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      Tapentadol prolonged release for patients with multiple myeloma suffering from moderate-to-severe cancer pain due to bone disease

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          Myeloma bone disease (MBD) is a devastating complication of multiple myeloma that leads to severe pain.


          The aim of this study was to evaluate the efficacy and tolerability of tapentadol prolonged release (PR) in the management of patients with MBD suffering from moderate-to-severe cancer pain.


          A 12-week prospective study was carried out in 25 opioid-naïve MBD patients. Patients initially received twice-daily doses of tapentadol PR 50 mg. Doses were then managed to maintain adequate relief or dose-limiting toxicity. The following parameters were recorded at weekly intervals for 4 weeks, and then at weeks 8 and 12: pain, opioid-related adverse effects, use of other analgesics, DN4 (Douleur Neuropathique 4) score. Quality of life (SF-36 [36-item short-form health survey]) was measured at baseline and at final evaluation.


          Of 25 patients, 22 completed the study. Pain intensity significantly decreased from baseline to all the week intervals ( P<0.01). Quality of life significantly improved with respect to all SF-36 subscale parameters ( P<0.01), and so did both the physical and mental status ( P<0.01). Tapentadol PR significantly reduced DN4 mean value ( P<0.01) and the number of patients with neuropathic component (DN4 ≥4) ( P<0.01). After 8 weeks of treatment, all patients were negative for the DN4 score. Tapentadol PR was well tolerated, and the use of other analgesics was reduced during the study period.


          Tapentadol PR started in doses of 100 mg/day was effective and well tolerated in opioid-naïve MBD patients with moderate-to-severe pain. Tapentadol PR can be considered a first-choice opioid in cancer patients suffering from mixed pain with a neuropathic component.

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          Most cited references 37

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          The Italian SF-36 Health Survey: translation, validation and norming.

           G Apolone,  P. Mosconi (1998)
          This article reports on the development and validation of the Italian SF-36 Health Survey using data from seven studies in which an Italian version of the SF-36 was administered to more than 7000 subjects between 1991 and 1995. Empirical findings from a wide array of studies and diseases indicate that the performance of the questionnaire improved as the Italian translation was revised and that it met the standards suggested by the literature in terms of feasibility, psychometric tests, and interpretability. This generally satisfactory picture strengthens the idea that the Italian SF-36 is as valid and reliable as the original instrument and applicable and valid across age, gender, and disease. Empirical evidence from a cross-sectional survey carried out to norm the final version in a representative sample of 2031 individuals confirms the questionnaire's characteristics in terms of hypothesized constructs and psychometric behavior and gives a better picture of its external validity (i.e., robustness and generalizability) when administered in settings that are very close to real world.
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            Pain and nociception: mechanisms of cancer-induced bone pain.

            Cancer pain, especially pain caused by metastasis to bone, is a severe type of pain, and unless the cause and consequences can be resolved, the pain will become chronic. As detection and survival among patients with cancer have improved, pain has become an increasing challenge, because traditional therapies are often only partially effective. Until recently, knowledge of cancer pain mechanisms was poor compared with understanding of neuropathic and inflammatory pain states. We now view cancer-induced bone pain as a complex pain state involving components of both inflammatory and neuropathic pain but also exhibiting elements that seem unique to cancer pain. In addition, the pain state is often unpredictable, and the intensity of the pain is highly variable, making it difficult to manage. The establishment of translational animal models has started to reveal some of the molecular components involved in cancer pain. We present the essential pharmacologic and neurobiologic mechanisms involved in the generation and continuance of cancer-induced bone pain and discuss these in the context of understanding and treating patients. We discuss changes in peripheral signaling in the area of tumor growth, examine spinal cord mechanisms of sensitization, and finally address central processing. Our aim is to provide a mechanistic background for the sensory characteristics of cancer-induced bone pain as a basis for better understanding and treating this condition.
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              Efficacy and safety of tapentadol extended release for the management of chronic low back pain: results of a prospective, randomized, double-blind, placebo- and active-controlled Phase III study.

              To evaluate the efficacy and safety of tapentadol extended release (ER) for the management of moderate to severe chronic low back pain. Patients (N = 981) were randomized 1:1:1 to receive tapentadol ER 100 - 250 mg b.i.d., oxycodone HCl controlled release (CR) 20 - 50 mg b.i.d., or placebo over 15 weeks (3-week titration period, 12-week maintenance period). Efficacy was assessed as change from baseline in average pain intensity (11-point NRS) at week 12 of the maintenance period and throughout the maintenance period; last observation carried forward was used to impute missing pain scores. Adverse events (AEs) were monitored throughout the study. Tapentadol ER significantly reduced average pain intensity versus placebo at week 12 (least squares mean difference vs placebo [95% confidence interval], -0.8 [-1.22, -0.47]; p < 0.001) and throughout the maintenance period (-0.7 [-1.06,-0.35]; p < 0.001). Oxycodone CR significantly reduced average pain intensity versus placebo at week 12 (-0.9 [-1.24,-0.49]; p < 0.001) and throughout the maintenance period (-0.8 [-1.16,-0.46]; p < 0.001). Tapentadol ER was associated with a lower incidence of treatment-emergent AEs (TEAEs) than oxycodone CR. Gastrointestinal TEAEs, including constipation, nausea, and vomiting, were among the most commonly reported TEAEs (placebo, 26.3%; tapentadol ER, 43.7%; oxycodone CR, 61.9%). The odds of experiencing constipation or the composite of nausea and/or vomiting were significantly lower with tapentadol ER than with oxycodone CR (both p < 0.001). Tapentadol ER (100 - 250 mg b.i.d.) effectively relieved moderate to severe chronic low back pain over 15 weeks and had better gastrointestinal tolerability than oxycodone HCl CR (20 - 50 mg b.i.d.).

                Author and article information

                J Pain Res
                J Pain Res
                Journal of Pain Research
                Journal of Pain Research
                Dove Medical Press
                08 May 2015
                : 8
                : 229-238
                [1 ]Department of Medical and Surgical Sciences and Biotechnologies, Faculty of Pharmacy and Medicine, Unit of Anaesthesiology, Intensive Care Medicine and Pain Therapy, Polo Pontino, Sapienza University of Rome, Latina, Italy
                [2 ]SIAARTI Study Group on Acute and Chronic Pain, Rome, Italy
                [3 ]Department of Pharmaceutical Sciences, Temple University School of Pharmacy, Philadelphia, PA, USA
                [4 ]Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA
                [5 ]Department of Cellular Biotechnology and Hematology, Sapienza University of Rome, Rome, Italy
                Author notes
                Correspondence: Flaminia Coluzzi, Department of Medical and Surgical Sciences and Biotechnologies, Faculty of Pharmacy and Medicine, Unit of Anaesthesia, Intensive Care and Pain Medicine, Sapienza University of Rome, Corso Della Repubblica 79, 04100 Latina, Italy, Tel +39 0773 6513 334, Fax +39 0773 6513 333, Email flaminia.coluzzi@ 123456uniroma1.it
                © 2015 Coluzzi et al. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License

                The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

                Original Research

                Anesthesiology & Pain management

                tapentadol, multiple myeloma, bone, neuropathic pain, opioids


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