Revista nº 809

Duque et al. Tolerability of tapentadol prolonged-release therapeutics in patients with chronic pain · 33 · Actualidad Médica · Número 809 · Enero/Abril 2020 Páginas 31 a 34 starting dose of tapentadol PR used was twice-daily 50 mg in most patients with titration to effective analgesic dose. The mean maximum daily dose of tapentadol PR for all patients was 172.4 ± 91.2 (100-400) mg/day in two divided doses. Table 1 shows the prevalence and characteristics of chronic pain patients who discontinued, reduced the dose, or continued the treatment with tapentadol PR. At eight months, the prevalence of all-cause treatment discontinuation and dose reduction of tapentadol PR was 20.5% (n = 26) and 3.9% (n = 5), respectively. All 31 patients who discontinued or re- duced the dose of tapentadol PR used concomitant analgesic medication (e.g., paracetamol, anti-inflammatory drugs, anti- epileptic drugs, antidepressants), and most of these patients were being treated for non-oncologic chronic pain (n = 28). Overall, the main reasons for treatment discontinuation were adverse reactions (16.5%, n = 21), lack of analgesic effect (6.3%, n = 8), or reduction of analgesic needs (0.8%, n = 1). The reasons that led to treatment discontinuation or dose reduction of tapentadol PR are summarized in Table 2. During the study period, 53.8% (n = 14) of patients who dis- continued tapentadol PR reported gastrointestinal disorders, which included nausea or vomiting (n = 6), constipation (n = 4), diarrhea (n = 2), and gastric discomfort (n = 2); and 30.8 % (n = 8) of patients reported lack of analgesic effect. Other reasons that led to discontinuation of tapentadol PR treatment were dizziness (n = 5), legs edema (n = 2), reduc- tion of analgesic needs because of reduction in patients’ pain severity (n = 1), among others (e.g., urinary incontinence, pru- ritus, feeling hot, lethargy, headache, dyspnea). On the other hand, reported main reasons leading to dose reduction of tapentadol PR were: constipation (n = 1), reduction of analgesic needs (n = 1), dyspnea (n = 1), and con- fusion (n = 1). Table 1. Demographic and clinical characteristics of patients with chronic pain who discontinued, reduced the dose, or continued the tapentadol prolonged-release (PR) treatment. Tapentadol PR treatment (n = 127) Characteristic Discontinuation Dose reduction Continuation No. of patients (%) 26 (20.5) 5 (3.9) 96 (75.6) Female, n (%) 20 (15.7) 4 (3.1) 68 (53.5) Etiology of chronic pain, n (%) Oncologic 3 (2.4) 0 (0.0) 17 (13.4) Non oncologic 23 (18.1) 5 (3.9) 79 (62.2) Analgesic medication, n (%) Tapentadol PR alone 0 (0.0) 0 (0.0) 8 (6.3) Tapentadol PR with concomitant analgesic drugs 26 (20.5) 5 (3.9) 88 (69.3) Tapentadol PR treatment Event Discontinuation (n = 26) Dose reduction (n = 5) Adverse reaction, n (%) 21 (80.8) 1 (24.2) Gastrointestinal disorders 14 (53.8) 1 (24.2) Nausea/vomiting 6 (23.1) Constipation 4 (15.4) 1 (24.2) Diarrhea 2 (7.7) Gastric discomfort 2 (7.7) Dizziness 5 (19.2) - Legs edema 2 (7.7) - Lack of analgesic effect, n (%) 8 (30.8) Reduction of analgesic needs, n (%) 1 (3.8) 1 (24.2) Other/unknown, n (%) 7 (26.9) 2 (40.0) Table 2. Reasons for discontinuation or dose reduction of tapentadol prolonged-release (PR) treatment in patients with chronic pain.