BIOMAT Database Logo BIOMAT Database Logo

The safety and tolerability of cyclosporine emulsion versus cyclosporine in a randomized, double-blind comparison in primary renal allograft recipients. The Neoral Study Group. 1996

G Barone, and C M Bunke, and M G Choc, and D E Hricik, and J H Jin, and J B Klein, and C L Marsh, and D I Min, and M D Pescovitz, and R Pollak, and T L Pruett, and J B Stinson, and J S Thompson, and E Vasquez, and T Waid, and D G Wombolt, and R L Wong
The Department of Vascular and Tranplant Surgery, University of Arkansas, Little Rock, USA.

A 12-week, randomized, double-blind, multicenter pharmacokinetics study was conducted to compare the clinical safety and tolerability of cyclosporine capsules and oral solution for microemulsion and cyclosporine in 101 primary renal transplant recipients Cyclosporine emulsion has more complete absorption and improved bioavailability compared with cyclosporine, and dosing of both cyclosporine formulations was adjusted to achieve comparable whole-blood trough levels. Mean serum creatinine values were higher in the cyclosporine emulsion group at baseline, 8, and 12 weeks (P<0.05). The incidence of acute rejection was similar in both treatment groups although fewer patients required monoclonal antibody therapy in the cyclosporine group (31% vs. 82%, respectively). Despite the increased bioavailability of cyclosporine emulsion, no significant differences in the incidence of adverse events were observed; the safety, tolerability, and efficacy of cyclosporine emulsion and cyclosporine were comparable.

UI MeSH Term Description Entries
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D002214 Capsules Hard or soft soluble containers used for the oral administration of medicine. Capsule,Microcapsule,Microcapsules
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D004655 Emulsions Colloids formed by the combination of two immiscible liquids such as oil and water. Lipid-in-water emulsions are usually liquid, like milk or lotion. Water-in-lipid emulsions tend to be creams. The formation of emulsions may be aided by amphiphatic molecules that surround one component of the system to form MICELLES. Emulsion
D005260 Female Females
D006085 Graft Survival The survival of a graft in a host, the factors responsible for the survival and the changes occurring within the graft during growth in the host. Graft Survivals,Survival, Graft,Survivals, Graft
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000284 Administration, Oral The giving of drugs, chemicals, or other substances by mouth. Drug Administration, Oral,Administration, Oral Drug,Oral Administration,Oral Drug Administration,Administrations, Oral,Administrations, Oral Drug,Drug Administrations, Oral,Oral Administrations,Oral Drug Administrations
D000293 Adolescent A person 13 to 18 years of age. Adolescence,Youth,Adolescents,Adolescents, Female,Adolescents, Male,Teenagers,Teens,Adolescent, Female,Adolescent, Male,Female Adolescent,Female Adolescents,Male Adolescent,Male Adolescents,Teen,Teenager,Youths

Related Publications

G Barone, and C M Bunke, and M G Choc, and D E Hricik, and J H Jin, and J B Klein, and C L Marsh, and D I Min, and M D Pescovitz, and R Pollak, and T L Pruett, and J B Stinson, and J S Thompson, and E Vasquez, and T Waid, and D G Wombolt, and R L Wong
Safety and tolerability of cyclosporine microemulsion versus cyclosporine: two-year data in primary renal allograft recipients: a report of the Neoral Study Group.
March 1997, Transplantation,
G Barone, and C M Bunke, and M G Choc, and D E Hricik, and J H Jin, and J B Klein, and C L Marsh, and D I Min, and M D Pescovitz, and R Pollak, and T L Pruett, and J B Stinson, and J S Thompson, and E Vasquez, and T Waid, and D G Wombolt, and R L Wong
Randomized, double-blind, one-year study of the safety and tolerability of cyclosporine microemulsion compared with conventional cyclosporine in renal transplant patients. International Sandimmun Neoral Study Group.
June 1998, Transplantation,
G Barone, and C M Bunke, and M G Choc, and D E Hricik, and J H Jin, and J B Klein, and C L Marsh, and D I Min, and M D Pescovitz, and R Pollak, and T L Pruett, and J B Stinson, and J S Thompson, and E Vasquez, and T Waid, and D G Wombolt, and R L Wong
The pharmacokinetics of a microemulsion formulation of cyclosporine in primary renal allograft recipients. The Neoral Study Group.
March 1996, Transplantation,
G Barone, and C M Bunke, and M G Choc, and D E Hricik, and J H Jin, and J B Klein, and C L Marsh, and D I Min, and M D Pescovitz, and R Pollak, and T L Pruett, and J B Stinson, and J S Thompson, and E Vasquez, and T Waid, and D G Wombolt, and R L Wong
A double-blind randomized study of Sandimmun Neoral versus Sandimmun in new renal transplant recipients: results after 12 months. The International Sandimmun Neoral Study Group.
April 1995, Transplantation proceedings,
G Barone, and C M Bunke, and M G Choc, and D E Hricik, and J H Jin, and J B Klein, and C L Marsh, and D I Min, and M D Pescovitz, and R Pollak, and T L Pruett, and J B Stinson, and J S Thompson, and E Vasquez, and T Waid, and D G Wombolt, and R L Wong
A randomized, controlled, double-blind study of the safety and tolerability of Sandimmun Neoral in stable renal transplant patients. Argentine Multicentre Study Group.
December 1996, Transplantation proceedings,
G Barone, and C M Bunke, and M G Choc, and D E Hricik, and J H Jin, and J B Klein, and C L Marsh, and D I Min, and M D Pescovitz, and R Pollak, and T L Pruett, and J B Stinson, and J S Thompson, and E Vasquez, and T Waid, and D G Wombolt, and R L Wong
Safety and tolerability of cyclosporine and cyclosporine microemulsion during 18 months of follow-up in stable renal transplant recipients: a report of the Canadian Neoral Renal Study Group.
February 1998, Transplantation,
G Barone, and C M Bunke, and M G Choc, and D E Hricik, and J H Jin, and J B Klein, and C L Marsh, and D I Min, and M D Pescovitz, and R Pollak, and T L Pruett, and J B Stinson, and J S Thompson, and E Vasquez, and T Waid, and D G Wombolt, and R L Wong
A randomized, open-label study of sirolimus versus cyclosporine in primary de novo renal allograft recipients.
May 2013, Transplantation,
G Barone, and C M Bunke, and M G Choc, and D E Hricik, and J H Jin, and J B Klein, and C L Marsh, and D I Min, and M D Pescovitz, and R Pollak, and T L Pruett, and J B Stinson, and J S Thompson, and E Vasquez, and T Waid, and D G Wombolt, and R L Wong
Randomized double-blind study of standard versus low-dose OKT3 induction therapy in renal allograft recipients.
July 1993, American journal of kidney diseases : the official journal of the National Kidney Foundation,
G Barone, and C M Bunke, and M G Choc, and D E Hricik, and J H Jin, and J B Klein, and C L Marsh, and D I Min, and M D Pescovitz, and R Pollak, and T L Pruett, and J B Stinson, and J S Thompson, and E Vasquez, and T Waid, and D G Wombolt, and R L Wong
Renal function in primary liver transplant recipients receiving neoral (cyclosporine) versus prograf (tacrolimus).
June 1998, Transplantation proceedings,
G Barone, and C M Bunke, and M G Choc, and D E Hricik, and J H Jin, and J B Klein, and C L Marsh, and D I Min, and M D Pescovitz, and R Pollak, and T L Pruett, and J B Stinson, and J S Thompson, and E Vasquez, and T Waid, and D G Wombolt, and R L Wong
Cyclosporine bioavailability of Neoral and Sandimmune in white and black de novo renal transplant recipients. Neoral Study Group.
December 1999, Therapeutic drug monitoring,
Copied contents to your clipboard!