Safety profile of cefditoren. A pooled analysis of data from clinical trials in community-acquired respiratory tract infections
2009
Introduction. A high number of individuals in the population
are exposed to antibiotics for the treatment of respiratory
tract infections. It is important to review the adverse
events profile related to antibiotic exposure during
the clinical development of drugs that are or have been recently
included in the therapeutic armamentarium.
Material and methods. Safety data from all 13 clinical
trials of cefditoren on community acquired respiratory infections
were reviewed. Safety population was defined as all
randomized patients with at least one dose intake. Adverse
events considered by investigators as related during antibiotic
exposure were considered.
Results. The overall safety population consisted in
4,592 patients for cefditoren and 2,784 for comparators.
Overall reported diarrhoea related to cefditoren administration
was significantly higher (p . 0.001) than comparators
(9.9% vs 6.9%) due to the significant difference in the
pooled pharyngotonsillitis studies (8.3% vs 3.2%), while no
significant differences in others pathologies were found,
with 9.4% (with cefditoren) vs 10.3% (with comparators) in
the case of community-acquired pneumonia (CAP). Dyspepsia
and abdominal pain were reported as adverse events in
< 2.7% patients regardless the treated disease. In females
population lower related vaginosis rate was found in cefditoren
vs comparators, mainly due to differences among patients
treated for sinusitis (4.5% vs 8.1%) and CAP (2.3% vs
5.5%) although differences were not significant (p = 0.017
and p = 0.008, respectively).
Conclusion. This study analysing reported adverse
events from clinical trials showed an adverse events profile
of cefditoren similar to those of standard antibiotics used in
the treatment of respiratory tract infections.
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