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. 2018 Dec 28;12(12):CD005061.
doi: 10.1002/14651858.CD005061.pub3.

Alpha-glucosidase inhibitors for prevention or delay of type 2 diabetes mellitus and its associated complications in people at increased risk of developing type 2 diabetes mellitus

Suzanne Vl Moelands  1 , Peter Lbj Lucassen, Reinier P Akkermans, Wim Jc De Grauw, Floris A Van de Laar
Affiliations

Alpha-glucosidase inhibitors for prevention or delay of type 2 diabetes mellitus and its associated complications in people at increased risk of developing type 2 diabetes mellitus

Suzanne Vl Moelands et al. Cochrane Database Syst Rev. .

Abstract

Background: Alpha-glucosidase inhibitors (AGI) reduce blood glucose levels and may thus prevent or delay type 2 diabetes mellitus (T2DM) and its associated complications in people at risk of developing of T2DM.

Objectives: To assess the effects of AGI in people with impaired glucose tolerance (IGT), impaired fasting blood glucose (IFG), moderately elevated glycosylated haemoglobin A1c (HbA1c) or any combination of these.

Search methods: We searched CENTRAL, MEDLINE, Embase, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform, and the reference lists of systematic reviews, articles and health technology assessment reports. The date of the last search of all databases was December 2017.

Selection criteria: We included randomised controlled trials (RCTs), with a duration of one year or more, comparing AGI with any pharmacological glucose-lowering intervention, behaviour-changing intervention, placebo or no intervention in people with IFG, IGT, moderately elevated HbA1c or combinations of these.

Data collection and analysis: Two review authors read all abstracts and full-text articles or records, assessed quality and extracted outcome data independently. One review author extracted data, which were checked by a second review author. We resolved discrepancies by consensus or involvement of a third review author. For meta-analyses we used a random-effects model with assessment of risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes, using 95% confidence intervals (CIs) for effect estimates. We assessed the overall quality of the evidence by using the GRADE instrument.

Main results: For this update of the Cochrane Review (first published 2006, Issue 4) we included 10 RCTs (11,814 participants), eight investigating acarbose and two investigating voglibose, that included people with IGT or people "at increased risk for diabetes". The trial duration ranged from one to six years. Most trials compared AGI with placebo (N = 4) or no intervention (N = 4).Acarbose reduced the incidence of T2DM compared to placebo: 670 out of 4014 people (16.7%) in the acarbose groups developed T2DM, compared to 812 out of 3994 people (20.3%) in the placebo groups (RR 0.82, 95% CI 0.75 to 0.89; P < 0.0001; 3 trials; 8008 participants; moderate-certainty evidence). One trial including participants with coronary heart disease and IGT contributed 64% of cases for this outcome. Acarbose reduced the risk of T2DM compared to no intervention: 7 out 75 people (9.3%) in the acarbose groups developed T2DM, compared to 18 out of 65 people (27.7%) in the no-intervention groups (RR 0.31, 95% CI 0.14 to 0.69; P = 0.004; 2 trials; 140 participants; very low-certainty evidence).Acarbose compared to placebo did not reduce or increase the risk of all-cause mortality (RR 0.98, 95% CI 0.82 to 1.18; P = 0.86; 3 trials; 8069 participants; very low-certainty evidence), cardiovascular mortality (RR 0.88; 95% CI 0.71 to 1.10; P = 0.26; 3 trials; 8069 participants; very low-certainty evidence), serious adverse events (RR 1.12, 95% CI 0.97 to 1.29; P = 0.13; 2 trials; 6625 participants; low-certainty evidence), non-fatal stroke (RR 0.50, 95% CI 0.09 to 2.74; P = 0.43; 1 trial; 1368 participants; very low-certainty evidence) or congestive heart failure (RR of 0.87; 95% CI 0.63 to 1.12; P = 0.40; 2 trials; 7890 participants; low-certainty evidence). Acarbose compared to placebo reduced non-fatal myocardial infarction: one out of 742 participants (0.1%) in the acarbose groups had a non-fatal myocardial infarction compared to 15 out of 744 participants (2%) in the placebo groups (RR 0.10, 95% CI 0.02 to 0.53; P = 0.007; 2 trials; 1486 participants; very low-certainty evidence). Acarbose treatment showed an increased risk of non-serious adverse events (mainly gastro-intestinal events), compared to placebo: 751 of 775 people (96.9%) in the acarbose groups experienced an event, compared to 723 of 775 people (93.3%) in the placebo groups (RR 1.04; 95% CI 1.01 to 1.06; P = 0.0008; 2 trials; 1550 participants). Acarbose compared to no intervention showed no advantage or disadvantage for any of these outcome measures (very low-certainty evidence).One trial each compared voglibose with placebo (1780 participants) or diet and exercise (870 participants). Voglibose compared to placebo reduced the incidence of T2DM: 50 out of 897 participants (5.6%) developed T2DM, compared to 106 out of 881 participants (12%) in the placebo group (RR 0.46, 95% CI 0.34 to 0.64; P < 0.0001; 1 trial; 1778 participants; low-certainty evidence). For all other reported outcome measures there were no clear differences between voglibose and comparator groups. One trial with 90 participants compared acarbose with diet and exercise and another trial with 98 participants reported data on acarbose versus metformin. There were no clear differences for any outcome measure between these two acarbose interventions and the associated comparator groups.None of the trials reported amputation of lower extremity, blindness or severe vision loss, end-stage renal disease, health-related quality of life, time to progression to T2DM, or socioeconomic effects.

Authors' conclusions: AGI may prevent or delay the development of T2DM in people with IGT. There is no firm evidence that AGI have a beneficial effect on cardiovascular mortality or cardiovascular events.

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Conflict of interest statement

SM: none known PL: co‐author of a trial mentioned in the background and discussion (Van de Laar 2005). RA: co‐author of a trial mentioned in the background and discussion (Van de Laar 2005). WG: none known. FL: author of a trial mentioned in the background and discussion (Van de Laar 2005).

Figures

1
1
Trial flow diagram
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included trials (blank cells indicate that the particular outcome was not measured in some trials). T2DM: type 2 diabetes mellitus
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included trial (blank cells indicate that the particular outcome was not measured in some trials) ABC: Alpha‐glucosidase‐inhiT2DM: type 2 diabetes mellitus
See this image and copyright information in PMC

Update of

References

References to studies included in this review

ABC 2017 {published and unpublished data}
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ACE 2017 {published data only (unpublished sought but not used)}
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Fang 2004 {published data only}
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Kawamori 2009 {published data only (unpublished sought but not used)}
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References to studies excluded from this review

ABDOMEN study {published data only}
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Aoki 2010 {published data only}
    1. UMIN000003170. Effect of miglitol and sitagliptin on incretin levels. upload.umin.ac.jp/cgi‐open‐bin/ctr_e/ctr_view.cgi?recptno=R000003662 (accessed 11 July 2018).
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JEDIS study {published data only}
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Kataoka 2012 {published data only}
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Medizinische Klinik B study {published data only}
    1. 2004‐002579‐17. A double‐blind, randomised placebo controlled study of the effects of acarbose on endothelial function, hemostatic and fibrinolytic plasmatic factors in patients with stable coronary artery disease and either impaired glucose intolerance or newly diagnosed diabetes mellitus. www.clinicaltrialsregister.eu/ctr‐search/trial/2004‐002579‐17/DE (accessed 11 July 2018).
MM study {published data only}
    1. UMIN000010282. Three‐arm comparative study of miglitol and mitiglinide alone and in combination ‐efficacy and safety studies. upload.umin.ac.jp/cgi‐open‐bin/ctr_e/ctr_view.cgi?recptno=R000012031 (accessed 11 July 2018).
Narita 2009 {published data only}
    1. UMIN000001671. The comparative study of the effects of miglitol and voglibose (alpha‐glucosidase inhibitors) on incretins secretion. upload.umin.ac.jp/cgi‐open‐bin/ctr_e/ctr_view.cgi?recptno=R000002020 (accessed 11 July 2018).
NCT00417950 {published data only}
    1. NCT00417950. Additional glucose lowering and anti‐inflammatory effects by acarbose and alcohol in subjects with impaired glucose tolerance or mild type 2 diabetes. www.clinicaltrials.gov/ct2/show/NCT00417950 (accessed 11 July 2018).
Toyoda 2012 {published data only}
    1. UMIN000008692. Study of the combination use effect of DPP‐4 inhibitor and alpha‐glucosidase inhibitor. upload.umin.ac.jp/cgi‐open‐bin/ctr_e/ctr_view.cgi?recptno=R000010217 (accessed 11 July 2018).
Watada 2012 {published data only}
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References to studies awaiting assessment

NCT00221156 {published data only}
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References to other published versions of this review

Van de Laar 2006
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