Frontiers in medicine · 2026
Effectiveness and tolerability of cephalexin and clavulanic acid fixed dose combination, amoxicillin and clavulanic acid fixed dose combination, and azithromycin in patients with pharyngitis in India: a real-world retrospective study from electronic medical records (PHARYSPOR).
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Sarof Subramanyam, Somana Nikita Kariappa, S Ravindra Channagiri, Venkataram Ramesh Chinthalapalli, R Jyothi Sharma, Sv Sabhapathi, Peddi Ramakrishnaiah, K Sadanandam, Vohra Nitin Rai, Bhama Lokesh Kumar, Shah Mahendrakumar, Chile Vijay, Gunderia Ameeta, Momin Farad, Banerjee Anit, Kumar Saumitra, Rungta Sandeep, Ikbal Ashik, Singhvi Sunil, Natarajan Annamalai, Mitra Monjori, Kadam Vijay, Dharmadhikari Shruti, Khandhedia Chintan, Puppalwar Gaurav, Markandeywar Neeraj, Mane Amey, Mehta Suyog
Аннотация
BACKGROUND: Acute pharyngitis is a common condition in outpatient departments. Increasing antimicrobial resistance (AMR) necessitates careful prescribing practices. A new fixed-dose combination (FDC) of cephalexin-clavulanate has been approved in India for bacterial infections. This real-world evidence (RWE) study assessed the effectiveness and tolerability of cephalexin-CV compared to co-amoxiclav FDC and azithromycin in adult patients with acute bacterial pharyngitis.
METHODS: This retrospective, multicenter, comparative observational study (CTRI/2023/08/056474; Registered on: 14 Aug 2023) analyzed aggregated and anonymized electronic medical records (EMRs) of adults with clinically suspected acute bacterial pharyngitis who received study medications between November 2022 and March 2023. Patients with incomplete records, hospitalizations, or requiring parenteral antibiotics were excluded. Primary outcomes included the proportion of patients achieving clinical cure, i.e., complete resolution of symptoms (fever, sore throat, throat pain/difficulty during swallowing, inflammation of tonsils, alone or in combination) by Day 10 from treatment initiation. Secondary outcomes included time to clinical improvement (partial symptomatic resolution at Days 2, 3, 5, and 7 from treatment initiation), non-steroidal anti-inflammatory drug (NSAID) requirements, addition or change in antibiotics, and reported adverse events (AEs).
RESULTS: The study analyzed 752 patient data treated with cephalexin-CV (n = 285), co-amoxiclav (n = 245), and azithromycin (n = 222) as per the eligibility criteria. The overall clinical cure rates achieved by Day 10, clinical improvement at Day 7, and the mean time to improvement were similar across all treatment groups. However, cephalexin-CV demonstrated early clinical improvement by Day 2 [27 vs. 18% for co-amoxiclav (p = 0.035) and 15% for azithromycin (p = 0.003)] and Day 3 [58 vs. 47% (p = 0.022) and 48% (p = 0.071), respectively]. The need for NSAIDs was similar for the cephalexin CV and co-amoxiclav groups at 46% each, but was significantly higher at 57% in the azithromycin group (p = 0.020). AEs were minimal across all groups, including mild gastritis in the cephalexin CV group and cough, rash, and joint pain in the azithromycin group.
CONCLUSION: This first-of-its-kind EMR-based RWE study did not demonstrate any statistically significant differences in overall clinical outcomes or tolerability among patients with pharyngitis treated with cephalexin-CV, co-amoxiclav, or azithromycin. However, cephalexin-CV was associated with earlier symptom improvement and lower NSAID use, making it a promising option for the treatment of pharyngitis.
METHODS: This retrospective, multicenter, comparative observational study (CTRI/2023/08/056474; Registered on: 14 Aug 2023) analyzed aggregated and anonymized electronic medical records (EMRs) of adults with clinically suspected acute bacterial pharyngitis who received study medications between November 2022 and March 2023. Patients with incomplete records, hospitalizations, or requiring parenteral antibiotics were excluded. Primary outcomes included the proportion of patients achieving clinical cure, i.e., complete resolution of symptoms (fever, sore throat, throat pain/difficulty during swallowing, inflammation of tonsils, alone or in combination) by Day 10 from treatment initiation. Secondary outcomes included time to clinical improvement (partial symptomatic resolution at Days 2, 3, 5, and 7 from treatment initiation), non-steroidal anti-inflammatory drug (NSAID) requirements, addition or change in antibiotics, and reported adverse events (AEs).
RESULTS: The study analyzed 752 patient data treated with cephalexin-CV (n = 285), co-amoxiclav (n = 245), and azithromycin (n = 222) as per the eligibility criteria. The overall clinical cure rates achieved by Day 10, clinical improvement at Day 7, and the mean time to improvement were similar across all treatment groups. However, cephalexin-CV demonstrated early clinical improvement by Day 2 [27 vs. 18% for co-amoxiclav (p = 0.035) and 15% for azithromycin (p = 0.003)] and Day 3 [58 vs. 47% (p = 0.022) and 48% (p = 0.071), respectively]. The need for NSAIDs was similar for the cephalexin CV and co-amoxiclav groups at 46% each, but was significantly higher at 57% in the azithromycin group (p = 0.020). AEs were minimal across all groups, including mild gastritis in the cephalexin CV group and cough, rash, and joint pain in the azithromycin group.
CONCLUSION: This first-of-its-kind EMR-based RWE study did not demonstrate any statistically significant differences in overall clinical outcomes or tolerability among patients with pharyngitis treated with cephalexin-CV, co-amoxiclav, or azithromycin. However, cephalexin-CV was associated with earlier symptom improvement and lower NSAID use, making it a promising option for the treatment of pharyngitis.