ADVERSE REACTIONS OF LOW OSMOLALITY CONTRAST-MEDIA DURING CARDIAC ANGIOGRAPHY - A PROSPECTIVE RANDOMIZED MULTICENTER STUDY

A multicenter study was performed to determine the incidence of advers e reactions to two contrast media with similar low osmolality during c ardiac angiography. The study was of a randomized double-blind design comparing ioxaglate (an ionic dimer) and iopamidol (a nonionic compoun d) and included 500 patients; 250 patients received ioxaglate and 250 iopamidol. There were 58 adverse reactions attributed to the contrast media in the ioxaglate group and 29 in the iopamidol group (p < 0.001) . Chest pain occurred in 11 patients in the ioxaglate group compared w ith 5 in the iopamidol group (p = 0.123). Nausea or vomiting was prese nt in 20 and 2 patients, respectively (p < 0.0003). Allergic adverse r eactions, such as bronchospasm, urticaria and itching, occurred in 15 of the ioxaglate group and only 1 of the patients receiving iopamidol (p < 0.0007). Fifty-two patients in the ioxaglate group had a known al lergic history (not to contrast medium) or asthma, whereas 77 receivin g iopamidol had a similar history. Seven of the 52 ioxaglate-treated p atients developed an allergic adverse reaction compared with none of t he 77 in the iopamidol group (p = 0.001). Of 41 patients receiving iox aglate who were premedicated with diphenhydramine, 4 had an allergic a dverse event. In the iopamidol group 45 patients received similar prem edication and none had an allergic adverse reaction (p < 0.03). Thus, this multicenter study shows that adverse reactions occur more often w ith ioxaglate than with iopamidol and that patients with an allergic h istory have a greater risk with ioxaglate therapy compared with iopami dol.