Meta-Analysis of 11 Heterogeneous Studies regarding Dipeptidyl Peptidase 4 Inhibitor Add-On Therapy for Type 2 Diabetes Mellitus Patients Treated with Insulin.

Autor: Shibuki K; Department of Pharmacy, Tokyo University of Science, 2641 Yamazaki, Noda 278-8510, Japan.; Clinical Research Center, Medical Hospital, Tokyo Medical and Dental University, 1-5-45 Yushima, Tokyo 113-8519, Japan., Shimada S; Department of Pharmacy, Tokyo University of Science, 2641 Yamazaki, Noda 278-8510, Japan., Aoyama T; Department of Pharmacy, Tokyo University of Science, 2641 Yamazaki, Noda 278-8510, Japan.
Jazyk: angličtina
Zdroj: Journal of diabetes research [J Diabetes Res] 2020 Nov 11; Vol. 2020, pp. 6321826. Date of Electronic Publication: 2020 Nov 11 (Print Publication: 2020).
DOI: 10.1155/2020/6321826
Abstrakt: Background: Several clinical trials have addressed the therapeutic strategy of adding dipeptidyl peptidase 4 (DPP-4) inhibitors to the treatment of type 2 diabetes mellitus (DM) inadequately controlled by insulin therapy. However, there is a high degree of heterogeneity in these studies, and the cause of which has not been identified.
Methods: We conducted a meta-analysis of randomized controlled trials, which compared the efficacy and safety of adding DPP-4 inhibitors or placebo to insulin therapy; the level of hemoglobin A1c (HbA1c) in the patients was >7.0%, and the duration of treatment was ≥8 weeks. We focused on the mean changes in HbA1c from the baseline ( Δ HbA1c) and the incidence of hypoglycemia. We assumed that five baseline parameters (HbA1c, fasting blood glucose, body mass index (BMI), duration of type 2 DM, and duration of treatment) could affect Δ HbA1c. Regarding the incidence of hypoglycemia, we suspected that the heterogeneity was caused by differences in the definition of hypoglycemia among the studies.
Results: Data obtained from 11 studies ( n = 4654 patients) were included in the analysis. The mean Δ HbA1c between the DPP-4 inhibitor and placebo groups was -0.61% (95% confidence interval (CI): -0.74 to -0.48, I 2 = 73.4%). There was substantial heterogeneity among the 11 studies, but 74.1% of this variability was explained by the difference in BMI. The odds ratio for the incidence of hypoglycemia was 1.02 (95% CI: 0.74 to 1.42, I 2 = 63.8%), with substantial heterogeneity due to differences in the definition of hypoglycemia among the studies. There was no apparent effect of publication bias.
Conclusions: The addition of DPP-4 inhibitors to insulin therapy for adult patients with type 2 DM can significantly reduce HbA1c levels without increasing the occurrence of hypoglycemia. BMI and hypoglycemia definition could explain the heterogeneity in the clinical trials. This trial is registered with PROSPERO #CRD42016035994.
Competing Interests: The authors declare that there is no conflict of interest regarding the publication of this article.
(Copyright © 2020 Katsuya Shibuki et al.)
Databáze: MEDLINE
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