Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Real-World Effectiveness of Meropenem: Results of an Observational Study in 84 Colombian Patients

Version 1 : Received: 17 November 2020 / Approved: 19 November 2020 / Online: 19 November 2020 (13:34:26 CET)

A peer-reviewed article of this Preprint also exists.

Garnica-Velandia, S.; Aristizábal-Ruiz, L.A.; Alvarez-Moreno, C.A. Real-World Use of Generic Meropenem: Results of an Observational Study. Antibiotics 2021, 10, 62. Garnica-Velandia, S.; Aristizábal-Ruiz, L.A.; Alvarez-Moreno, C.A. Real-World Use of Generic Meropenem: Results of an Observational Study. Antibiotics 2021, 10, 62.

Abstract

Background. To determine the effectiveness and safety 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 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.

Keywords

antimicrobials; meropenem; generic drug; real-life studies; product surveillance, postmarketing; treatment outcome; pharmacovigilance

Subject

Medicine and Pharmacology, Immunology and Allergy

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