liver, vitreous, urine, and gastric contents...
September 2016: Forensic Science International
https://www.readbyqxmd.com/read/27516366/efficacy-and-safety-of-tapentadol-immediate-release-assessment-in-treatment-of-moderate-to-severe-pain-a-systematic-review-and-meta-analysis
#9
Jing-Ping Xiao, Ai-Ling Li, Bi-Min Feng, Yun Ye, Guo-Jun Wang
OBJECTIVE: To assess the efficacy and safety of tapentadol IR for moderate to severe pain compared to oxycodone IR. METHODS: A search was carried out up to July 2015 for randomized controlled trials (RCTs) of tapentadol IR compared to placebo or oxycodone HCL IR 10 mg for moderate to severe pain. Studies were pooled by risk ratio (RR) and weighted mean differences (WMD) with 95% confidence interval (CI). RESULTS: Nine RCTs (n = 3,961) were analyzed...
August 11, 2016: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
https://www.readbyqxmd.com/read/27510567/prediction-of-response-to-tapentadol-in-chronic-low-back-pain
#10
M Reimer, P Hüllemann, M Hukauf, T Keller, A Binder, J Gierthmühlen, R Baron
BACKGROUND: Many chronic low back pain (cLBP) patients do not satisfactorily respond to treatment. The knowledge of responders and non-responders before initiating treatment would improve decision making and reduce health care costs. The aims of this exploratory prediction study in cLBP patients treated with tapentadol were to identify predictors of treatment outcome based on baseline characteristics, to evaluate quality-of-life and functionality as alternative outcome parameters and to develop nomograms to calculate the individual probability of response...
August 11, 2016: European Journal of Pain: EJP
https://www.readbyqxmd.com/read/27509314/central-antinociceptive-effect-of-tapentadol-is-increased-by-nitric-oxide-synthase-inhibitors
#11
Magdalena Bujalska-Zadrożny, Renata Wolińska, Anna Leśniak, Mariusz Sacharczuk
Nitric oxide synthases (NOSs) have been shown to participate in the mechanism of the antinociceptive action of tapentadol. The results obtained in this study indicate that tapentadol administered intrathecally at a range of doses (30-100 µg) increased nociceptive thresholds in the Randall-Selitto and tail-flick tests in rats; however, this effect was significant only for the higher doses. After intracerebroventricular administration of tapentadol at the same dose range, an antinociceptive effect was observed only in response to mechanical stimuli...
October 2016: Behavioural Pharmacology
https://www.readbyqxmd.com/read/27479625/treating-painful-diabetic-peripheral-neuropathy-an-update
#12
Matthew J Snyder, Lawrence M Gibbs, Tammy J Lindsay
Painful diabetic peripheral neuropathy occurs in approximately 25% of patients with diabetes mellitus who are treated in the office setting and significantly affects quality of life. It typically causes burning pain, paresthesias, and numbness in a stocking-glove pattern that progresses proximally from the feet and hands. Clinicians should carefully consider the patient's goals and functional status and potential adverse effects of medication when choosing a treatment for painful diabetic peripheral neuropathy...
August 1, 2016: American Family Physician
https://www.readbyqxmd.com/read/27448104/effectiveness-of-tapentadol-prolonged-release-for-the-management-of-painful-mucositis-in-head-and-neck-cancers-during-intensity-modulated-radiation-therapy
#13
Mazzola Rosario, Ricchetti Francesco, Fersino Sergio, Giaj Levra Niccolò, Fiorentino Alba, Nicodemo Maurizio, Albanese Sergio, Gori Stefania, Alongi Filippo
PURPOSE: To evaluate the effectiveness and tolerability profile of tapentadol prolonged release (PR) in a cohort of head and neck cancer (HNC) patients affected by background pain due to painful mucositis during intensity modulated radiation therapy with or without cisplatin with definitive and adjuvant intent. MATERIALS AND METHODS: Tapentadol PR was administered at the moment of pain onset in opioid-naive patients at the dosage of 50 mg BID. The dosage was increased 50 mg twice a day until the optimal dose of no more than 500 mg/day of tapentadol PR...
October 2016: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
https://www.readbyqxmd.com/read/27443249/single-isomer-carboxymethyl-%C3%AE-cyclodextrin-as-chiral-resolving-agent-for-capillary-electrophoresis
#14
Gábor Benkovics, Ida Fejős, András Darcsi, Erzsébet Varga, Milo Malanga, Éva Fenyvesi, Tamás Sohajda, Lajos Szente, Szabolcs Béni, Julianna Szemán
Herein we report on the synthesis, characterization and the novel capillary electrophoretic use of octakis-(2,3-di-O-methyl-6-O-carboxymethyl)-γ-cyclodextrin sodium salt (ODMCM). ODMCM is the first single-isomer carboxymethyl-γ-cyclodextrin that is fully methylated on its secondary side and carries ionizable carboxymethyl functions on its primary side. ODMCM was prepared with high isomeric purity through a four-step synthetic procedure. The purity of each intermediate was characterized by appropriate chromatographic methods, while the isomeric purity of the carboxymethylated product was determined by an HPLC method using a CD-Screen-IEC column and by a capillary electrophoretic method using indirect UV detection, as well...
October 7, 2016: Journal of Chromatography. A
https://www.readbyqxmd.com/read/27435439/effectiveness-and-tolerability-of-tapentadol-sustained-release-in-the-australian-setting
#15
Marc A Russo, Danielle M Santarelli
OBJECTIVE: To assess the effectiveness and tolerability of tapentadol sustained release (SR) following its introduction to the Australian private market. DESIGN: A retrospective audit of routine clinical practice with data collection beginning 2 months after the first tapentadol SR prescription. SETTING: A multidisciplinary Australian pain clinic. PATIENTS: Fifty patients who were prescribed tapentadol SR as part of routine clinical management at the pain clinic...
May 2016: Journal of Opioid Management
https://www.readbyqxmd.com/read/27413479/tapentadol-can-it-kill-two-birds-with-one-stone-without-breaking-windows
#16
REVIEW
Eun Jung Chang, Eun Ji Choi, Kyung Hoon Kim
Tapentadol is a novel oral analgesic with a dual mode of action as an agonist of the µ-opioid receptor (MOR), and as a norepinephrine reuptake inhibitor (NRI) all in a single molecule. Immediate release (IR) tapentadol shows its analgesic effect quickly, at around 30 minutes. Its MOR agonistic action produces acute nociceptive pain relief; its role as an NRI brings about chronic neuropathic pain relief. Absorption is rapid, with a mean maximal serum concentration at 1.25-1.5 h after oral intake. It is present primarily in the form of conjugated metabolites after glucuronidation, and excretes rapidly and completely via the kidneys...
July 2016: Korean Journal of Pain
https://www.readbyqxmd.com/read/27317026/comparative-study-of-the-neurotoxicological-effects-of-tramadol-and-tapentadol-in-sh-sy5y-cells
#17
Juliana Faria, Joana Barbosa, Odília Queirós, Roxana Moreira, Félix Carvalho, Ricardo Jorge Dinis-Oliveira
Opioid therapy and abuse are increasing, justifying the need to study their toxicity and underlying mechanisms. Given opioid pharmacodynamics at the central nervous system, the analysis of toxic effects in neuronal models gains particular relevance. The aim of this study was to compare the toxicological effects of acute exposure to tramadol and tapentadol in the undifferentiated human SH-SY5Y neuroblastoma cell line. Upon exposure to tramadol and tapentadol concentrations up to 600μM, cell toxicity was assessed through evaluation of oxidative stress, mitochondrial and metabolic alterations, as well as cell viability and death mechanisms through necrosis or apoptosis, and related signalling...
June 1, 2016: Toxicology
https://www.readbyqxmd.com/read/27303080/probable-tapentadol-associated-serotonin-syndrome-after-overdose
#18
Heather Walczyk, Cheuk H Michael Liu, Antonia Alafris, Henry Cohen
PURPOSE: Drug-induced serotonin syndrome is a potentially life-threatening condition. An Ovid MEDLINE, and PubMed search from 1950 to October 2015 revealed one published case report of suspected tapentadol-induced serotonin syndrome. We report a probable case of tapentadol-induced serotonin syndrome after overdose. CASE SUMMARY: A 48-year-old male was found unresponsive after a witnessed overdose of medications including tapentadol. After administration of naloxone by emergency medical services, the patient became combative and presented with altered mental status...
April 2016: Hospital Pharmacy
https://www.readbyqxmd.com/read/27295489/evaluation-of-the-antihyperalgesic-effect-of-tapentadol-in-two-human-evoked-pain-models-the-tapcapmentho-pilot-trial
#19
M Förster, S Helfert, R Dierschke, M Großkopf, P Hüllemann, T Keller, R Baron, A Binder
OBJECTIVE: Tapentadol is effective in the treatment of neuropathic and nociceptive pain and in acute and chronic pain conditions; two mechanisms combining opioid µ-receptor agonism and noradrenergic reuptake inhibition underlie its analgesic effect. RESEARCH DESIGN AND METHODS: With this single-center, placebo-controlled, double-blind, cross-over pilot-study, we investigated the antihyperalgesic effect of a single oral dose of 100 mg immediate-release tapentadol on thermal and mechanical hyperalgesia in two human models (i...
September 2016: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/27292786/%C3%AE-2-adrenoceptor-a-target-for-neuropathic-pain-treatment
#20
Lorenzo Di Cesare Mannelli, Laura Micheli, Letizia Crocetti, Maria Paola Giovannoni, Claudia Vergelli, Carla Ghelardini
Neuropathic pain is originated from different alterations of the nervous system. The difficulty of treatment strongly impairs quality of life of affected people. It is associated with severe, chronic sensory disturbances characterized by spontaneous pain, increased responsiveness to painful stimuli and pain perceived in response to normally non-noxious stimuli. The underlying mechanisms are complex and involve both peripheral and central nervous components.The noradrenergic system plays a pivotal role in the control of pain since its widespread distribution in the "pain matrix" representing a valuable therapeutic target...
June 8, 2016: Mini Reviews in Medicinal Chemistry
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