title: Intra-arterial and intravenous applications of Iosimenol 340 injection, a new non-ionic, dimeric, iso-osmolar radiographic contrast medium: phase 2 experience.
abstract: BACKGROUND
  Iosimenol 340 injection is a new, dimeric, iso-osmolar, iodinated contrast medium for X-ray angiography.
  
  
  OBJECTIVE
  To compare the safety and efficacy of iosimenol injection to iodixanol injection in two randomized, controlled phase 2 trials.
  
  
  METHODS
  One hundred and forty-four adult patients were enrolled in the two trials, one for evaluation during arteriography and the other for evaluation during computed tomography. Safety was compared by assessing adverse events, vital signs, ECGs, and laboratory parameters. Efficacy was assessed as X-ray attenuation in the computed tomography (CT) trial and as the quality of contrast enhancement in the arteriography trial.
  
  
  RESULTS
  There were no statistically significant differences in terms of safety or efficacy between the two contrast media. Both were well tolerated upon intravenous as well as intra-arterial injection. The most common adverse event was a feeling of warmth (observed in 35.1% of the patients with Iosimenol injection and 44.3% with iodixanol injection).
  
  
  CONCLUSIONS
  Iosimenol upon intravenous as well as upon intra-arterial injection exhibits a safety profile and shows an efficacy similar to that of iodixanol.
authors.affiliation: Otsuka Novel Products GmbH, Munich, Germany, Germany kmeurer@otsuka-onpg.com.
authors.forename: Karoline
authors.initials: K
authors.lastname: Meurer
authors.affiliation: Institut und Poliklinik für Radiologische Diagnostik, Universitätsklinikum Carl Gustav Carus, Dresden, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Laniado
authors.affiliation: Institut für Diagnostische Radiologie und Neuroradiologie, Ernst-Moritz-Arndt-Universität, Greifswald, Germany.
authors.forename: Norbert
authors.initials: N
authors.lastname: Hosten
authors.affiliation: Department of Radiology, Charité, Humboldt University, Berlin, Germany.
authors.forename: Bettina
authors.initials: B
authors.lastname: Kelsch
authors.affiliation: Otsuka Novel Products, Medical Imaging, Otsuka Pharmaceutical Development & Commercialization, Princeton, NJ, USA.
authors.forename: Barry
authors.initials: B
authors.lastname: Hogstrom
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015901:Angiography, Digital Subtraction / Q000379:methods*; D001549:Benzamides / Q000008:administration & dosage*; D003287:Contrast Media / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007269:Injections, Intra-Arterial; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D011412:Propanolamines / Q000008:administration & dosage*; D014057:Tomography, X-Ray Computed / Q000379:methods*; D055815:Young Adult
chemical_list: D001549:Benzamides; D003287:Contrast Media; D011412:Propanolamines; C450045:iosmin
keywords: Iosimenol; contrast media; iso-osmolar; viscosity