PMID- 9204351
OWN - NLM
STAT- MEDLINE
DCOM- 19970728
LR  - 20200330
IS  - 0938-7994 (Print)
IS  - 0938-7994 (Linking)
VI  - 7 Suppl 4
DP  - 1997
TI  - Iopentol (Imagopaque 300) compared with iopromide (Ultravist 300) in abdominal 
      CT. A multi-centre monitoring trial assessing adverse events and diagnostic 
      information--results from 518 patients in Spain.
PG  - S115-9
AB  - OBJECTIVES: Iopentol (Nycomed Imaging AS, Oslo, Norway) and iopromide (Schering 
      AG, Berlin, Germany) are low-osmolar, non-ionic, iodinated contrast media (CM) 
      used in abdominal CT examinations. The intravenous safety profile and 
      radiological efficacy of iopentol and iopromide were studied in 518 patients. 
      Specifically, frequency of adverse events (AEs), subjective change in quality of 
      diagnostic information, and quantitative enhancement characteristics were 
      compared. MATERIALS AND METHODS: A prospective, double-blind, randomized, 
      multicentre, parallel-group study was conducted at 8 hospitals. Patients received 
      100 ml of either iopentol 300 mg I/ml or iopromide 300 mg I/ml. RESULTS: The 
      incidence of patients with AEs was statistically significantly lower in the 
      iopentol group compared to the iopromide group (2.3% vs. 8.9%, p < 0.001). 
      Discomfort was frequent in both groups (44.8% vs. 49.4%, p = 0.33), sensation of 
      heat and warmth being most common. Overall, diagnostic information was similar in 
      both groups. Both CM gave high percentages of examinations rated as optimal 
      (87.1% vs. 90.5%, p = 0.34) and in which diagnostic confidence was increased 
      (87.5% vs. 91.1%, p = 0.22). No significant differences between the two CM were 
      found concerning quantitative enhancement characteristics. CONCLUSIONS: In this 
      study iopentol was significantly safer than iopromide for contrast enhanced CT 
      examination of the abdomen. Radiological efficacy was similar with both CM.
FAU - Encina, J L
AU  - Encina JL
AD  - Medical Department, Nycomed Spain, Madrid, Spain.
FAU - Marti-Bonmati, L
AU  - Marti-Bonmati L
FAU - Ronchera-Oms, C L
AU  - Ronchera-Oms CL
FAU - Rodriguez, V
AU  - Rodriguez V
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase IV
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - Germany
TA  - Eur Radiol
JT  - European radiology
JID - 9114774
RN  - 0 (Contrast Media)
RN  - 0 (Triiodobenzoic Acids)
RN  - 4419T9MX03 (Iohexol)
RN  - 712BAC33MZ (iopromide)
RN  - 7D6XWX076T (iopentol)
SB  - IM
MH  - Contrast Media/*adverse effects
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Iohexol/adverse effects/*analogs & derivatives
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Safety
MH  - Spain
MH  - *Tomography, X-Ray Computed
MH  - Triiodobenzoic Acids/*adverse effects
EDAT- 1997/01/01 00:00
MHDA- 1997/01/01 00:01
CRDT- 1997/01/01 00:00
PHST- 1997/01/01 00:00 [pubmed]
PHST- 1997/01/01 00:01 [medline]
PHST- 1997/01/01 00:00 [entrez]
AID - 10.1007/pl00006875 [doi]
PST - ppublish
SO  - Eur Radiol. 1997;7 Suppl 4:S115-9. doi: 10.1007/pl00006875.