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

Abstract

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.

Comparison in myelography between iodixanol 270 and 320 mgI/ml and iotrolan 300 mgI/ml: a multicentre, randomised, parallel-group, double-blind, phase III trial

“…In the present trial, lumbar puncture resulted in more adverse events than did cervical puncture. This observation is in accordance with other reports of lower frequencies of adverse events after cervical puncture [11]. A variety of factors has been proposed as being contributory to post-myelographic headache.…”

“…In our study however, only four of the 87 events were considered by the investigator to be related to the contrast medium. The time of onset and the duration of the events are comparable to those in other trials [11,16] contrast media, no mental disturbance was observed in any of the 312 patients evaluated. Also no adverse event was reported when a cervical puncture was performed for cervical myelography.…”

“…At centre 1 the patients with headache were encouraged to attend the pain clinic at the hospital and be treated with a blood patch even in cases of moderate headache. A rather high frequency of adverse events and a great centre variation have been observed in other myelography studies [11,15,16]. In our study however, only four of the 87 events were considered by the investigator to be related to the contrast medium.…”

“…Iodixanol (Visipaque, Nycomed Imaging AS, Oslo, Norway) is a non-ionic, isotonic [6], dimeric contrast medium, which is well tolerated in cerebral angiography [7,8] and in other intravascular administrations, with a lower frequency of adverse events such as injection-associated discomfort than the monomeric non-ionic contrast media [9,10]. The safety of iodixanol in intrathecal administration in adults has been demonstrated in comparison with the monomeric, non-ionic contrast medium, iohexol [11]. Iodixanol preparations differ from the other non-ionic, dimeric contrast medium, iotrolan (Isovist, Schering AG, Berlin, Germany) in electrolyte composition and molecular structure [12].…”

Nicht-ionische R�ntgenkontrastmittel - Klinische Relevanz der Unterschiede verschiedener Kontrastmittel. Vorbereitungspapier f�r Konsensuskonferenz. Studie im Auftrag des Wiener Krankenanstaltenverbundes. Institut f�r Technikfolgen-Absch�tzung

“…Bei einem Patienten konnten transiente EEG-Veränderungen nachgewiesen werden [2]. [155]. Auffallend war in dieser Studie, dass sich in beiden KM-Gruppen eine breite Streuung bei den Unverträglichkeits-reaktionen zeigte, sodass die Autoren zu dem Schluss kamen, dass die Häufig-keit weniger KM-assoziiert als von der Durchführung im jeweiligen Zentrum abhängig war.…”