Iopaque 300 versus Omnipaque300: A Randomized Double BlindClinical Trial for Comparison ofEfficacy and Adverse Effects inPeripheral Angiography

Background/ The contrast medium has to be selected with regard to safety and efficacy. Iohexol is produced in Iran as the brand name Iopaque. Currently, there are some concerns about using this brand instead of its traditional more expensive brand—Omnipaque. This study was conducted to compare the safety and radiographic efficacy of 300 mg I/mL of Iopaque and Omnipaque in peripheral angiography. Patients and 84 patients were randomly received 300 mg I/mL of one of the two brands of contrast mediums iohexol: Iopaque (Daroopakhsh, Tehran, Iran) or Omnipaque (Nycomed Imaging AS, Oslo, Norway). The radiological efficacy of the drugs was compared according to the distribution of the vascular enhancement and the amount of radiodensity in arterial, capillary, and venous phases of angiography, using visual analogue score (VAS). The adverse events were recorded by a close follow-up by the investigator at baseline, after 1 and 4 hours, and 3 days after angiography. Baseline characteristics including gender, age, and type of angiography were not statistically different between the two study groups. Both contrast agents produced acceptable visualization of the vascular structures [VAS: 8.2±1.4 in Omnipaque and 8.1±1.5 in Iopaque groups; p>0.05]. 23 patients in each group showed early and delayed adverse reactions related to contrast media. Changes in biochemistry parameters were not of clinical importance. The safety and efficacy of Iopaque and Omnipaque in peripheral angiography are the same.