Revista nº 809

Duque et al. Tolerability of tapentadol prolonged-release therapeutics in patients with chronic pain · 34 · Actualidad Médica · Número 809 · Enero/Abril 2020 Páginas 31 a 34 Mean time to treatment discontinuation with tapentadol PR for all patients was 42.4 ± 41.2 (1-120) days (n = 26). Six patients with- drew during the first week of tapentadol PR therapeutics, because of nausea, constipation, or dizziness, whereas 4 patients tolerated longest treatment periods of 110 to 120 days before discontinuation. These patients reported lack of analgesic effects as the main reason for discontinuation and resumed their previous opioid therapy. Table 3 shows the duration and median maximum daily dose of tapentadol PR treatment for the most common reasons for discontinuation. Gastrointestinal disorders led to tapentadol PR discontinuation after average of 25.8 ± 27.6 days of treatment (n = 14), dizziness led to discontinuation after an average of 23.4 ± 36.8 days (n = 5), and lack of analgesic effects led to discontinu- ation after an average of 62.0 ± 49.1 days of treatment (n = 8). DISCUSSION This was the first study that investigated the introduction and tolerability of tapentadol PR for chronic pain treatment in outpatients attending a chronic pain unit in Portugal. In these pa- tients, maximum daily dose of tapentadol PR ranged from 100 to 400 mg/day and duration of treatment was 1 to 120 days. Preva- lence of all-cause treatment discontinuation and dose reduction for tapentadol PR was 20.5% and 3.9%, respectively. These were primarily due to adverse reactions and lack of analgesic effect. Tapentadol PR use for up to 2 years has been reported to be generally well tolerated in the clinical trials, pooled analyses and clinical practice studies. 9 In our study, we found that the prevalence of tapentadol PR discontinuation owing to adverse reactions is 16.5%, which was similar to those of other studies about the tolerability of tapentadol in pain therapeutics (13-22%). 3,4 Moreover, we show that the most frequent adverse effects associated with the use of tapentadol PR reported in our unit - nausea, vomiting, cons- tipation, dizziness - are similar to the ones described in previous studies, being these less frequent than those of other opioids. 3-5 We also found other commonly described reasons for disconti- nuation (i.e., pruritus, feeling hot, and lethargy), 3 as well as less frequently reported adverse reactions (i.e., legs edema, urinary incontinence, and dyspnea). Several limitations may be presented for our study. We in- cluded in our study all patients that were available to us from a single unit, and no sample size calculation was carried out. There- fore, results from our study may not necessarily be generalized to other settings, or for patients with different clinical backgrounds. For instance, further studies with tapentadol PR should include more representative subsamples of patients with different etio- logies for chronic pain. In conclusion, we found that the most frequent reason for discontinuation of tapentadol PR was gastrointestinal disorders, followed by lack of analgesic effect, and dizziness. Patients dis- continued their tapentadol PR treatment at a non-negligible per- centage, but, in most of the cases, this medication was well-tole- rated by these patients in an outpatient chronic pain unit setting. FUNDING Grünenthal S.A. contributed with a grant to support Scienti- fic Toolbox Consulting regarding medical writing services. CONFLICT OF INTEREST Manuel Vico has received fees from Grünenthal for advice on chronic pain and for lectures at courses of chronic pain. Mélanie Duque and Maria do Céu Loureiro have no conflict of interest to declare. REFERENCIAS BIBLIOGRÁFICAS 1. Zampi M. Efficacy and tolerabylity of tapentadol prolonged release in the elderly and fragile patient: an observational study. Eur Rev Med Pharmacol Sci. 2019; 23 (4 Suppl):45-50. 2. World Health Organization. WHO's Pain Relief Ladder [homepage in Internet]. Genebra: WHO; 2017; [assessed 2017 Feb 9]. Available at: http://www.who.int/cancer/palliative/ painladder/en/. 3. Wade WE, Spruill WJ. Tapentadol hydrochloride: a centrally acting oral analgesic. Clin Ther. 2009;31:2804-18. 4. Vadivelu N, Timchenko A, Huang Y, Sinatra R. Tapentadol extended-release for treatment of chronic pain: a review. J Pain Res. 2011;4:211-8. 5. Taylor R, Pergolizzi JV, Raffa RB. Tapentadol extended release for chronic pain patients. Adv Ther. 2013;30:14-27. 6. Butterworth J, Mackey DC, Wasnick J. Morgan and Mikhail's Clinical Anesthesiology. 5th ed. New York: McGraw-Hill Education; 2013. 7. Sanchez Del AguilaMJ, SchenkM, Kern KU, Drost T, Steigerwald I. Practical considerations for the use of tapentadol prolonged release for the management of severe chronic pain. Clin Ther. 2015;37:94-113. 8. Ballantyne JC, Kalso E, Stannard C. WHO analgesic ladder: a good concept gone astray. BMJ. 2016;352:i20. 9. Deeks E. Tapentadol Prolonged Release: A Review in Pain Management. Drugs. 2018;78:1805-1816. Treatment Gastrointestinal disorders (n = 14) Dizziness (n = 5) Lack of analgesic effect (n = 8) Time to discontinuation, mean ± SD (min-max), days 25.8 ± 27.6 (1-89) 23.4 ± 36.8 (1-87) 62.0 ± 49.1 (11-120) Maximum daily dose, median (min-max), mg 100 (100-200) 100 (100-200) 200 (100-400) Table 3. Duration and daily dose of tapentadol prolonged-release treatment before discontinuation owing to the most frequent adverse effects in patients with chronic pain.