title: Results of randomized controlled trials of low-versus high-osmolality contrast media.
abstract: The authors reviewed 100 randomized controlled trials (RCTs) conducted in humans to compare safety or efficacy of new low-osmolality contrast media (LOM) with that of high-osmolality contrast media (HOM). Findings of the 43 RCTs judged to be of the highest quality suggest that the efficacy of LOM in imaging is equal or superior to that of HOM for all routes of administration. Heat sensation occurred less often with LOM for all routes and pain occurred less often with LOM for intraarterial routes. No differences were seen in nephrotoxicity or in frequency of nausea, vomiting, urticaria, bronchospasm, laboratory test abnormalities, or neurologic events. Greater cardiovascular changes were seen with HOM, including increased or decreased heart rate, increased left ventricular end-diastolic pressure, decreased systolic pressure, and QT prolongation, depending on route of administration. To demonstrate whether a reduction in clinically significant adverse outcomes truly occurs with LOM, trials will need to enlist larger numbers of patients and employ appropriate outcome measures. Future trials should stratify patients according to their risk of adverse reactions to provide better information about benefits of LOM in low- versus high-risk patients.
authors.affiliation: Johns Hopkins Program for Medical Technology and Practice Assessment, Johns Hopkins University School of Medicine, Baltimore, MD 21205.
authors.forename: M L
authors.initials: ML
authors.lastname: Kinnison
authors.forename: N R
authors.initials: NR
authors.lastname: Powe
authors.forename: E P
authors.initials: EP
authors.lastname: Steinberg
mesh_terms: D002986:Clinical Trials as Topic; D003287:Contrast Media / Q000008:administration & dosage / Q000009:adverse effects; D003331:Coronary Vessels; D006801:Humans; D007269:Injections, Intra-Arterial; D007275:Injections, Intravenous; D009994:Osmolar Concentration; D011651:Pulmonary Artery / Q000000981:diagnostic imaging; D011859:Radiography; D011897:Random Allocation
chemical_list: D003287:Contrast Media