4 P XENETIX P07021 190207.qxd
Transcription
4 P XENETIX P07021 190207.qxd
XENETIX ® Iobitridol ® XENETIX , well-documented tolerance profile confirmed in more than 163 700 patients Cumulative results from 3 post marketing surveillance studies Results of the safety and efficacy of iobitridol in more than 61 000 patients J. Petersein et al., Eur Radiol (2003) 13: 2006-2011 Safety of iobitridol in the general population and at-risk patients Th. J. Vogl et al., Eur radiol (2006) 16: 1288-1297 Intravenous Contrast Media in Uroradiology: Evaluation of Safety and Tolerability in Almost 50 000 patients G. Wendt-Nordahl et al., Med Princ Pract (2006) 15: 358-361 XENETIX ® a well-documented tolerance profile in Tolerance in general population: from 0.9% to maximum 1.1% of adverse events 100 80 60 Patients (%) 40 20 0 Petersein (61 754 pts) Vogl (52 057 pts) Wendt-Nordahl (49 975 pts) No adverse event 98.9% 99.04% 99.1% Total AE* 1.1% 0.96% 0.9% Serious AE** 0.05% 0.044% 0.002% Methodology • 3 post-marketing surveillance studies • Total number of patients included: 163 786 • 21.7% of at risk-patients i.e. 35 563 patients • Patients age: from few weeks to 101 years Type of examinations (number of patients) 2 374 3 106 4 650 Computed tomography Intravenous urography 999 Venography Digital substraction angiography (DSA) 55 882 96 775 Conventional angiography Others (either retrograde or other urological examinations) * ** Warmth sensation excluded Petersein: 1 patient enrolled for pulmonary embolis died from cardiac failure: 21 developed dyspnea, 9 patients presented a drop in blood pressure. Vogl: dyspnea in 17 patients, hypotension in 4 patients, anaphylactic shock in 3 patients Wendt-Nordahl: 1 patient developed anaphylactic shock following intravenous urography general population as in at-risk patients A good tolerance confirmed in 26 614 at-risk patients in 2 studies (J. Petersein & Th. J. Vogl) : under 1.4% of adverse events 100 80 60 Patients (%) 40 20 0 Vogl (14 068 pts) Petersein (1) (12 546 pts) No adverse event 99% 98.6% Total AE* 1.0% 1.4% 0.006% 0.057% Serious AE** Main pre-existing risk factors in the 2 studies (several items per patient) 40 000 35 846 30 000 Number of patients 20 000 12 633 10 000 1 229 1 012 Renal impairment Previous reaction to contrast media 0 Asthma and/or allergies Others*** *** Hypo- or hypertension, Coronary artery disease, Diabetes mellitus, Hearth failure (NYHA III or IV), Dehydration, Poor general condition 1) Total at-risk population in Petersein study: 17 797 patients Analysis realized on 12 546 patients: - 15-to-39 year group = 1 470 patients - 60 years or above = 11 076 patients Creation: Escapades - Realisation: Citron Marine - P07021 XEN - February 2007 www.guerbet.com Base your choice on a wide published experience