Philippe Alain Soyer MD, PhD, Presenter: Nothing to Disclose

To prospectively assess the general safety profile of meglumine gadoterate (Gd-DOTA) and evaluate the overall incidence of nephrogenic systemic fibrosis (NSF).

A worldwide post marketing study was conducted to collect safety data in 40,000 patients with or without renal insufficiency who had routine contrast-enhanced magnetic resonance (MR) imaging using Gd-DOTA. For each patient, risk factors at inclusion, indications for MR imaging examination, and conditions of use and administration of the contrast material were recorded. For any patient identified as renally impaired at the time of inclusion (i.e., estimated glomerular filtration rate or estimated creatinine clearance < 60 mL/min/1.73m²), a 3-month follow-up evaluation was performed in order to detect any suspicion or occurrence of NSF.

As of January 31, 2011, the cut-off date for the interim safety analysis, this ongoing PMS included data from 13,364 patients (mean age: 50 years; range: 0-98 years; female, 53.8%). MR imaging examinations were mainly performed to image the central nervous system (48.2%) and the body (23.5%). The main risk factors were arterial hypertension (12.9%) and prior history of allergy (10.7%). Moderate to severe impaired renal function was reported in 309 patients (2.3%). Among them, 204 (66.0%) had no suspicion of NSF, and for the remaining 105 patients (34.0%), follow-up evaluation was not yet completed at the time data were collected. At least one adverse event (mainly urticaria, vomiting, and nausea) was reported in 19 patients (0.14%). Two deaths due to an advanced underlying disease were reported.

This interim analysis already suggests an excellent safety profile for Gd-DOTA.

Clinicians and radiologists must be aware of of the increased risk of nephrogenic systemic fibrosis. This interim analysis suggests an excellent safety profile for Gd-DOTA.

Soyer, P, SECURE Study: Observational Post Marketing Study on the Safety of Meglumine Gadoterate—Interim Safety Analysis on 13,364 Patients.  Radiological Society of North America 2011 Scientific Assembly and Annual Meeting, November 26 - December 2, 2011 ,Chicago IL. http://archive.rsna.org/2011/11006185.html