Iodixanol versus iopromide in cancer patients: Evidence from a randomized clinical trial

I. Terrenato, F. Sperati, Felice Musicco, A. F. Pozzi, A. di Turi, M. Caterino, E. de Lutio di Castelguidone, S. V. Setola, M. Bellomi, C. E. Neumaier, L. Conti, G. Cigliana, R. Merola, A. Antenucci, G. Orlandi, A. Giordano, M. Barba, S. Canitano

Research output: Contribution to journalArticle

Abstract

To assess the safety profile of iso-osmolar contrast medium (CM) versus low osmolar CM in cancer patients with an estimated glomerular filtration rate (eGFR) >60 ml/min. In this multicenter, blind trial of patients seeking a chest-abdomen-pelvis contrast enhanced computed tomography (CT) with iodated CM, participants were centrally randomized to iodixanol or iopromide. Contrast induced nephropathy (CIN) at 24 and/or 72 hr were our primary outcomes. We further considered irreversible CIN, average eGFR percentage variation (%Delta), and adverse events (AEs). Overall, 607 patients were enrolled. Among them, 497 eligible patients were randomized to iodixanol (N: 247) or iopromide (N: 250). No differences emerged by descriptive characteristics. Seven and 3 CIN at 24 hr (p = 0.34) and 8 and 2 CIN at 72 hr (p = 0.11) occurred in the iopromide and iodixanol group, respectively. Within the subgroup of individual patients who developed CIN (N: 17), the event rate was higher in the iopromide arm (p = 0.045). No cases of permanent CIN or significant differences in terms of AEs or GFR %Delta were observed. Our results suggest a more favorable safety profile of iodixanol versus iopromide. Adequately sized trials with similar design are warranted to confirm our findings and clarify the underlying biological mechanisms.
Original languageEnglish
Pages (from-to)2572-2580
Number of pages9
JournalJournal of Cellular Physiology
Volume233
Issue number3
DOIs
Publication statusPublished - Mar 1 2018

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iopromide
Randomized Controlled Trials
Contrast Media
Neoplasms
Glomerular Filtration Rate
Safety
Pelvis
Abdomen
Arm
Thorax
Tomography
iodixanol

Keywords

  • Adolescent
  • Adult
  • Aged
  • Contrast Media/administration & dosage/adverse effects
  • Female
  • Glomerular Filtration Rate/drug effects
  • Humans
  • Iohexol/administration & dosage/adverse effects/analogs & derivatives
  • Italy
  • Kidney/drug effects/physiopathology
  • Kidney Diseases/chemically induced/diagnosis/physiopathology
  • Male
  • Middle Aged
  • Neoplasms/diagnostic imaging/pathology
  • Patient Safety
  • Predictive Value of Tests
  • Risk Factors
  • Time Factors
  • Tomography, X-Ray Computed/adverse effects
  • Triiodobenzoic Acids/administration & dosage/adverse effects
  • Young Adult
  • cancer patients
  • contrast induced nephropathy
  • low-osmolar/iso-osmolar contrast medium

Cite this

Iodixanol versus iopromide in cancer patients: Evidence from a randomized clinical trial. / Terrenato, I.; Sperati, F.; Musicco, Felice; Pozzi, A. F.; Turi, A. di; Caterino, M.; Castelguidone, E. de Lutio di; Setola, S. V.; Bellomi, M.; Neumaier, C. E.; Conti, L.; Cigliana, G.; Merola, R.; Antenucci, A.; Orlandi, G.; Giordano, A.; Barba, M.; Canitano, S.

In: Journal of Cellular Physiology, Vol. 233, No. 3, 01.03.2018, p. 2572-2580.

Research output: Contribution to journalArticle

Terrenato, I, Sperati, F, Musicco, F, Pozzi, AF, Turi, AD, Caterino, M, Castelguidone, EDLD, Setola, SV, Bellomi, M, Neumaier, CE, Conti, L, Cigliana, G, Merola, R, Antenucci, A, Orlandi, G, Giordano, A, Barba, M & Canitano, S 2018, 'Iodixanol versus iopromide in cancer patients: Evidence from a randomized clinical trial', Journal of Cellular Physiology, vol. 233, no. 3, pp. 2572-2580. https://doi.org/10.1002/jcp.26132 [doi]
Terrenato, I. ; Sperati, F. ; Musicco, Felice ; Pozzi, A. F. ; Turi, A. di ; Caterino, M. ; Castelguidone, E. de Lutio di ; Setola, S. V. ; Bellomi, M. ; Neumaier, C. E. ; Conti, L. ; Cigliana, G. ; Merola, R. ; Antenucci, A. ; Orlandi, G. ; Giordano, A. ; Barba, M. ; Canitano, S. / Iodixanol versus iopromide in cancer patients: Evidence from a randomized clinical trial. In: Journal of Cellular Physiology. 2018 ; Vol. 233, No. 3. pp. 2572-2580.
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abstract = "To assess the safety profile of iso-osmolar contrast medium (CM) versus low osmolar CM in cancer patients with an estimated glomerular filtration rate (eGFR) >60 ml/min. In this multicenter, blind trial of patients seeking a chest-abdomen-pelvis contrast enhanced computed tomography (CT) with iodated CM, participants were centrally randomized to iodixanol or iopromide. Contrast induced nephropathy (CIN) at 24 and/or 72 hr were our primary outcomes. We further considered irreversible CIN, average eGFR percentage variation ({\%}Delta), and adverse events (AEs). Overall, 607 patients were enrolled. Among them, 497 eligible patients were randomized to iodixanol (N: 247) or iopromide (N: 250). No differences emerged by descriptive characteristics. Seven and 3 CIN at 24 hr (p = 0.34) and 8 and 2 CIN at 72 hr (p = 0.11) occurred in the iopromide and iodixanol group, respectively. Within the subgroup of individual patients who developed CIN (N: 17), the event rate was higher in the iopromide arm (p = 0.045). No cases of permanent CIN or significant differences in terms of AEs or GFR {\%}Delta were observed. Our results suggest a more favorable safety profile of iodixanol versus iopromide. Adequately sized trials with similar design are warranted to confirm our findings and clarify the underlying biological mechanisms.",
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T1 - Iodixanol versus iopromide in cancer patients: Evidence from a randomized clinical trial

AU - Terrenato, I.

AU - Sperati, F.

AU - Musicco, Felice

AU - Pozzi, A. F.

AU - Turi, A. di

AU - Caterino, M.

AU - Castelguidone, E. de Lutio di

AU - Setola, S. V.

AU - Bellomi, M.

AU - Neumaier, C. E.

AU - Conti, L.

AU - Cigliana, G.

AU - Merola, R.

AU - Antenucci, A.

AU - Orlandi, G.

AU - Giordano, A.

AU - Barba, M.

AU - Canitano, S.

N1 - LR: 20171212; CI: (c) 2017; JID: 0050222; 0 (Contrast Media); 0 (Triiodobenzoic Acids); 4419T9MX03 (Iohexol); 712BAC33MZ (iopromide); HW8W27HTXX (iodixanol); OTO: NOTNLM; 2017/08/01 00:00 [received]; 2017/08/03 00:00 [accepted]; 2017/08/05 06:00 [pubmed]; 2017/12/13 06:00 [medline]; 2017/08/05 06:00 [entrez]; ppublish

PY - 2018/3/1

Y1 - 2018/3/1

N2 - To assess the safety profile of iso-osmolar contrast medium (CM) versus low osmolar CM in cancer patients with an estimated glomerular filtration rate (eGFR) >60 ml/min. In this multicenter, blind trial of patients seeking a chest-abdomen-pelvis contrast enhanced computed tomography (CT) with iodated CM, participants were centrally randomized to iodixanol or iopromide. Contrast induced nephropathy (CIN) at 24 and/or 72 hr were our primary outcomes. We further considered irreversible CIN, average eGFR percentage variation (%Delta), and adverse events (AEs). Overall, 607 patients were enrolled. Among them, 497 eligible patients were randomized to iodixanol (N: 247) or iopromide (N: 250). No differences emerged by descriptive characteristics. Seven and 3 CIN at 24 hr (p = 0.34) and 8 and 2 CIN at 72 hr (p = 0.11) occurred in the iopromide and iodixanol group, respectively. Within the subgroup of individual patients who developed CIN (N: 17), the event rate was higher in the iopromide arm (p = 0.045). No cases of permanent CIN or significant differences in terms of AEs or GFR %Delta were observed. Our results suggest a more favorable safety profile of iodixanol versus iopromide. Adequately sized trials with similar design are warranted to confirm our findings and clarify the underlying biological mechanisms.

AB - To assess the safety profile of iso-osmolar contrast medium (CM) versus low osmolar CM in cancer patients with an estimated glomerular filtration rate (eGFR) >60 ml/min. In this multicenter, blind trial of patients seeking a chest-abdomen-pelvis contrast enhanced computed tomography (CT) with iodated CM, participants were centrally randomized to iodixanol or iopromide. Contrast induced nephropathy (CIN) at 24 and/or 72 hr were our primary outcomes. We further considered irreversible CIN, average eGFR percentage variation (%Delta), and adverse events (AEs). Overall, 607 patients were enrolled. Among them, 497 eligible patients were randomized to iodixanol (N: 247) or iopromide (N: 250). No differences emerged by descriptive characteristics. Seven and 3 CIN at 24 hr (p = 0.34) and 8 and 2 CIN at 72 hr (p = 0.11) occurred in the iopromide and iodixanol group, respectively. Within the subgroup of individual patients who developed CIN (N: 17), the event rate was higher in the iopromide arm (p = 0.045). No cases of permanent CIN or significant differences in terms of AEs or GFR %Delta were observed. Our results suggest a more favorable safety profile of iodixanol versus iopromide. Adequately sized trials with similar design are warranted to confirm our findings and clarify the underlying biological mechanisms.

KW - Adolescent

KW - Adult

KW - Aged

KW - Contrast Media/administration & dosage/adverse effects

KW - Female

KW - Glomerular Filtration Rate/drug effects

KW - Humans

KW - Iohexol/administration & dosage/adverse effects/analogs & derivatives

KW - Italy

KW - Kidney/drug effects/physiopathology

KW - Kidney Diseases/chemically induced/diagnosis/physiopathology

KW - Male

KW - Middle Aged

KW - Neoplasms/diagnostic imaging/pathology

KW - Patient Safety

KW - Predictive Value of Tests

KW - Risk Factors

KW - Time Factors

KW - Tomography, X-Ray Computed/adverse effects

KW - Triiodobenzoic Acids/administration & dosage/adverse effects

KW - Young Adult

KW - cancer patients

KW - contrast induced nephropathy

KW - low-osmolar/iso-osmolar contrast medium

U2 - 10.1002/jcp.26132 [doi]

DO - 10.1002/jcp.26132 [doi]

M3 - Article

VL - 233

SP - 2572

EP - 2580

JO - Journal of Cellular Physiology

JF - Journal of Cellular Physiology

SN - 1097-4652

IS - 3

ER -