Description of blood pressure changes in patients beginning cyclosporin A therapy.
Cyclosporin A (CyA) is the primary immunosuppressive agent for the prophylaxis of rejection episodes in renal, cardiac, liver, and other transplants. Recently, its use in autoimmune diseases has been investigated as well. Although several studies have produced promising results, nephrotoxicity and hypertension can result from CyA treatment, and their development must be understood in order to facilitate patient management. This article describes the diastolic blood pressure (DBP) responses in two populations of patients during three months of CyA therapy. Study A involved psoriasis patients and Study B involved postoperative renal transplant patients. The relationship between blood pressure and systemic CyA exposure and other covariates was evaluated using linear mixed effects modeling. Temporal patterns of blood pressure changes with varying duration of CyA exposure were investigated. In Study A, the psoriasis patients showed transient exposure-related increases in DBP on CyA. These elevations, while statistically significant, were clinically insignificant. In Study B, the renal transplant patients showed no CyA-related rises in DBP. In neither study was there evidence for a difference in effect on DBP between Sandimmune and Neoral, the two formulations of CyA presently approved for marketing by the Food and Drug Administration, after differences in CyA exposure were taken into account.
Charnick
S B
SB
Clinical Pharmacology/Drug Safety, Sandoz Research Institute, East Hanover, New Jersey 07936, USA.
Nedelman
J R
JR
Chang
C T
CT
Hwang
D S
DS
Jin
J
J
Moore
M A
MA
Wong
R
R
Meligeni
J
J
D000328:Adult; D000367:Age Factors; D001794:Blood Pressure / Q000187:drug effects*; D001835:Body Weight; D016572:Cyclosporine / Q000009:adverse effects* / Q000097:blood / Q000627:therapeutic use; D005260:Female; D006801:Humans; D006973:Hypertension / Q000139:chemically induced*; D007166:Immunosuppressive Agents / Q000009:adverse effects* / Q000097:blood / Q000627:therapeutic use; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000139:chemically induced; D011565:Psoriasis / Q000188:drug therapy
D007166:Immunosuppressive Agents; D016572:Cyclosporine