Download with Tacrolimus Clinical Experience Ointment in Atopic Dermatitis III

Survey
yes no Was this document useful for you?
   Thank you for your participation!

* Your assessment is very important for improving the work of artificial intelligence, which forms the content of this project

Transcript
8 Clinical Experience in Adults
Table 8.5. Vehicle-controlled studies with tacrolimus: incidence (%) of non-application-site adverse
events (adapted from [29])*
Adverse Event
Treatment group
P value
Vehicle
(n=212)
0.03%
tacrolimus
ointment
(n=210)
0.1%
tacrolimus
ointment
(n=209)
0.03%
tacrolimus
ointment
vs. vehicle
0.1%
tacrolimus
ointment
vs. vehicle
Flu-like symptoms
19.3
23.2,
30.8,
NS
0.034
Headache
10.7
20.0
19.2
0.022
0.036
Acne
1.8
4.3
7.1
NS
0.028
Rash
0.5
4.9
2.1
0.017
NS
Sinusitis
0.7
3.9
2.2
0.048
NS
Cyst
0.0
1.1
3.1
NS
0.046
Myalgia
0.0
2.8
1.6
0.026
NS
Back pain
0.0
2.3
1.6
0.046
NS
* The incidence of flu-like symptoms, which included upper respiratory tract problems (colds, stuffy nose, etc.)
and other non-application-site events reported here is higher in tacrolimus-treated than vehicle-treated patients.
However, this observation has been noted within the stringent reporting confines of the clinical trial setting.
NS not significant.
studies the number of reported cases was too small to test for statistical significance.
When data from all three adult phase III studies plus two paediatric studies were
pooled, no local skin infection was found to be statistically significantly more common with tacrolimus ointment compared with reference therapy.
Although on the basis of these data there does not appear to be an increased risk
of viral infections with tacrolimus ointment, there have been several controversial
cases of eczema herpeticum in patients treated with tacrolimus [16]. Physicians
should therefore exercise caution in the use of this agent in patients who have active
herpes simplex or herpes zoster infections.
Non-Application-Site Adverse Events
There has been no evidence of a trend towards any non-application-site adverse
event with tacrolimus ointment in the clinical studies carried out to date or in postmarketing surveillance. In the two vehicle-controlled studies, there were no clear
differences between the tacrolimus ointment and vehicle arms with regard to the
frequency of non-application-site adverse events (Table 8.5). Flu-like symptoms
were the most commonly reported non-application-site adverse events occurring
in both the vehicle and tacrolimus treatment arms (20%–30% of tacrolimus-treated
patients versus 10%–15% of vehicle-treated patients). The increased incidence of flulike symptoms (colds and stuffy nose) is probably a result of the stringent reporting
150
Document related concepts

Management of multiple sclerosis wikipedia, lookup

Multiple sclerosis research wikipedia, lookup