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

2020 ◽  
Author(s):  
Santiago Garnica-Velandia ◽  
Aristizábal-Ruiz Luz Adriana ◽  
Carlos Arturo Alvarez-Moreno
Keyword(s):  
Older Adults ◽  
Clinical Practice ◽  
Real World ◽  
Adverse Reactions ◽  
Clinical History ◽  
Routine Clinical Practice ◽  
University Hospital ◽  
Daily Monitoring ◽  
Different Types ◽  
Sirs Criteria

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.

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

Antibiotics ◽  
2021 ◽  
Vol 10 (1) ◽  
pp. 62
Author(s):  
Santiago Garnica-Velandia ◽  
Luz Adriana Aristizábal-Ruiz ◽  
Carlos Arturo Alvarez-Moreno
Keyword(s):  
Older Adults ◽  
Clinical Practice ◽  
Real World ◽  
Adverse Reactions ◽  
Clinical History ◽  
Routine Clinical Practice ◽  
University Hospital ◽  
Daily Monitoring ◽  
Different Types ◽  
Sirs Criteria

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.

scholarly journals Insulin doses requirements in patients with type 1 diabetes using glargine U300 or degludec in routine clinical practice

2021 ◽  
pp. jim-2020-001633
Author(s):  
Florentino Carral San Laureano ◽  
Mariana Tomé Fernández-Ladreda ◽  
Ana Isabel Jiménez Millán ◽  
Concepción García Calzado ◽  
María del Carmen Ayala Ortega
Keyword(s):  
Type 1 Diabetes ◽  
Clinical Practice ◽  
Retrospective Study ◽  
Real World ◽  
Glycosylated Hemoglobin ◽  
Routine Clinical Practice ◽  
Insulin Analogs ◽  
Total P ◽  
Real Clinical Practice

There are not many real-world studies evaluating daily insulin doses requirements (DIDR) in patients with type 1 diabetes (T1D) using second-generation basal insulin analogs, and such comparison is necessary. The aim of this study was to compare DIDR in individuals with T1D using glargine 300 UI/mL (IGlar-300) or degludec (IDeg) in real clinical practice. An observational, retrospective study was designed in 412 patients with T1D (males: 52%; median age 37.0±13.4 years, diabetes duration: 18.7±12.3 years) using IDeg and IGla-300 ≥6 months to compare DIDR between groups. Patients using IGla-300 (n=187) were more frequently males (59% vs 45.8%; p=0.004) and had lower glycosylated hemoglobin (HbA1c) (7.6±1.2 vs 8.1%±1.5%; p<0.001) than patients using IDeg (n=225). Total (0.77±0.36 unit/kg/day), basal (0.43±0.20 unit/kg/day) and prandial (0.33±0.23 unit/kg/day) DIDR were similar in IGla-300 and IDeg groups. Patients with HbA1c ≤7% (n=113) used significantly lower basal (p=0.045) and total (p=0.024) DIDR, but not prandial insulin (p=0.241), than patients with HbA1c between 7.1% and 8% and >8%. Patients using IGla-300 and IDeg used similar basal, prandial and total DIDR regardless of metabolic control subgroup. No difference in basal, prandial and total DIDR was observed between patients with T1D using IGla-300 or IDeg during at least 6 months in routine clinical practice.

scholarly journals Real-World Effectiveness and Safety of Lixisenatide as Add-On to Oral Antidiabetic Drugs as Part of Routine Clinical Practice in Bulgaria: LIXODAR Study

2019 ◽  
Vol 10 (3) ◽  
pp. 981-993 ◽  
Author(s):  
Nataliya Temelkova ◽  
Stefka Vladeva ◽  
Aleksi Delchev ◽  
Kalina Ivanova ◽  
Yoanna Gerasimova-Zheleva ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Real World ◽  
Routine Clinical Practice ◽  
Antidiabetic Drugs ◽  
Oral Antidiabetic Drugs ◽  
Oral Antidiabetic

Neuropsychological assessment in older people: old principles and new directions

2000 ◽  
Vol 6 (5) ◽  
pp. 362-370 ◽  
Author(s):  
Robin G. Morris ◽  
Claire Worsley ◽  
David Matthews
Keyword(s):  
Older Adults ◽  
Clinical Practice ◽  
Older People ◽  
Neuropsychological Assessment ◽  
Rating Scales ◽  
Clinical Psychologist ◽  
Narrow Sense ◽  
New Directions ◽  
Different Types ◽  
Common Clinical Practice

Neuropsychological assessment, in the broader sense, is common clinical practice with older adults because of the widespread use of mental status examinations and dementia rating scales. In the more narrow sense, a neuropsychological assessment conducted by a clinical psychologist or clinical neuropsychologist is used less frequently and for more specific purposes. This paper outlines these uses and provides a brief overview of the different types of test that might be used, with a clinical example to illustrate the type of information gained. This review is designed not to be comprehensive, but to provide a pointer towards the latest trends in test development.

scholarly journals Delirium and post-discharge dementia: results from a cohort of older adults without baseline cognitive impairment

2019 ◽  
Vol 48 (6) ◽  
pp. 845-851 ◽  
Author(s):  
Flavia Barreto Garcez ◽  
Daniel Apolinario ◽  
Flavia Campora ◽  
Jose Antonio Esper Curiati ◽  
Wilson Jacob-Filho ◽  
...  
Keyword(s):  
Older Adults ◽  
Cognitive Decline ◽  
Clinical History ◽  
University Hospital ◽  
Proportional Hazard ◽  
Post Discharge ◽  
Preventable Risk Factor ◽  
Admission Data ◽  
Incident Dementia

Abstract Objectives to investigate the association between delirium occurrence in acutely ill older adults and incident dementia after hospital discharge. Methods retrospective cohort study examining acutely ill older adults aged +60 years and consecutively admitted to the geriatric ward of a tertiary university hospital from 2010 to 2016. Inclusion criteria were absence of baseline cognitive decline on admission and documented clinical follow-up of +12 months after discharge. Admission data were collected from our local database, including results from a standardized comprehensive geriatric assessment completed for every patient. Pre-existing cognitive decline was identified based on clinical history, CDR and IQCODE-16. Delirium was diagnosed using short-CAM criteria, while post-discharge dementia after 12 months was identified based on medical records’ review. We used competing-risk proportional-hazard models to explore the association between delirium and post-discharge dementia. Results we included 309 patients. Mean age was 78 years, and 186 (60%) were women. Delirium was detected in 66 (21%) cases. After a median follow-up of 24 months, 21 (32%) patients who had experienced delirium progressed with dementia, while only 38 (16%) of those without delirium had the same outcome (P = 0.003). After adjusting for possible confounders, delirium was independently associated with post-discharge dementia with a sub-hazard ratio of 1.94 (95%CI = 1.10–3.44; P = 0.022). Conclusion one in three acutely ill older adults who experienced delirium in the hospital developed post-discharge dementia during follow-up. Further understanding of delirium as an independent and potentially preventable risk factor for cognitive decline emphasizes the importance of systematic initiatives to fight it.

Safety of a trastuzumab biosimilar, used under routine clinical practice conditions in adult HER2+ breast cancer patients in Morocco.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e13024-e13024
Author(s):  
Hassan Errihani ◽  
Narjiss Berrada ◽  
Mouna Khouchani ◽  
Abdelkader Acharki ◽  
Kamal Lahbabi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Practice ◽  
Adverse Events ◽  
Early Breast Cancer ◽  
Real World ◽  
Safety Profile ◽  
Safety Data ◽  
Routine Clinical Practice ◽  
Her2 Breast Cancer

e13024 Background: Hertraz, the first trastuzumab biosimilar was approved in Morocco in 2017. Real world data on trastuzumab biosimilars are very limited or not available. HERLife is a prospective, non-interventional phase IV study program that investigated the experience of using Hertraz, a biosimilar for trastuzumab (Herceptin), under routine clinical practice conditions in Morocco. The primary aim of this study was to confirm the acceptable safety and tolerability of Hertraz. Methods: Ninety-nine patients with HER2-positive breast cancer treated with Hertraz were enrolled from 8 public and private sector hospitals and followed up for 12 months as part of this non-interventional study. Cardiac events (LVEF) and other unexpected or serious adverse events were monitored. The study arms consisted of patients with early breast cancer (Arm 1, n=70) and metastatic breast cancer (Arm 2, n=29) whose median age was 53 years in both groups. Results: Switching from Herceptin to Hertraz was observed in 45% of 29 MBC patients and 27% of 70 EBC patients. Switching was done at a median of 4th cycle. Pertuzumab was used in combination with Hertraz in 69% and 19% of patients in the metastatic and neoadjuvant settings, respectively. Two patients had a decline in LVEF. One patient treated with Hertraz alone and one patient treated with Hertraz and pertuzumab developed a decrease in LVEF requiring a three-week treatment discontinuation of Hertraz. Treatment of Hertraz was continued after 1 skipped cycle without occurrence of new side effects. No other trastuzumab related adverse events was observed. Four patients in the metastatic group and 2 patients in the early breast cancer arm had a relapse in the 12 months of clinical follow-up. Conclusions: The management of HER2+ breast cancer in Morocco follows the international recommendations. This is the first real world safety data of Hertraz from Morocco. The 12-month follow-up treatment with Hertraz showed an acceptable cardiac safety profile. In cases where there was a switch from Herceptin to Hertraz or Hertraz combined with pertuzumab, the safety profile was similar to that previously reported in other studies.

Assessing real-world clinical response in patients with multiple myeloma (MM): A survey of the literature.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19260-e19260
Author(s):  
Daniel Lane ◽  
Andrew D. Norden ◽  
Andrew J. Belli ◽  
Ching-Kun Wang
Keyword(s):  
Clinical Trial ◽  
Clinical Practice ◽  
Real World ◽  
English Language ◽  
Complete Response ◽  
Protein Electrophoresis ◽  
Mandatory Reporting ◽  
Routine Clinical Practice ◽  
Cell Transplant ◽  
Strict Adherence

e19260 Background: A recent study (Foster, Tromanhauser et al. 2019) utilizing Electronic Health Record (EHR) data found that patients with MM rarely have both serum protein electrophoresis (SPEP) and 24-hour urine protein electrophoresis (UPEP) documented in routine clinical practice settings. These elements are necessary to classify response using the International Myeloma Working Group (IMWG) consensus criteria. It could be hypothesized that adding the additional requirements for bone marrow biopsy necessary to confirm a complete response would further reduce the rate of strict adherence to the IMWG criteria in the real world (RW). Clinicians are however assessing response and progression in RW settings and often report these assessments in published literature. In this study, we survey the literature to determine how RW response is being captured and reported outside of the clinical trial setting. Methods: A systematic search was performed using Medline 2010-2019. Using a standardized grading system, English language articles were evaluated that utilized EHR data from routine clinical practice to report RW response in patients with active MM. Registry based and/or pragmatic observational studies were excluded as many had mandatory reporting procedures in place. Studies were then categorized based on methods of assessing response, progression and use of IMWG criteria. Results: The majority of studies grade 1 studies identified (21/25) utilized best response achieved based on treating physician-documented assessment and either did not specify the use of IMWG(10/21) criteria or explicitly stated they did not use conventional criteria (11/21). Progression event capture and reporting varied greatly with many using physician-documented progression, change in regimen, addition of additional agents to existing regimen, stem cell transplant, or an individually created algorithm. Conclusions: Our findings suggest that there is a need for further research on objective techniques for the assessment of RW progression and response in patients with MM. Additionally, validation of an approach that utilizes partial adherence to IMWG criteria would help in the ability to compare findings across clinical trial and RW settings. This validation work is under way, and preliminary results will be reported at the meeting.

Detection of total bile acids in biological samples using an indirect competitive ELISA based on four monoclonal antibodies

2017 ◽  
Vol 9 (4) ◽  
pp. 625-633 ◽  
Author(s):  
Shuchen Liu ◽  
Yue Zhang ◽  
Baoping Qu ◽  
Gaofeng Qin ◽  
Jinjun Cheng ◽  
...  
Keyword(s):  
Monoclonal Antibodies ◽  
Clinical Practice ◽  
Biological Samples ◽  
Competitive Elisa ◽  
Routine Clinical Practice ◽  
Enzyme Linked Immunosorbent Assay ◽  
Indirect Competitive Elisa ◽  
Different Types ◽  
Total Bile Acids

We investigated a newly developed indirect competitive enzyme-linked immunosorbent assay for the determination of 5 major components of TBA, which works efficiently in different types of biological samples, and may be suitable for routine clinical practice.

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