[Tolerability of nonionic contrast media--results of a multicenter double blind study].
The aim of the randomized multicentre double-blind study was to establish whether nonionic contrast media differ in tolerability. The controlled comparison was conducted at 4 centres on a total of 798 patients with indication for i.v. DSA and computed tomography. The nonionic contrast media Iopamidol and Iopromide with an iodine content of 300 mg/ml each were studied. The osmolality of both contrast media is virtually identical. Both groups of patients were largely homogeneous in terms of demographic data and case history. The history of allergies was positive in 32.4% of the Iopamidol group and in 32.3% of the Iopromide group. The arithmetic mean of the doses administered to each patients was 148.3 and 149.3 ml, respectively. At all 4 centres there was a higher incidence of adverse events with Iopromide than with Iopamidol. The main differences with regard to pseudo-allergic reactions was the incidence of urticarial reactions, pruritus, nausea, vomiting and coughing. 89 of the 399 patients (22.3%) receiving Iopamidol and 120 of the 399 patients (30.1%) receiving Iopromide experienced pseudo-allergic reactions. The difference between both contrast media is statistically significant (p less than 0.05). There is a 95% certainty that less pseudo-allergic reactions will occur after an Iopamidol injection than after Iopromide. Possible explanations for the differences in tolerability between the two nonionic contrast media with identical osmolality are discussed.
Schmiedel
E
E
Byk Gulden Pharmazeutika Konstanz.
D004311:Double-Blind Method; D006801:Humans; D007472:Iohexol / Q000009:adverse effects / Q000031:analogs & derivatives*; D007479:Iopamidol / Q000009:adverse effects*; D009994:Osmolar Concentration
D007472:Iohexol; C038192:iopromide; D007479:Iopamidol
Verträglichkeit nichtionischer Kontrastmittel--Ergebnis einer multizentrischen Doppelblindstudie.