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

Garnica-Velandia, Santiago and Aristizábal-Ruiz, Luz Adriana and Alvarez-Moreno, Carlos Arturo (2021) Real-World Use of Generic Meropenem: Results of an Observational Study. Antibiotics, 10 (1). p. 62. ISSN 2079-6382

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Journals Antibiotics Volume 10 Issue 1 10.3390/antibiotics10010062
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Open AccessArticle
Real-World Use of Generic Meropenem: Results of an Observational Study
by Santiago Garnica-Velandia 1,*,Luz Adriana Aristizábal-Ruiz 1 andCarlos Arturo Alvarez-Moreno 2,3ORCID
1
Vitalis SACI, Bogota 111121, Colombia
2
Internal Medicine, Department Facultad de Medicina, Universidad Nacional de Colombia, Bogota 111176, Colombia
3
Infectology Department, Clínica Universitaria Colombia, Clínicas Colsanitas S.A, Bogota 111176, Colombia
*
Author to whom correspondence should be addressed.
Antibiotics 2021, 10(1), 62; https://doi.org/10.3390/antibiotics10010062
Received: 12 November 2020 / Revised: 24 December 2020 / Accepted: 4 January 2021 / Published: 11 January 2021
(This article belongs to the Section Antibiotics Use and Antimicrobial Stewardship)
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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.

Item Type: Article
Uncontrolled Keywords: antimicrobials; meropenem; generic drug; real-world studies; product surveillance; postmarketing; treatment outcome; pharmacovigilance
Subjects: STM Repository > Biological Science
Depositing User: Managing Editor
Date Deposited: 17 Jun 2024 06:06
Last Modified: 17 Jun 2024 06:06
URI: http://classical.goforpromo.com/id/eprint/1182

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