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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. CsA RCT Investigator’s statement 23 Development 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. CsA RCT Investigator’s statement 963 Use 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) CC Investigator’s statement 19 case subjects, 141 control subjects Use 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) CC Normal fasting or random glucose concentration 26 case subjects and 26 control subjects matched for age, sex, transplantation date, liver disease, outcome, and follow-up In 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-Pred RCT Investigator’s statement 105 Two 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 methylprednisolone RCT Investigator’s statement 98 Use 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. CsA RCT Investigator’s statement 302 Use 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-MMF RCT Investigator’s statement 145 Use 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 2g RCT Investigator’s statement 126 Use 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) Co Investigator’s statement 125 Two fasting glucose >8 mmol/l (threshold) 38–67; 30.4–53.6 
 11. Friedman et al. (25) Single-center series (AZA-Pred) CC Investigator’s statement 119 case subjects and 119 control subjects matched for transplantation date and donor vital status Three 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) CC Normal fasting glucose or normal oral glucose tolerance test 32 case subjects and 32 control subjects matched for age, sex, immunosuppression, number of grafts received and function, transplantation date Two 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) Co Normal oral glucose tolerance test 83 Hyperglycemia 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) CC Normal fasting glucose concentration 3 case subjects, 21 control subjects Two 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) Co Investigator’s statement 387 Two 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) CC Investigator’s statement 33 case subjects and 33 control subjects matched for sex, number of grafts, transplantation date Fasting glucose >7.8 mmol/l requiring insulin therapy (combination) ND 
 17. Lanerolle et al. (16) Single-center series (AZA-Pred, CsA-Pred) CC Normal oral glucose tolerance test 34 case subjects, 131 control subjects Fasting 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) Co Normal fasting glucose concentration 40 case subjects and 38 unaffected patients randomly selected from a cohort of patients with graft survival>1 year Three or more fasting glucose >8.3 mmol/l over 3 months (threshold) ND 
 19. Fang et al. (23) Single-center series (CsA-Pred) Co Investigator’s statement 386 Three fasting glucose >7.8 mmol/l and use of glucose-lowering medication (combination) 7; 1.8 (0.7–3.7) 
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. CsA RCT Investigator’s statement 23 Development 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. CsA RCT Investigator’s statement 963 Use 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) CC Investigator’s statement 19 case subjects, 141 control subjects Use 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) CC Normal fasting or random glucose concentration 26 case subjects and 26 control subjects matched for age, sex, transplantation date, liver disease, outcome, and follow-up In 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-Pred RCT Investigator’s statement 105 Two 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 methylprednisolone RCT Investigator’s statement 98 Use 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. CsA RCT Investigator’s statement 302 Use 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-MMF RCT Investigator’s statement 145 Use 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 2g RCT Investigator’s statement 126 Use 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) Co Investigator’s statement 125 Two fasting glucose >8 mmol/l (threshold) 38–67; 30.4–53.6 
 11. Friedman et al. (25) Single-center series (AZA-Pred) CC Investigator’s statement 119 case subjects and 119 control subjects matched for transplantation date and donor vital status Three 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) CC Normal fasting glucose or normal oral glucose tolerance test 32 case subjects and 32 control subjects matched for age, sex, immunosuppression, number of grafts received and function, transplantation date Two 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) Co Normal oral glucose tolerance test 83 Hyperglycemia 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) CC Normal fasting glucose concentration 3 case subjects, 21 control subjects Two 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) Co Investigator’s statement 387 Two 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) CC Investigator’s statement 33 case subjects and 33 control subjects matched for sex, number of grafts, transplantation date Fasting glucose >7.8 mmol/l requiring insulin therapy (combination) ND 
 17. Lanerolle et al. (16) Single-center series (AZA-Pred, CsA-Pred) CC Normal oral glucose tolerance test 34 case subjects, 131 control subjects Fasting 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) Co Normal fasting glucose concentration 40 case subjects and 38 unaffected patients randomly selected from a cohort of patients with graft survival>1 year Three or more fasting glucose >8.3 mmol/l over 3 months (threshold) ND 
 19. Fang et al. (23) Single-center series (CsA-Pred) Co Investigator’s statement 386 Three 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.

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