Intervention Review

Alpha-glucosidase inhibitors for type 2 diabetes mellitus

  1. Floris A Van de Laar1,*,
  2. Peter LBJ Lucassen2,
  3. Reinier P Akkermans3,
  4. Eloy H Van de Lisdonk4,
  5. Guy EHM Rutten5,
  6. Chris Van Weel6

Editorial Group: Cochrane Metabolic and Endocrine Disorders Group

Published Online: 20 APR 2005

Assessed as up-to-date: 29 APR 2003

DOI: 10.1002/14651858.CD003639.pub2

How to Cite

Van de Laar FA, Lucassen PLBJ, Akkermans RP, Van de Lisdonk EH, Rutten GEHM, Van Weel C. Alpha-glucosidase inhibitors for type 2 diabetes mellitus. Cochrane Database of Systematic Reviews 2005, Issue 2. Art. No.: CD003639. DOI: 10.1002/14651858.CD003639.pub2.

Author Information

  1. 1

    Radboud University Nijmegen Medical Centre, Department of General Practice, 117 HAG, Nijmegen, Netherlands

  2. 2

    Radboud University Medical Centre, Department of General Practice and Family Medicine, Nijmegen, Netherlands

  3. 3

    Radboud University Nijmegen Medical Centre , Department of General Practice, 117 HAG, Nijmegen, Netherlands

  4. 4

    Radboud University Medical Centre , Department of General Practice and Family Medicine, Nijmegen, Netherlands

  5. 5

    University Medical Center Utrecht, Julius Center for Health Sciences and Primary Care, Utrecht, Netherlands

  6. 6

    Radboud University Nijmegen Medical Centre, Department of General Practice, Nijmegen, Netherlands

*Floris A Van de Laar, Department of General Practice, 117 HAG, Radboud University Nijmegen Medical Centre, P.O. Box 9101, Nijmegen, 6500 HB, Netherlands. f.vandelaar@cochraneprimarycare.org. f.vandelaar@hag.umcn.nl.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 20 APR 2005

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Abstract

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  2. Abstract
  3. Plain language summary
  4. 摘要
  5. 概要
  6. 摘要

Background

Alpha-glucosidase inhibitors such as acarbose or miglitol, have the potential to improve glycemic control in type 2 diabetes mellitus. The true value of these agents, especially in relation to diabetes related mortality and morbidity, has never been investigated in a systematic literature review and meta-analysis.

Objectives

To assess the effects of alpha-glucosidase inhibitors in patients with type 2 diabetes mellitus.

Search methods

We searched The Cochrane Library, MEDLINE, EMBASE, Current Contents, LILACS, databases of ongoing trials, reference lists of reviews on the topic of alpha-glucosidase inhibitors and we contacted experts and manufacturers for additional trials.

Selection criteria

Randomised controlled trials of at least 12 weeks duration comparing alpha-glucosidase inhibitor monotherapy in patients with type 2 diabetes with any other intervention and that included at least one of the following outcomes: mortality, morbidity, quality of life, glycemic control, lipids, insulin levels, body weight, adverse events.

Data collection and analysis

Two reviewers read all abstracts, assessed quality and extracted data independently. Discrepancies were resolved by consensus or by the judgement of a third reviewer. A statistician checked all extracted data entrance in the database. We attempted to contact all authors for data clarification.

Main results

We included 41 trials (8130 participants), 30 investigated acarbose, seven miglitol, one trial voglibose and three trials compared different alpha-glucosidase inhibitors. Study duration was 24 weeks in most cases and only two studies lasted amply longer than one year. We found only few data on mortality, morbidity and quality of life. Acarbose had a clear effect on glycemic control compared to placebo: glycated haemoglobin -0.8% (95% confidence interval -0.9 to -0.7), fasting blood glucose -1.1 mmol/L (95% confidence interval -1.4 to -0.9), post-load blood glucose -2.3 mmol/L (95% confidence interval -2.7 to -1.9). The effect on glycated haemoglobin by acarbose was not dose-dependent. We found a decreasing effect on post-load insulin and no clinically relevant effects on lipids or body weight. Adverse effects were mostly of gastro-intestinal origin and dose dependent. Compared to sulphonylurea, acarbose decreased fasting and post-load insulin levels by -24.8 pmol/L (95% confidence interval -43.3 to -6.3) and -133.2 pmol/L (95% confidence interval -184.5 to -81.8) respectively and acarbose caused more adverse effects.

Authors' conclusions

It remains unclear whether alpha-glucosidase inhibitors influence mortality or morbidity in patients with type 2 diabetes. Conversely, they have a significant effect on glycemic control and insulin levels, but no statistically significant effect on lipids and body weight. These effects are less sure when alpha-glucosidase inhibitors are used for a longer duration. Acarbose dosages higher than 50 mg TID offer no additional effect on glycated hemoglobin but more adverse effects instead. Compared to sulphonylurea, alpha-glucosidase inhibitors lower fasting and post-load insulin levels and have an inferior profile regarding glycemic control and adverse effects.

 

Plain language summary

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  2. Abstract
  3. Plain language summary
  4. 摘要
  5. 概要
  6. 摘要

Alpha-glucosidase inhibitors for type 2 diabetes mellitus

Alpha-glucosidase inhibitors may be used for patients with type 2 diabetes. They delay the absorbance of carbohydrates ('complex form of sugar') in the gut. In this review we present data from meta-analyses that show (among other things) a decrease in glycated haemoglobin, fasting and post-load blood glucose and post-load insulin. But we found no evidence for an effect on mortality or morbidity. We found clues that with higher dosages the effect on glycated haemoglobin, in contrast to post-load blood glucose, remains the same. This might be because a lower compliance due to increasing side-effects.

 

摘要

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  2. Abstract
  3. Plain language summary
  4. 摘要
  5. 概要
  6. 摘要

α-葡糖苷酶抑制剂治疗2型糖尿病

研究背景

α-葡糖苷酶抑制剂,如acarbose(阿卡波糖)或miglitol(米格列醇),可以改善2型糖尿病患者的血糖控制。但是,目前尚无系统评价或Meta-分析研究这类药物的疗效,特别是在降低糖尿病相关的死亡率与发病率方面。

研究目的

评价α-葡糖苷酶抑制剂对2型糖尿病患者的治疗效果。

检索方法

检索了The Cochrane Library、MEDLINE、EMBASE、Current Contents、LILACS、在研试验数据库以及以α-葡糖苷酶抑制剂为主题的综述的参考文献,并通过联系本领域专家和药品制造商以获取额外信息。

纳入标准

纳入的随机对照试验至少进行12周,比较单用α-葡糖苷酶抑制剂与其他治疗措施在治疗2型糖尿病效果方面的差异,至少包括以下一种结局指标: 死亡率、发病率、生命质量、血糖控制水平、血脂、胰岛素水平、体重、不良事件发生率。

数据收集与分析

两名评价者独立阅读所有摘要,完成质量评价及数据提取。存在不同意见时,通过讨论或寻求第三方评判以达成共识。所有进入数据库的数据由一位统计学专家进行核查。同时,尽可能联系所有作者以获得更准确的数据信息。

主要结果

共纳入41个试验(n=8130),其中30个评价acarbose,7个评价miglitol,1个针对voglibose(伏格列波糖),另外还有3项比较不同α-葡糖苷酶抑制剂疗效。多数研究持续时间为24周,只有2项研究持续时间超过1年。关于死亡率、发病率或生命质量等指标的数据很少。与安慰剂相比,acarbose的血糖控制效果明显: 糖化血红蛋白−0.8%(95% CI: −0.9 ∼ −0.7),空腹血糖−1.1 mmol / L(95%CI: −1.4 ∼ −0.9),餐后血糖−2.3 mmol / L(95% CI: −2.7 ∼ −1.9)。Acarbose对糖化血红蛋白的影响与剂量无关。我们发现acarbose可降低餐后胰岛素浓度,而对血脂或体重则无明显影响。不良反应以肠胃道症状居多并存在剂量反应关系。与sulphonylurea(磺脲类药物)相比,acarbose可降低空腹和餐后胰岛素浓度,分别为−24.8pmol / L(95% CI: −43.3 ∼ −6.3)和−133.2 pmol / L(95% CI: −184.5 ∼ −81.8),但acarbose的不良反应发生率较高。

作者结论

目前还不清楚α-葡糖苷酶抑制剂是否对2型糖尿病患者的发病或死亡有影响,但其在控制血糖及调节胰岛素水平方面有显著效果,且对患者的血脂和体重无明显影响。然而α-葡糖苷酶抑制剂的长期用药效果却不那么肯定。当acarbose用量高于50mg TID时,并不能增强降糖效果,反而增加了不良反应发生率。与磺脲类降糖药相比,α-葡糖苷酶抑制剂能更有效的降低空腹及餐后胰岛素水平,但在血糖控制和不良反应方面不如前者。

 

概要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要
  5. 概要
  6. 摘要

α-葡糖苷酶抑制剂治疗2型糖尿病

α-葡糖苷酶抑制剂治疗2型糖尿病

α-葡糖苷酶抑制剂可用于治疗2型糖尿病。其机理是延缓碳水化合物(糖的各种形式)在肠道内吸收。本Meta-分析结果显示,α-葡糖苷酶抑制剂可有效降低糖化血红蛋白、空腹血糖、餐后血糖及餐后胰岛素水平,但尚无证据表明其是否对2型糖尿病相关的死亡率或发病率有影响。此外,本研究发现,与餐后血糖不同,糖化血红蛋白水平不随α-葡糖苷酶抑制剂的剂量增加而改变。这可能与副作用增加而使依从性降低有关。

翻译注解

本摘要由重庆医科大学中国循证卫生保健协作网(China Effective Health Care Network)翻译。

翻译注解":本摘要由重庆医科大学中国循证卫生保健协作网(China Effective Health Care Network)翻译。: China Effective Health Care Network

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要
  5. 概要
  6. 摘要

背景

治療第2型糖尿病的Alphaglucosidase抑制劑

Alphaglucosidase抑制劑如acarbose或miglitol對第2型糖尿病有改善血糖控制的潛力。這些藥物的真正價值,特別是與糖尿病相關的死亡率或發病率,從未用系統性回顧或統合性分析調查。

目標

評估Alphaglucosidase抑制劑在治療第2型糖尿病患的作用。

搜尋策略

我們檢索The Cochrane Library、MEDLINE、EMBASE、Current Contents、LILACS,正在進行的試驗的資料庫,及與Alphaglucosidase抑制劑主題相關之回顧參考目錄。我們也與相關的專家和與試驗有關的藥廠接觸。最近的檢索日期:2006年12月(Current Contents),2003年4月(其他資料庫)。

選擇標準

進行至少12週的隨機對照試驗。比較Alphaglucosidase抑制劑在第2型糖尿病患者的單獨治療與任何其他介入的差異,其中至少包括一種以下結果:死亡率、發病率、生活品質、血糖控制、血脂、胰島素濃度、體重、不良事件。

資料收集與分析

兩名審核者獨立地閱讀所有的摘要,評估文獻的品質和摘錄的資料。如有歧見,則以第三位回顧者的評判或以共識的方式解決。統計學家檢查所有進入資料庫的摘錄數據。我們試圖聯繫所有作者以釐清數據。

主要結論

我們收錄了41個試驗(共有8130受試者),30個調查acarbose,7個調查miglitol,1個調查voglibose和3個比較不同Alphaglucosidase抑制劑的試驗。在大多數情況下,研究時間為24週,只有2個研究充分地持續了超過1年的時間。我們發現只有少數的資料針對死亡率,發病率和生活品質。與安慰劑相比,acarbose有一個明確的血糖控制效果:糖化血色素−0.8%(95%CI −0.9至−0.7),空腹血糖−1.1 mmol / L(95%CI −1.4至−0.9),負荷後血糖−2.3 mmol / L(95% CI −2.7至−1.9)。acarbose對糖化血色素的影響不是劑量依賴性。我們發現有一個負荷後胰島素濃度減少的作用,而對血脂或體重則無臨床上有關的作用。不良作用主要是來自腸胃道且是劑量依賴性。與磺醯?素類相比,acarbose降低空腹和負荷後胰島素濃度分別是−24.8pmol / L(95% CI −43.3至−6.3)和−133.2 pmol / L的(95% CI −184.5至−81.8),且acarbose造成更多的不良作用。

作者結論

目前還不清楚Alphaglucosidase抑制劑是否對2型糖尿病患者的死亡率或發病率有影響。相反地,他們對血糖控制和胰島素濃度有顯著的作用,但對血脂和體重則無統計學上顯著的作用。這些作用當Alphaglucosidase抑制劑使用時間較長時,就較不明確。acarbose劑量一天高於150毫克時,對糖化血色素不能提供任何額外的作用,反而增加不良作用。與磺月安類相比,Alphaglucosidase抑制劑降低空腹和後負荷胰島素濃度,而在血糖控制和不良作用方面效果較劣勢。

翻譯人

本摘要由慈濟醫院李哲全翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

Alphaglucosidase抑制劑可降低血糖,但對血脂並沒有影響,且沒有證據顯示對發病率和死亡率有影響。Alphaglucosidase抑制劑可用於治療第 2型糖尿病。他們延緩碳水化合物(‘複雜形式的糖’)在腸道的吸收。在本回顧中,我們從統合分析呈現的數據顯示(除其他事項外)空腹血糖,負荷後血糖和負荷後胰島素的減少。但是,我們沒有發現任何對發病率或死亡率有影響的證據。我們發現與負荷後血糖相較,較高劑量的acarbose對糖化血色素的作用保持不變的線索。這可能是因為由於越來越多的副作用使順從性較低的關係。