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

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...

Full description

Bibliographic Details
Main Authors: Santiago Garnica-Velandia, Luz Adriana Aristizábal-Ruiz, Carlos Arturo Alvarez-Moreno
Format: Article
Language:English
Published: MDPI AG 2021-01-01
Series:Antibiotics
Subjects:
Online Access:https://www.mdpi.com/2079-6382/10/1/62
id doaj-c6f590fba459427087cb6b6e7ec4d5fd
record_format Article
spelling doaj-c6f590fba459427087cb6b6e7ec4d5fd2021-01-12T00:00:03ZengMDPI AGAntibiotics2079-63822021-01-0110626210.3390/antibiotics10010062Real-World Use of Generic Meropenem: Results of an Observational StudySantiago Garnica-Velandia0Luz Adriana Aristizábal-Ruiz1Carlos Arturo Alvarez-Moreno2Vitalis SACI, Bogota 111121, ColombiaVitalis SACI, Bogota 111121, ColombiaInternal Medicine, Department Facultad de Medicina, Universidad Nacional de Colombia, Bogota 111176, ColombiaBackground: 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, <i>p</i> = 0.000), tachycardia (13% vs. 47%, <i>p</i> = 0.049), and leukocytosis (39% vs. 15% at the beginning, <i>p</i> = 0.008) were evidenced. The improvement in the indicator that combines all the Systemic Inflammatory Response Syndrome (SIRS) criteria was also significant (<i>p</i> = 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.https://www.mdpi.com/2079-6382/10/1/62antimicrobialsmeropenemgeneric drugreal-world studiesproduct surveillancepostmarketing
collection DOAJ
language English
format Article
sources DOAJ
author Santiago Garnica-Velandia
Luz Adriana Aristizábal-Ruiz
Carlos Arturo Alvarez-Moreno
spellingShingle Santiago Garnica-Velandia
Luz Adriana Aristizábal-Ruiz
Carlos Arturo Alvarez-Moreno
Real-World Use of Generic Meropenem: Results of an Observational Study
Antibiotics
antimicrobials
meropenem
generic drug
real-world studies
product surveillance
postmarketing
author_facet Santiago Garnica-Velandia
Luz Adriana Aristizábal-Ruiz
Carlos Arturo Alvarez-Moreno
author_sort Santiago Garnica-Velandia
title Real-World Use of Generic Meropenem: Results of an Observational Study
title_short Real-World Use of Generic Meropenem: Results of an Observational Study
title_full Real-World Use of Generic Meropenem: Results of an Observational Study
title_fullStr Real-World Use of Generic Meropenem: Results of an Observational Study
title_full_unstemmed Real-World Use of Generic Meropenem: Results of an Observational Study
title_sort real-world use of generic meropenem: results of an observational study
publisher MDPI AG
series Antibiotics
issn 2079-6382
publishDate 2021-01-01
description 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, <i>p</i> = 0.000), tachycardia (13% vs. 47%, <i>p</i> = 0.049), and leukocytosis (39% vs. 15% at the beginning, <i>p</i> = 0.008) were evidenced. The improvement in the indicator that combines all the Systemic Inflammatory Response Syndrome (SIRS) criteria was also significant (<i>p</i> = 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.
topic antimicrobials
meropenem
generic drug
real-world studies
product surveillance
postmarketing
url https://www.mdpi.com/2079-6382/10/1/62
work_keys_str_mv AT santiagogarnicavelandia realworlduseofgenericmeropenemresultsofanobservationalstudy
AT luzadrianaaristizabalruiz realworlduseofgenericmeropenemresultsofanobservationalstudy
AT carlosarturoalvarezmoreno realworlduseofgenericmeropenemresultsofanobservationalstudy
_version_ 1724341153087619072