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Meta-Analysis
. 2020 Jul 30;8(8):CD009966.
doi: 10.1002/14651858.CD009966.pub3.

Glucose-lowering agents for treating pre-existing and new-onset diabetes in kidney transplant recipients

Clement Lo  1   2 , Tadashi Toyama  3   4   5 , Megumi Oshima  3   4   5 , Min Jun  3 , Ken L Chin  1   6 , Carmel M Hawley  7   8   9 , Sophia Zoungas  1   3   2
Affiliations
Meta-Analysis

Glucose-lowering agents for treating pre-existing and new-onset diabetes in kidney transplant recipients

Clement Lo et al. Cochrane Database Syst Rev. .

Abstract

Background: Kidney transplantation is the preferred management for patients with end-stage kidney disease (ESKD). However, it is often complicated by worsening or new-onset diabetes. The safety and efficacy of glucose-lowering agents after kidney transplantation is largely unknown. This is an update of a review first published in 2017.

Objectives: To evaluate the efficacy and safety of glucose-lowering agents for treating pre-existing and new onset diabetes in people who have undergone kidney transplantation.

Search methods: We searched the Cochrane Kidney and Transplant Register of Studies up to 16 January 2020 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.

Selection criteria: All randomised controlled trials (RCTs), quasi-RCTs and cross-over studies examining head-to-head comparisons of active regimens of glucose-lowering therapy or active regimen compared with placebo/standard care in patients who have received a kidney transplant and have diabetes were eligible for inclusion.

Data collection and analysis: Four authors independently assessed study eligibility and quality and performed data extraction. Continuous outcomes were expressed as post-treatment mean differences (MD) or standardised mean difference (SMD). Adverse events were expressed as post-treatment absolute risk differences (RD). Dichotomous clinical outcomes were presented as risk ratios (RR) with 95% confidence intervals (CI).

Main results: Ten studies (21 records, 603 randomised participants) were included - three additional studies (five records) since our last review. Four studies compared more intensive versus less intensive insulin therapy; two studies compared dipeptidyl peptidase-4 (DPP-4) inhibitors to placebo; one study compared DPP-4 inhibitors to insulin glargine; one study compared sodium glucose co-transporter 2 (SGLT2) inhibitors to placebo; and two studies compared glitazones and insulin to insulin therapy alone. The majority of studies had an unclear to a high risk of bias. There were no studies examining the effects of biguanides, glinides, GLP-1 agonists, or sulphonylureas. Compared to less intensive insulin therapy, it is unclear if more intensive insulin therapy has an effect on transplant or graft survival (4 studies, 301 participants: RR 1.12, 95% CI 0.32 to 3.94; I2 = 49%; very low certainty evidence), delayed graft function (2 studies, 153 participants: RR 0.63, 0.42 to 0.93; I2 = 0%; very low certainty evidence), HbA1c (1 study, 16 participants; very low certainty evidence), fasting blood glucose (1 study, 24 participants; very low certainty evidence), kidney function markers (1 study, 26 participants; very low certainty evidence), death (any cause) (3 studies, 208 participants" RR 0.68, 0.29 to 1.58; I2 = 0%; very low certainty evidence), hypoglycaemia (4 studies, 301 participants; very low certainty evidence) and medication discontinuation due to adverse effects (1 study, 60 participants; very low certainty evidence). Compared to placebo, it is unclear whether DPP-4 inhibitors have an effect on hypoglycaemia and medication discontinuation (2 studies, 51 participants; very low certainty evidence). However, DPP-4 inhibitors may reduce HbA1c and fasting blood glucose but not kidney function markers (1 study, 32 participants; low certainty evidence). Compared to insulin glargine, it is unclear if DPP-4 inhibitors have an effect on HbA1c, fasting blood glucose, hypoglycaemia or discontinuation due to adverse events (1 study, 45 participants; very low certainty evidence). Compared to placebo, SGLT2 inhibitors probably do not affect kidney graft survival (1 study, 44 participants; moderate certainty evidence), but may reduce HbA1c without affecting fasting blood glucose and eGFR long-term (1 study, 44 participants, low certainty evidence). SGLT2 inhibitors probably do not increase hypoglycaemia, and probably have little or no effect on medication discontinuation due to adverse events. However, all participants discontinuing SGLT2 inhibitors had urinary tract infections (1 study, 44 participants, moderate certainty evidence). Compared to insulin therapy alone, it is unclear if glitazones added to insulin have an effect on HbA1c or kidney function markers (1 study, 62 participants; very low certainty evidence). However, glitazones may make little or no difference to fasting blood glucose (2 studies, 120 participants; low certainty evidence), and medication discontinuation due to adverse events (1 study, 62 participants; low certainty evidence). No studies of DPP-4 inhibitors, or glitazones reported effects on transplant or graft survival, delayed graft function or death (any cause).

Authors' conclusions: The efficacy and safety of glucose-lowering agents in the treatment of pre-existing and new-onset diabetes in kidney transplant recipients is questionable. Evidence from existing studies examining the effect of intensive insulin therapy, DPP-4 inhibitors, SGLT inhibitors and glitazones is mostly of low to very low certainty. Appropriately blinded, larger, and higher quality RCTs are needed to evaluate and compare the safety and efficacy of contemporary glucose-lowering agents in the kidney transplant population.

Trial registration: ClinicalTrials.gov NCT03157414 NCT00980356 NCT00609986 NCT01643382 NCT00740363 NCT00598013 NCT00830297 NCT01680185 NCT01148680 NCT01346254 NCT00507494 NCT03642184.

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Conflict of interest statement

  1. Clement Lo: none known

  2. Tadashi Toyoma: none known

  3. Megumi Oshima: none known

  4. Min Jun: none known

  5. Ken L Chin: none known

  6. Carmel M Hawley has received fees from Amgen, Shire, Roche, Abbott, Bayer, Fresenius, Baxter, Gambro, Janssen‐Cilag and Genzyme in relation to consultancy, speakers' fees, education, and grants for activities unrelated to this review.

  7. Sophia Zoungas has previously received speaker honoraria from Servier, MSD, Sanofi Aventis, Eli Lilly, Astra Zeneca, BMS, Takeda and Janssen. She has previously served on external advisory boards for MSD, Novo Nordisk, Sanofi Aventis, Amgen, Novartis, Janssen, Astra Zeneca and Eli Lilly.

Figures

1
1
Study flow diagram
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1: More intensive versus less intensive insulin therapy, Outcome 1: Graft loss or rejection
1.2
1.2. Analysis
Comparison 1: More intensive versus less intensive insulin therapy, Outcome 2: Delayed graft function
1.3
1.3. Analysis
Comparison 1: More intensive versus less intensive insulin therapy, Outcome 3: Dialysis within 7 days
1.4
1.4. Analysis
Comparison 1: More intensive versus less intensive insulin therapy, Outcome 4: eGFR [mL/min/1.73 m²]
1.5
1.5. Analysis
Comparison 1: More intensive versus less intensive insulin therapy, Outcome 5: Serum creatinine [μmol/L]
1.6
1.6. Analysis
Comparison 1: More intensive versus less intensive insulin therapy, Outcome 6: Death (any cause)
1.7
1.7. Analysis
Comparison 1: More intensive versus less intensive insulin therapy, Outcome 7: Non‐fatal stroke
2.1
2.1. Analysis
Comparison 2: DPP‐4 inhibitors versus placebo, Outcome 1: HbA1c
2.2
2.2. Analysis
Comparison 2: DPP‐4 inhibitors versus placebo, Outcome 2: Fasting blood glucose
2.3
2.3. Analysis
Comparison 2: DPP‐4 inhibitors versus placebo, Outcome 3: eGFR [mL/min/1.73 m²]
3.1
3.1. Analysis
Comparison 3: DPP‐4 inhibitors versus insulin glargine, Outcome 1: Gastrointestinal side effects
4.1
4.1. Analysis
Comparison 4: Glitazones and insulin versus placebo and insulin, Outcome 1: Total cholesterol [mmol/L]
4.2
4.2. Analysis
Comparison 4: Glitazones and insulin versus placebo and insulin, Outcome 2: HDL cholesterol [mmol/L]
4.3
4.3. Analysis
Comparison 4: Glitazones and insulin versus placebo and insulin, Outcome 3: LDL cholesterol [mmol/L]
4.4
4.4. Analysis
Comparison 4: Glitazones and insulin versus placebo and insulin, Outcome 4: Triglyceride [mmol/L]
4.5
4.5. Analysis
Comparison 4: Glitazones and insulin versus placebo and insulin, Outcome 5: Body weight [kg]
See this image and copyright information in PMC

Update of

References

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Kharazmkia 2014 {published data only}
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Soliman 2013 {published data only}
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Clodi 1997 {published data only}
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Halden 2016 {published data only}
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Han 2010 {published data only}
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Hecking 2012 {published data only}
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Re 2010 {published data only}
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SAPT‐NODAT 2012 {published data only}
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Sharif 2009 {published data only}
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TransDiab 2017 {published data only}
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TRIMECO 2018 {published data only}
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Werzowa 2013 {published data only}
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Yates 2014 {published data only}
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References to studies awaiting assessment

Lakhani 2016 {published data only}
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NCT00507494 {published data only}
    1. Gross P. Influence of pioglitazone for renal transplant function in diabetics - a double blind randomised placebo controlled cross over study. www.clinicaltrials.gov/ct2/show/NCT00507494 (first received 26 July 2007).

References to ongoing studies

NCT03642184 {published data only}
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References to other published versions of this review

Jun 2012
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