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Lorabid

Clinical Pharmacology
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Clinical Pharmacology

Lorabid


Safety: The incidences of the following adverse events were clinically and statistically significantly higher in the control arm versus the loracarbef arm (TABLE 7).

TABLE 7
Event Loracarbef Control
Diarrhea 15% 26%
Rash* 8% 15%
* The majority of these involved the diaper area in young pediatric patients.


Study 2: In a controlled clinical study of acute otitis media performed in Europe, loracarbef was compared to amoxicillin. As expected in a European population, this study population had a lower incidence of b- lactamase-producing organisms than usually seen in U.S. trials. In this study, using very strict evaluability criteria and microbiologic and clinical response criteria at the 10- to 16-day post therapy follow-up, the following presumptive bacterial eradication/clinical cure outcomes (i.e., clinical success) were obtained (see TABLE 8).

TABLE 8 European Acute Otitis Media Study: Loracarbef vs Amoxicillin
Efficacy
Pathogen % of Cases With Pathogens (n=291) Outcome
 S. pneumoniae 51.5%  Loracarbef equivalent to amoxicillin
 H. influenzae 29.2%  Loracarbef success rate 14% greater than amoxicillin
 M. catarrhalis 15.8%  Loracarbef success rate 31% greater than amoxicillin
 S. pyogenes 3.4% Loracarbef equivalent to amoxicillin
Overall 100.0%  Loracarbef equivalent to amoxicillin


Acute Maxillary Sinusitis

In a controlled clinical study of acute maxillary sinusitis performed in Europe, loracarbef was compared to doxycycline. In this study there were 210 sinus-puncture evaluable patients. As expected in a European population, this study population had a lower incidence of b-lactamase-producing organisms than usually seen in U.S. trials. In this study, using very strict evaluability criteria and microbiologic and clinical response criteria at the 1- to 2-week post therapy follow-up, the following presumptive bacterial eradication/clinical cure outcomes (i.e., clinical success) were obtained (see TABLE 9).

TABLE 9 European Acute Maxillary Sinusitis Study: Loracarbef vs Doxycycline
Efficacy
Pathogen % of Cases With Pathogens (n=210) Outcome
 S. pneumoniae 47.6%  Loracarbef equivalent to doxycycline
 H. influenzae 41.4%  Loracarbef equivalent to doxycycline
 M. catarrhalis 11.0%  Loracarbef equivalent to doxycycline
 Overall 100.0%  Loracarbef equivalent to doxycycline


Cystitis

Study 1: In a controlled clinical study of cystitis performed in the United States, loracarbef was compared to cefaclor. In this study, using very strict evaluability criteria and microbiologic and clinical response criteria at the 5- to 9-day post therapy follow-up, the following bacterial eradication rates were obtained (see TABLE 10 ).

TABLE 10 U.S. Uncomplicated Cystitis Study: Loracarbef vs Cefaclor
Efficacy
Pathogen % of Cases With Pathogens (n=186) Outcome
 E. coli 77.4%  Loracarbef eradication rate 4% greater than cefaclor (loracarbef eradication rate 80%)
 Other major
 Enterobacteriaceae		 12.5%  Loracarbef equivalent to cefaclor (loracarbef eradication rate 61%)
 S. saprophyticus 3.8%  Loracarbef equivalent to cefaclor
Brand Name: Lorabid
Generic Name: Loracarbef
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