An Open Label, Multi-Center, Non-Interventional Post-Marketing Surveillance to Monitor the Safety and Efficacy of ALTARGO® (Retapamulin) Administered in Korean Patients According to the Prescribing Information
Annals of Dermatology
;
: 441-450, 2018.
Article
Dans Anglais
| WPRIM
| ID: wpr-716502
ABSTRACT
BACKGROUND:
With the approval of topical retapamulin ointment in 2011, it was officially required to conduct a post-marketing surveillance (PMS) study to obtain further data of its safety profile and effectiveness, in accordance with the requirement of the Korean Ministry of Food and Drug Safety (MFDS).OBJECTIVE:
This study had prospectively designed to monitor safety and tolerability with the effectiveness of topical retapamulin in clinical practices.METHODS:
Open label, multi-center, non-interventional observational study was done from May 2011 to October 2015. All subjects had bacterial skin infections of locally approved prescribing information accordingly. The study mainly focused on safety issues in the local target population (3,612 eligible subjects). And, drug effectiveness was also evaluated by physicians.RESULTS:
The incidence of adverse events (AEs) and adverse drug reactions (ADRs) were 2.53% and 0.97%, respectively. In terms of the incidence of unexpected AEs and ADRs, 1.45% and 0.33%, and for the incidence of serious AEs, 0.28%, whereas no serious ADRs reported. And, the effectiveness of topical retapamulin rate was 96.1% (1,697 of total 1,765 subjects).CONCLUSION:
Topical retapamulin is to be well-tolerated and effective in patients with bacterial skin infections of locally approved prescribing information.
Texte intégral:
Disponible
Indice:
WPRIM (Pacifique occidental)
Sujet Principal:
Peau
/
Maladies de la peau
/
Incidence
/
Études prospectives
/
Effets secondaires indésirables des médicaments
/
Étude d'observation
/
Besoins et demandes de services de santé
/
Antibactériens
Type d'étude:
Essai clinique contrôlé
/
Etude d'incidence
/
Étude observationnelle
/
Étude pronostique
/
Étude de dépistage
Limites du sujet:
Humains
langue:
Anglais
Texte intégral:
Annals of Dermatology
Année:
2018
Type:
Article
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