Buynak Robert, Rappaport Stephen A, Rod Kevin, Arsenault Pierre, Heisig Fabian, Rauschkolb Christine, Etropolski Mila
Northwest Indiana Center for Clinical Research, Valparaiso, Indiana.
Agewell(®) Health, Indianapolis, Indiana.
Clin Ther. 2015 Nov 1;37(11):2420-38. doi: 10.1016/j.clinthera.2015.08.014. Epub 2015 Oct 1.
Tapentadol extended release (ER) has demonstrated efficacy and safety for the management of moderate to severe, chronic pain in adults. This study evaluated the long-term safety and tolerability of tapentadol ER in patients with chronic osteoarthritis or low back pain.
Patients were enrolled in this 1-year, open-label extension study after completing one of two 15-week, placebo-controlled studies of tapentadol ER and oxycodone controlled release (CR) for osteoarthritis knee pain (NCT00421928) or low back pain (NCT00449176), a 7-week crossover study between tapentadol immediate release and tapentadol ER for low back pain (NCT00594516), or a 1-year safety study of tapentadol ER and oxycodone CR for osteoarthritis or low back pain (NCT00361504). After titrating the drug to an optimal dose, patients received tapentadol ER (100-250 mg BID) for up to 1 year (after finishing treatment in the preceding studies); patients who were previously treated with tapentadol ER in the 1-year safety study received tapentadol ER continuously for up to 2 years in total.
Of the 1,154 patients in the safety population, 82.7% were aged >65 years and 57.9% were female; 50.1% had mild baseline pain intensity. Mean (SD) pain intensity scores (11-point numerical rating scale) were 3.9 (2.38) at baseline (end of preceding study) and 3.7 (2.42) at end point, indicating that pain relief was maintained during the extension study. Improvements in measures of quality of life (eg, EuroQol-5 Dimension and the 36-item Short Form Health Survey [SF-36]) health status questionnaires) achieved during the preceding studies were maintained during the open-label extension study. Tapentadol ER was associated with a safety and tolerability profile comparable to that observed in the preceding studies. The most common treatment-emergent adverse events (incidence ≥10%; n = 1154) were headache (13.1%), nausea (11.8%), and constipation (11.1%). Similar efficacy and tolerability results were shown for patients who received up to 2 years of tapentadol ER treatment.
Pain relief and improvements in quality of life achieved during the preceding studies were maintained throughout this extension study, during which tapentadol ER was well tolerated for the long-term treatment of chronic osteoarthritis or low back pain over up to 2 years of treatment. (ClinicalTrials.gov identifier: NCT00487435.).
盐酸曲马多缓释片已证明对成人中度至重度慢性疼痛的治疗有效且安全。本研究评估了盐酸曲马多缓释片在慢性骨关节炎或腰痛患者中的长期安全性和耐受性。
患者在完成两项为期15周、针对膝骨关节炎疼痛（NCT00421928）或腰痛（NCT00449176）的盐酸曲马多缓释片与羟考酮控释片的安慰剂对照研究之一、一项为期7周的盐酸曲马多速释片与盐酸曲马多缓释片治疗腰痛的交叉研究（NCT00594516）或一项为期1年的盐酸曲马多缓释片与羟考酮控释片治疗骨关节炎或腰痛的安全性研究（NCT00361504）后，参加了这项为期1年的开放标签扩展研究。在将药物滴定至最佳剂量后，患者接受盐酸曲马多缓释片（100 - 250 mg，每日两次）治疗长达1年（在前述研究完成治疗后）；在1年安全性研究中先前接受过盐酸曲马多缓释片治疗的患者总共连续接受盐酸曲马多缓释片治疗长达2年。
在安全人群的1154名患者中，82.7%年龄大于65岁，57.9%为女性；50.1%基线疼痛强度为轻度。平均（标准差）疼痛强度评分（11点数字评定量表）在基线（先前研究结束时）为3.9（2.38），在终点时为3.7（2.42），表明在扩展研究期间疼痛缓解得以维持。在前述研究期间实现的生活质量测量指标（如欧洲五维健康量表和36项简短健康调查问卷[SF - 36]健康状况问卷）的改善在开放标签扩展研究期间得以维持。盐酸曲马多缓释片的安全性和耐受性与先前研究中观察到的相当。最常见的治疗中出现的不良事件（发生率≥10%；n = 1154）为头痛（13.1%）、恶心（11.8%）和便秘（11.1%）。接受长达2年盐酸曲马多缓释片治疗的患者显示出相似的疗效和耐受性结果。
在前述研究期间实现的疼痛缓解和生活质量改善在整个扩展研究期间得以维持，在此期间盐酸曲马多缓释片在长达2年的慢性骨关节炎或腰痛长期治疗中耐受性良好。（ClinicalTrials.gov标识符：NCT00487435.）
