Limits...
Amoxicillin/Clavulanic Acid for the Treatment of Odontogenic Infections: A Randomised Study Comparing Efficacy and Tolerability versus Clindamycin.

Tancawan AL, Pato MN, Abidin KZ, Asari AS, Thong TX, Kochhar P, Muganurmath C, Twynholm M, Barker K - Int J Dent (2015)

Bottom Line: Secondary efficacy results showed a higher clinical success rate at Day 5 in the amoxicillin/clavulanic acid arm.Conclusion.Amoxicillin/clavulanic acid was comparable to clindamycin in achieving clinical success (88.2% versus 89.7%) in acute odontogenic infections and the safety profile was consistent with the known side effects of both drugs.

View Article: PubMed Central - PubMed

Affiliation: Tancawan Dental Clinic, Door 2 Cebu Coliseum Building, Leon Kilat Street, 6000 Cebu City, Philippines.

ABSTRACT
Background. Treatment of odontogenic infections includes surgical drainage and adjunctive antibiotics. This study was designed to generate efficacy and safety data to support twice daily dosing of amoxicillin/clavulanic acid compared to clindamycin in odontogenic infections. Methods. This was a phase IV, randomised, observer blind study; 472 subjects were randomised to receive amoxicillin/clavulanic acid (875 mg/125 mg BID, n = 235) or clindamycin (150 mg QID, n = 237) for 5 or 7 days based on clinical response. The primary endpoint was percentage of subjects achieving clinical success (composite measure of pain, swelling, fever, and additional antimicrobial therapy required) at the end of treatment. Results. The upper limit of two-sided 95% confidence interval for the treatment difference between the study arms (7.7%) was within protocol specified noninferiority margin of 10%, thus demonstrating noninferiority of amoxicillin/clavulanic acid to clindamycin. Secondary efficacy results showed a higher clinical success rate at Day 5 in the amoxicillin/clavulanic acid arm. Most adverse events (raised liver enzymes, diarrhoea, and headache) were similar across both arms and were of mild to moderate intensity. Conclusion. Amoxicillin/clavulanic acid was comparable to clindamycin in achieving clinical success (88.2% versus 89.7%) in acute odontogenic infections and the safety profile was consistent with the known side effects of both drugs. Trial Registration. This trial is registered with Clinicaltrials.gov identifier: NCT02141217.

No MeSH data available.


Related in: MedlinePlus

Scatter plot of LFT with respect to baseline and end of study by treatment. Normalised value = laboratory value/upper limit of normal reference range of the respective local laboratory.
© Copyright Policy - open-access
Related In: Results  -  Collection


getmorefigures.php?uid=PMC4537712&req=5

fig2: Scatter plot of LFT with respect to baseline and end of study by treatment. Normalised value = laboratory value/upper limit of normal reference range of the respective local laboratory.

Mentions: A total of 243 treatment emergent AEs (TEAEs) were reported in 123 subjects in the amoxicillin/clavulanic acid arm and 236 events were reported in 124 subjects in the clindamycin arm. The most frequently observed TEAEs with frequency ≥3% were abdominal discomfort, raised liver enzymes (AST, ALT, and bilirubin), diarrhoea, dizziness, headache, increased appetite, and somnolence (Table 4). Generally the incidence of TEAEs was similar between treatment arms, except for diarrhoea and headache which were reported in slightly more patients in the clindamycin arm. Most AEs were of mild to moderate intensity. The incidence of drug related TEAEs in both the treatment arms was similar (165 AEs reported in 93 (39.4%) subjects and 171 AEs reported in 97 (41.3%) subjects in the amoxicillin/clavulanic acid and clindamycin arms, resp.). The most frequently reported drug related TEAEs were gastrointestinal disorders including abdominal discomfort, diarrhoea, nausea and vomiting, abnormal LFTs, increased appetite, somnolence, dizziness, and headache. Most of the related TEAEs were mild to moderate in intensity except for six events of severe intensity. These were elevated ALT, headache, and vomiting reported in the amoxicillin/clavulanic acid arm and burning sensation, hypertension, and hypersomnia in the clindamycin arm. All events had resolved by the end of the study except hypersomnia. A total of 89 subjects in the amoxicillin/clavulanic acid arm and 76 subjects in the clindamycin arm had AEs that remained ongoing at the end of the study. Increased LFT was the predominant ongoing AE and was present in 46 subjects in the amoxicillin/clavulanic acid arm and 40 subjects in clindamycin arm, respectively. The probable reason for the ongoing AEs could be the short duration of the study (7 to 8 days) and the lack of a planned follow-up visit after study treatment. No subjects in the study showed shift in ALT and AST from normal at baseline (with respect to local laboratory reference range) to PCC range (as defined in statistical analysis section) at end of the study whereas three subjects each in both the study arms showed shift in total bilirubin to PCC range at the end of the study. However, since these subjects only had increased bilirubin with no increase in ALT or AST, these were not of clinical concern. Four subjects in the clindamycin arm with high LFT parameter (one subject each for ALT and AST and two subjects for total bilirubin) at baseline remained in the PCC range at the end of the study (Figure 2). No events of SAE or death were reported in the study.


Amoxicillin/Clavulanic Acid for the Treatment of Odontogenic Infections: A Randomised Study Comparing Efficacy and Tolerability versus Clindamycin.

Tancawan AL, Pato MN, Abidin KZ, Asari AS, Thong TX, Kochhar P, Muganurmath C, Twynholm M, Barker K - Int J Dent (2015)

Scatter plot of LFT with respect to baseline and end of study by treatment. Normalised value = laboratory value/upper limit of normal reference range of the respective local laboratory.
© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4537712&req=5

fig2: Scatter plot of LFT with respect to baseline and end of study by treatment. Normalised value = laboratory value/upper limit of normal reference range of the respective local laboratory.
Mentions: A total of 243 treatment emergent AEs (TEAEs) were reported in 123 subjects in the amoxicillin/clavulanic acid arm and 236 events were reported in 124 subjects in the clindamycin arm. The most frequently observed TEAEs with frequency ≥3% were abdominal discomfort, raised liver enzymes (AST, ALT, and bilirubin), diarrhoea, dizziness, headache, increased appetite, and somnolence (Table 4). Generally the incidence of TEAEs was similar between treatment arms, except for diarrhoea and headache which were reported in slightly more patients in the clindamycin arm. Most AEs were of mild to moderate intensity. The incidence of drug related TEAEs in both the treatment arms was similar (165 AEs reported in 93 (39.4%) subjects and 171 AEs reported in 97 (41.3%) subjects in the amoxicillin/clavulanic acid and clindamycin arms, resp.). The most frequently reported drug related TEAEs were gastrointestinal disorders including abdominal discomfort, diarrhoea, nausea and vomiting, abnormal LFTs, increased appetite, somnolence, dizziness, and headache. Most of the related TEAEs were mild to moderate in intensity except for six events of severe intensity. These were elevated ALT, headache, and vomiting reported in the amoxicillin/clavulanic acid arm and burning sensation, hypertension, and hypersomnia in the clindamycin arm. All events had resolved by the end of the study except hypersomnia. A total of 89 subjects in the amoxicillin/clavulanic acid arm and 76 subjects in the clindamycin arm had AEs that remained ongoing at the end of the study. Increased LFT was the predominant ongoing AE and was present in 46 subjects in the amoxicillin/clavulanic acid arm and 40 subjects in clindamycin arm, respectively. The probable reason for the ongoing AEs could be the short duration of the study (7 to 8 days) and the lack of a planned follow-up visit after study treatment. No subjects in the study showed shift in ALT and AST from normal at baseline (with respect to local laboratory reference range) to PCC range (as defined in statistical analysis section) at end of the study whereas three subjects each in both the study arms showed shift in total bilirubin to PCC range at the end of the study. However, since these subjects only had increased bilirubin with no increase in ALT or AST, these were not of clinical concern. Four subjects in the clindamycin arm with high LFT parameter (one subject each for ALT and AST and two subjects for total bilirubin) at baseline remained in the PCC range at the end of the study (Figure 2). No events of SAE or death were reported in the study.

Bottom Line: Secondary efficacy results showed a higher clinical success rate at Day 5 in the amoxicillin/clavulanic acid arm.Conclusion.Amoxicillin/clavulanic acid was comparable to clindamycin in achieving clinical success (88.2% versus 89.7%) in acute odontogenic infections and the safety profile was consistent with the known side effects of both drugs.

View Article: PubMed Central - PubMed

Affiliation: Tancawan Dental Clinic, Door 2 Cebu Coliseum Building, Leon Kilat Street, 6000 Cebu City, Philippines.

ABSTRACT
Background. Treatment of odontogenic infections includes surgical drainage and adjunctive antibiotics. This study was designed to generate efficacy and safety data to support twice daily dosing of amoxicillin/clavulanic acid compared to clindamycin in odontogenic infections. Methods. This was a phase IV, randomised, observer blind study; 472 subjects were randomised to receive amoxicillin/clavulanic acid (875 mg/125 mg BID, n = 235) or clindamycin (150 mg QID, n = 237) for 5 or 7 days based on clinical response. The primary endpoint was percentage of subjects achieving clinical success (composite measure of pain, swelling, fever, and additional antimicrobial therapy required) at the end of treatment. Results. The upper limit of two-sided 95% confidence interval for the treatment difference between the study arms (7.7%) was within protocol specified noninferiority margin of 10%, thus demonstrating noninferiority of amoxicillin/clavulanic acid to clindamycin. Secondary efficacy results showed a higher clinical success rate at Day 5 in the amoxicillin/clavulanic acid arm. Most adverse events (raised liver enzymes, diarrhoea, and headache) were similar across both arms and were of mild to moderate intensity. Conclusion. Amoxicillin/clavulanic acid was comparable to clindamycin in achieving clinical success (88.2% versus 89.7%) in acute odontogenic infections and the safety profile was consistent with the known side effects of both drugs. Trial Registration. This trial is registered with Clinicaltrials.gov identifier: NCT02141217.

No MeSH data available.


Related in: MedlinePlus