Does treatment with duloxetine for neuropathic pain impact glycemic control?
Does treatment with duloxetine for neuropathic pain impact glycemic control?
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DOI：
10.2337/dc06-0947
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发表时间：
2007-01-01
期刊：
影响因子：
16.2
通讯作者：
Boulton, Andrew J. M.
中科院分区：
文献类型：
--
作者：
Hardy, Thomas;Sachson, Richard;Boulton, Andrew J. M.
目的-我们研究了度洛西汀治疗糖尿病周围神经病理性疼痛（DPNP）的临床试验中代谢参数的变化。研究设计和方法-数据来自三个相似设计的临床试验。患有糖尿病和DPNP的成人（n = 1，024）被随机分配至60 mg度洛沙汀q.d.，60 mg b.i.d.，或安慰剂治疗12周。受试者（ri = 867）重新随机分配至60 mg度洛昔单抗b.i.d.组。或常规护理52周。评价血糖、血脂和体重的平均变化。回归和亚组分析被用来确定代谢措施和人口统计学，临床和电生理参数之间的关系。结果-度洛昔单抗治疗导致空腹血糖在短期和长期研究（0.50和0.67 mmol/l，分别）适度增加。在安慰剂对照研究中，A1 C没有增加;然而，在长期研究中，相对于常规治疗，观察到更大的增加（0.52 vs. 0.19%）。短期度洛沙坦治疗导致平均体重减轻（与安慰剂相比，-1.03 k& P < 0.001），而在度洛沙坦和常规护理组中，随着治疗时间的延长，体重略有增加，但不显著。观察到一些血脂参数的组间差异，但这些变化通常较小。代谢的变化似乎并没有影响改善疼痛的严重程度与度洛沙坦，神经传导也没有显着的影响treatment.CONCLUSIONS -度洛沙坦治疗与DPNP患者的神经功能的适度变化。其他代谢变化有限且意义不确定。这些变化不影响度洛沙汀治疗观察到的疼痛显著改善。
OBJECTIVE - We examined changes in metabolic parameters in clinical trials of duloxetine for diabetic peripheral neuropathic pain (DPNP).RESEARCH DESIGN AND METHODS - Data were pooled from three similarly designed clinical trials. Adults with diabetes and DPNP (n = 1,024) were randomized to 60 mg duloxetine q.d., 60 mg b.i.d., or placebo for 12 weeks. Subjects (ri = 867) were re-randomized to 60 mg duloxetine b.i.d. or routine care for an additional 52 weeks. Mean changes in plasma glucose, lipids, and weight were evaluated. Regression and subgroup analyses were used to identify relationships between metabolic measures and demographic, clinical, and electrophysiological parameters.RESULTS - Duloxetine treatment resulted in modest increases in fasting plasma glucose in short- and long-term studies (0.50 and 0.67 mmol/l, respectively). A1C did not increase in placebo-controlled studies; however, a greater increase was seen relative to routine care in long-term studies (0.52 vs. 0.19%). Short-term duloxetine treatment resulted in mean weight loss (- 1.03 k& P < 0.001 vs, placebo), whereas slight, nonsignificant weight gain was seen in both duloxetine and routine care groups with longer treatment. Between-group differences were seen for some lipid parameters, but these changes were generally small. Metabolic changes did not appear to impact improvement in pain severity seen with duloxetine, and nerve conduction was also not significantly impacted by treatment.CONCLUSIONS - Duloxetine treatment was associated with modest changes in glycemia in patients with DPNP. Other metabolic changes were limited and of uncertain significance. These changes did not impact the significant improvement in pain observed with duloxetine treatment.