Contrast between innovator drug- and generic drug-induced renal dysfunction on coronary angiography (CONTRAST study).
Contrast-induced nephropathy (CIN) has gained increasing attention in clinical practice, particularly during coronary angiography (CAG). However, some "bioequivalent" generic (GE) drugs are less effective than the innovator (IN) drug. Therefore, the aim of this study was to compare contrast media (IN drug)-induced renal dysfunction with contrast media (GE drug)-induced dysfunction. We enrolled 44 patients who underwent elective CAG or percutaneous coronary intervention (PCI) and randomly divided them into two groups that received contrast media (Iohexol, nonionic and low-osmolality contrast agent) containing either IN drug (Omnipaque) or GE drug (Iopaque). Blood and urine sampling were performed before and after (24 and 48 h) CAG or PCI. Biochemical parameters in blood (serum creatinine, cystatin C, high-sensitivity C-reactive protein, and pentraxin-3) and urine (urinary albumin/Cr and liver-type fatty acid binding protein/Cr) were measured. There were no significant differences in the biochemical parameters at baseline between the groups. In addition, there were no differences in changes in biochemical parameters in blood and urine before and after CAG or PCI between the groups, although one patient in the GE group had CIN. The degree of contrast in Iopaque-induced renal dysfunction was comparable with that in Omnipaque-induced dysfunction.
Department of Cardiology, Fukuoka University School of Medicine, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan.
Ayumi
A
Nakamura
Shin-Ichiro
S
Miura
Makoto
M
Sugihara
Yuiko
Y
Miyase
Kenji
K
Norimatsu
Yuhei
Y
Shiga
Hiroaki
H
Nishikawa
Keijiro
K
Saku
D000368:Aged; D000419:Albuminuria / Q000139:chemically induced; D015415:Biomarkers / Q000097:blood / Q000652:urine; D002097:C-Reactive Protein / Q000378:metabolism; D003287:Contrast Media / Q000009:adverse effects*; D017023:Coronary Angiography / Q000009:adverse effects*; D003404:Creatinine / Q000097:blood / Q000652:urine; D055316:Cystatin C / Q000097:blood; D016568:Drugs, Generic / Q000009:adverse effects*; D050556:Fatty Acid-Binding Proteins / Q000652:urine; D005260:Female; D006801:Humans; D007472:Iohexol / Q000009:adverse effects*; D007564:Japan; D007674:Kidney Diseases / Q000139:chemically induced* / Q000175:diagnosis / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects*; D011446:Prospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D000683:Serum Amyloid P-Component / Q000378:metabolism; D013997:Time Factors; D000099153:Pentraxins
D015415:Biomarkers; D002097:C-Reactive Protein; D003287:Contrast Media; D003404:Creatinine; D055316:Cystatin C; D016568:Drugs, Generic; D050556:Fatty Acid-Binding Proteins; D007472:Iohexol; D000683:Serum Amyloid P-Component; D000099153:Pentraxins; C525030:CST3 protein, human; C493319:FABP1 protein, human