Iomeprol versus iopromide for intravenous urography.

Iomeprol (B16880) is a new non-ionic tri-iodinated radiographic contrast medium. It was the aim of this double blind randomized phase III clinical trial to compare the local and systemic tolerance of iomeprol-300 (300 mg I ml-1) with the commercially available iopromide-300 (300 mg I ml-1) in a group of 198 patients needing intravenous urography. The contrast medium was injected rapidly into an antecubital vein within 2-3 min in most cases, using a standard dosage of 1 ml kg-1 body weight. The proportion of patients with an allergic diathesis was 25% in the iomeprol group and 17.3% in the iopromide group. There were no life-threatening adverse reactions. Eight patients (8%) receiving iomeprol and 6 (6.1%) receiving iopromide had a sensation of heat related to the injection of contrast medium. Only one patient (1%) in the iomeprol group and two patients (2%) in the iopromide group noted pain on injection. Although the incidence of all other side-effects was relatively high (7% after iomeprol and 11.2% after iopromide) these reactions were generally harmless. The most common symptom was nausea and/or vomiting, which occurred with the same incidence (5%) in both groups. Only one patient in each group developed urticaria or erythema. Vital parameters remained essentially unchanged in all patients. The results suggest that iomeprol is a safe contrast medium, with a tendency to produce fewer side effects than iopromide, which is known to be particularly well tolerated.

RCT Entities:   Population Interventions Outcomes