Augmentin (Amoxicillin/Clavulanate) versus ...
Both clarithromycin and amoxicillin/clavulanate are first line antibiotics for acute rhinosinusitis and are equally effective. Clarithromycin produces more rapid improvement in symptoms.
The study4 examined the efficacy of clarithromycin and amoxicillin/clavulanate for the treatment of acute rhinosinusitis relative to the patient's quality of life. Twenty patients completed the study. The six-item Symptom Severity Survey and the Rhinoconjunctivitis quality of life Questionnaire demonstrated significant improvement for all patients at week 4. This Survey demonstrated significant improvement for clarithromycin at 14 days and at 28 days, whereas amoxicillin/clavulanate patients demonstrated significant improvement in symptoms only at 28 days. The Rhinoconjunctivitis quality of life Questionnaire, which reflects the previous 2 weeks, demonstrated significant improvement for the amoxicillin/clavulanate patients at 28 days.
Clarithromycin ER is comparable, and for selected measures superior, to Augmentin in the treatment of acute bacterial sinusitis.
The controlled, multicenter, investigator-blinded study3, compared the efficacy and tolerability of clarithromycin extended-release (ER) to amoxicillin/ clavulanate in patients with acute bacterial sinusitis. The clinical cure rate was 98% (184/188) in the clarithromycin ER group and 97% (179/185) in the amoxicillin/clavulanate group. Clinical cure was sustained at the follow-up visit (96% for each group). The pathogen eradication rates were 94% (61/65) in the clarithromycin ER group and 98% (61/62) in the amoxicillin/clavulanate group. The radiological success rate was 94% (172/183) in both groups. Symptomatic improvement or relief was observed as early as 2-5 days after the initiation of the treatment, with a statistically significantly higher resolution rate of sinus pressure and improvement/resolution rate of nasal congestion during treatment with clarithromycin ER. The resolution and improvement rate at the test-of-cure visit for each study group was > or = 94% for the primary acute sinusitis symptoms, with a statistically significantly higher resolution or improvement rate of purulent nasal discharge with clarithromycin ER. Both had a positive and rapid impact on quality of life. Patients reported a high level of satisfaction and probability of using either study antibiotic again, and health care resource use was low, with slightly fewer sinusitis-related physician and outpatient visits required by patients on clarithromycin ER. The incidence of side effects was comparable.
Both clarithromycin extended-release and Augmentin are effective in the treatment of acute exacerbation of chronic bronchitis. However, clarithromycin is better tolerated.
The study2 compared extended-release formulation of clarithromycin with amoxicillin/clavulanate in the treatment of acute exacerbation of chronic bronchitis. Among clinically evaluable patients at test of cure, 85% of clarithromycin- and 87% of amoxicillin/clavulanate-treated patients, demonstrated clinical cure; among evaluable patients, 92% versus 89%, respectively, demonstrated bacteriologic cure. Overall pathogen eradication rates were similar in the 2 groups (88% clarithromycin, 89% amoxicillin/clavulanate). Rates of premature discontinuation were different: 3% (4/142) of clarithromycin-treated patients versus 12% (17/145) of amoxicillin/clavulanate-treated patients. Adverse events generally occurred with a similar frequency. However, taste alteration was more common with clarithromycin (9/142) than with amoxicillin/clavulanate (1/145). Mean severity scores for gastrointestinal adverse events showed a significant difference between groups (1.16 for clarithromycin- and 1.58 for amoxicillin/clavulanate).
The efficacy of clarithromycin is comparable with Augmentin in the treatment of acute otitis media in children. Clarithromycin is better tolerated with a lower incidence of gastrointestinal side effects.
The randomized, investigator-blinded, multicenter trial1 compared the safety and efficacy of clarithromycin and amoxicillin/clavulanate in the treatment of acute otitis media in patients ages 6 months to 12 years. A successful clinical response was seen in 90% (121 of 135) of evaluable clarithromycin patients vs. 92% (133 of 145) of evaluable amoxicillin/clavulanate patients. Clinical failure or relapse (Posttreatment Days 0 to 4) occurred in 10% (14 of 135) of clarithromycin-treated patients vs. 8% (12 of 145) of amoxicillin/clavulanate-treated patients. Gastrointestinal adverse effects were the most commonly reported in both groups. Diarrhea was the most frequent, occurring in 12% (19 of 161) of clarithromycin and 32% (57 of 177) of amoxicillin/clavulanate recipients.
Acute Otitis Media
There is evidence from a randomized study in children 6–36 months of age with acute otitis media that a 5-day regimen of cefuroxime axetil is as effective as and may be better tolerated than an 8- or 10-day regimen of amoxicillin/clavulanate8.
Acute Otitis Media with Effusion
Cefuroxime axetil suspension 15 mg/kg twice daily is as effective as amoxicillin/clavulanate suspension 13.3 mg/kg three times daily in children diagnosed with acute otitis media with effusion, but produces fewer gastrointestinal side effects, particularly diarrhea9.
Cefuroxime axetil is as effective as amoxicillin/clavulanate in the treatment of acute bronchitis. Cefuroxime produces fewer diarrhea and nausea.
Two independent, investigator-blinded, multicenter, randomized clinical trials10 compared the clinical and bacteriologic efficacy and safety of cefuroxime axetil and amoxicillin/clavulanate, in the treatment of secondary bacterial infections of acute bronchitis. Three hundred sixty patients with acute bronchitis were enrolled at 22 centers and were randomly assigned to receive 10 days of either cefuroxime axetil 250 mg twice daily (BID) (n= 177) or amoxicillin/clavulanate 500 mg three times daily (TID) (n = 183).
A satisfactory clinical outcome (cure or improvement) was achieved in 86% (117 of 136) and 83% (130 of 157) of the patients treated with cefuroxime axetil or amoxicillin/clavulanate, respectively. With respect to the eradication of bacterial pathogens, a satisfactory outcome (cure, presumed care, or cure with colonization) was obtained in 91% (53 of 58) and 86% (60 of 70) of patients treated with cefuroxime axetil or amoxicillin/clavulanate, respectively. Amoxicillin/clavulanate was associated with a significantly higher incidence of side effects than cefuroxime axetil (39% vs 23%), primarily reflecting a higher incidence of gastrointestinal adverse effects (37% vs 15%), particularly diarrhea and nausea. Four patients on cefuroxime axetil and eight patients on amoxicillin/clavulanate withdrew from the study because of adverse effects.
Cefuroxime axetil is as effective as Augmentin in the treatment of outpatients with mild to moderate community-acquired pneumonia.
In a multicentre, investigator-blinded clinical trial11, 162 patients with community-acquired pneumonia were randomly assigned to receive orally either cefuroxime axetil 500 mg twice a day (n = 84) or amoxicillin/clavulanate 500 mg/125 mg three times a day (n = 78) for 10 days. Cure or improvement were achieved in 100% (55 of 55) and 96% (49 of 51) of patients treated with cefuroxime axetil or amoxicillin/clavulanate, respectively. With respect to eradication of bacterial pathogens, a satisfactory outcome was obtained in 94% (32 of 34) and 93% (37 of 40) of patients treated with cefuroxime axetil or amoxicillin/clavulanate, respectively. Both study regimens were well tolerated. The most common side effects were gastrointestinal, reported by 8% and 4%, respectively, of the patients in the amoxicillin/clavulanate and cefuroxime axetil groups.
Cefuroxime axetil is as effective as Augmentin in the treatment of acute bacterial sinusitis but produces fewer side effects.
Multicenter study12 compared the clinical and bacteriologic efficacy of cefuroxime axetil and amoxicillin/clavulanate, in the treatment of acute bacterial maxillary sinusitis. A satisfactory clinical outcome (cure or improvement) was achieved in 85% (98 of 115) and 82% (102 of 124) of patients treated with cefuroxime axetil or amoxicillin/clavulanate, respectively. With respect to the eradication of the bacterial pathogens, a satisfactory outcome (cure or presumed cure) was obtained in 84% (31 of 37) and 87% (34 of 39) of patients treated with cefuroxime axetil or amoxicillin/clavulanate, respectively. Amoxicillin/clavulanate was associated with a significantly higher incidence of adverse effects (13% versus 3%), particularly diarrhea (8% versus 1%).
Acute otitis media
High-dose amoxicillin/clavulanic acid is significantly more effective than cefdinir as a therapy for children with acute otitis media (AOM).
The study14 compared the clinical efficacy of amoxicillin/clavulanic acid high-dose therapy for 10 days with cefdinir therapy for 5 days for acute otitis media at recommended doses. Children treated with amoxicillin/clavulanic acid had a better cure rate (86.5%) than children treated with cefdinir (71.0%). Cefdinir was correlated with less frequent cure results as children increased in age between 6 and 24 months.
Levofloxacin and amoxicillin/clavulanate are similarly effective for recurrent acute otitis media.
In an evaluator-blinded, active-comparator, noninferiority, multicenter study7, children (6 months to < 5 years) were randomized to receive levofloxacin (10 mg/kg twice daily) or amoxicillin/clavulanate (14:1; amoxicillin 45 mg/kg twice daily) for 10 days. 630 children received levofloxacin and 675 received levofloxacin. Clinical cure (resolution of signs and symptoms) rates were 72.4% (456 of 630) in levofloxacin-treated and 69.9% (472 of 675) in amoxicillin/clavulanate-treated children. Cure rates were also similar for levofloxacin and comparator for each age group (< or =24 months: 68.9% versus 66.2%; > 24 months: 76.9% versus 75.1%; respectively). Cure rates at last visit (10-17 days after the last dose) were 74.9% and 73.8% in levofloxacin and amoxicillin/clavulanate groups, respectively. Thus, levofloxacin was found to be non-inferior to amoxicillin/clavulanate overall and in both infants (6 months to 2 years) and children 2-5 years. No differences regarding the frequency or type of side effects were observed.
Levofloxacin is as effective and safe as Augmentin in the treatment of maxillary sinusitis. Levofloxacin is more effective in the bacteriological eradication of the infection.
The study6 compared the clinical efficacy and bacteriological response of levofloxacin and co-amoxiclav in the treatment of purulent maxillary sinusitis. Sixty patients randomly received either levofloxacin 300 mg orally once daily or co-amoxiclav 625 mg three times a day for 14 days. Radiological improvement was 61.8% with levofloxacin (41.2% resolution, 20.6% improvement) and 61.5% with co-amoxiclav (26.9% resolution, 34.6% improvement). Pretreatment maxillary antral aspiration cultures were positive in 28 patients (82.4%) in the levofloxacin group and 20 patients (76.9%) in the co-amoxiclav group. Bacteriological eradication was 78.5% in the LEV group and 70.0% in the COA group, which was not significantly different. In the LEV group, the eradication rate for major pathogens of acute sinusitis was 100% for H. influenzae, 100% for S. pneumoniae and S. aureus, 100% for Neisseria species, and 66.7% for P. aeruginosa. The eradication rate in the COA group was 75% for H. influenzae, 100% for S. pnumoniae and S. aureus, 50% for Neisseria species, and 0% for P. aeruginosa.
Side effects (mainly nausea, abdominal ache, and diarrhea) were reported in 8.8% of patients in the LEV and in 7.7% of patients in the COA group.
Levofloxacin appears to be slightly more effective than Augmentin for acute bacterial exacerbation of chronic bronchitis.
Post hoc analysis5 of data from a previous randomized, blinded, multicenter, parallel, noninferiority study assessed the bacterial etiology, symptom resolution, and tolerability of severe acute bacterial exacerbation of chronic bronchitis (ABECB) patients treated with either levofloxacin for 5 days or amoxicillin/clavulanate for 10 days. And 175 patients were microbiologically assessable (86 treated with levofloxacin and 89 treated with amoxicillin/clavulanate). At the on-treatment visit, a significantly higher proportion of patients in the levofloxacin group resolved purulent sputum production (57.5% vs 35.6%), sputum production (65.4% vs 45.3%), and cough (60.0% vs 44.0%), compared with the amoxicillin/clavulanate group. However, no significant between-group differences were observed at posttreatment. A total of 341 pathogens were isolated, of which 143 (41.9%) were traditional ABECB flora, 181 (53.1%) were other gram-negative organisms, and 17 (5.0%) were gram-positive organisms. Overall susceptibility of the pathogens was 97.1% for levofloxacin and 90.6% for amoxicillin/clavulanate. The prevalence of adverse events was 42.1 % in patients who received levofloxacin and 48.6 % in those who received amoxicillin/clavulanate.
Doxycycline and Augmentin are equally effective in the treatment of tracheobronchitis in adults. Gastrointestinal side effects occur more frequently with Augmentin.
Doxycycline and co-amoxiclav were compared in a randomized clinical trial13 in patients with acute suppurative tracheobronchitis. Patients were treated for 5 to 10 days with either antibiotic following three schemes: co-amoxiclav 500 mg three times daily, or doxycycline 200 mg on day 1 followed by 100 mg daily, or 200 mg daily. Patients with inadequate response to the initial treatment were crossed over to the alternative antibiotic. Both regimens proved equally efficacious, with rates of clinical response (cure or improvement) of 89% and 91% for doxycycline and co-amoxiclav, respectively. Patients who were crossed over to the alternative antibiotic had a significantly lower cure rate after their second course of antibiotics (22% compared with 70%). Adverse effects, most often of gastro-intestinal, were more common in the co-amoxiclav group, but rarely caused cessation of treatment.
Published: March 31, 2008