Cyclosporine microemulsion formulation (sigmasporin microral) effect as first-line immunosuppressant on renal functions at 3 years.
BACKGROUND
Cyclosporine (CsA) remains a mainstay of immunosuppressive maintenance regimens in developing countries, but its effects on long-term kidney allograft survival are still unclear. Our aim was to assess a generic microemulsion CsA (Sigmasporin) for long-term impact on graft function and patient survival among stable renal transplant patients.


METHODS
Over a 36-month period, patients with transplantations from >6 months earlier were maintained on CsA doses of 2-8 mg/kg/d to keep C(2) within the recommended therapeutic range. We assessed 25 efficacy and tolerability parameters of scheduled intervals.


RESULTS
Twenty-seven patients (9 female, 18 male) from 6 centers in 4 Middle-Eastern countries were enrolled between 2004 and 2009. Their average age was 35.1 ± 9.8 years, body mass index ranged from 15.7 to 41.2 kg/m(2), and average time from transplantation was 2.2 ± 1.6 years. Within the 36-month observation period the CsA dose was reduced by 17.3% from 2.89 ± 0.88 mg/kg/d to achieve C(2) levels of 600-1000 ng/mL. After 36 months the glomerular filtration rate declined by 8.2% from an overall baseline mean of 72.7 ± 23.5 mL/min/1.73 m(2). It improved in 11.1% of patients and remained unchanged in 44.4%. No new cases of hypertension or diabetes mellitus were reported, and there was 1 case of borderline hyperlipidemia. Graft functions were stable, apart from 2 incidences of CsA nephrotoxicity. Both graft and patient 3-year survival rates were 100%.


CONCLUSIONS
On a 3-year basis, Sigmasporin Microral was effective to maintain stable renal functions in kidney transplant patients, with safety and tolerability profiles similar to those reported in the international literature.
King Saud University, Riyadh, Saudi Arabia.
J
J
Al Wakeel
F A M
FA
Shaheen
A
A
Al Alfi
E H
EH
Abbas Fagir
A
A
Iman
M R N
MR
Nampoory
M S A
MS
Al Mousawi
T
T
Said
H
H
Abou Zeinab
D S
DS
Shaker
B B
BB
Ghaedi
D000328:Adult; D002626:Chemistry, Pharmaceutical; D016572:Cyclosporine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016568:Drugs, Generic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004655:Emulsions; D005260:Female; D006084:Graft Rejection / Q000276:immunology / Q000517:prevention & control; D006085:Graft Survival / Q000187:drug effects; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007668:Kidney / Q000187:drug effects* / Q000503:physiopathology / Q000601:surgery*; D007674:Kidney Diseases / Q000139:chemically induced; D016030:Kidney Transplantation / Q000276:immunology; D008297:Male; D008875:Middle Aged; D008877:Middle East; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
D016568:Drugs, Generic; D004655:Emulsions; D007166:Immunosuppressive Agents; D016572:Cyclosporine