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[EASD2008]PREDICTIVETM研究亚组分析:2型糖尿病初始胰岛素为地特胰岛素治疗后高BMI者经历体重下降
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临床科研 临床试验 作者:H.Hanaire 来源:国际糖尿病 2008/9/12 18:01:00    加入收藏
内容概要:背景和目的:体重增加是进行胰岛素治疗的一个重要障碍并且会影响依从性,可能低估患者的生活质量。来自于临床试验的证据显示,与接受NPH和甘精胰岛素相比,地特胰岛素较少引起体重增加。多中心观察研究PREDICTIVETM,提供了判定这种趋势的临床实践的机会。本亚组分析的目的是判定2型糖尿病患者初始胰岛素治疗为地特胰岛素治疗12、26和52周后体重下降是否与BMI相关。对象和方法:本分析针对PREDICTIVETM研究中,初始胰岛素治疗为地特胰岛素加OADs的2型糖尿病患者。数据根据患者基线BMI进行分层。监测基线和终点时体重(kg)和BMI(kg/m2)的变化。

    背景和目的:体重增加是进行胰岛素治疗的一个重要障碍并且会影响依从性,可能低估患者的生活质量。来自于临床试验的证据显示,与接受NPH和甘精胰岛素相比,地特胰岛素较少引起体重增加。多中心观察研究PREDICTIVETM,提供了判定这种趋势的临床实践的机会。本亚组分析的目的是判定2型糖尿病患者初始胰岛素治疗为地特胰岛素治疗12、26和52周后体重下降是否与BMI相关。

    对象和方法:本分析针对PREDICTIVETM研究中,初始胰岛素治疗为地特胰岛素加OADs的2型糖尿病患者。数据根据患者基线BMI进行分层。监测基线和终点时体重(kg)和BMI(kg/m2)的变化。

    结果:共计1963例患者(男性47%,平均年龄60.5岁;平均糖尿病病程8年;平均体重84.3kg,BMI 29.8 kg/m2)来自11个国家接受12周的治疗。来自6个国家的277例患者接受26周的治疗(男性53%,60.2岁;平均糖尿病病程9.1年;平均体重88.2kg;BMI 31.1kg m2),以及159例法国患者(男性56%;平均年龄61.7岁;平均糖尿病病程13.1年;平均体重82.1kg;BMI 29.2kg m2)接受了52周的治疗。接受12周治疗的患者在改为地特胰岛素治疗后体重下降了0.6kg(SD=3.4kg, P<0.0001),那些接受26周治疗的体重轻度下降(没有显著性意义)0.4kg((SD=4.2kg, P=0.20),而法国的受试人群接受52周治疗后体重轻度上升(没有显著性意义)0.1kg(SD=5.8kg, P=0.85)。

    每个治疗周期体重变化的数据根据BMI进行分层,并重新进行分析(表)。体重正常者和那些超重或肥胖者相比,体重的变化是不同的;总的来说,BMI最高的亚组(≥30 kg/m2)当改为地特胰岛素治疗后体重下降。

    结论:来自于PREDICTIVETM研究的数据提示,地特胰岛素治疗12周的患者有轻中度但是有统计学意义的平均体重下降。长时间治疗(26周、52周)体重变化不明显。在所有组中,地特胰岛素治疗降低体重的效应在那些高BMI(>30 kg/m2)患者中更加明显。
 

英文原文:

Insulin-naïve patients with type 2 diabetes and higher BMI experience weight loss when initiated onto insulin detemir: 12-week, 26-week and 52-week follow-up data from PREDICTIVETM
H. Hanaire1, S. Sreenan2, A. Dornhorst3, S. Gonbert4, J.B. Hansen5;
1Service Diabetologie, Hopital Rangueil, Toulouse, France, 2Department of Endocrinology, Connolly Hospital, Dublin, Ireland, 3Department of Metabolic Medicine, Imperial College, London, United Kingdom, 4Medical Affairs, Novo Nordisk Pharmaceutique SAS, Paris, France, 5Medical Affairs, Novo Nordisk A/S, Bagsvaerd, Denmark.

Background and aims: Weight gain is a well-recognised barrier to insulin initiation and compliance, and it can undermine patient quality of life. Evidence from clinical trials has consistently shown less weight gain for patients taking insulin detemir compared with NPH and insulin glargine. The multi-national observational study, PREDICTIVETM, provides the opportunity to determine this trend in clinical practice. The aim of this subset analysis was to determine whether a weight sparing effect correlates with BMI in insulin-naïve patients with type 2 diabetes initiated onto insulin detemir and treated for over 12, 26 or 52 weeks.

Materials and methods: This analysis concerned insulin-naïve patients with type 2 diabetes recruited into the PREDICTIVETM study, and initiated onto insulin detemir with OADs. Data were stratified by patients’ baseline BMI. Weight change (kg) and BMI (kg/m2) were monitored at baseline and endpoint.

Results: A total of 1964 patients (47% male; mean age 60.5 years; mean duration of diabetes 8 years; mean weight 84.3 kg, and BMI 29.8 kg/m2) from 11 countries were treated for 12 weeks. 277 patients (53% male; 60.2 years; mean duration of diabetes 9.1 years; mean weight 88.2 kg, and BMI 31.1 kg/m2) from 6 countries were treated for 26 weeks, and 159 French patients (56% male; mean age 61.7 years; mean duration of diabetes 13.1 years; mean weight 82.1 kg, and BMI 29.2 kg/m2) were treated for 52 weeks. Patients treated for 12 weeks lost weight when initiated onto insulin detemir ~0.6 kg of weight (SD=3.4 kg, p<0.0001), those treated for 26 weeks tended to lose a small (non-significant) amount of weight ~0.4 kg (SD=4.2 kg, p=0.20) and patients in the French cohort treated for 52 weeks had minimal (non-significant) weight gain ~0.1 kg (SD=5.8 kg, p=0.85).

Weight change data for each of the three treatment periods were then stratified by BMI, and reanalysed (table). The pattern of weight change was different in subjects with normal BMI and those who were overweight or obese; on average, patients in the highest BMI categories (≥30 kg/m2) lost weight when initiated onto insulin detemir.

Conclusion: Data from the PREDICTIVETM study show a modest but statistically significant mean weight loss for insulin-naïve patients initiated onto and treated with insulin detemir for 12 weeks. Subsets with longer treatment periods (26 weeks, 52 weeks) experienced no significant weight changes. Across groups, insulin detemir’s weight sparing benefit was more noticeable in patients with high BMI (>30 kg/m2) who tended to lose weight.
 

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