O'Connor Alec B, Noyes Katia, Holloway Robert G
Department of Medicine, University of Rochester School of Medicine and Dentistry, University of Rochester, Rochester, New York 14642, USA.
Pharmacoeconomics. 2008;26(12):1045-64. doi: 10.2165/0019053-200826120-00007.
Painful diabetic neuropathy is common and adversely affects patients' quality of life and function. Several treatment options exist, but their relative efficacy and value are unknown.
To determine the relative efficacy, costs and cost effectiveness of the first-line treatment options for painful diabetic neuropathy.
Published and unpublished clinical trial and cross-sectional data were incorporated into a decision analytic model to estimate the net health and cost consequences of treatment for painful diabetic peripheral neuropathy over 3-month (base case), 1-month and 6-month timeframes. Efficacy was measured in QALYs, and costs were measured in $US, year 2006 values, using a US third-party payer perspective. The patients included in the model were outpatients with moderate to severe pain associated with diabetic peripheral neuropathy and no contraindications to treatment with tricyclic antidepressants. Four medications were compared: desipramine 100 mg/day, gabapentin 2400 mg/day, pregabalin 300 mg/day and duloxetine 60 mg/day.
Desipramine and duloxetine were both more effective and less expensive than gabapentin and pregabalin in the base-case analysis and through a wide range of sensitivity analyses. Duloxetine offered borderline value compared with desipramine in the base case ($US47,700 per QALY), but not when incorporating baseline-observation-carried-forward analyses of the clinical trial data ($US867,000 per QALY). The results were also sensitive to the probability of obtaining pain relief with duloxetine.
Desipramine (100 mg/day) and duloxetine (60 mg/day) appear to be more cost effective than gabapentin or pregabalin for treating painful diabetic neuropathy. The estimated value of duloxetine relative to desipramine depends on the assumptions made in the statistical analyses of clinical trial data.
疼痛性糖尿病神经病变很常见,会对患者的生活质量和功能产生不利影响。有多种治疗选择,但它们的相对疗效和价值尚不清楚。
确定疼痛性糖尿病神经病变一线治疗选择的相对疗效、成本及成本效益。
已发表和未发表的临床试验及横断面数据被纳入一个决策分析模型,以估计在3个月(基础病例)、1个月和6个月时间范围内治疗疼痛性糖尿病周围神经病变的净健康和成本后果。疗效以质量调整生命年(QALYs)衡量,成本以2006年美元价值衡量,采用美国第三方支付方的视角。模型纳入的患者为患有与糖尿病周围神经病变相关的中度至重度疼痛且无三环类抗抑郁药治疗禁忌证的门诊患者。比较了四种药物:去甲丙咪嗪100毫克/天、加巴喷丁2400毫克/天、普瑞巴林300毫克/天和度洛西汀60毫克/天。
在基础病例分析及广泛的敏感性分析中,去甲丙咪嗪和度洛西汀均比加巴喷丁和普瑞巴林更有效且成本更低。在基础病例中,度洛西汀与去甲丙咪嗪相比具有临界价值(每质量调整生命年47,700美元),但在纳入临床试验数据的基线观察结转分析时则不然(每质量调整生命年867,000美元)。结果对度洛西汀获得疼痛缓解的概率也很敏感。
对于治疗疼痛性糖尿病神经病变,去甲丙咪嗪(100毫克/天)和度洛西汀(60毫克/天)似乎比加巴喷丁或普瑞巴林更具成本效益。度洛西汀相对于去甲丙咪嗪的估计价值取决于临床试验数据统计分析中所做的假设。