Title of article
Comparison of high and low dose of cyclophosphamide in lupus nephritis patients: a long-term randomized controlled trial
Author/Authors
Mitwalli, Ahmed H. King Saud University - King Khalid University Hospital - Department of Medicine, Saudi Arabia , Al Wakeel, Jamal S. King Saud University - King Khalid University Hospital - Department of Medicine, Saudi Arabia , Hurraib, Sameer King Saud University - King Khalid University Hospital - Department of Medicine, Saudi Arabia , Abu Aisha King Saud University - King Khalid University Hospital - Department of Medicine, Saudi Arabia , Al Suwaida, Abdulkaraem King Saud University - King Khalid University Hospital - Department of Medicine, Saudi Arabia , Alam, Awatif King Saud University - King Khalid University Hospital - Department of Family and Community Medicine, Saudi Arabia , Hammad, Durdana King Saud University - King Khalid University Hospital - Department of Medicine, Saudi Arabia , Sulimani, Fathia King Saud University - King Khalid University Hospital - Department of Medicine, Saudi Arabia , Memon, Nawaz A. King Saud University - King Khalid University Hospital - Department of Medicine, Saudi Arabia , Askar, Akram King Saud University - King Khalid University Hospital - Department of Medicine, Saudi Arabia , Al Tuwaijri, Ali King Saud University - King Khalid University Hospital - Department of Physiology, Saudi Arabia , Qudsi, Abdo King Saud University - King Khalid University Hospital - Department of Medicine, Saudi Arabia
From page
935
To page
940
Abstract
To evaluate the outcome of low doses of cyclophosphamide (Cyclo) therapy in lupus nephritis (LN) patients,we studied 117 biopsy-proven,de novo LN WHO class IV patients double-blinded and randomized in December 1997 to receive Cyclo in different doses; Group I (n=73) received Cyclo 10 mg/kg monthly for six months then every two months for 12 months. Group II (n=44) received Cyclo 5 mg/kg monthly for six months then every two months for 36 months. The patients were followed-up till January 2007. Six months post-induction values for creatinine clearance were significantly higher in Group I (67.7 ± 28.6 mL/min) compared with Group II (55.1 ± 30.1 mL/min),P = 0.026. Serum C4 and ANA were not significantly different between the groups (P 0.05). At the mean follow-up of 6.77 ± 3.3 years,the mean creatinine clearance was 44.74 ± 31.7 mL/min in Group I vs. 49.3 ± 38.8 in Group II. Urinary protein was 1.65 ± 1.8 g/dL in Group I vs. 1.02 ± 1.01 in Group II (P = 0.03). The survival curve showed that kidney survival overtime was comparable in both groups (P = 0.2). Complete remission was observed in 25 (34.2%) patients in Group I vs. 11 (25%) in Group II (P = 0.288),while partial remission was similar in both groups; 43 (58.9%) patients in Group I vs. 26 (59%) patients in Group II. End-stage renal disease was observed in 10 (13.7%) patients in Group I vs. 9 (20.4%) patients in Group II (P = 0.359). Side-effects were more frequent in Group I patients than in Group II patients; gonadal toxicity and malignancy were lower in Group II patients (P = 0.0000). Moreover,different infections occurred in 23 (31.3%) patients vs. six (13.6%),digital infarcts occurred in 1.35% vs. 0%,diabetes in 4.1% vs. 2.27%,and vasculitis in 4.1% vs. 2.27% in Group I vs. Group II,respectively. Sustained amenorrhea without pregnancy was observed in both groups; however,significantly more in Group I patients,P ≤ 0.05. We conclude that low-dose Cyclo therapy is sufficiently effective for WHO class IV LN patients with lower side-effects compared with standard dose.
Journal title
Saudi Journal of Kidney Diseases and Transplantation
Journal title
Saudi Journal of Kidney Diseases and Transplantation
Record number
2675459
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