Efficacy and Safety of Amoxicillin/Clavulanic Acid Compared to Clindamycin in Odontogenic Infections

3 Mar, 21

Introduction

Odontogenic infections are one of the most prevalent diseases worldwide and the principal reason for seeking dental care. Dental prescriptions account for nearly 7% to 11% of all common antibiotic prescriptions. The primary treatment in acute odontogenic infections is surgical drainage while antibiotics are an adjunct in patients showing signs of systemic involvement.

Aim

To evaluate efficacy and safety data to support twice daily dosing of amoxicillin/clavulanic acid compared to clindamycin in odontogenic infections

Patient Profile

Patients with ≥18 years of age with a diagnosis of acute odontogenic infections (periapical abscess, acute periodontitis, and pericoronitis) that required antibiotic therapy

Methods

Phase IV, randomised, observer blind study

Study Endpoints

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
The secondary endpoints of the study included percentage of subjects achieving clinical success at Day 5 and change in the VAS score for pain and swelling from baseline to Days 2, 5, and 7

Results

Clinical efficacy of amoxicillin/clavulanic acid was noninferior to clindamycin

Figure 1: Primary efficacy endpoint: clinical success outcome at the end of the study

Secondary efficacy results showed a higher clinical success rate at Day 5 in the amoxicillin/clavulanic acid arm.
VAS by visit and treatment arms demonstrated that higher mean percentage reduction in pain by Day 2

Table 1: Secondary Endpoint results

	Amoxicillin /Clavulanic	Clindamycin
VAS Score for pain
Day 2	3.34	3.07
Day 5	5.49	5.38
Day 7	6.38	6.34
Mean percentage reduction in pain by Day 2	49.5%	45.6%
Mean percentage reduction in swelling by Day 2	43.6%	39.6%

Microbiological Results

A total of 61 isolates were obtained from 56 samples,
26 in the amoxicillin/clavulanic acid arm
35 in the clindamycin arm
Organisms isolated in both the treatment arms were similar and predominantly viridans streptococci group ((n= 24) including Streptococcus oralis,Streptococcus mitis, and Streptococcus parasanguinis), Enterobacter spp. (n= 10), Klebsiella spp. (n= 9), Pseudomonas spp. (n= 7), and Staphylococcus spp. (n= 5)

Safety

Most adverse events (raised liver enzymes, diarrhoea, and headache) were similar across both arms and were of mild to moderate intensity
The incidence of treatment emergent Adverse events (TEAEs) was similar between treatment arms, except for diarrhoea and headache which were reported in slightly more patients in the clindamycin arm

Table 2: Summary of commonly observed treatment emergent AEs (≥3% in either of the arms)

MedDRA preferred term	Amoxicillin/clavulanic acid (n=236)	Clindamycin (n=235)
Total number of treatment emergent AEs	243	236
Subjects who experienced at least one AE	123 (52.1%)	124 (52.8%)
Abdominal discomfort	11 (4.7%)	7 (3.0%)
Alanine aminotransferase increased	26 (11.0%)	24 (10.2%)
Aspartate aminotransferase increased	24 (10.2%)	20 (8.5%)
Blood bilirubin increased	12 (5.1%)	13 (5.5%)
Diarrhoea	19 (8.1%)	28 (11.9%)
Dizziness	18 (7.6%)	14 (6.0%)
Headache	8 (3.4%)	14 (6.0%)
Increased appetite	20 (8.5%)	15 (6.4%)
Nausea	7 (3.0%)	4 (1.7%)
Somnolence	19 (8.1%)	17 (7.2%)

Conclusion

Amoxicillin/clavulanic acid was comparable to clindamycin in achieving clinical success in acute odontogenic infections
It was also found to be well tolerated with a safety profile consistent with the known pharmacologic effects of amoxicillin/clavulanic acid and with that described in the global prescribing information

Reference

Int J Dent. 2015; 2015: 472470