United States Medical Division, Lilly USA, LLC, Indianapolis, IN 46285, USA.
Int J Clin Pract. 2011 Mar;65(3):341-9. doi: 10.1111/j.1742-1241.2011.02635.x.
Report weight change baseline up to 12-15 months in duloxetine-treated patients during clinical trials of chronic painful conditions of diabetic peripheral neuropathic pain (DPNP), fibromyalgia, chronic low back pain (CLBP) and chronic knee pain as a result of osteoarthritis.
Weight change data from 16 duloxetine studies in chronic painful conditions were pooled by pain condition and duration, creating 10 datasets. Datasets included placebo-controlled, open-label and routine-care-controlled designs. Assessments included mean weight change from baseline, baseline body mass index category, potentially clinically significant (PCS) weight change and weight-related treatment-emergent adverse events.
Total number of patients was 5111 with mean baseline weight ranging from 70 to 97 kg. All duloxetine groups had significant mean weight loss compared with placebo at acute phase completion (p ≤ 0.001). In studies > 3 months, patients from fibromyalgia and CLBP studies had overall mean weight increase (up to 1.1 kg), whereas patients in DPNP studies had overall mean weight loss (-0.33 to -1.7 kg) at end-point. Overall, the percentage of patients with PCS weight gain was 0.4-16% and PCS weight loss was 2.5-9.9%.
Weight change data in clinical trials of patients with fibromyalgia or CLBP treated with duloxetine for up to 15 months were consistent with data reported in 10 clinical trials of patients with major depressive disorder (MDD) using duloxetine up to 52 weeks. Patients with DPNP had weight loss at end-point.
Mean weight changes and percentages of patients with PCS weight loss and weight gain observed in DPNP, fibromyalgia and CLBP with long-term duloxetine treatment were consistent with those reported previously for MDD studies.
报告在治疗糖尿病周围神经病理性疼痛（DPNP）、纤维肌痛、慢性腰痛（CLBP）和骨关节炎引起的慢性膝痛等慢性疼痛疾病的临床试验中，度洛西汀治疗患者在 12-15 个月时的体重变化基线。
通过疼痛状况和持续时间对来自 16 项度洛西汀治疗慢性疼痛疾病的研究中的体重变化数据进行汇总，共创建了 10 个数据集。数据集包括安慰剂对照、开放标签和常规护理对照设计。评估包括从基线开始的平均体重变化、基线体重指数类别、潜在临床显著（PCS）体重变化和与体重相关的治疗中出现的不良事件。
共有 5111 名患者，平均基线体重范围为 70-97 公斤。所有度洛西汀组在急性阶段结束时与安慰剂相比均有显著的平均体重减轻（p ≤ 0.001）。在持续时间超过 3 个月的研究中，纤维肌痛和 CLBP 研究的患者总体平均体重增加（最高达 1.1 公斤），而 DPNP 研究的患者总体平均体重减轻（-0.33 至-1.7 公斤）。总体而言，PCS 体重增加的患者比例为 0.4-16%，PCS 体重减轻的患者比例为 2.5-9.9%。
接受度洛西汀治疗长达 15 个月的纤维肌痛或 CLBP 患者的临床试验中的体重变化数据与在接受度洛西汀治疗长达 52 周的 10 项抑郁症患者临床试验中报告的数据一致。DPNP 患者在终点时体重减轻。
DPNP、纤维肌痛和 CLBP 患者在长期度洛西汀治疗后的平均体重变化和 PCS 体重减轻和体重增加的患者比例与之前报告的 MDD 研究一致。
