A new contrast agent for oral cholecystography: iopronic acid (Oravue).

In a preliminary study to determine the safety and minimal effective dose in patients with impaired hepatic function, the cholecystographic agent iopronic acid (Oravue, research contrast material from Squibb) was well tolerated in single oral doses of 1.5, 3.0, 4.5, or 6.0 g. None of the patients experienced clinical adverse reactions. The radiologic results were generally poor, as anticipated for patients with total serum bilirubin concentrations of 2.0-11.4 mg/100 ml. In a subsequent double-blind controlled study in patients without hapatic dysfunction, 4.5 g of iopronic acid or 3.0 g of iopanoic acid (Telepaque, Winthrop) was given to two groups of 90 patients each. Serial radiographs were obtained 13, 14, 15, and 16 hr after ingestion of the drug. Both drugs were highly effective cholecystographic agents, producing visualization in 88% of the patients. Although not statistically significant, a repeat dose was required for visualization in only 4% of the patients given iopronic acid compared to 9% of the patients given iopanoic acid. Visualization was nearly always observed on the first film obtained 13 hr after drug administration. The contrast agents were similar in terms of safety.

RCT Entities:   Population Interventions Outcomes