Neuroscience, Johnson & Johnson Pharmaceutical Research & Development, Titusville, New Jersey 08560, USA.
Adv Ther. 2011 May;28(5):401-17. doi: 10.1007/s12325-011-0018-0. Epub 2011 Apr 13.
Two randomized, double-blind, placebo-controlled studies in acute and chronic pain treatment, powered to assess noninferiority of the efficacy of tapentadol immediate release (IR) (50 mg, 75 mg) versus oxycodone hydrochloride (HCl) IR (10 mg), established comparable efficacy of tapentadol IR with oxycodone HCl IR, and suggested tapentadol IR's improved gastrointestinal tolerability. The impact of these equianalgesic doses of tapentadol and oxycodone HCl on bowel function and gastrointestinal tolerability was then directly assessed in the current study, using a validated bowel function diary to comprehensively assess opioid-induced constipation symptoms and outcomes.
In this double-blind study, patients with end-stage joint disease were randomized to tapentadol IR (50 mg or 75 mg), oxycodone HCl IR 10 mg, or placebo. Treatment with IR formulations (14 days) was followed by treatment (28 days) with extended-release (ER) formulations of active drugs (or placebo).
Oxycodone HCl IR treatment significantly decreased (P<0.001) mean (SD) number of spontaneous bowel movements over the 14-day period (average per week: [6.7 (5.44)] versus tapentadol IR 50 mg [9.0 (4.04)], tapentadol IR 75 mg [8.6 (4.65)], and placebo [9.9 (5.16)]) (primary measure), confirming the tolerability findings of the earlier studies. Additionally, incidences of nausea and vomiting were significantly lower over the 14-day period (nominal P<0.001) for tapentadol IR 50 and 75 mg, versus oxycodone HCl IR 10 mg. Results with ER formulations of tapentadol and oxycodone HCl over a longer treatment period were consistent with those of IR formulations.
Tapentadol IR (50 mg, 75 mg) consistently demonstrated superior gastrointestinal tolerability, including for the most commonly reported events, such as nausea, vomiting, and constipation at doses that provide comparable efficacy with oxycodone HCl IR 10 mg. These findings validate and extend the tolerability findings of the two earlier studies that established comparable efficacy of these tapentadol and oxycodone HCl doses.
两项在急性和慢性疼痛治疗中进行的随机、双盲、安慰剂对照研究，旨在评估曲马多即时释放（IR）（50mg、75mg）与盐酸羟考酮（HCl）IR（10mg）疗效的非劣效性，结果表明曲马多 IR 与盐酸羟考酮 HCl IR 的疗效相当，并提示曲马多 IR 的胃肠道耐受性更好。在这项研究中，使用经过验证的肠道功能日记全面评估阿片类药物引起的便秘症状和结果，直接评估这些等效剂量的曲马多和盐酸羟考酮对肠道功能和胃肠道耐受性的影响。
在这项双盲研究中，患有终末期关节疾病的患者被随机分配至曲马多 IR（50mg 或 75mg）、盐酸羟考酮 HCl IR 10mg 或安慰剂组。IR 制剂治疗（14 天）后，再进行活性药物（或安慰剂）的延长释放（ER）制剂治疗（28 天）。
盐酸羟考酮 HCl IR 治疗组在 14 天内平均（SD）自发性排便次数明显减少（P<0.001）（每周平均次数：[6.7（5.44）]与曲马多 IR 50mg [9.0（4.04）]、曲马多 IR 75mg [8.6（4.65）]和安慰剂[9.9（5.16）]）（主要指标），证实了早期研究中的耐受性结果。此外，在 14 天内，曲马多 IR 50mg 和 75mg 的恶心和呕吐发生率明显低于盐酸羟考酮 HCl IR 10mg（名义 P<0.001）。曲马多和盐酸羟考酮 HCl 的 ER 制剂在更长的治疗期间的结果与 IR 制剂的结果一致。
曲马多 IR（50mg、75mg）始终表现出更好的胃肠道耐受性，包括最常见的报告事件，如恶心、呕吐和便秘，其剂量与盐酸羟考酮 HCl IR 10mg 提供的疗效相当。这些发现验证并扩展了早期两项研究的耐受性发现，这些研究证实了这些曲马多和盐酸羟考酮剂量的疗效相当。
