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Objectives: A substantial proportion of patients with chronic noncancer pain (CNCP) are treated with tapentadol (TAP) or oxycodone/naloxone (OXN) to improve their perceived physical and mental health over time., Methods: A cross-sectional study was conducted in 135 CNCP outpatients with usual prescribing (TAP: n = 58, OXN: n = 77) at a tertiary-care Spanish Hospital to compare health-related quality-of-life (HRQoL) records. Health utility was derived from the EQ-5D-3L. Regression models were performed to search for other HRQoL determinants. Pain intensity, relief, analgesic prescription, adverse events, inpatient stays, emergency department visits, and change to painkiller prescriptions were registered from electronic records., Results: Health utility (0.43 ± 0.24 scores, from -0.654 to 1) was similar for both opioids, although TAP showed a significantly low daily opioid dose requirement, neuromodulators use, and constipation side effect compared with OXN. After multivariable adjustment, the significant predictors of impaired HRQoL were pain intensity (β = -0.227, 95% CI -0-035 to -0.005), number of adverse events (β = -0.201, 95% CI -0.024 to -0.004), and opioid daily dose (β = -0.175, 95% CI -0.097 to -0.012). Male sex (β = -0.044) and pain relief (β = 0.158) should be taken into account for future studies., Conclusions: HRQoL was similar for TAP and OXN in real-world patients with CNCP, albeit with a TAP opioid-sparing effect. More work is needed to explore HRQoL determinants in relation to long-term opioid use in CNCP., Competing Interests: Author Disclosures Author disclosure forms can be accessed below in the Supplemental Material section., (Copyright © 2024 International Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Objective: This study aimed to evaluate pain control, functioning, and quality of life (QoL) recovery in patients with chronic low back pain (cLBP) or post-traumatic osteoarthritis (OA) pain in the ankle/foot area, treated with tapentadol prolonged release and unresponsive to other treatments., Patients and Methods: Two observational retrospective studies were conducted using clinical practice datasets of patients with chronic pain in cLBP and OA foot/ankle at different time points (total follow-up=60-90 days). The studies assessed pain intensity by the Numerical Rating Scale (NRS) pain scale (patients were classified as responder in case of ≥30% pain reduction), QoL by the 5-level EQ-5D (EQ-5D-5L) questionnaire, patient satisfaction by the 7-point Patients' Global Impression of Change (PGIC) scale; cLBP health status by the Roland Morris Disability Questionnaire (RMDQ); foot and ankle functional status by European Foot and Ankle Society (EFAS) score; and treatment-related AEs., Results: For the cLBP setting, 37 patients were enrolled, of which 86.50% were classified as responders (n=32; CI: 75.5% ÷ 97.5%). For the foot/ankle OA pain setting, 21 patients were enrolled. Pain assessment at final follow-up was available only for 11 patients, of which 72.73% (n=8; CI: 39.0% ÷ 94.0%) were classified as responders. Statistically significant improvements were seen in the RMDQ, EQ-5D-5L, and PGIC scores in cLBP. Improvements in the EFAS, EQ-5D-5L, and PGIC scores were seen in OA as well. The incidence of treatment-related adverse reactions was low in both studies., Conclusions: In the study population, tapentadol prolonged release was effective and well tolerated in treating cLBP and post-traumatic foot/ankle OA chronic pain when used in a multimodal manner. The reduction in pain was accompanied by clinically relevant improvements in patients' functionality and QoL.

Aims: To investigate quality of life (QOL) and functionality changes in chronic pain during tapentadol prolonged release (PR) treatment. Patients & methods: Post hoc analysis of data from three Phase III trials in patients with osteoarthritis knee pain or low back pain. QOL and functionality changes were assessed by SF-36 scores. Results: Tapentadol PR provides consistent, clinically relevant improvements in QOL and functionality in chronic pain.Conclusion: Tapentadol PR provides consistent, clinically relevant improvements in QOL and functionality in chronic pain.

Objective: To compare concomitant benzodiazepine (BZDs) use among chronic pain patients adherent to extended-release tapentadol (TapER) or oxycodone (OxnER) and estimate the number of lives potentially saved by switching pa-tients to the less BZD coprescribed treatment., Design: Retrospective database study., Setting: Patients were identified using the IBM MarketScan® Commercial Database. The opioid overdose death esti-mates were obtained from the US national mortality register and were used to estimate the number of lives potentially saved by switching patients to the opioid treatment with lower rates of BZD coprescribing., Patients, Participants: The authors identified 30,213 chronic pain patients between October 2012 and March 2016. Af-ter propensity score matching, N = 2,355 and N = 6,761 patients were adherent (proportion of days covered ≥80 percent) to TapER and OxnER, respectively., Interventions: TapER versus OxnER, during the 180-day treatment., Main Outcome Measure(s): Proportions of BZD coprescribing, BZD dosing patterns in matched patients, and the esti-mated number of lives potentially saved by the opioid treatment switch., Results: TapER patients were less coprescribed BZDs during the treatment period (38.9 percent versus 49.2 percent, OR = 0.659, p < 0.001), and had fewer days of BZD supply per patient (mean: 49.6 versus 70.2 days, p < 0.001) with similar BZD average daily dose. Due to less frequent coprescribing of BZDs with TapER, it is estimated that ~800 deaths may have been avoided in the U.S. as a result of switching patients from OxnER to TapER., Conclusions: Among treatment-adherent patients, TapER patients had fewer BZD coprescriptions than OxnER pa-tients had. Moreover, when BZDs were coprescribed, those BZD prescriptions were for shorter periods of time. Pro-spective studies are warranted to explore rates and consequences of BZD coprescribing among opioids.

Background: Despite the high prevalence of neck pain, few studies have addressed the pharmacological treatment of this condition. Purpose: We evaluated the effectiveness of tapentadol prolonged-release (PR) in patients with or without a neuropathic pain component, with a focus on functional movements, disability and Quality of Life (QoL). Study design/setting: Observational, retrospective study. Patient sample: Ninety-four adult patients with severe neck pain not responsive to opioid step III treatment. Outcome measures: The primary endpoint was a  ≥ 30% improvement of pain intensity at 4 weeks (W4). Several secondary outcomes were evaluated, including neck disability index (NDI), range of motion (ROM), and QoL. Methods: Patients received tapentadol PR at the starting dose of 100 mg/day. Dose titration was allowed in 50 mg increments, up to 500 mg daily. Results: At W4, the primary endpoint of ≥30% improvement of pain was reported in 70% ( n  = 35; 95% confidence interval [CI]: 55-82%) of patients with a neuropathic pain component and in 69% ( n  = 20; 95% CI: 49-85%) of those without a neuropathic component. The percentage of patients reporting a neuropathic pain component significantly decreased from baseline (64.2%) to W4 (27.8%). NDI significantly improved in both groups at W12. ROM significantly improved in all three planes of motion ( p  < .01), with no difference between the two groups. Interference of pain with sleep and QoL also improved. Conclusions: The reduction in pain provided by tapentadol is associated with functional recovery, which may in turn be linked to an improvement in QoL.

Background: Chronic osteoarthritis (OA) pain leads to severe impairments in physical functioning and quality of life. Patients & methods: Data of patients with severe chronic knee and/or hip OA pain were extracted from the database of a prospective, noninterventional trial to assess the benefits of tapentadol prolonged release (PR) in elderly patients (>65 years of age; n = 1162) compared with younger patients (≤65 years of age; n = 498). Results: Tapentadol PR treatment (up to 3 months) significantly reduced pain intensity and pain-related restrictions on daily functioning and significantly improved physical and mental quality of life in both patient groups. The incidence of adverse drug reactions was low. Conclusion: Tapentadol PR is a useful strong analgesic to improve pain intensity, physical functioning and quality of life in elderly OA patients.

Objective: Chronic pain is highly prevalent in the elderly, and the prolonged use of long-term opioids for the management of chronic musculoskeletal pain is controversial. Tapentadol, combining μ-opioid receptor (MOR) agonism and noradrenaline reuptake inhibition (NRI) in a unique mechanism of action, may be a valid option for chronic pain management in the geriatric population. The aim of the study was to assess the efficacy and tolerability of tapentadol prolonged release (PR), administered to patients aged ≥ 70 years with chronic pain., Patients and Methods: A total of 20 elderlies, naïve to opioids and with persistent moderate-to-severe chronic pain from different etiologies received tapentadol PR with up-titrations as necessary. The response to treatment, defined as at least 30% reduction in pain intensity compared with baseline, was the primary endpoint. Secondary endpoints were pain intensity on the Numeric Rating Scale (NRS) both at rest and during loading and sleep quality., Results: Tapentadol PR was safe and effective in our population of elderlies with chronic pain from different etiologies: pain intensity compared with baseline, both at rest and during load, was statistically lower at each visit (p<0.01), whereas sleep quality improved significantly throughout the study (p<0.05). Only few minor side effects were reported, with an overall good safety profile and a very high tolerability and satisfaction for treatment., Conclusions: Tapentadol PR, adequately titrated according to patients' response in naïve subjects, is safe and effective to control pain in the elderly.

Objective: The treatment of chronic pain frequently combines pharmacologic and non-pharmacological options, and analgesia after surgery is of major importance. Tapentadol is both µ-opioid receptor agonist (with a 40% agonism on these receptors) and noradrenaline reuptake inhibitor, with similar analgesic efficacy to strong opioids, but fewer adverse effects. For these reasons, tapentadol may represent a valuable first choice option in the treatment of chronic, neuropathic, and mixed pain., Patients and Methods: The primary endpoint of the present study was the proportion of responder patients, with ≥30% reduction in pain intensity during loading on the NRS; several additional endpoints were also evaluated., Results: Twenty-five adult patients were enrolled, with a rate of response to treatment of 100%. Moreover, pain reduction was as high as 50% in 23/25 patients (92%). The average NRS at rest at V0 was 7.2 ± 1.0, whereas the average NRS at loading was 7.7 ± 0.9; this score significantly decreased at all visits. The score of the Roland-Morris questionnaire, a score of disability, improved significantly throughout the study (p<0.0001), as well as the Barthel Index (p<0.0005), and the neuropathic component of pain, which was significantly reduced during the study, from 88% at V0 to 12% at V3. Sleep quality improved throughout the study, and the treatment was rated as good (91% of patients) or optimal (9%)., Conclusions: Our findings show that tapentadol PR may contribute to improve patients' quality of life, especially during rehabilitation after back surgery, when tapentadol PR treatment is effective and well tolerated.

Objective: Chronic pain is frequently irreversible, representing a major health problem. A survey has shown that 19% of European adults experience chronic pain which is not adequately managed. Innovative interventional techniques for the treatment of chronic pain have been developed, as a further step beyond the three-layer WHO analgesic ladder. Among these techniques, continuous and pulsed radiofrequency (RF) are very effective in the management of radicular pain syndrome. Usually, these techniques are associated with a pharmacologic approach with a wide-spectrum analgesic. Tapentadol has a double mechanism of action, as a μ-opioid receptor agonism (MOR) and noradrenaline reuptake inhibitor (NRI), contributing synergistically to its analgesic efficacy on both nociceptive and neuropathic pain., Patients and Methods: We aimed to test the efficacy of tapentadol prolonged release (PR) combined with pulsed RF in improving neuropathic symptoms and disability in 50 patients with moderate-to-severe chronic pain due to lumbar radiculopathy., Results: The responders to treatment, showing at least a 30% reduction in pain intensity on the Numerical Rating Scale (NRS), were 38 (76%). Both average NRS at rest and during loading were statistically significantly reduced compared with baseline (p<0.0001). Other parameters investigated (sleep quality, neuropathic symptoms, the degree of disability) were all statistically better with tapentadol PR. Patients requiring RF intervention dropped dramatically from 98% at baseline to 10% at the end of the study (p<0.01). Adverse events were reported in 14 patients (28%), four of which required therapy discontinuation. However, patients' satisfaction and overall tolerability of tapentadol PR treatment were high., Conclusions: Tapentadol PR is effective in reducing pain intensity at rest and during loading, with a favorable safety and tolerability profile. Moreover, the use of tapentadol PR decreases the degree and severity of disability, as well as the intensity of neuropathic symptoms.

Objective: The use of long-term opioids for the management of chronic musculoskeletal pain is a hot topic in the scientific community, especially when it concerns the elderly. This paper aimed at assessing the efficacy and tolerability of tapentadol prolonged release (PR), a molecule with a unique mechanism of action combining μ-opioid-receptor (MOR) agonism and noradrenaline reuptake inhibition (NRI), administered to patients aged ≥80 years with chronic persistent pain. The effect of this molecule on anxiety, depression, cognitive status, and overall quality of life were investigated., Patients and Methods: This was a spontaneous, observational, open-label, prospective study, in 80 older patients aged ≥80 years, naïve to strong opioids, presenting moderate-to-severe chronic pain from different etiologies. Tapentadol PR was initially prescribed at the dose of 25-50 mg/day and increased gradually in case of insufficient analgesia. Pain intensity was assessed by a 10-point Numeric Rating Scale (NRS). Other endpoints were as follows: DN4 questionnaire for the evaluation of the neuropathic component of pain, SF12, HADS, and MMSE questionnaires to evaluate the quality of life, anxiety, and cognitive impairment, respectively. Safety evaluations were also performed through the assessment of the frequency and severity of adverse events., Results: At T45, NRS score reduction was achieved in 86.0% of patients. On average, pain decreased by 55% from a mean of 8.2 to a mean of 3.6. At T90, tapentadol PR did not affect the psychophysical and cognitive abilities of older patients., Conclusions: The benefits with tapentadol PR in controlling pain have improved the quality of life of our patients, also showing a favorable effect on their cognitive performance.

We present the case of a 59-year-old woman with third-grade obesity and severe comorbidities including osteoporosis, dyslipidemia, diabetes mellitus, hypertension, night eating following bariatric biliary-intestinal bypass surgery, severe fibromyalgia, poly-arthrosis, lumbar disc herniation in L5S1, sleep disorders and sleep apnea syndrome, and emotional disorders with anxiety and depression, who suffered from chronic pain unresponsive to a combination of multiple analgesics. After a period of metabolic and nutritional rehabilitation, analgesic treatment with tapentadol prolonged release (PR) was started and gradually increased to a daily dose of 300 mg with optimal pain control and a marked improvement in the quality of life and autonomy. Therapy suspension was followed by rebound pain with a worsening in functional capacity, and thus, the patient requested a new rehabilitation treatment, with new benefits. Analgesia is of paramount importance in fragile patients who are undergoing a rehabilitation period, in order to improve compliance with the rehabilitation protocols and increase the success of behavioral therapy. Tapentadol PR can be an effective analgesic therapy for pain control in several settings. Its peculiar tolerability profile improves the acceptability of tapentadol, even in patients with multiple previous analgesic treatments.

Introduction: This study compared adverse outcomes and resource use for patients with a diagnosis of pain treated with tapentadol prolonged-release (PR) versus those treated with morphine controlled-release (CR) and oxycodone CR., Methods: Data were sourced from the Clinical Practice Research Datalink (CPRD), a database derived from UK primary care. Patients prescribed tapentadol PR between May 2011 and December 2016 were selected and matched to two groups of controls treated with either morphine CR or oxycodone CR on gender, age, pain duration, pain site, pain aetiology, Charlson index and prior analgesia. Times to first adverse event (constipation or nausea/vomiting) were compared within a Cox proportional hazards model. Rates of primary care contacts, accident and emergency contacts and, for a subset of patients linked to Hospital Episode Statistics (HES), inpatient admissions and outpatient contacts were compared using incidence rate ratios (IRRs) derived from Poisson regression., Results: A total of 1907 patients prescribed tapentadol PR were identified and 1791 (93.9%) had a pain diagnosis. Of these 1246 (65.3%) were matched to morphine controls and 829 (43.4%) to oxycodone controls. Compared to controls, gastrointestinal adverse events with tapentadol PR treatment were reduced; aHR = 0.532 (0.402-0.703; p < 0.001) versus morphine CR and 0.517 (0.363-0.735; p < 0.001) versus oxycodone CR. Compared with morphine CR, primary care contacts [IRR = 0.831 (0.802-0.861)], accident and emergency attendance [0.739 (0.572-0.951)], outpatient contacts [0.917 (0.851-0.989)] and inpatients contacts [0.789 (0.664-0.938)] were reduced. For oxycodone, the respective figures were 0.735 (0.703-0.768), 0.971 (0.699-1.352), 0.877 (0.799-0.962) and 0.748 (0.601-0.932)., Conclusion: Tapentadol PR was associated with significantly fewer adverse gastrointestinal events than morphine CR and oxycodone CR in patients with a diagnosis of pain. There was also significantly reduced primary and secondary care resource use. As with all observational studies, potential bias due to residual confounding and confounding by indication should be considered., Funding: Grünenthal Ltd.

Objective: To compare efficacy and safety of tapentadol prolonged release (PR) vs oxycodone controlled release (CR) in younger patients (<65 years of age) and in elderly patients (≥65 and ≥75 years of age) in the treatment of moderate-to-severe chronic osteoarthritis (OA) knee pain., Methods: Data from two double-blind, randomized, placebo-, and oxycodone CR-controlled phase 3 trials were pooled and stratified by age. Primary efficacy end-points were change from baseline in average pain intensity at week 12 (US end-point) and over the entire maintenance period (non-US end-point)., Results: A total of 1357 patients <65 years, 653 patients ≥65 years, and 176 patients ≥75 years of age were assessed. The comparison between tapentadol PR and oxycodone CR showed numerically better pain relief under tapentadol PR for both primary end-points in all three age groups. More favorable improvements were also observed for patient global impression of change, the Short Form-36 physical component score, and EuroQoL-5Dimensions health status index. In the elderly, incidences of dizziness and somnolence were comparable between active treatments, but incidences of nausea, vomiting, and constipation were considerably lower under tapentadol PR. Treatment completion rates were lowest under oxycodone CR; > 50% of elderly oxycodone CR patients named side-effects as the main reason for discontinuation., Conclusions: Tapentadol PR was effective in the treatment of moderate-to-severe chronic OA pain in elderly and younger patients. Compared to oxycodone CR, the overall and the gastrointestinal tolerability profile in particular were better in all tapentadol PR groups, regardless of age.