Table 1—

Studies of PTD

Study numberStudy description (immunosuppressive regimen)Study designEvidence of no pretransplantation diabetesPatients without pretransplantation diabetes (n)Definition of PTD (definition category*)Patients with PTD at 1 year (n); 12-month cumulative incidence of PTD [% (95% CI)]
Heart transplantation
 1. Rinaldi et al. (14)Trial of FK506 vs. CsARCTInvestigator’s statement23Development of glucose intolerance (threshold)3; 13 (2.8–33.6)
Liver transplantation
 2. Cavaille-Coll and Elashoff (6)FDA reanalysis of the U.S. and European phase III trials of FK506 vs. CsARCTInvestigator’s statement963Use of insulin for ≥30 days with <5-day gap (medication)110; 11.4 (9.5–13.6)
 3. Wahlstrom et al. (26)Single-center series (AZA-CsA-Pred)CCInvestigator’s statement19 case subjects, 141 control subjectsUse of insulin (medication)19 (160 at risk); 11.9 (7.3–17.9)
 4. Trail et al. (22)Single-center series (CsA-Pred, FK506-Pred)CCNormal fasting or random glucose concentration26 case subjects and 26 control subjects matched for age, sex, transplantation date, liver disease, outcome, and follow-upIn first month after transplantation: two fasting glucose >8.3 mmol/l, one random value >11.1 mmol/l, or use of glucose-lowering medication (combination)ND
Kidney transplantation
 5. Boudreaux et al. (8,9)Trial of ALG-AZA-Pred vs. CsA-PredRCTInvestigator’s statement105Two fasting glucose ≥7.8 mmol/l and an abnormal glucose tolerance test (threshold)7; 6.7 (2.7–13.3)
 6. Isoniemi et al. (18,19)Trial of all possible combinations of AZA, CsA, and methylprednisoloneRCTInvestigator’s statement98Use of glucose-lowering medication (medication)7; 7.1 (2.9–14.2)
 7. FK506-Kidney Transplant Study Group (2–6)Multicenter study of FK506 vs. CsARCTInvestigator’s statement302Use of insulin for ≥30 days with <5 day gap (medication)36; 11.9 (8.5–16.1)
 8. Johnson et al. (7)Multicenter study of FK506-AZA, FK506-MMF, and CsA-MMFRCTInvestigator’s statement145Use of insulin for ≥30 days or after 6- and 12-month transplantation (medication)14; 9.6 (5–15.7)
 9. Miller et al. (12,13)Multicenter study of FK506-AZA, FK506-MMF 1g, and MMF 2gRCTInvestigator’s statement126Use of insulin for ≥30 consecutive days (medication)15; 11.9 (6.8–18.9)
 10. Arner et al. (27) and Gunnarsson et al. (28)Single-center series (AZA-Pred)CoInvestigator’s statement125Two fasting glucose >8 mmol/l (threshold)38–67; 30.4–53.6
 11. Friedman et al. (25)Single-center series (AZA-Pred)CCInvestigator’s statement119 case subjects and 119 control subjects matched for transplantation date and donor vital statusThree fasting glucose >8.3 mmol/l (threshold)116 (758 at risk); 15.3 (12.8–18)
 12. von Kiparski et al. (21)Single-center series (AZA-Pred, AZA-CsA-Pred)CCNormal fasting glucose or normal oral glucose tolerance test32 case subjects and 32 control subjects matched for age, sex, immunosuppression, number of grafts received and function, transplantation dateTwo fasting glucose >6.7 mmol/l and use of glucose-lowering medication (combination)18 (901 at risk); 2 (1.2–3)
 13. Ochiai et al. (20)Multicenter phase II study of FK506 (historical CsA cohort)CoNormal oral glucose tolerance test83Hyperglycemia and use of glucose-lowering medication (combination)18; 21.7 (13.4–32.1)
 14. Wu et al. (15)Single-center series (AZA-CsA-Pred)CCNormal fasting glucose concentration3 case subjects, 21 control subjectsTwo fasting glucose >7.8 mmol/l, postprandial glucose >11.1 mmol/l, or abnormal glucose tolerance test (threshold)2 (24 at risk); 8.3 (1–27)
 15. Sakhuja et al. (24)Single-center series (AZA-Pred, AZA-CsA-Pred)CoInvestigator’s statement387Two fasting glucose >7.8 mmol/l or two 2-h postprandial values >11.1 mmol/l (threshold)21; 5.4 (3.4–8.2)
 16. Vesco et al. (10,11)Analysis of a transplant registry (AZA-Pred, AZA-CsA-Pred)CCInvestigator’s statement33 case subjects and 33 control subjects matched for sex, number of grafts, transplantation dateFasting glucose >7.8 mmol/l requiring insulin therapy (combination)ND
 17. Lanerolle et al. (16)Single-center series (AZA-Pred, CsA-Pred)CCNormal oral glucose tolerance test34 case subjects, 131 control subjectsFasting glucose >6.8 mmol/l or 2-h glucose (75-g oral glucose tolerance test) >10 mmol/l (threshold)ND
 18. Miles et al. (17)Single-center prospective series (AZA-CsA-Pred, CsA-Pred)CoNormal fasting glucose concentration40 case subjects and 38 unaffected patients randomly selected from a cohort of patients with graft survival>1 yearThree or more fasting glucose >8.3 mmol/l over 3 months (threshold)ND
 19. Fang et al. (23)Single-center series (CsA-Pred)CoInvestigator’s statement386Three fasting glucose >7.8 mmol/l and use of glucose-lowering medication (combination)7; 1.8 (0.7–3.7)
  • *

    * PTD definition categories: threshold, glycemic threshold; medication, use of glucose-lowering medication; combination, combination of threshold and medication.

  • If reported in case-control studies, the total number of PTD cases in the first year after transplantation was used to calculate the cumulative incidence of PTD.

  • Data are range of cumulative incidence estimates taking the number of new cases at 3 months and the number of new cases at 20 months. ALG, antilymphocyte globulin; AZA, azathioprine; CC, case-control study; Co, cohort study; CsA, cyclosporine; FDA, Food and Drug Administration; FK506, tacrolimus; MMF, mycophenolate mofetil; ND, not determined: information needed was not available; Pred, prednisone; RCT, randomized controlled trial.