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Comparison of cefprozil, cefpodoxime proxetil, loracarbef, cefixime, and
ceftibuten.
Schatz B S, Karavokiros K T, Taeubel M A, Itokazu G S..
Comparison of cefprozil, cefpodoxime proxetil, loracarbef, cefixime, and
ceftibuten.
Annals of Pharmacotherapy,
1996,
30(3),
pp. 258-268
Record status
This record is a structured abstract written by CRD reviewers. The original
has met a set of quality criteria.
Author's objective
To review the clinical trials of the effectiveness and safety of oral
beta-lactams. Type of intervention
Treatment.
Specific interventions included in the review
Cefprozil, cefpodoxime proxetil, loracarbef, cefixime, and ceftibuten.
Participants included in the review
Patients with community-acquired infections. Infections included are acute
otitis media, pharyngitis, sinusitis, bronchitis, pneumonia, uncomplicated
gonococcal infection, urinary tract infection, and skin and skin-structure
infections. Some trials included both children and adults.
Outcomes assessed in the review
Clinical response to therapy as defined in the primary studies, including cure
rate and recurrence rate.
Study designs of evaluations included in the review
Randomised, controlled trials (RCTs) comparing cefprozil, cefpodoxime
proxetil, loracarbef, cefixime, or ceftibuten to conventional therapies.
Uncontrolled studies were included where data was limited for FDA-improved
indications.
What sources were searched to identify primary studies?
MEDLINE, 1986 to January 1995.
Criteria on which the validity (or quality) of studies was assessed
Differences in validity are discussed in the text of the review.
Methodological shortcomings of studies are highlighted.
How were the judgements of validity (or quality) made?
Not stated.
How were decisions on the relevence of primary studies made?
Not stated.
How was the data extracted from primary studies?
Not stated.
Number of studies included
Acute otitis media: Cefprozil, 5 studies; cefpodoxime, 2 studies; cefixime, 7
studies; loracarbef, 3 studies; ceftibuten, 2 studies.
Pharyngitis: 13 studies in total
Sinusitis: 4 studies in total
Bronchitis: 10 studies
Pneumonia: 7 studies
Urinary tract infection: 11 studies
Skin and skin-structure infections: 4 studies
No patient numbers are given for the included studies, though the authors
state that generally 30-50 patients were enrolled per treatment arm.
How were the studies combined?
Narrative review, with some quantitative summaries. Overall clinical response
rates are presented, for example to summarise the percentage of patients in
primary studies who were cured at follow-up.
How were differences between studies investigated?
Reasons for differences between studies are examined in the text of the
review.
Results of the review
Acute otitis media: For most studies, clinical response (within 1-4 days of
completing therapy) was more than 85%. Significant differences between the
drug regimens were not found.
Pharyngitis: Most studies in paediatric and adult patients demonstrated
similar clinical efficacy with no significant differences among the regimens.
Response rates of 84-100% during the early (<10 days post-treatment) and/or
late (10-50 days post-treatment) evaluation periods were reported. Early
bacterial eradication rates of more than 75% were noted for all of the new
beta-lactams.
Sinusitis: Clinical response within three days of treatment was more than 90%
and usually not significantly different between the regimens. Presumed or
documented bacterial eradication was 80% or more in these studies.
Bronchitis: In patients with acute bacterial bronchitis loracarbef or cefixime
were compared with amoxicillin/clavulanate or cefaclor, and clinical response
or bacterial eradication were similar for patients enrolled in either
treatment arm. One study found a lower response with cefixime and
amoxicillin/clavulanate and this was attributed to the greater age of the
patients in this trial. In patients with acute exacerbations of chronic
bronchitis, the clinical success rate was 84-97% in studies comparing
cefpodoxime or cefixime with amoxicillin/clavulanate cefaclor or cephalexin.
Cefprozil or ceftibuten 400 mg once daily was as efficacious as cefaclor
250-500 mg tid. Clinical success was achieved in 80-96% of patients assigned
to either treatment arm, though clinical response was greater with cefprozil
than cefuroxime (p=0.032). S. pneumoniae and H. influenzae were isolated
frequently in studies enrolling patients with either acute bronchitis or acute
exacerbations of chronic bronchitis. Bacteriologic eradication for these
studies was 73% or more and not significantly different between drug regimens.
Pneumonia: In all studies clinical response was achieved in more than 90% of
evaluable patients. When reported, bacterial eradication was 70% or more and
was similar for all regimens that were compared. Uncomplicated gonococcal
infection: Greater than 95% eradication of N. gonorrhoea was achieved in two
studies which examined ceftriaxone and amoxicillin plus probenecid. A single
dose of cefpodoxime (50-600mg) was effective for gonococcal urethritis.
Urinary tract infection: No statistically significant differences could be
detected in the clinical or bacteriologic responses for different
beta-lactams. Clinical cure was achieved in at least 75% of patients during
early evaluation (5-10 days after treatment). Re-evaluation during the late
period (4-6 weeks after therapy) confirmed clinical resolution in at least 65%
of patients. The bacterial response (eradication of e. coli) occurred in a
minimum of 70% of patients at the early evaluation period and was maintained
in 65% or more of evaluable patients.
Skin and skin-structure infections: Loracarbef, cefprozil and cefpodoxime
appear to be as efficacious as amoxicillin/clavulanate or cefaclor. Clinical
response and bacterial improvement were favourable in 85-100% of patients
evaluated.Overall response (favourable clinical response with concomitant
documented/presumed bacterial cure or colonisation) determined 3-18 days after
completion of therapy was more than 84% for patients treated with loracarbef,
cefaclor, cefprozil or amoxicillin/clavulanate, with no significant
differences between the regimens.
Safety: In paediatric patients, a significantly higher incidence of
diarrhoea/loose stools was noted with amoxicillin/clavulanate than with other
antibiotics, while in adults this effect was more common with
amoxicillin/clavulanate than with loracarbef (p<=0.033) or cefprozil (p<0.05).
Four case-reports have described a serum-sickness type reaction following
cefprozil therapy.
Was any cost information reported?
No.
Author's conclusions
These newer agents appear to be as clinically effective as conventional
therapies for the treatment of common community-acquired infections. They may
also have the potential to improve compliance due to their once/twice daily
mode of administration.
CRD commentary
A detailed and critical review. Although the review appears to be similar in
format to a conventional narrative review, there does appear to be an
assessment of the validity of the primary studies, and investigation of
differences in results between studies does occur where it appears warranted.
However, a wider search (i.e. of databases other than MEDLINE) would perhaps
have identified a larger number of primary studies for inclusion in the
review.
Also, many different antibiotic regimens are compared and it would have been
helpful if a summary table had been used to summarise details from individual
studies: the numbers of patients in trails is not always presented, and the
small sample size in many trials may be related to the non-significant
differences between regimens.
Subject index terms
Subject indexing assigned by CRD: Administration,-Oral; Antibiotics/tu
[therapeutic-use]; Anti-Infective-Agents; Bacterial-Infections/dt
[drug-therapy]; Bronchitis/dt [drug-therapy]; Cephalosporins/pk
[pharmacokinetics]; Cephalosporins/pd [pharmacology]; Cephalosporins/tu
[therapeutic-use]; Lactams/tu [therapeutic-use]; Otitis-Media/dt
[drug-therapy]; Pharyngitis/dt [drug-therapy]; Pneumonia/dt [drug-therapy];
Sinusitis/dt [drug-therapy]; Skin-Diseases,-Bacterial/dt [drug-therapy];
Urinary-Tract-Infections/dt [drug-therapy];
Correspondence address
G. S. Itokazu, Department of Pharmacy, Cook County Hospital, 1900 W Polk
Street, Suite 522, Chicago, IL 60612, USA.
Copyright
University of York, 1998
Database no.: DARE-960607
