Clinical safety assessment of iotrolan 280 in European clinical studies

Abstract

Iotrolan (280 mg iodine/ml) a new non ionic, isotonic dimeric, contrast agent, was evaluated in multicenter clinical stidues conducted in Europe between March 1987 and September 1992. The studies compared the efficacy and safety of the agent with the non-ionic monomeric contrast agents available at the time. Iotrolan was given intravenously to patients undergoing urography, head and body computed tomography phlebography and digital subtraction angiography. The agent was also studied after intra-arterial injections in cerebral, visceral and peripheral angiographic procedures as well as digital subtraction angiography. Data from 32 prospective double blind, randomized, controlled clinical studies, were evaluated. A total of 1203 patients received either iopromide, iohexol or iopamidol (all in concentration of 300 mg iodine/ml), and a further 1207 patients received iortrolan. As there were no sognificant differences (P = 0.0853) in adverse events between the comparative agents, their adverse event data were pooled for evaluation with data from patients receiving iotrolan. Adverse experiences were recorded in two categories — local tolerance (heat and pain) and general tolerance (generalized heat and adverse clinical events). After intra-arterial injection iotrolan had a significantly lower incidence of local heat sensation (P = 0.0001) and a significantly lower incidence of local pain (P = 0.0001) compared with comparator agents. Also, after intravenous injection iotrolan had a significantly lower incidence of local heat (P = 0.0038). In the overall evaluation of general tolerance for all indications, iotrolan was shown to produce significantly less generalized heat (P = 0.0012) and a lower incidence of adverse events (P = 0.061) compared with the reference agents.