title: Long-term results of a randomized study comparing three immunosuppressive schedules with cyclosporine in cadaveric kidney transplantation.
abstract: In this randomized controlled trial started in October 1990, 354 cadaveric kidney transplant recipients were assigned to receive either cyclosporine (CsA) monotherapy (115 patients), CsA + steroids (117 patients), or CsA + steroids + azathioprine (122 patients). The median follow-up was 85.1 mo. Thirty-one deaths occurred (infection, 12; cardiovascular disease, 11; neoplasia, 4; and others, 4), and 65 grafts were lost, mostly due to acute (15) or chronic rejection (50). The cumulative graft half-life was 18.1 yr. According to the "intention-to-treat," the 9-yr actuarial patient and graft survival were 94.0% and 73.3%, respectively, in monotherapy, 87.3% and 65.9% in dual therapy, and 87% and 72.2% in triple therapy (P = 0.647). At the last follow-up, the percentage of patients who remained with the original treatment was 51.2% in monotherapy, 81.7% in dual therapy, and 63.3% in triple therapy. At the seventh year, the mean creatinine clearances were 54.9 +/- 17.6 ml/min in monotherapy, 57.9 +/- 23.4 in dual therapy, and 60.6 +/- 20.7 in triple therapy (P = 0.375). Cataracts (P = 0.000), osteoporosis (P = 0.000), and cardiovascular complications (P = 0.000) were more frequent in dual or triple therapy than in monotherapy. Actuarial graft survival at 9 yr in patients on monotherapy who had to have steroids added was similar to that of the other two groups (62.2% versus 69.3%, P = 0.134). In conclusion, actuarial patient and graft survivals did not differ among the three schemes. The long-term renal function and survival were not affected in the patients on monotherapy who needed the addition of steroids. Monotherapy was associated with a lower incidence of extrarenal complications than the other two regimens.
authors.affiliation: Divisione di Nefrologia e Dialisi IRCCS Ospedale Maggiore, Milan, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Montagnino
authors.affiliation: Divisione di Nefrologia e Dialisi IRCCS Ospedale Maggiore, Milan, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Tarantino
authors.affiliation: Divisione di Nefrologia e Dialisi, A.O.S. Giovanni Battista, Turin, Italy.
authors.forename: Giuseppe P
authors.initials: GP
authors.lastname: Segoloni
authors.affiliation: Cattedra di Nefrologia Università di Parma, Parma, Italy.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Cambi
authors.affiliation: U.O. Nefrologia e Trapianti, Ospedale S. Chiara, Pisa, Italy.
authors.forename: Gaetano
authors.initials: G
authors.lastname: Rizzo
authors.affiliation: Divisione di Nefrologia e Dialisi, Ospedale Brotzu, Cagliari, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Altieri
authors.affiliation: Cattedra di Chirurgia Sostitutiva e del Trapianto d'Organo, Università Cattolica, Rome, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Castagneto
authors.affiliation: Divisione di Nefrologia e Dialisi, Policlinico Careggi, Firenze, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Salvadori
authors.affiliation: Divisione di Nefrologia e Dialisi, Ospedale Civile, Sassari, Italy.
authors.forename: Maria
authors.initials: M
authors.lastname: Cossu
authors.affiliation: Università di "Tor Vergata" and Divisione di Clinica Chirurgica, Ospedale S. Eugenio, Rome (FP), Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Pisani
authors.affiliation: Istituto di Scienze Chirurgiche, Università di Siena, Siena, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Carmellini
authors.affiliation: Divisione di Nefrologia e Dialisi, Ospedale Fazzi, Lecce, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Mastrangelo
authors.affiliation: Novartis Farma SpA, Origgio, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Ferrara
authors.affiliation: Divisione di Nefrologia e Dialisi IRCCS Ospedale Maggiore, Milan, Italy.
authors.forename: Claudio
authors.initials: C
authors.lastname: Ponticelli
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001379:Azathioprine / Q000009:adverse effects / Q000627:therapeutic use; D002102:Cadaver; D003401:Creatine / Q000378:metabolism; D016572:Cyclosporine / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D006084:Graft Rejection; D006085:Graft Survival; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016030:Kidney Transplantation / Q000401:mortality; D008137:Longitudinal Studies; D008875:Middle Aged; D013256:Steroids / Q000009:adverse effects / Q000627:therapeutic use; D016019:Survival Analysis; D013997:Time Factors
chemical_list: D007166:Immunosuppressive Agents; D013256:Steroids; D016572:Cyclosporine; D001379:Azathioprine; D003401:Creatine