Safety profile of cefditoren. A pooled analysis of data from clinical trials in community-acquired respiratory tract infections.
BACKGROUND
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.


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 < or = 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).


CONCLUSIONS
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.
Granizo
J J
JJ
Granadatos Pozuelo de Alarcón, Madrid, Spain. jjgranizo@ya.com
Aguilar
L
L
Gimenez
M J
MJ
Coronel
P
P
Gimeno
M
M
Prieto
J
J
D019980:Amoxicillin-Potassium Clavulanate Combination / Q000009:adverse effects / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000009:adverse effects* / Q000627:therapeutic use; D002511:Cephalosporins / Q000009:adverse effects* / Q000627:therapeutic use; D017326:Clinical Trials, Phase III as Topic / Q000706:statistics & numerical data; D017714:Community-Acquired Infections / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced* / Q000453:epidemiology; D006801:Humans; D008297:Male; D010406:Penicillins / Q000009:adverse effects / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D012141:Respiratory Tract Infections / Q000188:drug therapy*; D015163:Superinfection / Q000453:epidemiology / Q000209:etiology*; D014627:Vaginitis / Q000453:epidemiology / Q000209:etiology*
D000900:Anti-Bacterial Agents; D002511:Cephalosporins; D010406:Penicillins; D019980:Amoxicillin-Potassium Clavulanate Combination; C073460:cefditoren