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
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