Real-World Use of Generic Meropenem: Results of an Observational Study.

Santiago Garnica-Velandia,Carlos Arturo Alvarez-Moreno,Luz Adriana Aristizábal-Ruiz

doi:10.3390/antibiotics10010062

Santiago Garnica-Velandia, Carlos Arturo Alvarez-Moreno + Show 1 more

Open Access

https://doi.org/10.3390/antibiotics10010062

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Abstract

Background: To determine the therapeutic effect and tolerability of meropenem in routine clinical practice, in terms of clinical and microbiological response. Methods: A real-world, observational, descriptive, longitudinal study with daily monitoring of clinical history records was conducted on all patients who were medically prescribed meropenem during a period between October 2015 and March 2016 at a university hospital in Bucaramanga (Colombia). Results: The study evaluated 84 patients with an average age of 63.2 years, mostly older adults with multiple comorbidities, of whom 54.8% were men. A positive clinical or microbiological response was obtained in 98.8% of the patients. At the end of the treatments, significant improvements in dysthermia (0% vs. 29% at the beginning, p = 0.000), tachycardia (13% vs. 47%, p = 0.049), and leukocytosis (39% vs. 15% at the beginning, p = 0.008) were evidenced. The improvement in the indicator that combines all the Systemic Inflammatory Response Syndrome (SIRS) criteria was also significant (p = 0.000). The treatment was well tolerated, although we identified some non-serious and expected adverse reactions. Conclusions: Generic meropenem proved to be effective and well tolerated for different types of infection in routine clinical practice. The results are consistent with the findings of the clinical studies with the innovator drug.

Highlights

Antimicrobials have been of great therapeutic use for more than half a century as indispensable tools for treating a wide variety of infections [1,2], enabling to save the lives of millions of people
This study found the disappearance of Systemic Inflammatory Response Syndrome (SIRS) over time for a significant proportion of patients, despite complex factors that threaten therapeutic success, including older patients with multiple comorbidities such as hypertension, diabetes, chronic obstructive pulmonary disease, kidney disease, and infection with human immunodeficiency virus
We mainly identified pathogens that have developed significant antimicrobial resistance: Pseudomonas aeruginosa, Escherichia coli, and Klebsiella pneumoniae

Summary

Introduction

Antimicrobials have been of great therapeutic use for more than half a century as indispensable tools for treating a wide variety of infections [1,2], enabling to save the lives of millions of people. It is important to monitor its use and results at a local level in order to conserve its effectiveness and its safety in terms of development of bacterial resistance and other related problems In this sense, real-world studies are becoming increasingly important as a trustworthy source of evidence for the behavior of treatments in routine clinical practice and as a support for clinical decision judgment. Real-world studies are becoming increasingly important as a trustworthy source of evidence for the behavior of treatments in routine clinical practice and as a support for clinical decision judgment These studies include patients that are normally excluded from clinical studies and provide information about the local use of medications, allowing us to identify factors that can have an impact regarding safety and in terms of therapeutic results [6,7]. The results are consistent with the findings of the clinical studies with the innovator drug

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