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Am J Kidney Dls：降糖药物或使肾病透析患者获益

2013-02-01 Am J Kidney Dls 中国医学论坛报 GZQ

降糖药肾病透析西格列汀格列吡嗪

　　美国一项随机双盲试验显示，对于2型糖尿病和接受透析治疗的终末期肾脏病(ESRD)患者，使用西格列汀或格列吡嗪单药治疗54周以上有效且耐受性良好。 　　该研究纳入年龄为30岁及以上罹患2型糖尿病和接受透析治疗的ESRD 者129例，且糖化血红蛋白（HbAlc)为7%、9%,将其按1:1随机分为西格列汀组（n=64，25 tng/d，平均年龄为61岁，Hb/Uc为7.&nbs

　　美国一项随机双盲试验显示，对于2型糖尿病和接受透析治疗的终末期肾脏病(ESRD)患者，使用西格列汀或格列吡嗪单药治疗54周以上有效且耐受性良好。

　　该研究纳入年龄为30岁及以上罹患2型糖尿病和接受透析治疗的ESRD 者129例，且糖化血红蛋白（HbAlc)为7%、9%,将其按1:1随机分为西格列汀组（n=64，25 tng/d，平均年龄为61岁，Hb/Uc为7. 9%)和格列吡嗪组（xi=65;起始剤童为2. 5 cng/d,滴定加至可能最大剤童10 mg/d或减少剤童以避免低血糖；平均年龄为59岁；Hb/Uc%7.8%). 主要终点是54周时，与基线水平相比HbAlc水平的改变，以及西格列汀的耐受性。次要终点是比较西格列汀和格列吡嗪组有症状低血糖的发病率。

　　结果显示，54周后，与基线水平相比，西格列汀和格列D比曉组HbAic 水平平均改变的最小平方分别为-0. 72%和-0.87%。上述两组有症状低血糖和严重低血糖的发生率分别是6. 3%对10.8% (组间差异为-4.8%) 和0%对7.7% (组间差异为-7.8%) 。与格列吡嗪组相比，西格列汀组蜂窝组织炎和头痛的发生率较高(6. 3对0%)

　　该研究论文于2013年1月25日在线发表于《美国肾脏病杂志》（Am J Kidney Dls) 。

 

Efficacy and Safety of Sitagliptin in Patients With Type 2 Diabetes and ESRD Receiving Dialysis: A 54-Week Randomized Trial

Background
Treatment with oral antihyperglycemic agents has not been well characterized in patients with type 2 diabetes and end-stage renal disease (ESRD). The efficacy and safety of sitagliptin and glipizide monotherapy in patients with type 2 diabetes and ESRD on dialysis therapy were assessed in this study.
Study Design
54-week, randomized, double-blind, parallel-arm study.
Setting & Participants
From 31 clinical sites in 12 countries, 129 patients 30 years or older with type 2 diabetes and ESRD who were on dialysis therapy and had a hemoglobin A1c (HbA1c) level of 7%-9% were randomly assigned 1:1 to treatment.
Intervention
Monotherapy with sitagliptin, 25 mg daily or glipizide (initiated with 2.5 mg daily and titrated up to a potential maximum dose of 10 mg twice daily or down to avoid hypoglycemia).
Outcomes
Primary end points were 54-week change in HbA1c level from baseline and tolerability with sitagliptin. A secondary end point was the comparison of sitagliptin versus glipizide on the incidence of symptomatic hypoglycemia.
Results
Of 129 patients randomly assigned, 64 were in the sitagliptin group (mean baseline age, 61 years; HbA1c, 7.9%) and 65 were in the glipizide group (mean baseline age, 59 years; HbA1c, 7.8%). After 54 weeks, the least squares mean change from baseline in HbA1c level was −0.72% (95% CI, −0.95% to −0.48%) with sitagliptin and −0.87% (95% CI, −1.11% to −0.63%) with glipizide, for a difference of 0.15% (95% CI, −0.18% to 0.49%). The incidences of symptomatic hypoglycemia and severe hypoglycemia were 6.3% versus 10.8% (between-group difference, −4.8% [95% CI, −15.7% to 5.6%]) and 0% versus 7.7% (between-group difference, −7.8% [95% CI, −17.1% to −1.9%]) in the sitagliptin and glipizide groups, respectively. Higher incidences (ie, 95% CI around between-treatment difference excluded 0) of cellulitis and headache were found with sitagliptin compared to glipizide (6.3% vs 0%, respectively, for both).
Limitations
Small sample size limits between-group comparisons.
Conclusions
Treatment with sitagliptin or glipizide monotherapy was effective and well tolerated over 54 weeks in patients with type 2 diabetes and ESRD who were receiving dialysis.    

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    2013-02-03 minlingfeng

    #降糖药#

    0

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    2013-02-03 yuhaisheng_ibp_32061711

    #降糖药物#

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    2013-02-03 ewsr6

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    2013-02-03 gwc389

    #kidney#

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