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Meta-Analysis
. 2008 Apr 16;2008(2):CD006739.
doi: 10.1002/14651858.CD006739.pub2.

Dipeptidyl peptidase-4 (DPP-4) inhibitors for type 2 diabetes mellitus

B Richter  1 , E Bandeira-Echtler, K Bergerhoff, C L Lerch
Affiliations
Meta-Analysis

Dipeptidyl peptidase-4 (DPP-4) inhibitors for type 2 diabetes mellitus

B Richter et al. Cochrane Database Syst Rev. .

Abstract

Background: In type 2 diabetes mellitus there is a progressive loss of beta-cell function. One new approach yielding promising results is the use of the orally active dipeptidyl peptidase-4 (DPP-4) inhibitors like sitagliptin and vildagliptin.

Objectives: To assess the effects of dipeptidyl peptidase-4 (DPP-4) inhibitors for type 2 diabetes mellitus.

Search strategy: Studies were obtained from computerised searches of MEDLINE, EMBASE and The Cochrane Library.

Selection criteria: Studies were included if they were randomised controlled trials in adult people with type 2 diabetes mellitus and had a trial duration of at least 12 weeks.

Data collection and analysis: Two authors independently assessed risk of bias and extracted data. Pooling of studies was performed by means of fixed-effect meta-analysis.

Main results: Twenty-five studies of good quality were identified, 11 trials evaluated sitagliptin and 14 trials vildagliptin treatment. Altogether, 6743 patients were randomised in sitagliptin and 6121 patients in vildagliptin studies, respectively. Sitagliptin and vildagliptin studies ranged from 12 to 52 weeks duration. No data were published on mortality, diabetic complications, costs of treatment and health-related quality of life. Sitagliptin and vildagliptin therapy in comparison with placebo resulted in an HbA1c reduction of approximately 0.7% and 0.6%, respectively. Data on comparisons with active comparators were limited but indicated no improved metabolic control following DPP-4 intervention in contrast to other hypoglycaemic agents. Sitagliptin and vildagliptin therapy did not result in weight gain but weight loss was more pronounced following placebo interventions. No definite conclusions could be drawn from published data on sitagliptin and vildagliptin effects on measurements of beta-cell function. Overall, sitagliptin and vildagliptin were well tolerated, no severe hypoglycaemia was reported in patients taking sitagliptin or vildagliptin. All-cause infections increased significantly after sitagliptin treatment but did not reach statistical significance following vildagliptin therapy. All published randomised controlled trials of at least 12 weeks treatment with sitagliptin and vildagliptin only reported routine laboratory safety measurements

Authors' conclusions: DPP-4 inhibitors have some theoretical advantages over existing therapies with oral antidiabetic compounds but should currently be restricted to individual patients. Long-term data especially on cardiovascular outcomes and safety are urgently needed before widespread use of these new agents. More information on the benefit-risk ratio of DPP-4 inhibitor treatment is necessary especially analysing adverse effects on parameters of immune function. Also, long-term data are needed investigating patient-oriented parameters like health-related quality of life, diabetic complications and all-cause mortality.

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Conflict of interest statement

None known

Figures

1
1
Amended QUOROM (quality of reporting of meta‐analyses) flow chart of study selection
2
2
Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
3
3
Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
1.1
1.1. Analysis
Comparison 1 Sitagliptin, Outcome 1 Change in haemoglobin A1c from baseline to endpoint.
1.2
1.2. Analysis
Comparison 1 Sitagliptin, Outcome 2 Adverse events [n].
1.3
1.3. Analysis
Comparison 1 Sitagliptin, Outcome 3 Change in body weight from baseline to endpoint.
2.1
2.1. Analysis
Comparison 2 Vildagliptin, Outcome 1 Change in haemoglobin A1c from baseline to endpoint.
2.2
2.2. Analysis
Comparison 2 Vildagliptin, Outcome 2 Adverse events [n].
2.3
2.3. Analysis
Comparison 2 Vildagliptin, Outcome 3 Change in body weight from baseline to endpoint.
See this image and copyright information in PMC

Update of

  • doi: 10.1002/14651858.CD006739

References

References to studies included in this review

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Aschner 2006 {published data only}
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Bolli 2008 {published data only}
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Charbonnel 2006 {published data only}
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Nonaka 2008 {published data only}
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Pi‐Sunyer 2007 {published data only}
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Pratley 2006 {published data only}
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Raz 2006 {published data only}
    1. Raz I, Hanefeld M, Xu L, Caria C, Williams‐Herman D, Khatami H. Efficacy and safety of the dipeptidyl peptidase‐4 inhibitor sitagliptin as monotherapy in patients with type 2 diabetes mellitus. Diabetologia 2006;49(11):2564‐71. - PubMed
Ristic 2005 {published data only}
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Rosenstock 2006 {published data only}
    1. Rosenstock J, Brazg R, Andryuk PJ, Lu K, Stein P. Efficacy and safety of the dipeptidyl peptidase‐4 inhibitor sitagliptin added to ongoing pioglitazone therapy in patients with type 2 diabetes: a 24‐week, multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group study. Clinical Therapeutics 2006;28(10):1556‐68. - PubMed
Rosenstock 2007a {published data only}
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Rosenstock 2007b {published data only}
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Scherbaum 2008 {published data only}
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