Tolerability of enteric-coated mycophenolate sodium to 1 year in combination with cyclosporine and corticosteroids in renal transplant recipients.
Enteric-coated mycophenolate sodium (EC-MPS) is therapeutically equivalent to mycophenolate mofetil, but delays release of mycophenolic acid until it reaches the small intestine. De novo renal transplant patients taking part in a 12-month, multicenter, randomized study received cyclosporine microemulsion (CsA-ME, early or delayed to day 6), EC-MPS, steroids, and interleukin-2 antagonist induction. Tolerability data relating to EC-MPS are reported. Ninety-seven patients were randomized to early CsA-ME and 100 patients to delayed CsA-ME. Median daily dose of EC-MPS was 1440 mg at all time points throughout the 12-month period. The most frequently reported adverse events were constipation, anemia, urinary tract infection, abdominal pain, leukopenia, and cytomegalovirus infection; there were four malignancies. Fifty patients (24.6%) discontinued EC-MPS prematurely by 12 months, including 42 patients (84%) who discontinued owing to adverse events. No patient discontinued treatment because of gastrointestinal adverse events. Two-thirds of patients (137 [67.5%]) maintained full EC-MPS dose throughout the 12-month study and did not require any dose reduction or dose interruption. EC-MPS is well tolerated in de novo renal transplant recipients when administered in combination with CsA-ME and steroids, with low rates of dose reductions or interruptions. Gastrointestinal adverse events were responsible for dose reduction or interruption in only 5% of patients.
Rostaing
L
L
Department of Nephrology-Transplantation, Hôpital Rangueil, Toulouse, France.
Mourad
G
G
Kamar
N
N
Garrigue
V
V
Karras
A
A
Lefrançois
N
N
Charpentier
B
B
Bourbigot
B
B
Pouteil-Noble
C
C
Bayle
F
F
Lebranchu
Y
Y
Berthoux
F
F
Le Meur
Y
Y
Kessler
M
M
Moulin
B
B
Ducloux
D
D
Delahousse
M
M
Lang
P
P
Merville
P
P
Chaouche-Teyara
K
K
Legendre
C
C
D000305:Adrenal Cortex Hormones / Q000627:therapeutic use*; D000328:Adult; D016572:Cyclosporine / Q000008:administration & dosage / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D004361:Drug Tolerance; D004655:Emulsions; D005260:Female; D006650:Histocompatibility Testing; D006801:Humans; D007518:Isoantibodies / Q000097:blood; D007674:Kidney Diseases / Q000145:classification / Q000601:surgery; D016030:Kidney Transplantation / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000627:therapeutic use*; D013608:Tablets, Enteric-Coated; D014019:Tissue Donors / Q000706:statistics & numerical data
D000305:Adrenal Cortex Hormones; D004655:Emulsions; D007518:Isoantibodies; D013608:Tablets, Enteric-Coated; D016572:Cyclosporine; D009173:Mycophenolic Acid