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

Table of Content

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