Seoul Asan Medical Center Pharmacy Team Conducts Retrospective Study on 95 Inpatients
What were the findings of a domestic general hospital’s evaluation of the combination antibiotic ‘Zabiceftazol,’ which Pfizer received domestic approval for in 2022?
The Seoul Asan Medical Center Pharmaceutical Team (Researchers Hwang Myeong-ju, Lee Sang-eun, Yang Sa-mi, Choi Ji-young, and Han Hye-won) recently published the results of a study titled ‘Evaluation of the Use of ‘Ceftazidime-Avibactam’ in a General Hospital.’
Here, Pfizer’s ‘Zabiceftaz’ is a ceftazidime-avibactam (CZA) preparation. It is a combination drug of ‘ceftazidime,’ a third-generation cephalosporin, and ‘avibactam,’ a beta-lactamase inhibitor. This antibiotic was launched domestically in July 2023 for the treatment of resistant gram-negative bacterial infections that do not respond to carbapenem.
This study evaluated the appropriateness of treatment by monitoring the indications, efficacy, and side effects of patients administered CZA. Electronic medical records were retrospectively collected and analyzed for adult patients who received CZA treatment for at least 3 days following hospitalization at Seoul Asan Medical Center from August 1, 2023, to February 29, 2024.
Of the 95 monitored patients, 53 (55.8%) met the approved indications (complicated intra-abdominal infection, complicated urinary tract infection, hospital-acquired pneumonia), while the remaining 42 (44.2%) used the drug outside the approved range (bacteremia, other than effective strains) based on the infectious disease department’s opinion.
The efficacy evaluation, excluding two patients who used non-valid strains, showed a treatment success rate of 55.9% for 93 patients. There was no significant difference in the treatment success rate according to the indication, and the treatment success rate of patients receiving monotherapy was significantly higher than that of patients receiving combination therapy (p<0.001).
There was no significant difference in the 30-day mortality rate depending on the indication. However, in the case of bacteremia, patients who received combination therapy with other antibiotics had a longer treatment period and a higher mortality rate than those receiving monotherapy (p<0.05).
In the adverse effect evaluation, non-specific adverse reactions such as thrombocytopenia, increased LFT, increased LDH, and diarrhea were observed at a higher frequency than reported in the approval information.
The research team explained, “CZA has been frequently used not only for its approved indications but also as a treatment for bacteremia caused by multidrug-resistant Gram-negative bacteria.” They added, “When CZA was used for bacteremia, combination therapy had a significantly higher mortality rate than monotherapy. Additionally, when readministered following CZA treatment was terminated, the success of the first treatment was associated with the success of retreatment.”
The team concluded, “In the future, long-term monitoring and prospective studies should be conducted to specify the use policy of CZA for the effective treatment of resistant Gram-negative bacterial infections.”
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Seoul Asan Medical Center Pharmacy Team Conducts Retrospective Study on 95 Inpatients
Evaluation of Ceftazidime-Avibactam (CZA) in a General Hospital
This retrospective study, conducted by the Seoul Asan Medical Center Pharmaceutical Team, aimed to evaluate the efficacy and safety of ceftazidime-avibactam (CZA) in a general hospital setting. CZA is a combination antibiotic approved in South Korea in 2022 for the treatment of resistant gram-negative bacterial infections, including those unresponsive to carbapenem.
Methodology
The study involved a retrospective analysis of electronic medical records from adult patients hospitalized at Seoul Asan Medical Center who received CZA treatment for at least 3 days between August 1, 2023, and February 29, 2024.
Patient Characteristics
A total of 95 patients were included in the study. Of these, 53 (55.8%) met the indications for approval, which included:
- Complicated intra-abdominal infection
- Complicated urinary tract infection
- Hospital-acquired pneumonia
The remaining 42 (44.2%) patients received CZA for indications outside the approval range, such as bacteremia, based on the infectious disease department’s opinion.
Efficacy Evaluation
The efficacy evaluation excluded 2 patients who used non-valid strains, leaving 93 patients for analysis. The overall treatment success rate was 55.9%. Notably, there was no significant difference in the treatment success rate based on the indication. However, patients receiving CZA as monotherapy had a significantly higher treatment success rate compared to those receiving combination therapy (p < 0.05).
Mortality Rate
While there was no significant difference in the 30-day mortality rate across various indications, a concerning finding emerged for patients with bacteremia. Those receiving combination therapy with other antibiotics had a longer treatment period and higher mortality rate compared to those receiving CZA monotherapy (p < 0.05).
Adverse Effects
Adverse effect evaluation revealed a higher frequency of non-specific adverse reactions, including:
- Thrombocytopenia
- Increased LFT (Liver Function Test)
- Increased LDH (Lactate Dehydrogenase)
- Diarrhea
These reactions were observed more frequently than reported in the approval information.
Key Findings and Recommendations
The researchers highlighted the following crucial observations:
- CZA is frequently used not only for its approved indications but also as a treatment for bacteremia caused by multidrug-resistant Gram-negative bacteria.
- Combination therapy with other antibiotics for bacteremia significantly increased mortality rate compared to monotherapy.
- Success in the initial CZA treatment was associated with the success of retreatment following discontinuation.
Based on these findings, they emphasized the need for long-term monitoring and prospective studies to refine the use policy of CZA for the effective treatment of resistant Gram-negative bacterial infections.
Discussion
This study provides valuable insights into the clinical use of CZA, a promising antibiotic for challenging bacterial infections. The findings underscore the importance of careful patient selection, appropriate dosing, and monitoring for adverse effects. The study highlights the need for ongoing research to optimize the use of CZA in diverse clinical settings.
As a leading antibiotic for resistant Gram-negative infections, CZA’s impact on patient outcomes is substantial. Understanding its efficacy, safety, and appropriate use is crucial for healthcare professionals. Further research is essential to determine optimal treatment strategies, identify risk factors for adverse events, and refine dosing recommendations.
This study provides an important foundation for future research and clinical practice. By meticulously evaluating the use of CZA in a diverse patient population, the Seoul Asan Medical Center Pharmaceutical Team has contributed valuable knowledge for improving patient care and optimizing antibiotic stewardship.
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