Conversion to generic cyclosporine A in stable chronic patients after heart transplantation

Figures & data

Figure 1 Study timeline with time points of clinical and laboratory assessments under Neoral (before switch) and Equoral (after switch).

Abbreviation: C0, trough level.

Table 1 Patient characteristics (n=20)

Patient number, n	20
Sex male/female, n (%)	13 (65.0%)/7 (35.0%)
Initial cardiac diagnosis, n (%)	• Dilated cardiomyopathy, 10 (50.0%)
	• Ischemic cardiomyopathy, 6 (30.0%)
	• Transthyretin-amyloidosis, 2 (10.0%)
	• Congenital aortic coarctation, 1 (5.0%)
	• Valvular cardiomyopathy, 1 (5.0%)

Abbreviation: n, number of patients.

Table 2 Pre- and postconversion

	Neoral	Equoral
Graft survival, n (%)	20 (100.0)	20 (100.0)
Patient survival, n (%)	20 (100.0)	20 (100.0)
Mean daily CSA dose, mg (SD)	140.67 (39.81)	134.58 (41.61)
Mean DNL, (ng/mL)/mg (SD)	0.71 (0.26)	0.68 (0.23)
Lower 95% CI of DNL	0.64	0.62
Upper 95% CI of DNL	0.77	0.73

Abbreviations: n, number of patients; CSA, cyclosporine A; SD, standard deviation; CI, confidence interval; DNL, dose-normalized predose level.

Figure 2 Mean DNL and 95% confidence interval in all patients under Neoral and Equoral.

Note: Switch: time point of conversion from Neoral to Equoral.
Abbreviation: DNL, dose-normalized predose level.

Table 3 Differences in DNL on Neoral before switch

Neoral	8 months before switch	4 months before switch	P-value
Mean DNL	0.74	0.73	0.84
SD	0.27	0.27
Minimum DNL	0.37	0.39
Maximum DNL	1.31	1.33
Median DNL	0.74	0.70

Abbreviations: DNL, dose-normalized level; SD, standard deviation.

Table 4 Differences in C0 (ng/mL) Level on Neoral before switch

Neoral	8 months before switch	4 months before switch	P-value
Mean C0	102.2	97.2	0.60
SD	39.6	31.3
Minimum C0	55.0	58.0
Maximum C0	197.0	164.0
Median C0	94.0	90.0

Abbreviations: C0, trough level; SD, standard deviation.

Table 5 Differences in DNL on Equoral after switch

Equoral	4 months after switch	8 months after switch	P-value
Mean DNL	0.69	0.66	0.57
SD	0.22	0.27
Minimum DNL	0.40	0.24
Maximum DNL	1.14	1.31
Median DNL	0.64	0.65

Abbreviations: DNL, dose-normalized predose level; SD, standard deviation.

Table 6 Differences in C0 (ng/mL) level on Equoral after the switch

Equoral	4 months after switch	8 months after switch	P-value
Mean C0	87.0	79.7	0.23
SD	26.3	24.9
Minimum C0	51.0	32.0
Maximum C0	143.0	127.0
Median C0	90.0	79.0

Abbreviations: C0, trough level; SD, standard deviation.

Figure 3 Corresponding values of mean cyclosporine dose and 95% confidence interval in all patients under Neoral and Equoral.

Note: Switch: time point of conversion from Neoral to Equoral.

Table 7 Routine laboratory

	Baseline		4 months after switch			8 months after switch
	Mean	SD	Mean	SD	P-value*	Mean	SD	P-value*
Hb g/dL	12.88	1.68	13.02	1.81	0.45	12.82	1.55	0.66
Leucocytes/nL	5.79	1.60	5.92	1.49	0.65	6.18	1.95	0.28
Thrombocytes/nL	214.10	67.82	215.25	61.59	0.88	213.05	72.29	0.89
Creatinine mg/dL	1.28	0.33	1.30	0.33	0.63	1.27	0.37	0.96
MDRD mL/minute *1.73 m^2	59.93	21.98	59.57	20.23	0.54	59.57	20.23	0.89

Note:

* Versus baseline.

Abbreviations: Hb, hemoglobin; MDRD, Modification of Diet in Renal Disease; SD, standard deviation.