Skip to main content
Erschienen in: Heart and Vessels 5/2014

01.09.2014 | Original Article

Contrast between innovator drug- and generic drug-induced renal dysfunction on coronary angiography (CONTRAST study)

verfasst von: Ayumi Nakamura, Shin-ichiro Miura, Makoto Sugihara, Yuiko Miyase, Kenji Norimatsu, Yuhei Shiga, Hiroaki Nishikawa, Keijiro Saku

Erschienen in: Heart and Vessels | Ausgabe 5/2014

Einloggen, um Zugang zu erhalten

Abstract

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.
Literatur
1.
Zurück zum Zitat Briguori C, Airoldi F, D’Andrea D, Bonizzoni E, Morici N, Focaccio A, Michev I, Montorfano M, Carlino M, Cosgrave J, Ricciardelli B, Colombo A (2007) Renal insufficiency following contrast media administration trial (REMEDIAL): a randomized comparison of 3 preventive strategies. Circulation 115:1211–2117PubMed Briguori C, Airoldi F, D’Andrea D, Bonizzoni E, Morici N, Focaccio A, Michev I, Montorfano M, Carlino M, Cosgrave J, Ricciardelli B, Colombo A (2007) Renal insufficiency following contrast media administration trial (REMEDIAL): a randomized comparison of 3 preventive strategies. Circulation 115:1211–2117PubMed
2.
Zurück zum Zitat Briguori C, Visconti G, Rivera NV, Focaccio A, Golia B, Giannone R, Castaldo D, De Micco F, Ricciardelli B, Colombo A (2010) Cystatin C and contrast-induced acute kidney injury. Circulation 121:2117–2122PubMedCrossRef Briguori C, Visconti G, Rivera NV, Focaccio A, Golia B, Giannone R, Castaldo D, De Micco F, Ricciardelli B, Colombo A (2010) Cystatin C and contrast-induced acute kidney injury. Circulation 121:2117–2122PubMedCrossRef
3.
Zurück zum Zitat Briguori C, Visconti G, Focaccio A, Airoldi F, Valgimigli M, Sangiorgi GM, Golia B, Ricciardelli B, Condorelli G, REMEDIAL II Investigators (2011) Renal insufficiency after contrast media administration trial II (REMEDIAL II): Renal guard system in high-risk patients for contrast-induced acute kidney injury. Circulation 124:1260–1269PubMedCrossRef Briguori C, Visconti G, Focaccio A, Airoldi F, Valgimigli M, Sangiorgi GM, Golia B, Ricciardelli B, Condorelli G, REMEDIAL II Investigators (2011) Renal insufficiency after contrast media administration trial II (REMEDIAL II): Renal guard system in high-risk patients for contrast-induced acute kidney injury. Circulation 124:1260–1269PubMedCrossRef
4.
Zurück zum Zitat Hamasaki S, Tei C (2011) Effect of coronary endothelial function on outcomes in patients undergoing percutaneous coronary intervention. J Cardiol 57:231–238PubMedCrossRef Hamasaki S, Tei C (2011) Effect of coronary endothelial function on outcomes in patients undergoing percutaneous coronary intervention. J Cardiol 57:231–238PubMedCrossRef
5.
Zurück zum Zitat Buja P, Lanzellotti D, Isabella G, Napodano M, Panfili M, Favaretto E, Iliceto S, Tarantini G (2012) Comparison between sirolimus- and paclitaxel-eluting stents for the treatment of older patients affected by coronary artery disease: results from a single-center allcomers registry. Heart Vessels 27:553–558PubMedCrossRef Buja P, Lanzellotti D, Isabella G, Napodano M, Panfili M, Favaretto E, Iliceto S, Tarantini G (2012) Comparison between sirolimus- and paclitaxel-eluting stents for the treatment of older patients affected by coronary artery disease: results from a single-center allcomers registry. Heart Vessels 27:553–558PubMedCrossRef
6.
Zurück zum Zitat Song YB, Lee SY, Hahn JY, Choi SH, Choi JH, Lee SH, Hong KP, Park JE, Gwon HC (2012) Complete versus incomplete revascularization for treatment of multivessel coronary artery disease in the drug-eluting stent era. Heart Vessels 27:433–442PubMedCrossRef Song YB, Lee SY, Hahn JY, Choi SH, Choi JH, Lee SH, Hong KP, Park JE, Gwon HC (2012) Complete versus incomplete revascularization for treatment of multivessel coronary artery disease in the drug-eluting stent era. Heart Vessels 27:433–442PubMedCrossRef
7.
Zurück zum Zitat Persson PB, Hansell P, Liss P (2005) Pathophysiology of contrast medium-induced nephropathy. Kidney Int 68:14–22PubMedCrossRef Persson PB, Hansell P, Liss P (2005) Pathophysiology of contrast medium-induced nephropathy. Kidney Int 68:14–22PubMedCrossRef
8.
Zurück zum Zitat Murphy SW, Barrett BJ, Parfrey PS (2000) Contrast nephropathy. J Am Soc Nephrol 11:177–178PubMed Murphy SW, Barrett BJ, Parfrey PS (2000) Contrast nephropathy. J Am Soc Nephrol 11:177–178PubMed
9.
Zurück zum Zitat McCullough PA, Wolyn R, Rocher LL, Levin RN, O’Neill WW (1997) Acute renal failure after coronary intervention: incidence, risk factors, and relationship to mortality. Am J Med 103:368–375PubMedCrossRef McCullough PA, Wolyn R, Rocher LL, Levin RN, O’Neill WW (1997) Acute renal failure after coronary intervention: incidence, risk factors, and relationship to mortality. Am J Med 103:368–375PubMedCrossRef
10.
Zurück zum Zitat Maeder M, Klein M, Fehr T, Rickli H (2004) Contrast nephropathy: review focusing on prevention. J Am Coll Cardiol 44:1763–1771PubMedCrossRef Maeder M, Klein M, Fehr T, Rickli H (2004) Contrast nephropathy: review focusing on prevention. J Am Coll Cardiol 44:1763–1771PubMedCrossRef
11.
Zurück zum Zitat Goldenberg I, Matetzky S (2005) Nephropathy induced by contrast media: pathogenesis, risk factors and preventive strategies. CMAJ 172:1461–1471PubMedCrossRefPubMedCentral Goldenberg I, Matetzky S (2005) Nephropathy induced by contrast media: pathogenesis, risk factors and preventive strategies. CMAJ 172:1461–1471PubMedCrossRefPubMedCentral
12.
Zurück zum Zitat Gruberg L, Mehran R, Dangas G, Mintz GS, Waksman R, Kent KM, Pichard AD, Satler LF, Wu H, Leon MB (2001) Acute renal failure requiring dialysis after percutaneous coronary interventions. Cathet Cardiovasc Intervent 52:409–416CrossRef Gruberg L, Mehran R, Dangas G, Mintz GS, Waksman R, Kent KM, Pichard AD, Satler LF, Wu H, Leon MB (2001) Acute renal failure requiring dialysis after percutaneous coronary interventions. Cathet Cardiovasc Intervent 52:409–416CrossRef
13.
Zurück zum Zitat Dunne S, Shannon B, Dunne C, Cullen W (2013) A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study. BMC Pharmacol Toxicol 14:1PubMedCrossRefPubMedCentral Dunne S, Shannon B, Dunne C, Cullen W (2013) A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study. BMC Pharmacol Toxicol 14:1PubMedCrossRefPubMedCentral
14.
Zurück zum Zitat Vesga O, Agudelo M, Salazar BE, Rodriguez CA, Zuluaga AF (2010) Generic vancomycin products fail in vivo despite being pharmaceutical equivalents of the innovator. Antimicrob Agents Chemother 54:3271–3279PubMedCrossRefPubMedCentral Vesga O, Agudelo M, Salazar BE, Rodriguez CA, Zuluaga AF (2010) Generic vancomycin products fail in vivo despite being pharmaceutical equivalents of the innovator. Antimicrob Agents Chemother 54:3271–3279PubMedCrossRefPubMedCentral
15.
Zurück zum Zitat Oike T, Ohno T, Noda SE, Sato H, Tamaki T, Kiyohara H, Ando K, Nakano T (2012) Comparison of hematological toxicities between innovator and generic cisplatin formulations in cervical cancer patients treated with concurrent chemoradiotherapy. J Radiat Res. doi:10.1093/jrr/rrs121 PubMedPubMedCentral Oike T, Ohno T, Noda SE, Sato H, Tamaki T, Kiyohara H, Ando K, Nakano T (2012) Comparison of hematological toxicities between innovator and generic cisplatin formulations in cervical cancer patients treated with concurrent chemoradiotherapy. J Radiat Res. doi:10.​1093/​jrr/​rrs121 PubMedPubMedCentral
16.
Zurück zum Zitat Newman DJ, Thakkar H, Edwards RG, Wilkie M, White T, Grubb AO, Price CP (1995) Serum cystatin C measured by automated immunoassay: a more sensitive marker of changes in GFR than serum creatinine. Kidney Int 47:312–318PubMedCrossRef Newman DJ, Thakkar H, Edwards RG, Wilkie M, White T, Grubb AO, Price CP (1995) Serum cystatin C measured by automated immunoassay: a more sensitive marker of changes in GFR than serum creatinine. Kidney Int 47:312–318PubMedCrossRef
17.
Zurück zum Zitat Dharnidharka VR, Kwon C, Stevens G (2002) Serum cystatin C is superior to serum creatinine as a marker of kidney function: a meta-analysis. Am J Kidney Dis 40:221–226PubMedCrossRef Dharnidharka VR, Kwon C, Stevens G (2002) Serum cystatin C is superior to serum creatinine as a marker of kidney function: a meta-analysis. Am J Kidney Dis 40:221–226PubMedCrossRef
18.
Zurück zum Zitat Liu XL, Wang ZJ, Yang Q, Yu M, Shen H, Nie B, Han HY, Gao F, Zhou YJ (2012) Plasma neutrophil-gelatinase-associated lipocalin and cystatin C could early diagnose contrast-induced acute kidney injury in patients with renal insufficiency undergoing an elective percutaneous coronary intervention. Chin Med J 125:1051–1056PubMed Liu XL, Wang ZJ, Yang Q, Yu M, Shen H, Nie B, Han HY, Gao F, Zhou YJ (2012) Plasma neutrophil-gelatinase-associated lipocalin and cystatin C could early diagnose contrast-induced acute kidney injury in patients with renal insufficiency undergoing an elective percutaneous coronary intervention. Chin Med J 125:1051–1056PubMed
19.
Zurück zum Zitat Ramsammy LS, Josepovitz C, Lane BP, Kaloyanides GJ (1989) Polyaspartic acid protects against gentamicin nephrotoxicity in the rat. J Pharmacol Exp Ther 250:149–153PubMed Ramsammy LS, Josepovitz C, Lane BP, Kaloyanides GJ (1989) Polyaspartic acid protects against gentamicin nephrotoxicity in the rat. J Pharmacol Exp Ther 250:149–153PubMed
20.
Zurück zum Zitat Kamijo A, Sugaya T, Hikawa A, Okada M, Okumura F, Yamanouchi M, Honda A, Okabe M, Fujino T, Hirata Y, Omata M, Kaneko R, Fujii H, Fukamizu A, Kimura K (2004) Urinary excretion of fatty acid-binding protein reflects stress overload on the proximal tubules. Am J Pathol 165:1243–1255PubMedCrossRefPubMedCentral Kamijo A, Sugaya T, Hikawa A, Okada M, Okumura F, Yamanouchi M, Honda A, Okabe M, Fujino T, Hirata Y, Omata M, Kaneko R, Fujii H, Fukamizu A, Kimura K (2004) Urinary excretion of fatty acid-binding protein reflects stress overload on the proximal tubules. Am J Pathol 165:1243–1255PubMedCrossRefPubMedCentral
21.
Zurück zum Zitat Katoh H, Nozue T, Kimura Y, Nakata S, Iwaki T, Kawano M, Kawashiri MA, Michishita I, Yamagishi M (2013) Elevation of urinary liver-type fatty acid-binding protein as predicting factor for occurrence of contrast-induced acute kidney injury and its reduction by hemodiafiltration with blood suction from right atrium. Heart Vessels. doi:10.1007/s00380-013-0347-9 Katoh H, Nozue T, Kimura Y, Nakata S, Iwaki T, Kawano M, Kawashiri MA, Michishita I, Yamagishi M (2013) Elevation of urinary liver-type fatty acid-binding protein as predicting factor for occurrence of contrast-induced acute kidney injury and its reduction by hemodiafiltration with blood suction from right atrium. Heart Vessels. doi:10.​1007/​s00380-013-0347-9
22.
Zurück zum Zitat Bottazzi B, Garlanda C, Cotena A, Moalli F, Jaillon S, Deban L, Mantovani A (2009) The long pentraxin PTX3 as a prototypic humoral pattern recognition receptor: interplay with cellular innate immunity. Immunol Rev 227:9–18PubMedCrossRef Bottazzi B, Garlanda C, Cotena A, Moalli F, Jaillon S, Deban L, Mantovani A (2009) The long pentraxin PTX3 as a prototypic humoral pattern recognition receptor: interplay with cellular innate immunity. Immunol Rev 227:9–18PubMedCrossRef
23.
Zurück zum Zitat Sekine I, Kubota K, Tamura Y, Asahina H, Yamada K, Horinouchi H, Nokihara H, Yamamoto N, Tamura T (2011) Innovator and generic cisplatin formulations: comparison of renal toxicity. Cancer Sci 102:162–165PubMedCrossRef Sekine I, Kubota K, Tamura Y, Asahina H, Yamada K, Horinouchi H, Nokihara H, Yamamoto N, Tamura T (2011) Innovator and generic cisplatin formulations: comparison of renal toxicity. Cancer Sci 102:162–165PubMedCrossRef
24.
Zurück zum Zitat Mehran R, Aymong ED, Nikolsky E, Lasic Z, Iakovou I, Fahy M, Mintz GS, Lansky AJ, Moses JW, Stone GW, Leon MB, Dangas G (2004) A simple risk score for prediction of contrast-induced nephropathy after percutaneous coronary intervention: development and initial validation. J Am Coll Cardiol 44:1393–1399PubMed Mehran R, Aymong ED, Nikolsky E, Lasic Z, Iakovou I, Fahy M, Mintz GS, Lansky AJ, Moses JW, Stone GW, Leon MB, Dangas G (2004) A simple risk score for prediction of contrast-induced nephropathy after percutaneous coronary intervention: development and initial validation. J Am Coll Cardiol 44:1393–1399PubMed
25.
Zurück zum Zitat Tanaga K, Tarao K, Nakamura Y, Inoue T, Jo K, Ishikawa T, Miyazaki A (2012) Percutaneous coronary intervention causes increase of serum cystatin C concentration even in the patients with a low risk of contrast-induced nephropathy. Cardiovasc Interv Ther 27:168–173PubMedCrossRef Tanaga K, Tarao K, Nakamura Y, Inoue T, Jo K, Ishikawa T, Miyazaki A (2012) Percutaneous coronary intervention causes increase of serum cystatin C concentration even in the patients with a low risk of contrast-induced nephropathy. Cardiovasc Interv Ther 27:168–173PubMedCrossRef
26.
Zurück zum Zitat Scoditti E, Massaro M, Montinari MR (2013) Endothelial safety of radiological contrast media: why being concerned. Vascul Pharmacol 58:48–53PubMedCrossRef Scoditti E, Massaro M, Montinari MR (2013) Endothelial safety of radiological contrast media: why being concerned. Vascul Pharmacol 58:48–53PubMedCrossRef
27.
Zurück zum Zitat Goldenberg I, Matetzky S (2005) Nephropathy induced by contrast media: pathogenesis, risk factors and preventive strategies. CMAJ 172:1461–1471PubMedCrossRefPubMedCentral Goldenberg I, Matetzky S (2005) Nephropathy induced by contrast media: pathogenesis, risk factors and preventive strategies. CMAJ 172:1461–1471PubMedCrossRefPubMedCentral
28.
Zurück zum Zitat Evola S, Lunetta M, Macaione F, Fonte G, Milana G, Corrado E, Bonura F, Novo G, Hoffmann E, Novo S (2012) Risk factors for contrast induced nephropathy: a study among Italian patients. Indian Heart J 64:484–491PubMedCrossRefPubMedCentral Evola S, Lunetta M, Macaione F, Fonte G, Milana G, Corrado E, Bonura F, Novo G, Hoffmann E, Novo S (2012) Risk factors for contrast induced nephropathy: a study among Italian patients. Indian Heart J 64:484–491PubMedCrossRefPubMedCentral
29.
Zurück zum Zitat Taira N (1989) Nicorandil as a hybrid between nitrates and potassium channel activators. Am J Cardiol 63:18J–24JPubMedCrossRef Taira N (1989) Nicorandil as a hybrid between nitrates and potassium channel activators. Am J Cardiol 63:18J–24JPubMedCrossRef
30.
Zurück zum Zitat Sun Z, Zhang X, Ito K, Li Y, Montgomery RA, Tachibana S, Williams GM (2008) Amelioration of oxidative mitochondrial DNA damage and deletion after renal ischemic injury by the KATP channel opener diazoxide. Am J Physiol Renal Physiol 294:F491–F498PubMedCrossRef Sun Z, Zhang X, Ito K, Li Y, Montgomery RA, Tachibana S, Williams GM (2008) Amelioration of oxidative mitochondrial DNA damage and deletion after renal ischemic injury by the KATP channel opener diazoxide. Am J Physiol Renal Physiol 294:F491–F498PubMedCrossRef
31.
Zurück zum Zitat Solomon R, Werner C, Mann D, D’Elia J, Silva P (1994) Effects of saline, mannitol, and furosemide on acute decreases in renal function induced by radiocontrast agents. N Engl J Med 331:1416–1420PubMedCrossRef Solomon R, Werner C, Mann D, D’Elia J, Silva P (1994) Effects of saline, mannitol, and furosemide on acute decreases in renal function induced by radiocontrast agents. N Engl J Med 331:1416–1420PubMedCrossRef
32.
Zurück zum Zitat Mueller C, Buerkle G, Buettner HJ, Petersen J, Perruchoud AP, Eriksson U, Marsch S, Roskamm H (2002) Prevention of contrast media-associated nephropathy: randomized comparison of 2 hydration regimens in 1620 patients undergoing coronary angioplasty. Arch Intern Med 162:329–336PubMedCrossRef Mueller C, Buerkle G, Buettner HJ, Petersen J, Perruchoud AP, Eriksson U, Marsch S, Roskamm H (2002) Prevention of contrast media-associated nephropathy: randomized comparison of 2 hydration regimens in 1620 patients undergoing coronary angioplasty. Arch Intern Med 162:329–336PubMedCrossRef
33.
Zurück zum Zitat Merten GJ, Burgess WP, Gray LV, Holleman JH, Roush TS, Kowalchuk GJ, Bersin RM, Van Moore A, Simonton CA 3rd, Rittase RA, Norton HJ, Kennedy TP (2004) Prevention of contrast-induced nephropathy with sodium bicarbonate: a randomized controlled trial. JAMA 291:2328–2334PubMedCrossRef Merten GJ, Burgess WP, Gray LV, Holleman JH, Roush TS, Kowalchuk GJ, Bersin RM, Van Moore A, Simonton CA 3rd, Rittase RA, Norton HJ, Kennedy TP (2004) Prevention of contrast-induced nephropathy with sodium bicarbonate: a randomized controlled trial. JAMA 291:2328–2334PubMedCrossRef
34.
Zurück zum Zitat Briguori C, Colombo A, Violante A, Balestrieri P, Manganelli F, Paolo Elia P, Golia B, Lepore S, Riviezzo G, Scarpato P, Focaccio A, Librera M, Bonizzoni E, Ricciardelli B (2004) Standard vs double dose of N-acetylcysteine to prevent contrast agent associated nephrotoxicity. Eur Heart J 25:206–211PubMedCrossRef Briguori C, Colombo A, Violante A, Balestrieri P, Manganelli F, Paolo Elia P, Golia B, Lepore S, Riviezzo G, Scarpato P, Focaccio A, Librera M, Bonizzoni E, Ricciardelli B (2004) Standard vs double dose of N-acetylcysteine to prevent contrast agent associated nephrotoxicity. Eur Heart J 25:206–211PubMedCrossRef
Metadaten
Titel
Contrast between innovator drug- and generic drug-induced renal dysfunction on coronary angiography (CONTRAST study)
verfasst von
Ayumi Nakamura
Shin-ichiro Miura
Makoto Sugihara
Yuiko Miyase
Kenji Norimatsu
Yuhei Shiga
Hiroaki Nishikawa
Keijiro Saku
Publikationsdatum
01.09.2014
Verlag
Springer Japan
Erschienen in
Heart and Vessels / Ausgabe 5/2014
Print ISSN: 0910-8327
Elektronische ISSN: 1615-2573
DOI
https://doi.org/10.1007/s00380-013-0410-6

Weitere Artikel der Ausgabe 5/2014

Heart and Vessels 5/2014 Zur Ausgabe

Update Kardiologie

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.