BACKGROUND: Recently, sirolimus (SRL) was introduced as an immunosuppressant in solid-organ transplantation. This study evaluated combinations of SRL and tacrolimus (Tac). METHODS: This 6-month study investigated the safety and efficacy of Tac and steroids in combination with three different doses of SRL in renal-transplant recipients. A total of 104 patients were randomized in four groups: one group received Tac and steroids (control n=28), and three groups also received the following daily SRL doses: 0.5 mg (TacSRL0.5, n=25), 1 mg (TacSRL1, n=25), or 2 mg (TacSRL2, n=26). Tac doses were adjusted to whole-blood trough levels. Steroids were tapered from 20 mg per day to 5 mg per day. The SRL groups underwent a second randomization to discontinue SRL at either month 3 or 5. RESULTS: At month 6, patient survival rates were 100%, 100%, 96.0%, and 100%, and graft survival rates were 96.4%, 84.0%, 88.0%, and 84.6%, respectively. The overall safety profile was similar in all groups. The incidences of infections during months 1 to 3 were similar in all groups (control 46.4%, TacSRL0.5 32.0%, TacSRL1 56.0%, TacSRL2 46.2%). The 3-month incidences of hypercholesteremia (cholesterol >240 mg/dL or low-density lipoprotein cholesterol >160 mg/dL) were 21.4%, 36.0%, 48.0%, and 50.0% (P=0.019). Lipid levels improved after withdrawal of SRL. The 3-month incidences of biopsy-proven acute rejection were 28.6% (control), 8.0% (TacSRL0.5), 8.0% (TacSRL1), and 3.8% (TacSRL2) (P=0.014). CONCLUSION: Tac in combination with low doses of SRL provides a very effective and safe regimen.
RCT Entities:
BACKGROUND: Recently, sirolimus (SRL) was introduced as an immunosuppressant in solid-organ transplantation. This study evaluated combinations of SRL and tacrolimus (Tac). METHODS: This 6-month study investigated the safety and efficacy of Tac and steroids in combination with three different doses of SRL in renal-transplant recipients. A total of 104 patients were randomized in four groups: one group received Tac and steroids (control n=28), and three groups also received the following daily SRL doses: 0.5 mg (TacSRL0.5, n=25), 1 mg (TacSRL1, n=25), or 2 mg (TacSRL2, n=26). Tac doses were adjusted to whole-blood trough levels. Steroids were tapered from 20 mg per day to 5 mg per day. The SRL groups underwent a second randomization to discontinue SRL at either month 3 or 5. RESULTS: At month 6, patient survival rates were 100%, 100%, 96.0%, and 100%, and graft survival rates were 96.4%, 84.0%, 88.0%, and 84.6%, respectively. The overall safety profile was similar in all groups. The incidences of infections during months 1 to 3 were similar in all groups (control 46.4%, TacSRL0.5 32.0%, TacSRL1 56.0%, TacSRL2 46.2%). The 3-month incidences of hypercholesteremia (cholesterol >240 mg/dL or low-density lipoprotein cholesterol >160 mg/dL) were 21.4%, 36.0%, 48.0%, and 50.0% (P=0.019). Lipid levels improved after withdrawal of SRL. The 3-month incidences of biopsy-proven acute rejection were 28.6% (control), 8.0% (TacSRL0.5), 8.0% (TacSRL1), and 3.8% (TacSRL2) (P=0.014). CONCLUSION: Tac in combination with low doses of SRL provides a very effective and safe regimen.
Authors: Eveline Van Gurp; Jesus Bustamante; Antonio Franco; Lionel Rostaing; Thomas Becker; Eric Rondeau; Zenon Czajkowski; Andrzej Rydzewski; Antonio Alarcon; Petr Bachleda; Jiri Samlik; Dirk Burmeister; Luis Pallardo; Marie-Christine Moal; Boleslaw Rutkowski; Zbigniew Wlodarczyk Journal: J Transplant Date: 2010-10-05
Authors: Deirdre Hahn; Elisabeth M Hodson; Lorraine A Hamiwka; Vincent Ws Lee; Jeremy R Chapman; Jonathan C Craig; Angela C Webster Journal: Cochrane Database Syst Rev Date: 2019-12-16
Authors: Juhan Lee; Jung Jun Lee; Beom Seok Kim; Jae Geun Lee; Kyu Ha Huh; Yongjung Park; Yu Seun Kim Journal: J Korean Med Sci Date: 2015-05-13 Impact factor: 2.153