Pharmatelligence, Cardiff, UK.
Grünenthal Ltd, Stokenchurch, UK.
Adv Ther. 2019 Jun;36(6):1412-1425. doi: 10.1007/s12325-019-00932-7. Epub 2019 Apr 8.
This study compared adverse outcomes and resource use for patients with a diagnosis of pain treated with tapentadol prolonged-release (PR) versus those treated with morphine controlled-release (CR) and oxycodone CR.
Data were sourced from the Clinical Practice Research Datalink (CPRD), a database derived from UK primary care. Patients prescribed tapentadol PR between May 2011 and December 2016 were selected and matched to two groups of controls treated with either morphine CR or oxycodone CR on gender, age, pain duration, pain site, pain aetiology, Charlson index and prior analgesia. Times to first adverse event (constipation or nausea/vomiting) were compared within a Cox proportional hazards model. Rates of primary care contacts, accident and emergency contacts and, for a subset of patients linked to Hospital Episode Statistics (HES), inpatient admissions and outpatient contacts were compared using incidence rate ratios (IRRs) derived from Poisson regression.
A total of 1907 patients prescribed tapentadol PR were identified and 1791 (93.9%) had a pain diagnosis. Of these 1246 (65.3%) were matched to morphine controls and 829 (43.4%) to oxycodone controls. Compared to controls, gastrointestinal adverse events with tapentadol PR treatment were reduced; aHR = 0.532 (0.402-0.703; p < 0.001) versus morphine CR and 0.517 (0.363-0.735; p < 0.001) versus oxycodone CR. Compared with morphine CR, primary care contacts [IRR = 0.831 (0.802-0.861)], accident and emergency attendance [0.739 (0.572-0.951)], outpatient contacts [0.917 (0.851-0.989)] and inpatients contacts [0.789 (0.664-0.938)] were reduced. For oxycodone, the respective figures were 0.735 (0.703-0.768), 0.971 (0.699-1.352), 0.877 (0.799-0.962) and 0.748 (0.601-0.932).
Tapentadol PR was associated with significantly fewer adverse gastrointestinal events than morphine CR and oxycodone CR in patients with a diagnosis of pain. There was also significantly reduced primary and secondary care resource use. As with all observational studies, potential bias due to residual confounding and confounding by indication should be considered.
Grünenthal Ltd.
本研究比较了诊断为疼痛的患者接受他喷他多延长释放制剂(PR)治疗与接受吗啡控释制剂(CR)和羟考酮 CR 治疗的不良结局和资源利用情况。
数据来自临床实践研究数据库(CPRD),这是一个源自英国初级保健的数据库。选择了 2011 年 5 月至 2016 年 12 月期间接受他喷他多 PR 治疗的患者,并根据性别、年龄、疼痛持续时间、疼痛部位、疼痛病因、Charlson 指数和先前的镇痛药物将其与两组对照进行匹配,分别接受吗啡 CR 或羟考酮 CR 治疗。采用 Cox 比例风险模型比较首次不良事件(便秘或恶心/呕吐)的时间。使用泊松回归得出的发病率比(IRR)比较初级保健接触、急症就诊次数,以及部分与医院入院统计(HES)相关联的患者的住院和门诊就诊次数。
共确定了 1907 例接受他喷他多 PR 治疗的患者,其中 1791 例(93.9%)有疼痛诊断。这些患者中有 1246 例(65.3%)与吗啡对照匹配,829 例(43.4%)与羟考酮对照匹配。与对照相比,他喷他多 PR 治疗的胃肠道不良事件减少;HR = 0.532(0.402-0.703;p < 0.001)与吗啡 CR 相比,0.517(0.363-0.735;p < 0.001)与羟考酮 CR 相比。与吗啡 CR 相比,初级保健接触[IRR = 0.831(0.802-0.861)]、急症就诊[0.739(0.572-0.951)]、门诊就诊[0.917(0.851-0.989)]和住院就诊[0.789(0.664-0.938)]减少。对于羟考酮,相应的数字分别为 0.735(0.703-0.768)、0.971(0.699-1.352)、0.877(0.799-0.962)和 0.748(0.601-0.932)。
与吗啡 CR 和羟考酮 CR 相比,诊断为疼痛的患者接受他喷他多 PR 治疗时,胃肠道不良事件明显减少。初级和二级医疗资源的使用也显著减少。与所有观察性研究一样,应考虑由于残余混杂和指示性混杂引起的潜在偏倚。
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