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Real-World Use of Generic Meropenem: Results of an Observational Study
To determine the therapeutic effect and tolerability of meropenem in routine clinical practice, in terms of clinical and microbiological response. A real-world, observational, descriptive, longitudinal study with daily monitoring of clinical history records was conducted on all patients who were med...
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Published in: | Antibiotics (Basel) 2021-01, Vol.10 (1), p.62 |
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description | To determine the therapeutic effect and tolerability of meropenem in routine clinical practice, in terms of clinical and microbiological response.
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).
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,
= 0.000), tachycardia (13% vs. 47%,
= 0.049), and leukocytosis (39% vs. 15% at the beginning,
= 0.008) were evidenced. The improvement in the indicator that combines all the Systemic Inflammatory Response Syndrome (SIRS) criteria was also significant (
= 0.000). The treatment was well tolerated, although we identified some non-serious and expected adverse reactions.
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. |
doi_str_mv | 10.3390/antibiotics10010062 |
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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).
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,
= 0.000), tachycardia (13% vs. 47%,
= 0.049), and leukocytosis (39% vs. 15% at the beginning,
= 0.008) were evidenced. The improvement in the indicator that combines all the Systemic Inflammatory Response Syndrome (SIRS) criteria was also significant (
= 0.000). The treatment was well tolerated, although we identified some non-serious and expected adverse reactions.
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.</description><identifier>ISSN: 2079-6382</identifier><identifier>EISSN: 2079-6382</identifier><identifier>DOI: 10.3390/antibiotics10010062</identifier><identifier>PMID: 33440602</identifier><language>eng</language><publisher>Switzerland: MDPI AG</publisher><subject>Antimicrobial agents ; antimicrobials ; Bacteria ; Cardiac arrhythmia ; Chronic obstructive pulmonary disease ; Correlation analysis ; Drug dosages ; E coli ; generic drug ; Generic drugs ; Gram-positive bacteria ; Health care expenditures ; Hospitals ; Infections ; Inflammation ; Inflammatory response ; Intensive care ; Kidney diseases ; Leukocytosis ; Meropenem ; Microorganisms ; Mortality ; Observational studies ; Older people ; Pathogens ; Patients ; Pneumonia ; postmarketing ; product surveillance ; real-world studies ; Systemic inflammatory response syndrome ; Tachycardia</subject><ispartof>Antibiotics (Basel), 2021-01, Vol.10 (1), p.62</ispartof><rights>2021. This work is licensed under http://creativecommons.org/licenses/by/3.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2021 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2021 by the authors. 2021</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c477t-c950b42729595de41eb3af2b9056ba45e7a71c7d769031e3535572334a8951293</cites><orcidid>0000-0001-5419-4494</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.proquest.com/docview/2478178910/fulltextPDF?pq-origsite=primo$$EPDF$$P50$$Gproquest$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.proquest.com/docview/2478178910?pq-origsite=primo$$EHTML$$P50$$Gproquest$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,881,25732,27903,27904,36991,36992,44569,53769,53771,74872</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33440602$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Garnica-Velandia, Santiago</creatorcontrib><creatorcontrib>Aristizábal-Ruiz, Luz Adriana</creatorcontrib><creatorcontrib>Alvarez-Moreno, Carlos Arturo</creatorcontrib><title>Real-World Use of Generic Meropenem: Results of an Observational Study</title><title>Antibiotics (Basel)</title><addtitle>Antibiotics (Basel)</addtitle><description>To determine the therapeutic effect and tolerability of meropenem in routine clinical practice, in terms of clinical and microbiological response.
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).
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,
= 0.000), tachycardia (13% vs. 47%,
= 0.049), and leukocytosis (39% vs. 15% at the beginning,
= 0.008) were evidenced. The improvement in the indicator that combines all the Systemic Inflammatory Response Syndrome (SIRS) criteria was also significant (
= 0.000). The treatment was well tolerated, although we identified some non-serious and expected adverse reactions.
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.</description><subject>Antimicrobial agents</subject><subject>antimicrobials</subject><subject>Bacteria</subject><subject>Cardiac arrhythmia</subject><subject>Chronic obstructive pulmonary disease</subject><subject>Correlation analysis</subject><subject>Drug dosages</subject><subject>E coli</subject><subject>generic drug</subject><subject>Generic drugs</subject><subject>Gram-positive bacteria</subject><subject>Health care expenditures</subject><subject>Hospitals</subject><subject>Infections</subject><subject>Inflammation</subject><subject>Inflammatory response</subject><subject>Intensive care</subject><subject>Kidney diseases</subject><subject>Leukocytosis</subject><subject>Meropenem</subject><subject>Microorganisms</subject><subject>Mortality</subject><subject>Observational studies</subject><subject>Older people</subject><subject>Pathogens</subject><subject>Patients</subject><subject>Pneumonia</subject><subject>postmarketing</subject><subject>product surveillance</subject><subject>real-world studies</subject><subject>Systemic inflammatory response syndrome</subject><subject>Tachycardia</subject><issn>2079-6382</issn><issn>2079-6382</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>PIMPY</sourceid><sourceid>DOA</sourceid><recordid>eNp9kl1LHTEQhoNUqqi_oCALvenN1nxukl4UilQrWASreBmS7KzNIWdzmuwK_vvmeFS0SEMgQ-adJzOTQegDwZ8Z0_jIjlNwIU3BF4Jx3R3dQrsUS912TNF3L-wddFDKAtelCVNYvUc7jHGOO0x30ckl2NjepBz75rpAk4bmFEbIwTc_IadVtZdfmksoc5zK2mvH5sIVyHd2Cmm0sfk1zf39PtoebCxw8HjuoeuT71fHP9rzi9Oz42_nredSTq3XAjtOJdVCix44AcfsQJ3GonOWC5BWEi972WnMCDDBhJC0ZmuVFoRqtofONtw-2YVZ5bC0-d4kG8zDRcq3xubalAjGd4PQeFhjdX0SK-ld5zqQ4Hkvhr6yvm5Yq9ktofcwTtnGV9DXnjH8NrfpzkhVK2C8Aj49AnL6M0OZzDIUDzHaEdJcDOVS4fpbWlTpx3-kizTn2r6qEpRzorhQ_1VVFpFKE1xVbKPyOZWSYXhOmWCzHg7zxnDUqMOX1T7HPI0C-wuY6LWG</recordid><startdate>20210101</startdate><enddate>20210101</enddate><creator>Garnica-Velandia, Santiago</creator><creator>Aristizábal-Ruiz, Luz Adriana</creator><creator>Alvarez-Moreno, Carlos Arturo</creator><general>MDPI AG</general><general>MDPI</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QL</scope><scope>7T7</scope><scope>8FD</scope><scope>8FE</scope><scope>8FH</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FR3</scope><scope>GNUQQ</scope><scope>HCIFZ</scope><scope>LK8</scope><scope>M7P</scope><scope>P64</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope><orcidid>https://orcid.org/0000-0001-5419-4494</orcidid></search><sort><creationdate>20210101</creationdate><title>Real-World Use of Generic Meropenem: Results of an Observational Study</title><author>Garnica-Velandia, Santiago ; Aristizábal-Ruiz, Luz Adriana ; Alvarez-Moreno, Carlos Arturo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c477t-c950b42729595de41eb3af2b9056ba45e7a71c7d769031e3535572334a8951293</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Antimicrobial agents</topic><topic>antimicrobials</topic><topic>Bacteria</topic><topic>Cardiac arrhythmia</topic><topic>Chronic obstructive pulmonary disease</topic><topic>Correlation analysis</topic><topic>Drug dosages</topic><topic>E coli</topic><topic>generic drug</topic><topic>Generic drugs</topic><topic>Gram-positive bacteria</topic><topic>Health care expenditures</topic><topic>Hospitals</topic><topic>Infections</topic><topic>Inflammation</topic><topic>Inflammatory response</topic><topic>Intensive care</topic><topic>Kidney diseases</topic><topic>Leukocytosis</topic><topic>Meropenem</topic><topic>Microorganisms</topic><topic>Mortality</topic><topic>Observational studies</topic><topic>Older people</topic><topic>Pathogens</topic><topic>Patients</topic><topic>Pneumonia</topic><topic>postmarketing</topic><topic>product surveillance</topic><topic>real-world studies</topic><topic>Systemic inflammatory response syndrome</topic><topic>Tachycardia</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Garnica-Velandia, Santiago</creatorcontrib><creatorcontrib>Aristizábal-Ruiz, Luz Adriana</creatorcontrib><creatorcontrib>Alvarez-Moreno, Carlos Arturo</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Technology Research Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>ProQuest Natural Science Collection</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central</collection><collection>Engineering Research Database</collection><collection>ProQuest Central Student</collection><collection>SciTech Premium Collection</collection><collection>Biological Sciences</collection><collection>Biological Science Database</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Publicly Available Content (ProQuest)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>Antibiotics (Basel)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Garnica-Velandia, Santiago</au><au>Aristizábal-Ruiz, Luz Adriana</au><au>Alvarez-Moreno, Carlos Arturo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Real-World Use of Generic Meropenem: Results of an Observational Study</atitle><jtitle>Antibiotics (Basel)</jtitle><addtitle>Antibiotics (Basel)</addtitle><date>2021-01-01</date><risdate>2021</risdate><volume>10</volume><issue>1</issue><spage>62</spage><pages>62-</pages><issn>2079-6382</issn><eissn>2079-6382</eissn><abstract>To determine the therapeutic effect and tolerability of meropenem in routine clinical practice, in terms of clinical and microbiological response.
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).
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,
= 0.000), tachycardia (13% vs. 47%,
= 0.049), and leukocytosis (39% vs. 15% at the beginning,
= 0.008) were evidenced. The improvement in the indicator that combines all the Systemic Inflammatory Response Syndrome (SIRS) criteria was also significant (
= 0.000). The treatment was well tolerated, although we identified some non-serious and expected adverse reactions.
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.</abstract><cop>Switzerland</cop><pub>MDPI AG</pub><pmid>33440602</pmid><doi>10.3390/antibiotics10010062</doi><orcidid>https://orcid.org/0000-0001-5419-4494</orcidid><oa>free_for_read</oa></addata></record> |
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subjects | Antimicrobial agents antimicrobials Bacteria Cardiac arrhythmia Chronic obstructive pulmonary disease Correlation analysis Drug dosages E coli generic drug Generic drugs Gram-positive bacteria Health care expenditures Hospitals Infections Inflammation Inflammatory response Intensive care Kidney diseases Leukocytosis Meropenem Microorganisms Mortality Observational studies Older people Pathogens Patients Pneumonia postmarketing product surveillance real-world studies Systemic inflammatory response syndrome Tachycardia |
title | Real-World Use of Generic Meropenem: Results of an Observational Study |
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