Tacrolimus versus cyclosporin as primary immunosuppression for kidney transplant recipients

Angela C Webster; Rod RS Taylor; Jeremy R Chapman; Jonathan C Craig

doi:10.1002/14651858.CD003961.pub2

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Figure 1

Fig 1. Flow chart showing source and identification of studies for inclusion

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Figure 2

Figure 2. Risk ratio of graft loss (censored for death) versus the weighted average of the target tacrolimus trough levels over the first year after transplantation *.
* Each circle represents a study, with the area proportional to the inverse of the variance of the estimated treatment effect (larger circles show studies given more weight in the meta‐analysis). The colour of the circles represents the formulation of cyclosporin used in each study; dark circles are cyclosporin solution, light grey circles are cyclosporin microemulsion.

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Figure 3

Figure 3. Risk ratio of diabetes mellitus requiring insulin treatment for >30 days, in previously non‐diabetic patients, versus the weighted average of the target tacrolimus trough levels over the first year after transplantation *.
* Each circle represents a study, with the area proportional to the inverse of the variance of the estimated treatment effect (larger circles show studies given more weight in the meta‐analysis). The colour of the circles represents the formulation of cyclosporin used in each study; dark circles are cyclosporin solution, light grey circles are cyclosporin microemulsion.

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Analysis 1.1

Comparison 1 Tacrolimus versus cyclosporin for primary therapy, Outcome 1 Graft loss (censored for death).

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Analysis 1.2

Comparison 1 Tacrolimus versus cyclosporin for primary therapy, Outcome 2 Acute rejection (clinical or biopsy proven).

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Analysis 1.3

Comparison 1 Tacrolimus versus cyclosporin for primary therapy, Outcome 3 Acute rejection (biopsy proven).

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Analysis 1.4

Comparison 1 Tacrolimus versus cyclosporin for primary therapy, Outcome 4 Acute rejection (steroid resistant).

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Analysis 1.5

Comparison 1 Tacrolimus versus cyclosporin for primary therapy, Outcome 5 Total graft loss (with death).

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Analysis 1.6

Comparison 1 Tacrolimus versus cyclosporin for primary therapy, Outcome 6 Mortality.

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Analysis 1.7

Comparison 1 Tacrolimus versus cyclosporin for primary therapy, Outcome 7 Chronic allograft nephropathy (CAN).

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Analysis 1.8

Comparison 1 Tacrolimus versus cyclosporin for primary therapy, Outcome 8 Total infection.

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Analysis 1.9

Comparison 1 Tacrolimus versus cyclosporin for primary therapy, Outcome 9 Total CMV infection.

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Analysis 1.10

Comparison 1 Tacrolimus versus cyclosporin for primary therapy, Outcome 10 Invasive CMV infection.

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Analysis 1.11

Comparison 1 Tacrolimus versus cyclosporin for primary therapy, Outcome 11 Delayed graft function.

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Analysis 1.12

Comparison 1 Tacrolimus versus cyclosporin for primary therapy, Outcome 12 Hypercholesterolaemia.

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Analysis 1.13

Comparison 1 Tacrolimus versus cyclosporin for primary therapy, Outcome 13 Neurological side effects.

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Analysis 1.14

Comparison 1 Tacrolimus versus cyclosporin for primary therapy, Outcome 14 Gastrointestinal side effects.

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Analysis 1.15

Comparison 1 Tacrolimus versus cyclosporin for primary therapy, Outcome 15 Total malignancy.

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Analysis 1.16

Comparison 1 Tacrolimus versus cyclosporin for primary therapy, Outcome 16 de novo hypertension.

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Analysis 1.17

Comparison 1 Tacrolimus versus cyclosporin for primary therapy, Outcome 17 Bacterial infection.

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Analysis 1.18

Comparison 1 Tacrolimus versus cyclosporin for primary therapy, Outcome 18 Viral infection.

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Analysis 1.19

Comparison 1 Tacrolimus versus cyclosporin for primary therapy, Outcome 19 Fungal infection.

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Analysis 1.20

Comparison 1 Tacrolimus versus cyclosporin for primary therapy, Outcome 20 Protozoal infection.

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Analysis 1.21

Comparison 1 Tacrolimus versus cyclosporin for primary therapy, Outcome 21 Other unclassifiable infection.

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Analysis 1.22

Comparison 1 Tacrolimus versus cyclosporin for primary therapy, Outcome 22 Serum creatinine µmol/L.

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Analysis 1.23

Comparison 1 Tacrolimus versus cyclosporin for primary therapy, Outcome 23 Haematological side effects.

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Analysis 1.24

Comparison 1 Tacrolimus versus cyclosporin for primary therapy, Outcome 24 Cosmetic side effects.

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Analysis 1.25

Comparison 1 Tacrolimus versus cyclosporin for primary therapy, Outcome 25 Lymphoma/PTLD.

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Analysis 1.26

Comparison 1 Tacrolimus versus cyclosporin for primary therapy, Outcome 26 Biochemical side effects.

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Analysis 1.27

Comparison 1 Tacrolimus versus cyclosporin for primary therapy, Outcome 27 Fever.

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Analysis 1.28

Comparison 1 Tacrolimus versus cyclosporin for primary therapy, Outcome 28 Surgical side effects.

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Analysis 1.29

Comparison 1 Tacrolimus versus cyclosporin for primary therapy, Outcome 29 GFR (mL/min).

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Analysis 1.30

Comparison 1 Tacrolimus versus cyclosporin for primary therapy, Outcome 30 Total cholesterol (µmol/L).

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Analysis 1.31

Comparison 1 Tacrolimus versus cyclosporin for primary therapy, Outcome 31 Total triglycerides (µmol/L).

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Analysis 1.32

Comparison 1 Tacrolimus versus cyclosporin for primary therapy, Outcome 32 Treament withdrawal/crossover.

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Analysis 1.33

Comparison 1 Tacrolimus versus cyclosporin for primary therapy, Outcome 33 Sustained diabetes mellitus requiring insulin.

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Analysis 1.34

Comparison 1 Tacrolimus versus cyclosporin for primary therapy, Outcome 34 Requirement for insulin >30 days in previously non‐diabetic patients.

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Analysis 2.1

Comparison 2 Stratified analysis, by publication type, Outcome 1 Graft loss (death censored) 1 year.

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Analysis 2.2

Comparison 2 Stratified analysis, by publication type, Outcome 2 Acute rejection (all) 1 year.

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Analysis 2.3

Comparison 2 Stratified analysis, by publication type, Outcome 3 New requirement for insulin >30 days.

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Analysis 3.1

Comparison 3 Stratified analysis, by ITT quality, Outcome 1 Graft loss (death censored) 1 year.

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Analysis 3.2

Comparison 3 Stratified analysis, by ITT quality, Outcome 2 Acute rejection (all) 1 year.

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Analysis 3.3

Comparison 3 Stratified analysis, by ITT quality, Outcome 3 New requirement for insulin >30 days.

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Analysis 4.1

Comparison 4 Stratified analysis, by immunological risk, Outcome 1 Acute rejection (all) 1 year.

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Analysis 4.2

Comparison 4 Stratified analysis, by immunological risk, Outcome 2 Graft loss (death censored) 1 year.

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Analysis 4.3

Comparison 4 Stratified analysis, by immunological risk, Outcome 3 New requirement for insulin >30 days.

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Analysis 5.1

Comparison 5 Stratified analysis, by cyclosporin formulation, Outcome 1 Graft loss (death censored) 1 year.

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Analysis 5.2

Comparison 5 Stratified analysis, by cyclosporin formulation, Outcome 2 Acute rejection (all) 1 year.

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Analysis 5.3

Comparison 5 Stratified analysis, by cyclosporin formulation, Outcome 3 New requirement for insulin >30 days.

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Analysis 6.1

Comparison 6 Stratified analysis, by antiproliferative cointervention, Outcome 1 Graft loss (death censored) 1 year.

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Analysis 6.2

Comparison 6 Stratified analysis, by antiproliferative cointervention, Outcome 2 Acute rejection (all) 1 year.

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Analysis 6.3

Comparison 6 Stratified analysis, by antiproliferative cointervention, Outcome 3 New requirement for insulin >30 days.

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Analysis 7.1

Comparison 7 Heterogeneity investigation, Outcome 1 Acute rejection (biopsy proven).

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Analysis 7.2

Comparison 7 Heterogeneity investigation, Outcome 2 Serum creatinine.

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Analysis 7.3

Comparison 7 Heterogeneity investigation, Outcome 3 Graft loss (death censored).

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Analysis 7.4

Comparison 7 Heterogeneity investigation, Outcome 4 New requirement for insulin >30 days.

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Table 1. Electronic search strategies

Database	Search terms
Cochrane Renal Group's Specialised Register	1. Kidney Transplant* 2. Kidney‐Transplant 3. Kidney Allograft* 4. Graft Rejection*
CENTRAL	1. kidney transplant$ 2. kidney transplantation/ 3. #1 or #2
MEDLINE and pre‐MEDLINE	1. exp kidney transplantation/ 2. exp tacrolimus/ 3. tacrolimus.tw. 4. prograf.tw. 5. FK 506.tw. 6. FK506.tw. 7. Tsukubaenolide.tw. 8. fr‐900506.tw. 9 . fujimycin.tw. 10. protopic.tw. 11. or/2‐10 12. 1 and 11
EMBASE	1. exp Tsukubaenolide/ 2. prograf?.tw. 3. protopic.tw. 4. tacrolimus.tw. 5. fujimycin.tw. 6. fk506.tw. 7. fk 506.tw. 8. fr‐900506.tw. 9. Tsukubaenolide.tw. 10. or/1‐9 11. exp Kidney Transplantation/ 12. 10 and 11

Table 1. Electronic search strategies

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Table 2. Subgroup analyses

Potential bias	Graft loss*	P (for interaction)	Acute rejection	P (for interaction)	New diabetes	P (for interaction)
STATISTICAL METHOD ‐ Random effect ‐ Fixed effects	14; 10.77 (0.58 to 1.02)# 14; 0.74 (0.56 to 0.97)	‐	14; 0.69 (0.60 to 0.80) 14; 0.67 (0.60 to 0.73)	‐	12; 1.86 (1.11 to 3.09) 12; 2.03 (1.49 to 2.76)	‐
PUBLICATION TYPE ‐ Abstract or non‐peer reviewed journal ‐ Peer reviewed journal	4; 0.75 (0.31 to 1.79) 10; 0.75 (0.55 to 1.02)	0.36	3; 1.02 (0.57 to 1.82) 11; 0.64 (0.57 to 0.72)	0.01	3; 2.10 (0.94 to 4.29) 9; 1.84 (0.95 to 3.57)	0.89
TRIAL QUALITY ‐ ITT analysis unclear or not undertaken ‐ ITT analysis performed	8; 0.70 (0.44 to 1.12) 6; 0.83 (0.55 to 1.23)	0.86	7; 0.77 (0.59 to 1.01) 7; 0.63 (0.54 to 0.73)	0.10	5; 2.09 (1.11 to 3.96) 7; 1.49 (0.74 to 3.01)	0.87
TRIAL POPULATION ‐ low immunological risk ‐ Mixed and high immunological risk	5; 0.48 (0.17 to 1.33) 9; 0.79 (0.55 to 1.12)	0.35	4; 0.65 (0.25 to 1.69) 10; 0.66 (0.60 to 0.73)	0.33	5; 1.02 (0.46 to 2.27) 7; 2.24 (1.43 to 3.49)	0.16

* censored for death	# Number of studies; RR (95% CI)

Table 2. Subgroup analyses

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Table 3. Meta‐regression and confounding

Potential confounder	Graft loss*		Acute rejection		New diabetes#
	UNADJUSTED RR (95% CI); P value	ADJUSTED ++ RR (95% CI); P value	UNADJUSTED RR (95% CI); P value	ADJUSTED RR (95% CI); P value	UNADJUSTED RR (95% CI); P value	UNADJUSTED RR (95% CI); P value
Cyclosporin microemulsion versus solution	0.83 (0.49 to 1.40); 0.48	1.01 (0.52 to 1.95); 0.97	1.10 (0.88 to 1.36); 0.40	0.99 (0.78 to 1.28); 0.99	0.35 (0.17 to 0.74); 0.006	0.30 (0.13 to 0.66); 0.003
Cyclosporin trough (per 25 ng/mL)+	1.02 (0.89 to 1.47); 0.76	0.92 (0.77 to 1.11); 0.38	1.06 (1.01 to 1.11); 0.02	1.07 (0.98 to 1.17); 0.14	1.03 (0.79 to 1.33); 0.83	1.05 (0.86 to 1.29); 0.61
Cyclosporin trough (per 1 ng/mL)+	1.20 (1.02 to 1.41); 0.04	1.33 (1.02 to 1.74); 0.04	1.04 (0.99 to 1.08); 0.10	0.98 (0.83 to 1.14); 0.77	1.20 (1.05 to 1.38); 0.007	1.18 (0·97 to 1·45); 0.10
Mycophenolate versus azathioprine	0.73 (0.23 to 2.29); 0.59	NAª	1.47 (0.88 to 2.48); 0.14	0.99 (0.52 to 1.91); 0.98	NA	NA

+ see results section	* censored for death	++ See results section ª Not available. See text			# new insulin‐treated see results section
(*) Censored for death. (#) New insulin‐treated diabetes mellitus. (+) Cyclosporin and tacrolimus levels are calculated by taking the weighted average of the 'intention‐to‐treat' target trough range values over the first year post transplantation, in ng/mL, using the stated initial target trough range and the target from three months post‐transplantation. (++) Adjusted ratio for each outcome is for multivariate model containing all explanatory variables that have an adjusted ratio quoted. (ª) Not available. Insufficient data reported across studies, so limiting the number of possible confounders that could be controlled for in the multivariate model. Multivariate model limited to those factors felt, a priori, to be of most clinical interest and have most potential to confound the analysis.

Table 3. Meta‐regression and confounding

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Table 4. Applicability in clinical practice ‐ absolute risk per 100 treated recipients

Immunological risk	Acute rejection*			Graft loss			Diabetes mellitus
	Cyclosporin	Tacrolimus	Avoided cases+	Cyclosporin	Tacrolimus	Avoided cases	Cyclosporin	Tacrolimus	Avoided cases
LOW	20	14	6	6	5	1	6	11	5
MEDIUM	40	28	12	9	7	2	6	11	5
HIGH	55	38	17	11	8	3	6	11	5

+ see results section	* see results section
(+) Calculated as absolute risk reduction/increase. (*) Cyclosporin rates for acute rejection were calculated using summary rate in cyclosporin (control) arms of studies. Studies were grouped by immunological risk of participating population, based on known associations; age, race, PRA level, prior transplantation. These estimates were corroborated with current cohort data (ANZDATA). Rates of graft loss and diabetes were derived from the summary rates of these outcomes in the cyclosporine (control) arms of studies reported at one year. Tacrolimus rate calculated on basis of overall RR 0.69 for acute rejection, RR 0.77 for death‐censored graft loss, and RR 1.86 for new onset diabetes mellitus requiring insulin for >30 days, all at one year post‐transplantation.

Table 4. Applicability in clinical practice ‐ absolute risk per 100 treated recipients

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Comparison 1. Tacrolimus versus cyclosporin for primary therapy

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Graft loss (censored for death) Show forest plot	20		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.1 3 months	1	80	Risk Ratio (M‐H, Random, 95% CI)	0.14 [0.01, 2.68]
1.2 6 months	7	1552	Risk Ratio (M‐H, Random, 95% CI)	0.56 [0.36, 0.86]
1.3 1 year	14	2604	Risk Ratio (M‐H, Random, 95% CI)	0.77 [0.58, 1.02]
1.4 2 years	4	1259	Risk Ratio (M‐H, Random, 95% CI)	0.74 [0.46, 1.21]
1.5 3 years	7	1513	Risk Ratio (M‐H, Random, 95% CI)	0.71 [0.52, 0.96]
1.6 4 years	1	448	Risk Ratio (M‐H, Random, 95% CI)	0.77 [0.48, 1.21]
1.7 5 years	2	827	Risk Ratio (M‐H, Random, 95% CI)	0.86 [0.65, 1.14]
2 Acute rejection (clinical or biopsy proven) Show forest plot	24		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2.1 3 months	5	248	Risk Ratio (M‐H, Random, 95% CI)	0.95 [0.44, 2.08]
2.2 6 months	10	1778	Risk Ratio (M‐H, Random, 95% CI)	0.68 [0.60, 0.78]
2.3 1 year	14	2751	Risk Ratio (M‐H, Random, 95% CI)	0.69 [0.60, 0.79]
2.4 2 years	3	1102	Risk Ratio (M‐H, Random, 95% CI)	0.57 [0.46, 0.72]
2.5 3 years	2	643	Risk Ratio (M‐H, Random, 95% CI)	0.69 [0.46, 1.04]
3 Acute rejection (biopsy proven) Show forest plot	15		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

3.1 3 months	1	80	Risk Ratio (M‐H, Random, 95% CI)	1.23 [0.68, 2.21]
3.2 6 months	7	1605	Risk Ratio (M‐H, Random, 95% CI)	0.68 [0.48, 0.96]
3.3 1 year	9	2094	Risk Ratio (M‐H, Random, 95% CI)	0.61 [0.52, 0.72]
3.4 2 years	1	223	Risk Ratio (M‐H, Random, 95% CI)	0.78 [0.45, 1.34]
3.5 3 years	1	223	Risk Ratio (M‐H, Random, 95% CI)	0.75 [0.45, 1.25]
4 Acute rejection (steroid resistant) Show forest plot	18		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

4.1 3 months	4	204	Risk Ratio (M‐H, Random, 95% CI)	0.96 [0.13, 7.15]
4.2 6 months	7	1511	Risk Ratio (M‐H, Random, 95% CI)	0.45 [0.33, 0.60]
4.3 1 year	9	1770	Risk Ratio (M‐H, Random, 95% CI)	0.49 [0.37, 0.64]
4.4 2 years	1	223	Risk Ratio (M‐H, Random, 95% CI)	0.79 [0.36, 1.74]
4.5 3 years	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
5 Total graft loss (with death) Show forest plot	20		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

5.1 3 months	1	80	Risk Ratio (M‐H, Random, 95% CI)	0.08 [0.00, 1.32]
5.2 6 months	8	1702	Risk Ratio (M‐H, Random, 95% CI)	0.60 [0.42, 0.86]
5.3 1 year	14	2604	Risk Ratio (M‐H, Random, 95% CI)	0.90 [0.71, 1.13]
5.4 2 years	4	1262	Risk Ratio (M‐H, Random, 95% CI)	0.77 [0.55, 1.08]
5.5 3 years	7	1513	Risk Ratio (M‐H, Random, 95% CI)	0.74 [0.59, 0.93]
5.6 4 years	1	448	Risk Ratio (M‐H, Random, 95% CI)	0.97 [0.71, 1.32]
5.7 5 years	2	827	Risk Ratio (M‐H, Random, 95% CI)	0.94 [0.77, 1.14]
6 Mortality Show forest plot	21		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

6.1 3 months	2	164	Risk Ratio (M‐H, Random, 95% CI)	0.14 [0.01, 2.68]
6.2 6 months	8	1702	Risk Ratio (M‐H, Random, 95% CI)	0.68 [0.36, 1.31]
6.3 1 year	14	2604	Risk Ratio (M‐H, Random, 95% CI)	1.05 [0.66, 1.68]
6.4 2 years	4	1262	Risk Ratio (M‐H, Random, 95% CI)	0.78 [0.48, 1.27]
6.5 3 years	6	1290	Risk Ratio (M‐H, Random, 95% CI)	0.91 [0.59, 1.40]
6.6 4 years	1	448	Risk Ratio (M‐H, Random, 95% CI)	1.27 [0.75, 2.13]
6.7 5 years	2	827	Risk Ratio (M‐H, Random, 95% CI)	1.00 [0.75, 1.33]
7 Chronic allograft nephropathy (CAN) Show forest plot	5		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

7.1 3 months	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
7.2 6 months	1	557	Risk Ratio (M‐H, Random, 95% CI)	0.47 [0.09, 2.57]
7.3 1 year	3	914	Risk Ratio (M‐H, Random, 95% CI)	0.28 [0.11, 0.68]
7.4 2 years	1	144	Risk Ratio (M‐H, Random, 95% CI)	0.86 [0.68, 1.08]
7.5 3 years	1	179	Risk Ratio (M‐H, Random, 95% CI)	1.19 [0.88, 1.60]
7.6 4 years	1	448	Risk Ratio (M‐H, Random, 95% CI)	0.51 [0.26, 0.98]
7.7 5 years	1	451	Risk Ratio (M‐H, Random, 95% CI)	0.42 [0.24, 0.75]
8 Total infection Show forest plot	10		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

8.1 3 months	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
8.2 6 months	4	380	Risk Ratio (M‐H, Random, 95% CI)	1.05 [0.87, 1.28]
8.3 1 year	6	1572	Risk Ratio (M‐H, Random, 95% CI)	0.99 [0.91, 1.07]
8.4 3 years	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
9 Total CMV infection Show forest plot	12		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

9.1 3 months	2	97	Risk Ratio (M‐H, Random, 95% CI)	0.52 [0.02, 12.46]
9.2 6 months	3	1335	Risk Ratio (M‐H, Random, 95% CI)	0.78 [0.60, 1.01]
9.3 1 year	7	1155	Risk Ratio (M‐H, Random, 95% CI)	0.97 [0.72, 1.29]
9.4 3 years	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
10 Invasive CMV infection Show forest plot	4		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

10.1 3 months	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
10.2 6 months	1	223	Risk Ratio (M‐H, Random, 95% CI)	0.76 [0.13, 4.45]
10.3 1 year	3	622	Risk Ratio (M‐H, Random, 95% CI)	1.46 [0.77, 2.75]
10.4 3 years	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
11 Delayed graft function Show forest plot	9	1688	Risk Ratio (M‐H, Random, 95% CI)	0.81 [0.58, 1.13]

11.1 Requirement for dialysis within 1st week post‐transplantation	9	1688	Risk Ratio (M‐H, Random, 95% CI)	0.81 [0.58, 1.13]
12 Hypercholesterolaemia Show forest plot	3		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

12.1 3 months	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
12.2 6 months	2	1112	Risk Ratio (M‐H, Random, 95% CI)	0.41 [0.24, 0.71]
12.3 1 year	1	412	Risk Ratio (M‐H, Random, 95% CI)	0.54 [0.30, 0.96]
12.4 3 years	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
13 Neurological side effects Show forest plot	6		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

13.1 tremor	6	2152	Risk Ratio (M‐H, Random, 95% CI)	2.18 [1.50, 3.17]
13.2 Insomnia	3	980	Risk Ratio (M‐H, Random, 95% CI)	1.03 [0.83, 1.28]
13.3 Headache	3	980	Risk Ratio (M‐H, Random, 95% CI)	1.23 [1.00, 1.52]
13.4 Paraesthesia	2	532	Risk Ratio (M‐H, Random, 95% CI)	1.64 [0.85, 3.16]
13.5 Anxiety	1	412	Risk Ratio (M‐H, Random, 95% CI)	1.72 [0.98, 3.04]
13.6 Dizziness	1	412	Risk Ratio (M‐H, Random, 95% CI)	1.23 [0.80, 1.88]
13.7 Neuropathy	1	120	Risk Ratio (M‐H, Random, 95% CI)	3.43 [0.20, 60.19]
13.8 Seizure	1	60	Risk Ratio (M‐H, Random, 95% CI)	5.0 [0.25, 99.95]
14 Gastrointestinal side effects Show forest plot	8		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

14.1 Constipation	3	980	Risk Ratio (M‐H, Random, 95% CI)	0.83 [0.69, 0.99]
14.2 Abdominal pain	1	448	Risk Ratio (M‐H, Random, 95% CI)	1.17 [0.83, 1.65]
14.3 Diarrhoea	7	1343	Risk Ratio (M‐H, Random, 95% CI)	1.98 [1.03, 3.83]
14.4 Nausea	2	860	Risk Ratio (M‐H, Random, 95% CI)	1.04 [0.84, 1.30]
14.5 Dyspepsia	3	980	Risk Ratio (M‐H, Random, 95% CI)	1.31 [1.00, 1.70]
14.6 Vomiting	3	980	Risk Ratio (M‐H, Random, 95% CI)	1.41 [1.05, 1.89]
14.7 Gastritis	1	557	Risk Ratio (M‐H, Random, 95% CI)	8.53 [1.09, 66.86]
14.8 Haemorrhage/bleed	1	557	Risk Ratio (M‐H, Random, 95% CI)	0.14 [0.02, 1.09]
15 Total malignancy Show forest plot	8		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

15.1 3 months	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
15.2 6 months	2	753	Risk Ratio (M‐H, Random, 95% CI)	1.21 [0.27, 5.47]
15.3 1 year	7	1765	Risk Ratio (M‐H, Random, 95% CI)	0.80 [0.37, 1.73]
15.4 3 years	2	608	Risk Ratio (M‐H, Random, 95% CI)	0.91 [0.52, 1.60]
15.5 5 years	2	860	Risk Ratio (M‐H, Random, 95% CI)	1.06 [0.70, 1.60]
16 de novo hypertension Show forest plot	5		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

16.1 3 months	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
16.2 6 months	2	753	Risk Ratio (M‐H, Random, 95% CI)	0.89 [0.52, 1.52]
16.3 1 year	3	1024	Risk Ratio (M‐H, Random, 95% CI)	1.04 [0.80, 1.36]
16.4 3 years	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
17 Bacterial infection Show forest plot	4		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

17.1 3 months	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
17.2 6 months	1	196	Risk Ratio (M‐H, Random, 95% CI)	1.02 [0.73, 1.43]
17.3 1 year	3	920	Risk Ratio (M‐H, Random, 95% CI)	0.83 [0.69, 1.01]
17.4 3 years	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
18 Viral infection Show forest plot	4		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

18.1 3 months	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
18.2 6 months	1	196	Risk Ratio (M‐H, Random, 95% CI)	0.90 [0.54, 1.50]
18.3 1 year	3	920	Risk Ratio (M‐H, Random, 95% CI)	1.02 [0.81, 1.28]
18.4 3 years	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
19 Fungal infection Show forest plot	5		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

19.1 3 months	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
19.2 6 months	2	419	Risk Ratio (M‐H, Random, 95% CI)	1.69 [0.86, 3.33]
19.3 1 year	3	920	Risk Ratio (M‐H, Random, 95% CI)	1.29 [0.70, 2.37]
19.4 3 years	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
20 Protozoal infection Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

20.1 3 months	0		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
20.2 6 months	0		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
20.3 1 year	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
20.4 3 years	0		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
21 Other unclassifiable infection Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

21.1 3 months	0		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
21.2 6 months	0		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
21.3 1 year	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
21.4 3 years	0		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
22 Serum creatinine µmol/L Show forest plot	14		Mean Difference (IV, Random, 95% CI)	Subtotals only

22.1 1 month	2	67	Mean Difference (IV, Random, 95% CI)	‐63.98 [‐205.66, 77.69]
22.2 3 months	3	137	Mean Difference (IV, Random, 95% CI)	1.26 [‐22.52, 25.04]
22.3 6 months	7	939	Mean Difference (IV, Random, 95% CI)	‐15.88 [‐30.30, ‐1.46]
22.4 1 year	8	569	Mean Difference (IV, Random, 95% CI)	‐13.07 [‐37.27, 11.12]
22.5 2 years	1	144	Mean Difference (IV, Random, 95% CI)	‐7.95 [‐23.83, 7.93]
22.6 3 years	2	506	Mean Difference (IV, Random, 95% CI)	2.50 [‐6.93, 11.94]
22.7 5 years	1	448	Mean Difference (IV, Random, 95% CI)	‐13.0 [‐27.38, 1.38]
23 Haematological side effects Show forest plot	3		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

23.1 Anaemia	1	448	Risk Ratio (M‐H, Random, 95% CI)	1.06 [0.68, 1.64]
23.2 Leucopaenia	2	1003	Risk Ratio (M‐H, Random, 95% CI)	0.83 [0.53, 1.31]
23.3 Thrombocytopeania	1	555	Risk Ratio (M‐H, Random, 95% CI)	0.99 [0.54, 1.84]
23.4 Erythrocytosis	1	17	Risk Ratio (M‐H, Random, 95% CI)	0.30 [0.01, 6.47]
24 Cosmetic side effects Show forest plot	6		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

24.1 Acne	1	448	Risk Ratio (M‐H, Random, 95% CI)	0.27 [0.12, 0.64]
24.2 Hirsuitism	4	1613	Risk Ratio (M‐H, Random, 95% CI)	0.04 [0.01, 0.15]
24.3 Gingival hyperplasia	5	1673	Risk Ratio (M‐H, Random, 95% CI)	0.14 [0.06, 0.34]
24.4 Alopecia	2	969	Risk Ratio (M‐H, Random, 95% CI)	10.55 [2.91, 38.23]
24.5 Pruritis	1	412	Risk Ratio (M‐H, Random, 95% CI)	2.09 [1.16, 3.75]
24.6 Other	1	17	Risk Ratio (M‐H, Random, 95% CI)	0.13 [0.01, 2.16]
25 Lymphoma/PTLD Show forest plot	6		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

25.1 3 months	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
25.2 6 months	1	196	Risk Ratio (M‐H, Random, 95% CI)	0.45 [0.04, 4.90]
25.3 1 year	5	1016	Risk Ratio (M‐H, Random, 95% CI)	0.77 [0.29, 2.08]
25.4 2 years	2	635	Risk Ratio (M‐H, Random, 95% CI)	0.88 [0.27, 2.95]
25.5 3 years	2	608	Risk Ratio (M‐H, Random, 95% CI)	0.77 [0.31, 1.93]
25.6 5 years	2	860	Risk Ratio (M‐H, Random, 95% CI)	1.22 [0.46, 3.22]
26 Biochemical side effects Show forest plot	5		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

26.1 Hypomagnesaemia	2	753	Risk Ratio (M‐H, Random, 95% CI)	2.99 [1.78, 5.02]
26.2 Bilirubinaemia	1	557	Risk Ratio (M‐H, Random, 95% CI)	0.11 [0.01, 0.83]
26.3 Cholestasis	2	647	Risk Ratio (M‐H, Random, 95% CI)	0.23 [0.05, 1.05]
26.4 Hyperkalaemia	2	568	Risk Ratio (M‐H, Random, 95% CI)	1.33 [0.97, 1.82]
27 Fever Show forest plot	2	751	Risk Ratio (M‐H, Random, 95% CI)	0.35 [0.10, 1.22]

28 Surgical side effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

28.1 Lymphocoele	1	150	Risk Ratio (M‐H, Random, 95% CI)	0.86 [0.36, 2.04]
28.2 Dehiscence	1	150	Risk Ratio (M‐H, Random, 95% CI)	0.5 [0.07, 3.45]
28.3 Wound infection	1	150	Risk Ratio (M‐H, Random, 95% CI)	4.54 [0.25, 82.78]
28.4 Fistulae	1	150	Risk Ratio (M‐H, Random, 95% CI)	1.51 [0.06, 36.53]
28.5 Other	1	150	Risk Ratio (M‐H, Random, 95% CI)	0.10 [0.00, 2.06]
29 GFR (mL/min) Show forest plot	3		Mean Difference (IV, Random, 95% CI)	Subtotals only

29.1 6 months	2	213	Mean Difference (IV, Random, 95% CI)	0.38 [‐9.12, 9.89]
29.2 1 year	1	161	Mean Difference (IV, Random, 95% CI)	7.10 [0.50, 13.70]
29.3 2 years	1	137	Mean Difference (IV, Random, 95% CI)	13.20 [6.48, 19.92]
29.4 3 years	1	412	Mean Difference (IV, Random, 95% CI)	‐0.30 [‐6.16, 5.56]
29.5 5 years	1	376	Mean Difference (IV, Random, 95% CI)	7.00 [0.41, 13.59]
30 Total cholesterol (µmol/L) Show forest plot	7		Mean Difference (IV, Random, 95% CI)	Subtotals only

30.1 1 month	2	465	Mean Difference (IV, Random, 95% CI)	‐0.87 [‐1.08, ‐0.66]
30.2 3 months	2	530	Mean Difference (IV, Random, 95% CI)	‐0.75 [‐0.97, ‐0.54]
30.3 6 months	3	722	Mean Difference (IV, Random, 95% CI)	‐0.58 [‐0.77, ‐0.39]
30.4 1 year	3	183	Mean Difference (IV, Random, 95% CI)	‐0.80 [‐1.76, 0.17]
30.5 3 years	1	219	Mean Difference (IV, Random, 95% CI)	‐0.71 [‐1.03, ‐0.39]
30.6 5 years	0	0	Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
31 Total triglycerides (µmol/L) Show forest plot	4		Mean Difference (IV, Random, 95% CI)	Subtotals only

31.1 1 month	2	465	Mean Difference (IV, Random, 95% CI)	‐0.34 [‐0.84, 0.16]
31.2 3 months	2	530	Mean Difference (IV, Random, 95% CI)	‐0.33 [‐0.65, ‐0.00]
31.3 6 months	2	526	Mean Difference (IV, Random, 95% CI)	‐0.28 [‐0.60, 0.05]
31.4 1 year	1	91	Mean Difference (IV, Random, 95% CI)	‐0.27 [‐0.28, ‐0.26]
31.5 3 years	1	205	Mean Difference (IV, Random, 95% CI)	‐0.39 [‐0.69, ‐0.09]
31.6 5 years	0	0	Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
32 Treament withdrawal/crossover Show forest plot	10		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

32.1 3 months	1	80	Risk Ratio (M‐H, Random, 95% CI)	0.2 [0.02, 1.64]
32.2 6 months	3	1311	Risk Ratio (M‐H, Random, 95% CI)	0.59 [0.47, 0.74]
32.3 1 year	6	1402	Risk Ratio (M‐H, Random, 95% CI)	0.72 [0.36, 1.45]
32.4 within first year	9	2713	Risk Ratio (M‐H, Random, 95% CI)	0.69 [0.47, 1.02]
33 Sustained diabetes mellitus requiring insulin Show forest plot	17		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

33.1 3 months	1	80	Risk Ratio (M‐H, Random, 95% CI)	0.33 [0.01, 7.95]
33.2 6 months	6	915	Risk Ratio (M‐H, Random, 95% CI)	2.61 [1.16, 5.85]
33.3 1 year	11	1956	Risk Ratio (M‐H, Random, 95% CI)	1.70 [1.04, 2.78]
33.4 2 years	1	145	Risk Ratio (M‐H, Random, 95% CI)	1.24 [0.34, 4.46]
33.5 3 years	2	447	Risk Ratio (M‐H, Random, 95% CI)	3.26 [1.62, 6.57]
33.6 5 years	1	302	Risk Ratio (M‐H, Random, 95% CI)	3.33 [1.38, 8.07]
34 Requirement for insulin >30 days in previously non‐diabetic patients Show forest plot	19		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

34.1 3 months	2	97	Risk Ratio (M‐H, Random, 95% CI)	1.33 [0.10, 16.97]
34.2 6 months	7	1060	Risk Ratio (M‐H, Random, 95% CI)	2.56 [1.37, 4.78]
34.3 1 year	12	2013	Risk Ratio (M‐H, Random, 95% CI)	1.86 [1.11, 3.09]
34.4 2 years	1	145	Risk Ratio (M‐H, Random, 95% CI)	1.24 [0.34, 4.46]
34.5 3 years	2	447	Risk Ratio (M‐H, Random, 95% CI)	3.86 [2.01, 7.41]
34.6 5 years	1	302	Risk Ratio (M‐H, Random, 95% CI)	4.86 [2.22, 10.61]

Comparison 1. Tacrolimus versus cyclosporin for primary therapy

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Comparison 2. Stratified analysis, by publication type

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Graft loss (death censored) 1 year Show forest plot	13	2544	Risk Ratio (M‐H, Random, 95% CI)	0.77 [0.57, 1.04]

1.1 Transplantation proceedings +/‐ abstract	3	278	Risk Ratio (M‐H, Random, 95% CI)	1.04 [0.51, 2.12]
1.2 Peer reviewed journal	10	2266	Risk Ratio (M‐H, Random, 95% CI)	0.71 [0.49, 1.02]
2 Acute rejection (all) 1 year Show forest plot	14	2751	Risk Ratio (M‐H, Random, 95% CI)	0.69 [0.60, 0.80]

2.1 Transplantation proceedings +/‐ abstract	3	281	Risk Ratio (M‐H, Random, 95% CI)	1.02 [0.57, 1.82]
2.2 Peer reviewed journal	11	2470	Risk Ratio (M‐H, Random, 95% CI)	0.64 [0.57, 0.72]
3 New requirement for insulin >30 days Show forest plot	12		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

3.1 Transplantation proceedings +/‐ abstract	3	250	Risk Ratio (M‐H, Random, 95% CI)	2.01 [0.94, 4.29]
3.2 Peer reviewed journal	9	1763	Risk Ratio (M‐H, Random, 95% CI)	1.84 [0.95, 3.57]

Comparison 2. Stratified analysis, by publication type

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Comparison 3. Stratified analysis, by ITT quality

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Graft loss (death censored) 1 year Show forest plot	14	2604	Risk Ratio (M‐H, Random, 95% CI)	0.77 [0.58, 1.02]

1.1 Not ITT	6	1117	Risk Ratio (M‐H, Random, 95% CI)	0.79 [0.52, 1.18]
1.2 unclear ITT	1	102	Risk Ratio (M‐H, Random, 95% CI)	0.09 [0.00, 1.54]
1.3 Confirmed ITT	7	1385	Risk Ratio (M‐H, Random, 95% CI)	0.77 [0.50, 1.18]
2 Acute rejection (all) 1 year Show forest plot	14	2751	Risk Ratio (M‐H, Random, 95% CI)	0.69 [0.60, 0.80]

2.1 Not ITT	4	1037	Risk Ratio (M‐H, Random, 95% CI)	0.73 [0.58, 0.93]
2.2 Unclear ITT	2	162	Risk Ratio (M‐H, Random, 95% CI)	1.13 [0.69, 1.84]
2.3 Confirmed ITT	8	1552	Risk Ratio (M‐H, Random, 95% CI)	0.62 [0.53, 0.71]
3 New requirement for insulin >30 days Show forest plot	12		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

3.1 ITT not undertaken, or unclear	5	888	Risk Ratio (M‐H, Random, 95% CI)	1.58 [0.97, 2.59]
3.2 Confirmed ITT	7	1125	Risk Ratio (M‐H, Random, 95% CI)	1.77 [0.78, 4.01]

Comparison 3. Stratified analysis, by ITT quality

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Comparison 4. Stratified analysis, by immunological risk

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Acute rejection (all) 1 year Show forest plot	14	2751	Risk Ratio (M‐H, Random, 95% CI)	0.69 [0.60, 0.80]

1.1 Low risk	4	387	Risk Ratio (M‐H, Random, 95% CI)	0.65 [0.25, 1.69]
1.2 Mixed and high risk	10	2364	Risk Ratio (M‐H, Random, 95% CI)	0.66 [0.60, 0.73]
2 Graft loss (death censored) 1 year Show forest plot	14	2604	Risk Ratio (M‐H, Random, 95% CI)	0.77 [0.58, 1.02]

2.1 Low risk	5	444	Risk Ratio (M‐H, Random, 95% CI)	0.48 [0.17, 1.33]
2.2 Mixed and high risk	9	2160	Risk Ratio (M‐H, Random, 95% CI)	0.79 [0.55, 1.12]
3 New requirement for insulin >30 days Show forest plot	12		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

3.1 Low risk	5	347	Risk Ratio (M‐H, Random, 95% CI)	1.17 [0.49, 2.77]
3.2 Mixed or high risk	7	1666	Risk Ratio (M‐H, Random, 95% CI)	2.35 [1.31, 4.19]

Comparison 4. Stratified analysis, by immunological risk

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Comparison 5. Stratified analysis, by cyclosporin formulation

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Graft loss (death censored) 1 year Show forest plot	13	2192	Risk Ratio (M‐H, Random, 95% CI)	0.82 [0.60, 1.11]

1.1 Solution	3	625	Risk Ratio (M‐H, Random, 95% CI)	0.99 [0.61, 1.61]
1.2 Microemulsion	10	1567	Risk Ratio (M‐H, Random, 95% CI)	0.70 [0.44, 1.13]
2 Acute rejection (all) 1 year Show forest plot	14	2751	Risk Ratio (M‐H, Random, 95% CI)	0.69 [0.60, 0.80]

2.1 Solution	4	1028	Risk Ratio (M‐H, Random, 95% CI)	0.64 [0.55, 0.75]
2.2 Microemulsion	10	1723	Risk Ratio (M‐H, Random, 95% CI)	0.71 [0.57, 0.89]
3 New requirement for insulin >30 days Show forest plot	12		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

3.1 Solution	4	851	Risk Ratio (M‐H, Random, 95% CI)	4.33 [2.38, 7.87]
3.2 Microemulsion	8	1162	Risk Ratio (M‐H, Random, 95% CI)	1.20 [0.79, 1.82]

Comparison 5. Stratified analysis, by cyclosporin formulation

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Comparison 6. Stratified analysis, by antiproliferative cointervention

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Graft loss (death censored) 1 year Show forest plot	11	1827	Risk Ratio (M‐H, Random, 95% CI)	0.83 [0.61, 1.14]

1.1 Azathioprine	8	1600	Risk Ratio (M‐H, Random, 95% CI)	0.86 [0.63, 1.19]
1.2 MMF	3	227	Risk Ratio (M‐H, Random, 95% CI)	0.41 [0.10, 1.71]
2 Acute rejection (all) 1 year Show forest plot	12	2386	Risk Ratio (M‐H, Random, 95% CI)	0.67 [0.60, 0.76]

2.1 Azathioprine	9	2159	Risk Ratio (M‐H, Random, 95% CI)	0.65 [0.59, 0.73]
2.2 MMF	3	227	Risk Ratio (M‐H, Random, 95% CI)	0.89 [0.39, 2.08]
3 New requirement for insulin >30 days Show forest plot	11		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

3.1 Azathioprine	7	1550	Risk Ratio (M‐H, Random, 95% CI)	2.51 [1.34, 4.72]
3.2 MMF	4	287	Risk Ratio (M‐H, Random, 95% CI)	1.44 [0.65, 3.16]

Comparison 6. Stratified analysis, by antiproliferative cointervention

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Comparison 7. Heterogeneity investigation

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Acute rejection (biopsy proven) Show forest plot	7		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.1 6 months ‐ Charpentier 2002 excluded	6	1050	Risk Ratio (M‐H, Random, 95% CI)	0.61 [0.42, 0.87]
1.2 6 months ‐Margreiter 2002 excluded	6	1048	Risk Ratio (M‐H, Random, 95% CI)	0.74 [0.49, 1.12]
1.3 6 months	7	1605	Risk Ratio (M‐H, Random, 95% CI)	0.68 [0.48, 0.96]
2 Serum creatinine Show forest plot	7		Mean Difference (IV, Random, 95% CI)	Subtotals only

2.1 Number participants measured not stated, therefore inferred	4	771	Mean Difference (IV, Random, 95% CI)	‐5.47 [‐13.71, 2.76]
2.2 Number of participants measured stated	3	168	Mean Difference (IV, Random, 95% CI)	‐41.63 [‐71.89, ‐11.36]
3 Graft loss (death censored) Show forest plot	19		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

3.1 All trials reporting within 1st year, so contributing to meta‐regression	19	3403	Risk Ratio (M‐H, Random, 95% CI)	0.74 [0.57, 0.95]
4 New requirement for insulin >30 days Show forest plot	12		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

4.1 1 year	12	2013	Risk Ratio (M‐H, Random, 95% CI)	1.86 [1.11, 3.09]
4.2 1 year ‐ Miller 2002 excluded	11	1890	Risk Ratio (M‐H, Random, 95% CI)	2.19 [1.42, 3.38]

Comparison 7. Heterogeneity investigation

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