Introduction
Materials and methods
Data sources and searches
Study selection
Data extraction and study quality assessment
Results
Study selection
Study | Country | Study Design | Indication & Population | Contrast Media | Dose | N patients | Outcome | Quality Score a |
---|---|---|---|---|---|---|---|---|
Clinical development program of ioversol | ||||||||
McClennan 1989 [41] | USA | DB, RCT, S | Adult patients who underwent body CT | Ioversol 320 | 100.4 (33.7) mL | 40 | ADRs | Low risk of bias |
Diatrizoate 370 | 84.9 (28.6) mL | 40 | ||||||
Chagnaud 1992 [31] | France | DB, RCT, S | Adult patients who underwent body CT | Ioversol 300 | 146 (12.8) mL | 41 | ADRs | Low risk of bias |
Iopamidol 300 | 145 (15.4) mL | 39 | ||||||
Kopecky 1989 [32] | USA | OL, S | Adult patients who underwent body CT | Ioversol 320 | 141 (75–150) mL | 42 | ADRs | 5 |
Sartor 1989 [33] | USA | OL, S | Adult patients who underwent head CT | Ioversol 320 | 132.4 mL | 60 | ADRs | 5 |
Gillard 1992 [34] | France | OL, S | Adult patients who underwent head CT | Ioversol 300 | 60 mL | 92 | ADRs | 5 |
Théron 1991 [35] | France | OL, S | Adult patients who underwent head CT | Ioversol 350 | 1 (0.1) mL/kg | 40 | ADRs | 5 |
Wilkins 1990 [20] | England | DB, RCT, S | Adult patients who underwent venography | Ioversol 240 | 84.8 (40–200) mL | 25 | ADRs | Low risk of bias |
Iohexol 240 | 88.4 (40–150) mL | 25 | ||||||
Wilson 1989 [22] | USA | DB, RCT, S | Adult patients who underwent venography | Ioversol 240 | NR | 25 | ADRs | Low risk of bias |
Iothalamate 202 | 25 | |||||||
Scott 1990 [23] | Australia | RCT, S | Adult patients who underwent venography | Ioversol 240 | 71.3 (35–160) mL | 26 | ADRs | Low risk of bias |
Ioversol 320 | 76.3 (35–140) mL | 26 | ||||||
Colthurst 1990 [24] | England | DB, RCT, S | Adult patients who underwent urography | Ioversol 320 | 76.2 mL | 40 | ADRs | Low risk of bias |
Iohexol 300 | 76.6 mL | 40 | ||||||
Voegeli 1992 [25] | Switzerland | DB, RCT, S | Adult patients who underwent urography | Ioversol 350 | 50 mL | 42 | ADRs | Low risk of bias |
Iohexol 350 | 50 mL | 35 | ||||||
Lemaitre 1992 [26] | France | OL, S | Adult patients who underwent urography | Ioversol 350 | 45-100 mL | 100 | ADRs | 5 |
Rieser 1992 [29] | Germany | DB, RCT, S | Adult patients who underwent intravenous DSA | Ioversol 300 | 176.2 mL | 41 | ADRs | Low risk of bias |
Iohexol 300 | 182.2 mL | 39 | ||||||
Wilkins 1989 [21] | England | SB, RCT, S | Healthy volunteers undergoing pharmacokinetic study | Ioversol 320 | 50–100–150 mL | 18 | ADRs | 7 |
Saline | 6 | |||||||
Montagne 1992 [27] | France | OL, S | Pediatric patients who underwent urography | Ioversol 300 | 2 (1–3) mL/kg | 25 | ADRs | 5 |
Panuel 1992 [30] | France | OL, S | Pediatric patients who underwent body CT | Ioversol 300 | 2.8 (0.1) mL/kg | 40 | ADRs | 5 |
Other studies | ||||||||
Vogl 2012 [42] | Germany | O, P, M | Adult patients who underwent contrast-enhanced CT | Ioversol 160, 240, 300, 320, 350 | NR | 10,836 | ADRs Anaphylactoid reactions | 5 |
An 2019 [17] | Korea | R, M | Adult patients who underwent contrast-enhanced CT | Ioversol | NR | 1,592,523 b | ADRs | 6 |
Iohexol | 3,816,072 | |||||||
Iopamidol | 2,333,794 | |||||||
Iopromide | 1,310,393 | |||||||
Iomeprol | 1,042,096 | |||||||
Iobitridol | 938,251 | |||||||
Iodixanol | 679,667 | |||||||
Chen 2017 [43] | China | R, S | Adult patients who underwent contrast-enhanced CT | Ioversol (Optiray) | NR | 5261 | ADRs | 6 |
Ioversol (Hengrui) | 105 | |||||||
Iohexol (Omnipaque) | 12,824 | |||||||
Iohexol (Ousu) | 18,773 | |||||||
Iopamidol | 18,044 | |||||||
Iopromide | 17,616 | |||||||
Iodixanol | 5219 | |||||||
Morales 2017 [40] | Spain | P, S | Adult patients c, d | Ioversol | NR | 20,958 b | HSRs | 5 |
Iopamidol | 54,453 | |||||||
Iomeprol | 17,645 | |||||||
Cha 2019 [41] | Korea | P, M | Adult patients who underwent contrast-enhanced CT | Ioversol 240, 320, 350 | NR | 24,220 | HSRs | 6 |
Iopromide 370 | 7335 | |||||||
Iopamidol 300, 370 | 53,037 | |||||||
Iomeprol 350, 400 | 29,247 | |||||||
Iohexol 240, 300, 350 | 51,586 | |||||||
Iodixanol 270, 320 | 3043 | |||||||
Iobitrodol 300, 350 | 27,613 | |||||||
Gomi 2010 [37] | Japan | P, RCT, S | Adult patients who underwent contrast-enhanced CT | Ioversol 320 | 2 mL/kg | 1886 | Acute ADRs | Some concerns |
Iomeprol 300 | 1751 | |||||||
Iopamidol 300 | 1697 | |||||||
Iohexol 300 | 1792 | |||||||
Iopromide 300 | 1805 | |||||||
Juchem 2007 [18] | Brazil | P, S | Adult patients who underwent contrast-enhanced CT | Ioversol | NR | 190 | Acute ADRs | 6 |
Meglumine diatrizoate | 161 | |||||||
Motosugi 2016 [36] | Japan | P, RCT e, S | Adult patients who underwent contrast-enhanced abdominal and pelvic CT | Ioversol 320 | No reaction 583.8 ± 44.7 mgI/Kg | 440 | Acute allergic-like and physiologic reactions | 6 |
Iohexol 300 | 1722 | |||||||
Iopamidol 370 | Reaction 576.8 ± 42.4 mgI/Kg | 1298 | ||||||
Iomeprol 350 | 1028 | |||||||
Federle 1998 [43] | USA | P, S | Adult patients who underwent contrast-enhanced thorax or abdomen CT | Slow injection rate | 150 mL in 92% of cases | Anaphylactoid reactions | 7 | |
Ioversol 320 | 250 | |||||||
Iothalamate | 725 | |||||||
Fast injection rate | ||||||||
Ioversol 320 | 202 | |||||||
Iothalamate | 650 | |||||||
Callahan 2009 [38] | USA | R, S | Pediatric and young adults (up to 21 years old) who underwent contrast-enhanced CT or excretory urography. | Ioversol 320 | 1.5–2 mL/Kg | 12,494 | ADRs | 5 |
Louvel 1996 [46] | France | P, S | Contrast-enhanced CT in geriatric population | Ioversol 300 | Age > 69 years old 1.36 ± 0.06 mL/Kg | 47 | PC-AKI | 5 |
Age < 60 years old 1.39 ± 0.08 mL/Kg | 44 | |||||||
Ng 2010 [47] | USA | R, S | Head and torso CT in oncologic patients | Ioversol 320 | 95-150 mL | 81 | PC-AKI | 8 |
Unenhanced CT | 81 | |||||||
Gomez 2013 [19] | Spain | P, S | Contrast-enhanced CT in diabetic patients | Ioversol 320 | Mean: 100 mL Maximum: 150 mL | 98 | PC-AKI | 5 |
Moura 2017 [16] | Brazil | R, S | Patients undergoing examination with IV contrast injection, with a length of stay in ICU > 3 days | Ioversol 320 | 92.9 ± 10.3 mL | 140 | PC-AKI | 5 |
Gilligan 2020 [39] | USA | R, S | Hospitalized pediatric patients undergoing contrast-enhanced CT or abdominal US | Ioversol 320 | 1.5–2 mL/kg | 925 | PC-AKI | 7 |
Unenhanced US | 925 |
Study | Contrast Media | N Patients | Type of Reaction | Incidence (%) | Incidence of Serious/Severe Reactions (%) |
---|---|---|---|---|---|
McClennan 1989 [41] | Ioversol | 40 | ADRs | 0% | None severe |
Diatrizoate | 40 | 35% | |||
Chagnaud 1992 [31] | Ioversol | 41 | ADRs | 63.4%i | None severe |
Iopamidol | 39 | 69.2%i | |||
Kopecky 1989 [32] | Ioversol | 42 | ADRs | 0% | - |
Sartor 1989 [33] | Ioversol | 60 | ADRs | 3.3% | None severe |
Gillard 1992 [34] | Ioversol | 92 | ADRs | 42.4%i | None severe |
Théron 1991 [35] | Ioversol | 40 | ADRs | 12.5% | None severe |
Wilkins 1990 [20] | Severe ADRs | ||||
Ioversol | 25 | ADRs | 4% | 4% | |
Iohexol | 25 | 0% | 0% | ||
Wilson 1989 [22] | Ioversol | 25 | ADRs | 0% | None serious |
Iothalamate | 25 | 4% | |||
Scott 1990 [23] | Ioversol | 26 | ADRs | 0% | - |
Ioversol | 26 | ||||
Colthurst 1990 [24] | Ioversol | 40 | ADRs | 0% | None serious |
Iohexol | 40 | 2.5% | |||
Voegeli 1992 [25] | Ioversol | 42 | ADRs | 0% | - |
Iohexol | 35 | 0% | |||
Lemaitre 1992 [26] | Ioversol | 100 | ADRs | 1st injection 12%h 2nd injection 6.3%h | NR |
Rieser 1992 [29] | Ioversol | 41 | ADRs | 4.9% | NR |
Iohexol | 39 | 5.1% | |||
Wilkins 1989 [21] | ADRs | Severe ADRs | |||
Ioversol | 18 | 33.3% | 0% | ||
Saline | 6 | 16.7% | 16.7% | ||
Montagne 1992 [27] | Ioversol | 25 | ADRs | 4% | NR |
Panuel 1992 [30] | Ioversol | 40 | ADRs | 5% | NR |
Vogl 2012 [42] | Ioversol | 10836 | ADRs | 0.28% | Serious ADRs 0.037% |
Anaphylactoid reactions | 0.18% | Serious anaphylactoid reactions 0.028% | |||
An 2019 [17] | ADRs | Serious ADRs c | |||
Ioversol | 1592523 b | 0.23% | 0.01% | ||
Iohexol | 3816072 | 0.24% | 0.01% | ||
Iopamidol | 2333794 | 0.30% | 0.02% | ||
Iopromide | 1310393 | 0.59% | 0.03% | ||
Iomeprol | 1042096 | 0.70% | 0.05% | ||
Iobitridol | 938251 | 0.55% | 0.02% | ||
Iodixanol | 679667 | 0.27% | 0.03% | ||
Chen 2017 [43] | ADRs | Moderate/Severe ADRs d | |||
Ioversol (Optiray) | 5261 | 0.13% | 0.02% | ||
Ioversol (Hengrui) | 105 | 0.95% | 0.00% | ||
Iohexol (Omnipaque) | 12824 | 0.23% | 0.02% | ||
Iohexol (Ousu) | 18773 | 0.31% | 0.04% | ||
Iopamidol | 18044 | 0.25% | 0.06% | ||
Iopromide | 17616 | 0.61% | 0.02% | ||
Iodixanol | 5219 | 0.67% | 0.48% | ||
Morales 2017 [40] a | Ioversol | 20958 b | HSRs | 0.2% | NR |
Iopamidol | 54453 | 0.14% | |||
Iomeprol | 17645 | 0.4% | |||
Cha 2019 [44] | HSRs | Severe HSR e | |||
Ioversol | 24220 | 0.66% | 0.00% | ||
Iopromide | 7335 | 0.37% | 0.00% | ||
Iopamidol | 53037 | 0.70% | 0.01% | ||
Iomeprol | 29247 | 0.95% | 0.01% | ||
Iohexol | 51586 | 0.62% | 0.01% | ||
Iodixanol | 3043 | 0.99% | 0.07% | ||
Iobitrodol | 27613 | 0.89% | 0.01% | ||
Gomi 2010 [37] | Ioversol | 1886 | Acute ADRs | 1.80% | NR |
Iomeprol | 1751 | 3.90% | |||
Iopamidol | 1697 | 2.20% | |||
Iohexol | 1792 | 2.00% | |||
Iopromide | 1805 | 3.50% | |||
Juchem 2007 [18] | Ioversol | 190 | Acute ADRs | 1.0%c,f | None severe |
Meglumine diatrizoate | 161 | 12.4% g | |||
Motosugi 2016 [36] | Ioversol | 440 | Acute allergic-like reactions | 1.8% | None severe e |
2.0% | |||||
Iohexol | 1722 | 2.0% | |||
3.6% | |||||
Iopamidol | 1298 | Acute physiologic reactions | 1.1% | ||
1.6% | |||||
Iomeprol | 1028 | 2.5% | |||
2.7% | |||||
Federle 1998 [45] | Slow injection rate | Anaphylactoid reactions | NR | ||
Ioversol | 250 | 2.0% c | |||
Iothalamate | 725 | 8.3% | |||
Fast injection rate | |||||
Ioversol | 202 | 2.5% c | |||
Iothalamate | 650 | 9.1% | |||
Callahan 2009 [38] | Ioversol | 12494 | ADRs | 0.46% | None severe e |
Study | Outcome | Main source of classification | Mild | Moderate | Severe |
---|---|---|---|---|---|
Callahan 2009 [38] | ADRs | ACR Manual on Contrast Media (5th edition) | Itching, hives or rash, flushing, nasal congestion | Tachycardia, bradycardia, hypertension, hypotension, pronounced cutaneous reaction, dyspnea, wheezing | Laryngeal edema, cardiopulmonary arrest, profound hypotension, unstable arrhythmias, convulsions, unresponsiveness |
Chen 2017 [43] | ADRs | CSR guidelines for iodinated contrast agents use | Cough, sneezing, nasal congestion, transient chest tightness, conjunctivitis, rhinitis, nausea, systematic fever, urticaria, itching, angioneurotic edema, mild or localized facial swelling, mild trembling or shivering, single symptom such as mild gastrointestinal discomfort, feeling of binaural blockage, transient blurred vision, dizziness, and numb limbs | Severe vomiting, systematic urticaria, moderate or substantial facial swelling, dyspnea, and vasovagal reaction, single systematic trembling or shivering, hypertension, chest distress, palpitation | Laryngeal edema, seizure, trembling, convulsions, single trembling or shivering coupled with severe systematic symptoms, oxygen desaturation unconsciousness, shock, death |
Morales 2017 [40] | HSRs | Brown grading [48] | Generalized erythema, urticaria, periorbital edema, angioedema | Dyspnea, stridor, wheeze, nausea, vomiting, dizziness (presyncope), diaphoresis, chest or throat tightness, abdominal pain | Cyanosis or SpO2 ≤ 92%, hypotension, confusion, collapse, loss of consciousness, or incontinence |
Cha 2019 [44] | HSRs | ACR Manual on Contrast Media (10th edition) | Limited urticaria and pruritis, limited cutaneous edema, itching or scratchy throat, nasal congestion, sneezing, conjunctivitis, rhinorrhea | Diffuse urticaria and pruritis, diffuse erythema with stable vital signs, facial edema without dyspnea, throat tightness or hoarseness without dyspnea, wheezing or bronchospasm with mild or no hypoxia | Diffuse edema or facial edema with dyspnea, diffuse erythema with hypotension, anaphylactic shock with hypotension and tachycardia, wheezing or bronchospasm with marked hypoxia |
Adverse drug reactions and hypersensitivity reactions
Studies with a comparison with other ICM
Post-contrast acute kidney injury
Study | Contrast Media | N Patients | PC-AKI Definition | Incidence (%) |
---|---|---|---|---|
Louvel 1996 [46] | Ioversol | Total: 91 | sCr rise > 25% within 72 hours | 1.1% |
Age > 69 years old: 47 | 2.1% | |||
Age < 60 years old: 44 | 0% | |||
Ng 2010 [47] | Ioversol | 81 | sCr rise > 0.3 mg/dL or > 50% within 7 days | 17% |
Unenhanced CT | 81 | 17% | ||
Gomez 2013 [19] | Ioversol | 98 | sCr rise > 0.5 mg/dL | 1% |
Moura 2017 [16] | Ioversol | 140 | sCr rise ≥ 0.5 mg/dL or > 25% within 72 hours | 12.1% |
sCr rise > 0.3 mg/dL or > 50% within 48 hours | 42.1% | |||
KDIGO stage 1 (×1.5 sCr rise) | 23.5% | |||
KDIGO stage 2 (×2 sCr rise) | 8.5% | |||
KDIGO stage 3 (×3 sCr rise) | 12.1% | |||
Gilligan 2020 [39] | Ioversol | 925 | sCr rise ≥ 0.3 mg/dL or ≥ 50% within 48h | 2.4% |
Unenhanced US | 925 | 2.6% |