Patients were divided according to CyA administration frequency—once a day (group 1) or twice a day (group 2). In each therapeutic response, there was no significant difference However, the time-to-remission curve analyzed using the Kaplan–Meier technique revealed a significant deference in cumulative CR rate (p = 0.0282; Fig. 3a) but not in cumulative CR + ICR1 rate (p = 0.314, Fig. 3b). Fig. 3 Probability of cumulative complete remission (CR) (a) and CR + incomplete remission 1 (ICRI) (b) for patients treated with PSL and CyA. Group 1 showed a significantly higher rate of CR (a) but not of CR + ICRI (b) compared with group 2
Assessment of clinical selleck chemicals parameters After CyA + PSL treatment, the levels of UP, serum albumin, and serum total cholesterol significantly improved in both groups; however, there were no significant differences in each parameter
between the 2 groups. RG7112 Serum creatinine level slightly increased in both groups selleck products but was not significant. Two patients in each group exhibited a doubling of serum creatinine, around 2 mg/dL, at 48 weeks, although the levels were within the reference range at the start of treatment. At baseline, only 1 patient had mild hypertension in group 2 (155/89 mmHg), but the blood pressure normalized later. At the final observation, another patient in group 2 showed mild hypertension (150/88 mmHg). No patient had CyA-induced hypertension in either group. As the supportive therapy for MN, angiotensin II receptor blockers (4 and 2 patients in groups 1 and 2, respectively) Pregnenolone and angiotensin-converting enzyme inhibitors (one in group
1) and a combination of both (one in each group) were administered. However, these drugs did not produce any adverse effects including hyperkalemia. Although four patients in groups 1 and 2 showed mild hyperglycemia by steroids treatment, respectively, this did not have any serious influences on the results. Blood CyA concentrations The flowchart of the study design regarding assignment by blood CyA concentrations at 2 h post dose (C2) is shown in Fig. 4. Fig. 4 Flowchart of the study design: assignment by CyA blood concentrations at 2 h post dose (C2) Absorption profiles of CyA in groups 1 and 2 There were significant differences in AUC0–4 between groups (group 1 vs group 2: 3678 ± 181 vs 2506 ± 164 ng h/mL, p < 0.0001). In comparisons between AUC0–4 and CyA concentrations at each time point (C0–C4), C2 was most strongly correlated with AUC0–4 in the total patients (r = 0.032, 0.609, 0.780, 0.654, 0.579 for C0, C1, C2, C3, C4, respectively). Average C0 and C2 and the cut-off level for CR The average C0 and C2 during treatment were significantly correlated with the C0 and C2 at the AP, respectively (C0: r = 0.516, p = 0.0036; C2: r = 0.638, p = 0.0001). The average C2 in group 1 was significantly higher than in group 2; however, the average C0 in group 1 was significantly lower than in group 2.