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

I. Terrenato, F. Sperati, F. 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 (%Δ), 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 %Δ 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. © 2017 Wiley Periodicals, Inc.
Original languageEnglish
Pages (from-to)2572-2580
Number of pages9
JournalJournal of Cellular Physiology
Volume233
Issue number3
DOIs
Publication statusPublished - 2018

Fingerprint

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

Keywords

  • cancer patients
  • contrast induced nephropathy
  • low-osmolar/iso-osmolar contrast medium
  • iodixanol
  • iopromide
  • contrast medium
  • iodobenzoic acid derivative
  • iohexol
  • abdomen
  • adult
  • aged
  • Article
  • cancer patient
  • clinical assessment
  • contrast enhancement
  • controlled study
  • drug safety
  • estimated glomerular filtration rate
  • female
  • human
  • low risk patient
  • major clinical study
  • male
  • multicenter study
  • outcome assessment
  • pelvis
  • priority journal
  • randomized controlled trial
  • single blind procedure
  • thorax
  • x-ray computed tomography
  • adolescent
  • analogs and derivatives
  • chemically induced
  • clinical trial
  • comparative study
  • diagnostic imaging
  • drug effects
  • glomerulus filtration rate
  • Italy
  • kidney
  • kidney disease
  • middle aged
  • neoplasm
  • pathology
  • pathophysiology
  • patient safety
  • predictive value
  • risk factor
  • time factor
  • young adult
  • Adolescent
  • Adult
  • Aged
  • Contrast Media
  • Female
  • Glomerular Filtration Rate
  • Humans
  • Iohexol
  • Kidney
  • Kidney Diseases
  • Male
  • Middle Aged
  • Neoplasms
  • Patient Safety
  • Predictive Value of Tests
  • Risk Factors
  • Time Factors
  • Tomography, X-Ray Computed
  • Triiodobenzoic Acids
  • Young Adult

Cite this

Iodixanol versus iopromide in cancer patients: Evidence from a randomized clinical trial. / Terrenato, I.; Sperati, F.; Musicco, F.; Pozzi, A.F.; di Turi, A.; Caterino, M.; de Lutio di Castelguidone, E.; 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, 2018, p. 2572-2580.

Research output: Contribution to journalArticle

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author = "I. Terrenato and F. Sperati and F. Musicco and A.F. Pozzi and {di Turi}, A. and M. Caterino and {de Lutio di Castelguidone}, E. and S.V. Setola and M. Bellomi and C.E. Neumaier and L. Conti and G. Cigliana and R. Merola and A. Antenucci and G. Orlandi and A. Giordano and M. Barba and S. Canitano",
note = "Cited By :1 Export Date: 5 February 2019 CODEN: JCLLA Correspondence Address: Barba, M.; Scientific Direction, Regina Elena National Cancer InstituteItaly; email: maddalena.barba@gmail.com Chemicals/CAS: iodixanol, 92339-11-2; iopromide, 73334-07-3; iohexol, 66108-95-0; Contrast Media; iodixanol; Iohexol; iopromide; Triiodobenzoic Acids Tradenames: ultravist, Schering; visipaque, GE Healthcare Manufacturers: GE Healthcare; Schering",
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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, F.

AU - Pozzi, A.F.

AU - di Turi, A.

AU - Caterino, M.

AU - de Lutio di Castelguidone, E.

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 - Cited By :1 Export Date: 5 February 2019 CODEN: JCLLA Correspondence Address: Barba, M.; Scientific Direction, Regina Elena National Cancer InstituteItaly; email: maddalena.barba@gmail.com Chemicals/CAS: iodixanol, 92339-11-2; iopromide, 73334-07-3; iohexol, 66108-95-0; Contrast Media; iodixanol; Iohexol; iopromide; Triiodobenzoic Acids Tradenames: ultravist, Schering; visipaque, GE Healthcare Manufacturers: GE Healthcare; Schering

PY - 2018

Y1 - 2018

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 (%Δ), 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 %Δ 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. © 2017 Wiley Periodicals, Inc.

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 (%Δ), 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 %Δ 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. © 2017 Wiley Periodicals, Inc.

KW - cancer patients

KW - contrast induced nephropathy

KW - low-osmolar/iso-osmolar contrast medium

KW - iodixanol

KW - iopromide

KW - contrast medium

KW - iodobenzoic acid derivative

KW - iohexol

KW - abdomen

KW - adult

KW - aged

KW - Article

KW - cancer patient

KW - clinical assessment

KW - contrast enhancement

KW - controlled study

KW - drug safety

KW - estimated glomerular filtration rate

KW - female

KW - human

KW - low risk patient

KW - major clinical study

KW - male

KW - multicenter study

KW - outcome assessment

KW - pelvis

KW - priority journal

KW - randomized controlled trial

KW - single blind procedure

KW - thorax

KW - x-ray computed tomography

KW - adolescent

KW - analogs and derivatives

KW - chemically induced

KW - clinical trial

KW - comparative study

KW - diagnostic imaging

KW - drug effects

KW - glomerulus filtration rate

KW - Italy

KW - kidney

KW - kidney disease

KW - middle aged

KW - neoplasm

KW - pathology

KW - pathophysiology

KW - patient safety

KW - predictive value

KW - risk factor

KW - time factor

KW - young adult

KW - Adolescent

KW - Adult

KW - Aged

KW - Contrast Media

KW - Female

KW - Glomerular Filtration Rate

KW - Humans

KW - Iohexol

KW - Kidney

KW - Kidney Diseases

KW - Male

KW - Middle Aged

KW - Neoplasms

KW - Patient Safety

KW - Predictive Value of Tests

KW - Risk Factors

KW - Time Factors

KW - Tomography, X-Ray Computed

KW - Triiodobenzoic Acids

KW - Young Adult

U2 - 10.1002/jcp.26132

DO - 10.1002/jcp.26132

M3 - Article

VL - 233

SP - 2572

EP - 2580

JO - Journal of Cellular Physiology

JF - Journal of Cellular Physiology

SN - 1097-4652

IS - 3

ER -