Randomized double-blind cross-over study of iohexol and Amipaque in cerebral angiography

Iohexol was compared with Amipaque (metrizamide) in a double-blind study in one pair of injections in each of 20 patients referred for routine cerebral angiography. Catheter position, patient position, injection pressure, contrast medium volume, and concentration (300 mg l/ml) were the same in the two injections, with iohexol and Amipaque being used alternately. Except for these two injections iohexol was used throughout. The parameters studied included diagnostic information obtained (quality of the examination), circulation time, and comparison of patient reactions to the pair of injections (e.g., electrocardiogram, heart rate, and subjective reactions). The patients' reactions to the noncomparative part of the examination were evaluated also, and the patients were observed for possible adverse reactions after the examination. No difference could be detected between the two contrast media in this series. No serious adverse reactions occurred.     

Iohexol and ioxaglate in peripheral angiography

A double-blind, cross-over trial of the non-ionic, low-osmolar contrast medium iohexol (Omnipaque) and the ionic, low-osmolar medium ioxaglate (Hexabrix) at concentrations of 300 mg I/ml was carried out in 107 consecutive patients with arterial insufficiency of the lower limbs. The purpose of the study was to observe possible 'carry-over' effects from any of the contrast media, and to evaluate patient discomfort such as pain, adverse reactions, or effect on peripheral blood pressure. No carry-over effect was seen. Ioxaglate caused less injection pain and heat sensations than iohexol, and showed less effect on the systemic blood pressure.     

High dose urography in patients with renal failure. A double blind investigation of iohexol and metrizoate

The new non-ionic contrast medium iohexol 350 mg I/ml was compared with the ionic contrast medium metrizoate 350 mg I/ml in a double blind, two-group urographic study performed on 20 patients with stable, impaired renal function. A dose of contrast medium of 500 mg I/kg body weight was given to each patient. Iohexol resulted in significantly fewer subjective adverse reactions than metrizoate. A similar image quality was obtained with the two contrast media. No clinically significant difference existed between the two contrast media with respect to influence on blood pressure, pulse or clinical chemical parameters. A tendency to deterioration of renal function after urography was found in both groups, but no difference of statistical significance existed between the two contrast media with respect to possible nephrotoxicity. Inadequate hydration may have been partly responsible for the nephrotoxic effect of the urographic procedure.     

Intravenous urography with a new non-ionic contrast media in a clinical phase III study: iopentol vs iohexol

The safety and diagnostic efficacy of iopentol 300 mg I/ml were compared with iohexol 300 mg I/ml in 300 patients submitted for urography. The study was carried out as a double-blind, randomised parallel study where 149 patients received iopentol and 150 patients iohexol. There were no significant differences between the patients receiving the two contrast media with regard to demographic parameters, rate of injection or total dose of injected contrast media. No changes in blood pressure and no clinically important changes in heart rate were detected in the two groups. No serious adverse effects occurred. Seven patients (5%) in the iohexol and 12 patients (8%) in the iopentol group experienced adverse effects other than a sensation of warmth. Fourteen iohexol patients (9%) and 18 iopentol patients (12%) experienced warmth related to the contrast injection. Excellent films were obtained in most patients and no difference in diagnostic quality between iopentol and iohexol was observed.     

Comparative trial of Hexabrix (320 mg iodine/ml), iohexol (300 mg iodine/ml) and iopamiron (300 mg iodine/ml) in cerebral and spinal angiography: a preliminary report

A comparison has been carried out of results of cerebral and spinal-cord angiography with two non-ionic contrast media, iohexol and Iopamiron, and a low-osmolality contrast medium, Hexabrix. A comparative study of iohexol, Hexabrix, and Iopamiron was carried out in a first group of 41 patients, and Hexabrix was compared with Iopamiron in a second group of 56. Evaluation criteria included local and general safety, as well as quality of angioscopy and angiography. In the first group of patients there were no significant differences in safety between the three agents. On the other hand, quality of visualisation during angioscopy with Hexabrix was clearly better. In the second group, safety and quality of the radiographic images were identical; however, once again, quality of angioscopy was better with Hexabrix than with Iopamiron. We conclude that Hexabrix appears to be the best opacifying agent currently available for cerebral and spinal-cord angiography. While results with Iopamiron were quite similar, the latter agent is slightly more expensive.     

Myelography with a dimeric (iodixanol) and a monomeric (iohexol) contrast medium: a clinical multicentre comparative study

The purpose of this study was to evaluate and compare the radiographic efficacy and safety of iodixanol (Visipaque; 270 and 320 mg I/ml) and iohexol (Omnipaque; 300 mg I/ml) in myelography. The study was randomized, double-blind and comparative including 398 patients from five European university clinics. The radiographic visualisation was evaluated as poor, good or excellent. Adverse events were recorded by interviewing the patients after the myelography, and each patient was given a questionnaire to be returned after 1 week. In cervical myelography with cervical puncture more films with excellent quality was obtained after iodixanol 320 mgI/ml compared with iohexol 300 mgI/ml (p = 0.009). Also in lumbar myelography iodixanol 320 mgI/ml compared favourably with iohexol 300 mgI/ml (p = 0.006). The most frequent adverse event was headache, which occurred in 5–35 % of patients during the first 24 h and in 19–61 % within the first 7 days, depending on the centre. There was no difference in frequency and severity of the adverse effects between the contrast media. Received 13 March 1997; Revision received 29 December 1997; Accepted 5 January 1997     

Effect of an iso-osmolar contrast medium on pulmonary arterial pressure at pulmonary angiography

A clinical comparison of the effects on pulmonary arterial pressure induced by contrast media with various osmolalities, iohexol 140 mg I/ml (300 mosm/kg H2O), iohexol 300 mg I/ml (690 mosm/kg H2O), and diatrizoate 292 mg I/ml (1480 mosm/kg H2O) following selective pulmonary angiography was made in 12 patients with normal pulmonary arterial pressure. A double-blind crossover study was performed and the contrast media were administered in random order. The pulmonary arterial pressure was recorded continuously before, during, and for 3 min after the injection. The effect of iohexol 140 on the pulmonary arterial pressure was significantly less marked than that of diatrizoate 292, whereas no statistical significance was shown between iohexol 140 and iohexol 300. These results indicate that iso-osmolar contrast medium (iohexol 140), as well as iohexol 300, would be better tolerated than diatrizoate 292, and is therefore a safer contrast medium for selective pulmonary angiography.     

Intra-arterial digital subtraction angiography with isotonic dimeric (iodixanol) and monomeric (iohexol) nonionic contrast media: radiographic,clinical and neurophysiological evaluation

Monomeric (iohexol 300 mg I/ml) and dimeric (iodixanol 270 mg I/ml) nonionic contrast media were compared in a double-blind, randomised, parallel group trial. Safety and efficacy of the media in intra-arterial cerebral digital subtraction angiography were evaluated by assessing adverse events, discomfort, EEG, heart rate and quality of radiodiagnostic information. Seventy-six patients underwent selective injection of the carotid and/or vertebral arteries. Both contrast media were well tolerated. No serious adverse events occurred. No effects on heart rate and EEG were evident. The arteriograms were of high quality and overall diagnostic information was optimal in 94% of the examinations. No clinically important differences between the two contrast media were found.     

Comparison of iohexol and ioxaglate for intravenous digital subtraction angiography of the neck and head

Two hundred patients undergoing intravenous digital subtraction angiography of the cerebral circulation were examined on a random basis with either iohexol 350 mg I/mL or ioxaglate 320 mg I/mL. The two low osmotic media provided equally satisfactory image quality and diagnostic possibilities. No significant differences were found in incidence and severity of adverse reactions.     

Diagnostic efficacy and safety of two low-osmolar contrast media in cerebral angiography

A comparative randomised open study was carried out in 120 patients uncle undergoing cerebral angiography, to compare two low-osmolar contrast media (LOCM). All the patients participated voluntarily in the trial. Half the patients (n = 60) received sodium and meglumine ioxaglate (Hexabrix 320) and the other half (n = 60) iohexol (Omnipaque 300). Contrast agent efficacy was evaluated at the different cerebral levels explored. Adverse reactions were recorded immediately and 24 h post-administration. Diagnostic quality was considered excellent in 95% of cases with Omnipaque and in 97% of cases with Hexabrix. Image quality was excellent in 95%, of cases with Omnipaque and in 100 % of cases with Hexabrix. In terms of both efficacy and safety, no significant difference was observed between the agents. Thus, low osmolality would appear to be the essential factor in this indication as far as safety is concerned. No significant difference in safety was noted between the ionic LOCM Hexabrix and the non-ionic LOCM Omnipaque.     

Incidence of ventricular fibrillation during coronary arteriography in the rabbit. A comparative study of isotonic ioxaglate and iohexol

The incidence of major ECG changes, particularly ventricular fibrillation, was evaluated in rabbits during prolonged, selective right coronary injection of sodium/meglumine ioxaglate (Hexabrix 160) and iohexol (Omnipaque 140), two isotonic contrast media. The anesthetized animals (n = 12) per test solution) each received 1.5 ml of contrast material, delivered at a rate of 3 ml/minute. Both contrast media caused major ECG changes, which were reversible within seconds after administration. No fibrillation occurred with ioxaglate, but ventricular fibrillation was seen in seven animals given iohexol. There was a significant difference in the incidence of ventricular fibrillation between the contrast media (P less than .01). Both test solutions induced transient, more or less marked bradycardia, but without significant differences. The intracoronary injections produced similar decreases in blood pressure for both contrast agents. Reactive hypertension was observed only in those animals in which an episode of fibrillation occurred with iohexol. The causes underlying these effects are analyzed for both contrast agents.     

Comparison of iodixanol 270 with iohexol 300 in infrapopliteal arteriography. Digital densitometric analysis of angiographic opacification.

PURPOSE: To compare iodixanol 270 mg I/ml with iohexol 300 mg I/ml in infrapopliteal arteriography by measuring digital densitometric vessel opacification and by visually assessing angiographic enhancement. MATERIAL AND METHODS: In a double-blind, dual-balanced, 4-sequence cross-over design, 50 claudicant patients received two contrast media injections (10 min interval) in the superficial femoral artery. Digital angiography was performed at 8 frames/s and time-density curves with a circular region of interest over a distal calf artery were generated. A mixed, linear model was used to identify effects influencing the density measurements. Subjective evaluation of the image quality was made independently by two observers. RESULTS: No statistically significant difference between the contrast media was revealed in the analysis of the densitometric measurements (p=0.14) nor in the subjective visual evaluation (p=0.74). However, the mean density at the time of maximum opacification was higher after the first injection than that after the second injection (p=0.02). There was a tendency towards lower intensity of warmth during injection of iodixanol 270 than during injection of iohexol 300. CONCLUSION: In patients with severe occlusive atherosclerotic disease, iodixanol yielded the same image quality as iohexol in infrapopliteal arteriography, in spite of the 30 mg I/ml lower iodine concentration.     

Excretory urography with iohexol: evaluation in children

A multicenter clinical study was conducted using iohexol, a second-generation nonionic contrast medium, for excretory urography performed in 130 children. Doses of iohexol (300 mg iodine/ml) ranged between 150 and 660 mgI/kg (0.5 and 2.2 ml/kg). Iohexol was tolerated well, and no significant adverse reactions occurred. Sixty-five iohexol urograms were evaluated to determine the minimum dose for adequate visualization of the kidneys and collecting systems. A dose greater than 300 mgI/kg (1.0 ml/kg) always resulted in a urogram of diagnostic quality, while visualization was insufficient for diagnosis in 10% of studies done with doses of 150-300 mgI/kg (0.5-1.0 ml/kg). Another 65 iohexol urograms were compared in a blinded manner with a similar number of studies performed using iothalamate meglumine at comparable iodine concentration and dose. Visualization of calyces and pelvoinfundibular structures achieved with iohexol was rated better with statistical significance, but there was no difference in visualization of the renal parenchyma or ureters. Use of iohexol in excretory urography may be advantageous in children who are at greatest risk for an adverse reaction to contrast media or in those most likely to benefit from use of a low osmolality contrast agent.     

Pain in femoral arteriography. A double-blind, randomized, clinical study comparing safety and efficacy of the iso-osmolar iodixanol 270 mgI/ml and the low-osmolar iomeprol 300 mgI/ml in 9 European centers

PURPOSE: To compare the injection-associated pain and heat sensation after administration of the iso-osmolar contrast medium (IOCM) iodixanol (Visipaque trade mark 270 mg I/ml) and the low osmolar contrast medium (LOCM) iomeprol (Iomeron trade mark 300 mg I/ml) in femoral arteriography. MATERIAL AND METHODS: 352 patients received iodixanol or iomeprol in a prospective, double-blind, randomized, parallel-group clinical trial. The first injection during femoral arteriography (DSA with automated stepping) was standardized. Injection-associated pain and heat sensation, efficacy and safety up to 72 h were evaluated. RESULTS: The iodixanol group reported significant less injection-associated pain than the iomeprol group after the first injection (7.4% vs. 17.6%; p = 0.007), and after all injections (11% vs. 19.4%; p = 0.045). Iodixanol caused less heat sensation after the first injection (p = 0.007) and after all injections (p = 0.029). Heat sensations in the iodixanol group were less intense after all injections (p < 0.0001). No difference was found between the groups regarding the frequency of patients having adverse reactions (5.1% vs. 4%). CONCLUSION: The IOCM iodixanol caused significantly less frequent injection-associated pain and heat sensation than the LOCM iomeprol during femoral arteriography.     

Intravascular studies with iohexol (Omnipaque). Results from the first 49 clinical trials

In order to assess the vascular clinical trial program of iohexol (Omnipaque) in Europe, the results from the first 49 vascular trials are collectively reported. The included iohexol material comprises 1742 patients. In 40 comparative trials, other contrast media like metrizamide (Amipaque), ioxaglate (Hexabrix) and various monomeric ionic media were administered in 1292 patients included in this analysis. No severe or unexpected adverse reactions related to iohexol were encountered. No clinically significant differences in radiographic image quality between the media were documented. The overall tolerability of iohexol was superior to that of monomeric ionic media and seemed to be as good as that of metrizamide.     

Omnipaque and Urografin in left ventriculography and coronary arteriography. A randomised, double blind study

In order to compare tolerability and radiographic properties of Omnipaque (iohexol) 350 mg I/ml and Urografin (sodium meglumine diatrizoate) 76% (370 mg I/ml) in left ventriculography and coronary arteriography, a randomised, double-blind parallel study was conducted. ECG, heart rate, blood pressure, cardiac output, oxygen saturation, CK-MB, adverse reactions and opacification were recorded. Twenty-five patients received Omnipaque and 24 Urografin and all patients were included in the final material. Omnipaque was found to have less influence on haemodynamics than Urografin. Few adverse reactions were encountered in the entire study, but fewer after injections of Omnipaque than after Urografin. Equally good opacification was demonstrated for both media. Omnipaque was found well suited for cardioangiography and superior to standard ionic media.     

Iodixanol in cerebral computed tomography: a randomized, double-blind, phase-III, parallel study with iodixanol and iohexol

Iodixanol is a new nonionic dimer, isotonic with blood at all clinically relevant concentrations. Iodixanol (270 mg I/ml) was compared in a double-blind, randomized, parallel-group, phase-III study to the monomeric nonionic iohexol (300 mg I/ml) for evaluation of safety, tolerability and radiographic efficacy during cerebral CT. One hundred adult patients scheduled to undergo contrast-enhanced cerebral CT were randomly allocated to receive either iodixanol or iohexol. All completed the trial. Safety was evaluated by recording discomfort and other adverse events, tolerance by assessing intensity and incidence of discomfort. Radiographic efficacy was assessed from the diagnostic information and the radiographic density. No serious adverse events occurred. One patient (2 %) in the iodixanol group and one patient (2 %) in the iohexol group experienced a transient reddening at the neck and lower neck-line, respectively. Both contrast agents were well tolerated. One patient (2 %) in the iodixanol group and two patients (4 %) in the iohexol group experienced a sensation of warmth (discomfort) in connection with the injection. No difference between the two contrast media were noted radiographically. This comparison between iodixanol and iohexol showed both contrast media to be safe, well-tolerated and efficacious for use in cerebral CT. Received: 8 June 1998; Revision received: 26 August 1998; Accepted: 7 October 1998     

应用Hexabrix320冠状动脉造影的临床评价

Hexabrix 320(320mg l/ml)属低渗透压离子型造影剂。本研究通过30例冠状动脉造影及心血管造影(平均年龄:51.2岁,范围:39～65岁)评价Hexabrix 320的安全性及显影效果。所有病例在术前及术后(5″,15″)记录心率、心律,ECG,左室舒张末压及收缩压及主动脉压。由2名以上医生根据造影提供的显影质量及诊断信息来评价Hexabrix 320效果(评级为优、良、差)。本研究证明Hexabrix 320造影不引起病人ECG、血液动力学任何有意义的改变,无严重过敏反应,可以提供优良的冠状动脉及心血管影像及诊断。     

Iohexol in coronary angiography. A double blind investigation

Iohexol 350 mg I/ml (Omnipaque) was compared with the routine contrast medium meglumine, Na-Ca-metrizoate 370 mg I/ml (Isopaque Coronar) in coronary angiography in 30 patients. A randomized, double blind, crossover design was employed. Angiographic image quality, ECG, heart rate, aortic blood pressure and adverse reactions were recorded. Excellent image quality was obtained with both media. Except for one single event of hypotension, only few and minor changes in the parameters measured were recorded. No distinct difference between the two media was found. Iohexol seems to be suitable for selective coronary angiography.     

Ascending lower-limb phlebography: a comparative study of Hexabrix 320, iohexol 300 and iohexol 240

A prospective, randomised study on 60 legs in 45 patients examined by ascending lower-limb phlebography was conducted to compare Hexabrix 320 (May and Baker Ltd), iohexol 300 and iohexol 240. The quality of opacification of the veins, side-effects, cost and amount of contrast agent used were compared. All three agents produced adequate examinations. Iohexol 300 was preferred for its denser opacification. Iohexol 240 was associated with the lowest incidence of side-effects and Hexabrix 320 cost the least per examination.