A double-blind study comparing the efficiency, tolerance and renal effects of iopromide and iopamidol

A randomized double-blind, group comparative study was carried out to investigate the diagnostic efficiency and side-effect profiles, with particular reference to renal tolerance, of iopamidol and a newer non-ionic contrast medium iopromide, when used in excretory urography. The trial demonstrated that, in a population of 137 patients undergoing excretory urography and being investigated from baseline up to 2 weeks after the administration of the contrast medium, there were no significant adverse effects on the indicators currently thought to reflect renal function. The efficiency of the two contrast agents proved to be very similar and the radiographic quality of opacification was adequate in nearly every case.     

Iotrolan in urography: efficacy and tolerance in comparison with iohexol and iopamidol

Iotrolan was compared with iohexol and iopamidol for efficacy and general tolerance in excretory urography in three controlled, randomized, inte-individual, double-blind studies. Two hundred and eighty-four patients received fixed doses of 100 ml, 120 ml or 150 ml iotrolan 280 or iohexol 300/iopamidol 300 by rapid or bolus injection. Contrast quality in films taken 3–40 min after injection was rated by experienced radiologists both on an overall basis and with regard to distinct anatomical regions (parenchyma, pelvicalyceal system, ureter, bladder). In all studies, contrast quality was assessed as better in the iotrolan group. In two studies (dosages 100 and 120 ml), significant differences in contrast quality were found in lavour of iotrolan (P < 0.05), and in the third study (dosage 150 ml) there was a trend towards better contrast quality in the iotrolan group (P = 0.06). General tolerance of iotrolan was good with only minor side effects (iotrolan 6.3%, iohexol/iopamidol 9.9%), but the difference was not significant. No severe adverse reactions were observed with iotrolan. In comparison with non-ionic monomers, iotrolan shows very good efficacy and general tolerance for excretory urography.     

Iotrolan in urography: efficacy and tolerance in comparison with iohexol and iopamidol

Iotrolan was compared with iohexol and iopamidol for efficacy and general tolerance in excretory urography in three controlled, randomized, inte-individual, double-blind studies. Two hundred and eighty-four patients received fixed doses of 100 ml, 120 ml or 150 ml iotrolan 280 or iohexol 300/iopamidol 300 by rapid or bolus injection. Contrast quality in films taken 3–40 min after injection was rated by experienced radiologists both on an overall basis and with regard to distinct anatomical regions (parenchyma, pelvicalyceal system, ureter, bladder). In all studies, contrast quality was assessed as better in the iotrolan group. In two studies (dosages 100 and 120 ml), significant differences in contrast quality were found in lavour of iotrolan (P < 0.05), and in the third study (dosage 150 ml) there was a trend towards better contrast quality in the iotrolan group (P = 0.06). General tolerance of iotrolan was good with only minor side effects (iotrolan 6.3%, iohexol/iopamidol 9.9%), but the difference was not significant. No severe adverse reactions were observed with iotrolan. In comparison with non-ionic monomers, iotrolan shows very good efficacy and general tolerance for excretory urography.     

Unequal doses of ioversol versus diatrizoate for urography

A randomized, double-blind clinical trial was performed to compare a higher dose of conventional ionic contrast media (diatrizoate) with a lower dose of a new, nonionic contrast material (ioversol) for excretory urography (EU). One hundred twenty patients were randomized to receive either 100 ml of diatrizoate (Renografin-60) or 75 ml of ioversol (Optiray-320). Despite the lower iodine dose, the use of ioversol resulted in significantly better opacification of the calyces, renal pelves, and ureters. There was no significant difference in renal parenchymal opacification, opacification of the urinary bladder, or distention of the collecting system. We conclude that high-quality EU can be performed with a lower iodine dose using ioversol.     

Unequal doses of ioversol versus diatrizoate for urography

A randomized, double-blind clinical trial was performed to compare a higher dose of conventional ionic contrast media (diatrizoate) with a lower dose of a new, nonionic contrast material (ioversol) for excretory urography (EU). One hundred twenty patients were randomized to receive either 100 ml of diatrizoate (Renografin-60) or 75 ml of ioversol (Optiray-320). Despite the lower iodine dose, the use of ioversol resulted in significantly better opacification of the calyces, renal pelves, and ureters. There was no significant difference in renal parenchymal opacification, opacification of the urinary bladder, or distention of the collecting system. We conclude that high-quality EU can be performed with a lower iodine dose using ioversol.     

Preclinical evaluation of iotrolan as a contrast medium for angiography and urography]

Efficacy and tolerability of iotrolan, a nonionic isotonic dimer, as a contrast medium for angiography and urography were investigated in animals. In the arteriography of rabbit femur, the efficacy of iotrolan 280 mgI/ml was as good as iopamidol 300 mgI/ml and better than meglumine diatrizoate 306 mgI/ml. In rat urography, the efficacy of iotrolan 280 mgI/ml was better than both iopamidol 370 mgI/ml and iohexol 350 mgI/ml. Vascular pain was less with iotrolan 280 mgI/ml than with iohexol 300 mgI/ml in rats. Effect of iotrolan on the pulmo-cardiovascular parameters, arterial pO2, hematocrit and plasma osmolality was less than iopamidol and diatrizoate in rabbits. Iotrolan induced no renal dysfunction and diuresis where iopamidol induced diuresis in rats. Effect of iotrolan on the blood coagulation was similar to nonionic monomers and less than diatrizoate in rabbits. Because of its isotonicity, iotrolan induced little water shift in the blood vessel and urinary tract, which would result in good efficacy and tolerability. These results suggest that iotrolan is superior to ionic and nonionic monomers for angiography and urography.     

Frequency of angiography-induced gallbladder opacification assessed bt CT after 12–24 h

A series of CT examinations 12–24 h after angiography were performed to study the incidence of gallbladder opacification. A total of 526 patients were administered four kinds of intravascular contrast media: ioxaglate, iohexol, iopamidol and diatrizoate (mean dosage 321 ml). The degree of gallbladder opacification was classified into four grades, from normal (grade 0) to severe (grade 3), that showed high-density bile measuring more than 100 HU. Gallbladder opacification was observed in 325 patients (62%). Distinct opacification of grades 2 and 3 was shown in 48% of the ioxaglate, 46% of the iohexol, 23% of the iopamidol and 22% of the diatrizoate groups. In the ioxaglate group a high incidence of gallbladder opacification was noted not only in the renal dysfunction group, but also in the normal hepatobiliary function group with normal renal function. Gallbladder opacification after angiography was not a rare phenomenon and does not imply renal dysfunction. Correspondence to: H. Oi     

Iotrolan, a non-ionic dimeric contrast agent in cerebral angiography

We report the European experience with iotrolan 280, a new, non-ionic, isotonic, dimeric, iodinated contrast agent in cerebral angiography. Six randomized, double-blind, controlled, interindividual studies took place at four study centers in Germany. All the studies used intra-arterial contrast administration: iotrolan 280 was administered to 186 patients, iopamidol 300 to 127 patients, iohexol 300 tp 30 patients and iopromide 300 to 30 patients. Iotrolan 280 gave impoved contrast quality with improved opacification of small cerebral vessels. LOcal pain and heat sensations were fewer following iotrolan administration. There was a trend towards better neural tolerance of iotrolan 280 as shown by electroencephaplogram.     

Iopamidol in urography

The radiographic results obtained in urography with iopamidol, a new low osmolality contrast medium, given to 50 patients with normal renal function and 42 patients with impaired renal function, have been evaluated and compared with those obtained with ionic media of current use (meglumine sodium diatrizoate and sodium iothalamate). Based on this comparison, the authors believe there are no significant radiographic advantages to iopamidol.     

Clinical experience with iomeprol in myelography and myelo-CT: clinical pharmacology and double-blind comparisons with iopamidol, iohexol, and iotrolan

RATIONALE AND OBJECTIVES: To evaluate iomeprol, a new nonionic iodinated contrast medium, as a contrast agent for myelography and to compare it with iopamidol, iohexol, and iotrolan. METHODS: An extensive clinical program was conducted on more than 600 patients to assess iomeprol's pharmacokinetics, tolerability, safety, and efficacy after intrathecal injection. RESULTS: Pharmacokinetics study results showed that after intrathecal administration iomeprol is completely absorbed from the cerebrospinal fluid compartment; once absorbed into the systemic circulation, it is rapidly excreted, unmetabolized, by glomerular filtration. Dose-finding studies showed that the opacification produced by iomeprol depends on the injected dose. Although a dose-dependent increase in efficacy was observed, no differences in neurotolerability and safety were detected between the doses tested. Doses of iomeprol greater than 3 g I did not cause a greater incidence of adverse events and produced significantly better contrast efficacy. Comparative clinical trials showed that iomeprol and iopamidol, iohexol, and iotrolan always provided adequate opacification of the subarachnoid space, both in conventional myelography and myelo-CT, with adequate delineation of normal structures and pathologic processes. No serious adverse events occurred up to a total dose of 4.5 g I. No differences between the agents with regard to tolerance, adverse events, and effects on vital signs, physical examination, and neurologic examination were observed. CONCLUSIONS: Iomeprol is safe and effective and can be recommended for myelography and myelo-CT.     

Diagnostic efficacy of excretory urography with low-dose, nonionic contrast media.

A prospective, randomized, physician-blinded study was conducted to determine whether a smaller dose of low-osmolar, nonionic contrast medium can provide diagnostic information on excretory urograms equivalent to that obtained with higher doses of ionic and nonionic contrast agents. One hundred fifty adult patients who underwent excretory urography received a high-dose ionic contrast medium (diatrizoate sodium), high-dose nonionic contrast medium (iohexol), or low-dose nonionic contrast medium (iohexol). All urograms were scored for diagnostic quality. No difference in urographic quality was detected among the different doses of contrast media. The lower dose of low-osmolar nonionic contrast medium provided equivalent diagnostic information. The quality of the nephrotomograms, ureteral image, and overall image was slightly greater with diatrizoate than with a small dose of iohexol, but the difference was not significant. This study suggests that excretory urograms obtained in relatively healthy, well-prepared patients with smaller, less expensive doses of a nonionic contrast agent are at least diagnostically equivalent to those obtained with typical higher doses of ionic and nonionic agents.     

Quality control in urography with iopamidol and iohexol. A parallel comparison

Iohexol has a slightly higher osmolarity in comparison with iopamidol; therefore it might induce a more pronounced diuretic effect and then a better distension of the excretory pathway. A trial was carried out in two groups of 50 patients with normal renal function who underwent urography, namely with 50 ml (15 gI) of iopamidol and of iohexol. No significant differences in the evaluated parameters (nephrography, calyces, pelvis, ureters and bladder) have been found. Both contrast media allowed to perform good quality urographies.     

Maximizing opacification during excretory urography: effect of low-osmolarity contrast media.

Because of improved patient tolerance and decreased risks of idiosyncratic reaction, low-osmolarity contrast media are increasingly used for excretory urography. However, physiologic differences among patients may affect the optimal time for acquiring diagnostic radiographs during the pyelographic phase of the examination. A prospective, randomized, physician-blinded comparative study of 60 adult patients was undertaken to determine if the time to peak opacification of the pyelocaliceal systems differs with different doses of nonionic and ionic contrast media. Three doses of contrast media were used: a high dose (based on body weight) of a high-osmolarity ionic contrast medium, a high dose (based on body weight) of a low-osmolarity non-ionic contrast medium and a lower, fixed dose of a low-osmolarity nonionic contrast medium. The diagnostic quality of the radiographs did not differ statistically with the dose or the contrast medium. However, acquiring an additional radiograph during abdominal compression greatly increased the chance of obtaining at least one radiograph with maximal diagnostic information during the pyelographic phase. Despite potential differences among contrast media in the degree of pyelocaliceal opacification or distension and diuresis, it is not necessary to modify the timing of film acquisitions during excretory urography when lower doses of low-osmolarity agents are administered.     

Clinical intravenous urography: comparative trial of ioxaglate and iopamidol

A comparative trial of ioxaglate sodium meglumine and iopamidol in excretory urography was undertaken. The study failed to demonstrate any statistically significant differences between the two media in terms of urographic quality. Diagnostically adequate urograms were obtained in 92.6% of patients receiving ioxaglate and 89.6% of patients receiving iopamidol. There were no intermediate, major, or fatal reactions with either media. Minor reactions were slightly more common with ioxaglate. Both media are good, safe urographic agents, and either can be advocated when excretory urography with low-osmolar agents is indicated.     

A double-blind comparison of iopromide and iopamidol in intravenous urography

A randomised double-blind comparative study was performed to assess the imaging properties and side-effects of two non-ionic contrast media, iopromide and iopamidol, in intravenous urography in high risk patients. The results showed the two contrast media to be similar in their imaging efficacy and incidence of side-effects. Using 50 or 100 ml of iopromide or iopamidol (370 mgI/ml), the quality of nephrograms was found to be dose dependent but the quality of pyelograms was not dose dependent.     

Evaluation of pelvic masses during infusion excretory urography.

Infusion excretory urography not only clearly delineates the urinary tract structures, but provides additional information about the type of pelvic mass present. Benign uterine fibroids show contrast enhancement in a significant number of cases, whereas endometrial and cervial malignancies give no specific pattern. Cystic and mixed ovarian neoplasms show rim opacification in over 50 per cent of cases, and the presence of this rim sign points strongly to an ovarian lesion. The opacification of solid ovarian tumors cannot be differentiated from that of uterine fibroids unless other identifying features such as specific calcification or visualization of a normal uterus are present. Pelvic inflammatory disease shows no specific type of opacification. Excretory urography is part of the preoperative evaluation in most patients with pelvic mass lesions. By utilizing the infusion method, high quality excretory urograms are obtained, and, in addition, helpful information is obtained regarding the type of pelvic mass present.     

Compression CT urography: a comparison with IVU in the opacification of the collecting system and ureters

OBJECTIVE: The purpose of this study was to evaluate opacification of the collecting system and ureters using compression computed tomography (CT) urography compared with conventional intravenous urography (IVU). MATERIALS AND METHODS: Fifty consecutive patients underwent compression CT urography as part of a dedicated renal CT. A compression belt was applied prior to nephrographic phase imaging. Excretory phase scans were acquired through the kidneys 3 minutes post injection with the compression belt in place. The compression belt was then released, and scans were obtained through the ureters. Three independent readers then scored opacification of the collecting system and ureters on a scale of 0-2 (0 = no opacification, 1 = partial opacification, 2 = full opacification and distension). Fifty consecutive nonmatched IVUs were scored by segment by the same readers. Comparison of the two modalities was made using the Mann-Whitney U test. Interobserver agreement was assessed by the Kappa coefficient. RESULTS: CT demonstrated significantly better opacification (p < or = 0.02) of the upper and lower pole pelvicalyceal systems and midureters bilaterally. There was no difference in opacification of the proximal and distal ureters by CT compared with IVU. The Kappa coefficient was 0.53. CONCLUSIONS: Compression CT urography yields equal or better opacification of the collecting system and ureters when compared with IVU, and shows promise for the routine evaluation of the renal excretory system.     

Iopamidol arteriography: discomfort and pain

A double-blind, randomized study was performed to compare discomfort and pain associated with the use of iopamidol and Hypaque (diatrizoate sodium and diatrizoate meglumine) during iliofemoral runoff arteriography in 33 patients. Iopamidol caused substantially less discomfort and pain. The evaluation was helped by audiotaping the study and comparing patients' vocal responses to injections of these materials.     

Plasma histamine levels following administration of radiographic contrast media

The effect of two conventional high-osmolality and two new low-osmolality contrast media on plasma histamine levels has been examined. The study population included 25 patients undergoing intravenous urography with Urovison 58% (sodium and meglumine diatrizoate), 24 patients receiving intravenous Hexabrix 320 (sodium and meglumine ioxaglate) for urography, 16 patients receiving intravenous Iopamiro 370 (iopamidol) for urography and 12 patients receiving Urografin 76% (sodium and meglumine diatrizoate) for coronary angiography. Seventy-four percent of the 77 patients studied suffered adverse reactions ranging from a feeling of warmth and nausea to laryngeal oedema and bronchospasm. Hexabrix 320 and Iopamiro 370 were associated with the least patient discomfort. All contrast agents usually produced a rise in plasma histamine following injection (Iopamiro 370 causing the least change) and the histamine levels then fell towards preinjection values over a space of about 10 minutes. No relationship was observed between the magnitude of the increase in histamine and the severity of the reaction that occurred. However, a relationship was suggested between the mean peak plasma histamine level achieved and the occurrence of a Grade II reaction (i.e., dry retching/vomiting, mild urticaria or rash). These findings raise the probability that histamine contributes to the more severe grades of reaction to radiographic contrast media.     

Evaluation of myelographic contrast-medium tolerance with psychometric testing

Clinical tolerance to the myelographic contrast media metrizamide and iopamidol was evaluated in 26 and 30 patients, respectively, with a battery of neuropsychologic tests before and after myelography in a randomized, double-blind prospective study. Twenty hospitalized patients with chronic back pain were also studied before and after computed tomography to serve as controls relative to the groups administered contrast agents. Measures of conceptual reasoning and affect were sensitive tests of adverse reactions. These paralleled the incidence of somatic reactions and correlated with the dose of contrast medium. Methodologic problems included varying intervals between myelography and psychometric evaluation among subjects and use of a less-than-ideal control group. Neuropsychologic tests appear to be sensitive for detection of subtle adverse reactions and possibly predictive of their occurrence. Iopamidol was tolerated better than metrizamide, with somatic side effects occurring in 38% of patients receiving metrizamide and in 17% of patients receiving iopamidol.