Abstract
Whether it is better to treat renal transplant patients with cyclosporine alone, combined with steroids, or combined with steroids and azathioprine is still unclear. After initial therapy with cyclosporine and steroids, 354 cadaver renal transplant recipients were randomly assigned at the post-transplant day 5 to cyclosporine alone (monotherapy), cyclosporine plus steroids (double therapy), or cyclosporine plus steroids plus azathioprine (triple therapy). Monotherapy patients, after a second acute rejection, were switched to either of the two alternative therapies. According to intention-to-treat (ITT) analysis, the 4-year patient survival was 97% in monotherapy, 91% in double therapy, and 96% in triple therapy; the graft survival including death was 84%, 77%, and 88%, respectively; and the pure graft survival was 87%, 85% and 91%, respectively (P = not significant). Acute rejections were diagnosed in 79 patients in monotherapy, 58 in double therapy, and 59 in triple therapy (P <0.01). Of the patients on monotherapy, 52% were switched to double or triple therapy. In these patients, the 4-year graft survival including death was 68%, and the pure graft survival was 72%, in comparison with 93% and 94%, respectively, for patients who continued on cyclosporine alone. Patients with renal polycystic disease as a cause of renal failure and with low plasma creatinine at the time of randomization (5 days after transplant) had a higher probability of remaining on monotherapy, whereas those with glomerulonephritis or systemic lupus erythematosus (SLE) and with high plasma creatinine levels at randomisation had a higher probability of being switched to double or triple therapy. According to ITT analysis, there were fewer ocular (P <0.0001), osteomuscular (P <0.002) and cardiovascular complications (P = 0.05) and fewer patients with hypercholesterolemia (P <0.0028) in the monotherapy group, with no difference between double and triple therapy. Creatinine clearance at 3 years was lower in monotherapy, but no attrition of renal function was seen over the years in any of the groups. Cyclosporine, however used, provided good results in cadaveric renal transplantation. Triple therapy and monotherapy offered a nonsignificantly better patient and graft survival than double therapy. Patients on monotherapy had a higher risk of acute rejection but had fewer adverse events than those on double or triple therapy. Patients maintained on cyclosporine alone had the best graft survival, whereas those who were assigned to monotherapy and had to add steroids because of multiple rejections had the worst outcome. Therefore, it seems reasonable to limit the choice of monotherapy to patients without immune-mediated renal diseases and with good graft function in the early posttransplant period.
| Original language | English |
|---|---|
| Pages (from-to) | 638-646 |
| Number of pages | 9 |
| Journal | Journal of the American Society of Nephrology |
| Volume | 8 |
| Issue number | 4 |
| Publication status | Published - Apr 1997 |
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ASJC Scopus subject areas
- Nephrology
Cite this
A randomized study comparing three cyclosporine-based regimens in cadaveric renal transplantation. / Ponticelli, Claudio; Tarantino, Antonio; Segoloni, Giuseppe P.; Cambi, Vincenzo; Rizzo, Gaetano; Altieri, Paolo; Mastrangelo, Francesco; Castagneto, Marco; Salvadori, Maurizio; Valente, Umberto; Cossu, Maria; Federico, Stefano; Pisani, Francesco; Montagnino, Giuseppe; Messina, Maria; Arisi, Luca; Carmellini, Mario; Piredda, Gianbenedetto; Corbetta, Giuseppe.
In: Journal of the American Society of Nephrology, Vol. 8, No. 4, 04.1997, p. 638-646.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - A randomized study comparing three cyclosporine-based regimens in cadaveric renal transplantation
AU - Ponticelli, Claudio
AU - Tarantino, Antonio
AU - Segoloni, Giuseppe P.
AU - Cambi, Vincenzo
AU - Rizzo, Gaetano
AU - Altieri, Paolo
AU - Mastrangelo, Francesco
AU - Castagneto, Marco
AU - Salvadori, Maurizio
AU - Valente, Umberto
AU - Cossu, Maria
AU - Federico, Stefano
AU - Pisani, Francesco
AU - Montagnino, Giuseppe
AU - Messina, Maria
AU - Arisi, Luca
AU - Carmellini, Mario
AU - Piredda, Gianbenedetto
AU - Corbetta, Giuseppe
PY - 1997/4
Y1 - 1997/4
N2 - Whether it is better to treat renal transplant patients with cyclosporine alone, combined with steroids, or combined with steroids and azathioprine is still unclear. After initial therapy with cyclosporine and steroids, 354 cadaver renal transplant recipients were randomly assigned at the post-transplant day 5 to cyclosporine alone (monotherapy), cyclosporine plus steroids (double therapy), or cyclosporine plus steroids plus azathioprine (triple therapy). Monotherapy patients, after a second acute rejection, were switched to either of the two alternative therapies. According to intention-to-treat (ITT) analysis, the 4-year patient survival was 97% in monotherapy, 91% in double therapy, and 96% in triple therapy; the graft survival including death was 84%, 77%, and 88%, respectively; and the pure graft survival was 87%, 85% and 91%, respectively (P = not significant). Acute rejections were diagnosed in 79 patients in monotherapy, 58 in double therapy, and 59 in triple therapy (P <0.01). Of the patients on monotherapy, 52% were switched to double or triple therapy. In these patients, the 4-year graft survival including death was 68%, and the pure graft survival was 72%, in comparison with 93% and 94%, respectively, for patients who continued on cyclosporine alone. Patients with renal polycystic disease as a cause of renal failure and with low plasma creatinine at the time of randomization (5 days after transplant) had a higher probability of remaining on monotherapy, whereas those with glomerulonephritis or systemic lupus erythematosus (SLE) and with high plasma creatinine levels at randomisation had a higher probability of being switched to double or triple therapy. According to ITT analysis, there were fewer ocular (P <0.0001), osteomuscular (P <0.002) and cardiovascular complications (P = 0.05) and fewer patients with hypercholesterolemia (P <0.0028) in the monotherapy group, with no difference between double and triple therapy. Creatinine clearance at 3 years was lower in monotherapy, but no attrition of renal function was seen over the years in any of the groups. Cyclosporine, however used, provided good results in cadaveric renal transplantation. Triple therapy and monotherapy offered a nonsignificantly better patient and graft survival than double therapy. Patients on monotherapy had a higher risk of acute rejection but had fewer adverse events than those on double or triple therapy. Patients maintained on cyclosporine alone had the best graft survival, whereas those who were assigned to monotherapy and had to add steroids because of multiple rejections had the worst outcome. Therefore, it seems reasonable to limit the choice of monotherapy to patients without immune-mediated renal diseases and with good graft function in the early posttransplant period.
AB - Whether it is better to treat renal transplant patients with cyclosporine alone, combined with steroids, or combined with steroids and azathioprine is still unclear. After initial therapy with cyclosporine and steroids, 354 cadaver renal transplant recipients were randomly assigned at the post-transplant day 5 to cyclosporine alone (monotherapy), cyclosporine plus steroids (double therapy), or cyclosporine plus steroids plus azathioprine (triple therapy). Monotherapy patients, after a second acute rejection, were switched to either of the two alternative therapies. According to intention-to-treat (ITT) analysis, the 4-year patient survival was 97% in monotherapy, 91% in double therapy, and 96% in triple therapy; the graft survival including death was 84%, 77%, and 88%, respectively; and the pure graft survival was 87%, 85% and 91%, respectively (P = not significant). Acute rejections were diagnosed in 79 patients in monotherapy, 58 in double therapy, and 59 in triple therapy (P <0.01). Of the patients on monotherapy, 52% were switched to double or triple therapy. In these patients, the 4-year graft survival including death was 68%, and the pure graft survival was 72%, in comparison with 93% and 94%, respectively, for patients who continued on cyclosporine alone. Patients with renal polycystic disease as a cause of renal failure and with low plasma creatinine at the time of randomization (5 days after transplant) had a higher probability of remaining on monotherapy, whereas those with glomerulonephritis or systemic lupus erythematosus (SLE) and with high plasma creatinine levels at randomisation had a higher probability of being switched to double or triple therapy. According to ITT analysis, there were fewer ocular (P <0.0001), osteomuscular (P <0.002) and cardiovascular complications (P = 0.05) and fewer patients with hypercholesterolemia (P <0.0028) in the monotherapy group, with no difference between double and triple therapy. Creatinine clearance at 3 years was lower in monotherapy, but no attrition of renal function was seen over the years in any of the groups. Cyclosporine, however used, provided good results in cadaveric renal transplantation. Triple therapy and monotherapy offered a nonsignificantly better patient and graft survival than double therapy. Patients on monotherapy had a higher risk of acute rejection but had fewer adverse events than those on double or triple therapy. Patients maintained on cyclosporine alone had the best graft survival, whereas those who were assigned to monotherapy and had to add steroids because of multiple rejections had the worst outcome. Therefore, it seems reasonable to limit the choice of monotherapy to patients without immune-mediated renal diseases and with good graft function in the early posttransplant period.
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UR - http://www.scopus.com/inward/citedby.url?scp=1642363399&partnerID=8YFLogxK
M3 - Article
C2 - 10495794
AN - SCOPUS:1642363399
VL - 8
SP - 638
EP - 646
JO - Journal of the American Society of Nephrology : JASN
JF - Journal of the American Society of Nephrology : JASN
SN - 1046-6673
IS - 4
ER -