scholarly journals Detection of unknown ototoxic adverse drug reactions: an electronic healthcare record-based longitudinal nationwide cohort analysis

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Suehyun Lee ◽  
Jaehun Cha ◽  
Jong-Yeup Kim ◽  
Gil Myeong Son ◽  
Dong-Kyu Kim
Keyword(s):  
Hearing Loss ◽  
Adverse Drug Reactions ◽  
Cohort Analysis ◽  
Cox Proportional Hazards ◽  
Hazard Ratio ◽  
New Drugs ◽  
Rank Test ◽  
Drug Reactions ◽  
Bilateral Hearing Loss ◽  
Ototoxic Drugs

AbstractOtotoxic medications can lead to significant morbidity. Thus, pre-marketing clinical trials have assessed new drugs that have ototoxic potential. Nevertheless, several ototoxic side effects of drugs may remain undetected. Hence, we sought to retrospectively investigate the potential risk of ototoxic adverse drug reactions among commonly used drugs via a longitudinal cohort study. An electronic health records-based data analysis with a propensity-matched comparator group was carried out. This study was conducted using the MetaNurse algorithm for standard nursing statements on electronic healthcare records and the National Sample Cohort obtained from the South Korea National Health Insurance Service. Five target drugs capable of causing ototoxic adverse drug reactions were identified using MetaNurse; two drugs were excluded after database-based analysis because of the absence of bilateral hearing loss events in patients. Survival analysis, log-rank test, and Cox proportional hazards regression models were used to calculate the incidence, survival rate, and hazard ratio of bilateral hearing loss among patients who were prescribed candidate ototoxic drugs. The adjusted hazard ratio of bilateral hearing loss was 1.31 (1.03–1.68), 2.20 (1.05–4.60), and 2.26 (1.18–4.33) in cimetidine, hydroxyzine, and sucralfate users, respectively. Our results indicated that hydroxyzine and sucralfate may cause ototoxic adverse drug reactions in patients. Thus, clinicians should consider avoiding co-administration of these drugs with other well-confirmed ototoxic drugs should be emphasized.

scholarly journals Detection of Unknown Ototoxic Adverse Drug Reactions: An Electronic Healthcare Record-Based Longitudinal Nationwide Cohort Analysis

2021 ◽  
Author(s):  
Suehyun Lee ◽  
Jaehun Cha ◽  
Jong-Yeup Kim ◽  
Gil Myeong Son ◽  
Dong-Kyu Kim
Keyword(s):  
Hearing Loss ◽  
Adverse Drug Reactions ◽  
Proportional Hazards ◽  
Cohort Analysis ◽  
Cox Proportional Hazards ◽  
Hazard Ratio ◽  
New Drugs ◽  
Rank Test ◽  
Drug Reactions ◽  
Bilateral Hearing Loss

Abstract Ototoxic medications can lead to significant morbidity. Thus, pre-marketing clinical trials have assessed new drugs that have ototoxic potential. Nevertheless, several ototoxic side effects of drugs may remain undetected. Hence, we sought to retrospectively investigate the potential risk of ototoxic adverse drug reactions among commonly used drugs via a longitudinal cohort study. An electronic health records-based data analysis with a propensity-matched comparator group was carried out. This study was conducted using the MetaNurse algorithm for standard nursing statements on electronic healthcare records and the National Sample Cohort obtained from the South Korea National Health Insurance Service. Five target drugs capable of causing ototoxic adverse drug reactions were identified using MetaNurse; two drugs were excluded after database-based analysis because of the absence of bilateral hearing loss events in patients. Survival analysis, log-rank test, and Cox proportional hazards regression models were used to calculate the incidence, survival rate, and hazard ratio of bilateral hearing loss among patients who were prescribed candidate ototoxic drugs. The adjusted hazard ratio of bilateral hearing loss was 1.31 (1.03–1.68), 2.20 (1.05–4.60), and 2.26 (1.18–4.33) in cimetidine, hydroxyzine, and sucralfate users, respectively. Our results indicated that hydroxyzine and sucralfate may cause ototoxic adverse drug reactions in patients. Thus, clinicians should consider the risk of ototoxicity when prescribing these drugs.

Impact of Cognitive Dysfunction on Survival in Patients With and Without Statin Use Following Carotid Endarterectomy

Neurosurgery ◽  
2015 ◽  
Vol 77 (6) ◽  
pp. 880-887 ◽  
Author(s):  
Eric J. Heyer ◽  
Joanna L. Mergeche ◽  
Shuang Wang ◽  
John G. Gaudet ◽  
E. Sander Connolly
Keyword(s):  
Confidence Interval ◽  
Carotid Endarterectomy ◽  
Cognitive Dysfunction ◽  
Proportional Hazards ◽  
Cox Proportional Hazards ◽  
Hazard Ratio ◽  
Rank Test ◽  
Term Survival ◽  
Asymptomatic Patients ◽  
Statin Use

BACKGROUND: Early cognitive dysfunction (eCD) is a subtle form of neurological injury observed in ∼25% of carotid endarterectomy (CEA) patients. Statin use is associated with a lower incidence of eCD in asymptomatic patients having CEA. OBJECTIVE: To determine whether eCD status is associated with worse long-term survival in patients taking and not taking statins. METHODS: This is a post hoc analysis of a prospective observational study of 585 CEA patients. Patients were evaluated with a battery of neuropsychometric tests before and after surgery. Survival was compared for patients with and without eCD stratifying by statin use. At enrollment, 366 patients were on statins and 219 were not. Survival was assessed by using Kaplan-Meier methods and multivariable Cox proportional hazards models. RESULTS: Age ≥75 years (P = .003), diabetes mellitus (P < .001), cardiac disease (P = .02), and statin use (P = .014) are significantly associated with survival univariately (P < .05) by use of the log-rank test. By Cox proportional hazards model, eCD status and survival adjusting for univariate factors within statin and nonstatin use groups suggested a significant effect by association of eCD on survival within patients not taking statin (hazard ratio, 1.61; 95% confidence interval, 1.09–2.40; P = .018), and no significant effect of eCD on survival within patients taking statin (hazard ratio, 0.98; 95% confidence interval, 0.59–1.66; P = .95). CONCLUSION: eCD is associated with shorter survival in patients not taking statins. This finding validates eCD as an important neurological outcome and suggests that eCD is a surrogate measure for overall health, comorbidity, and vulnerability to neurological insult.

New drugs, new adverse drug reactions, and bibliographic databases

The Lancet ◽  
1999 ◽  
Vol 353 (9162) ◽  
pp. 1447-1448 ◽  
Author(s):  
A Figueras ◽  
F Estévez ◽  
J-R Laporte
Keyword(s):  
Adverse Drug Reactions ◽  
New Drugs ◽  
Bibliographic Databases ◽  
Drug Reactions

scholarly journals Nurse knowledge about potentially inappropriate medications for elderly

2021 ◽  
Vol 37 ◽  
pp. e37037
Author(s):  
Gabriela Garcia Soares ◽  
Ana Luisa Zanardo Buso ◽  
Bruna Stephanie Sousa Malaquias ◽  
Rodrigo Rodrigues Silva ◽  
Juliana Maria Soares ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Population Aging ◽  
The Elderly ◽  
New Drugs ◽  
Potentially Inappropriate Medications ◽  
Drug Reactions ◽  
Cross Sectional ◽  
Elderly Health ◽  
The Individual ◽  
Inappropriate Medications

Due to the consequences of changes in fertility and mortality rates, there is an increase in population aging. In this context, the use of potentially inappropriate medications in this population makes nurses important agents in the identification of adverse reactions, requiring their knowledge about these drugs and their effects. The study aimed to verify nurses knowledge about the 2015 AGS BeersCriteria, regarding the potentially inappropriate medications for the elderly, and their adverse effects. It is a cross-sectional, descriptive, and analytical study with a quantitative and qualitative approach performed in a teaching hospital in the Triângulo Mineiro, Minas Gerais. Of the 80 professionals, 74.1% reported attending the elderly frequently, and only 3.8% had a specialization course in elderly health. Only 13.8% reported knowing the Beers Criteria. And 69% believe that adverse drug reactions can be confused as a new symptom and because of this, new drugs can be inserted into the therapeutic plan. Three categories emerged: The importance of assertive knowledge about PIMs, The nurse as a fundamental character in ADR, and Knowledge as a reinforcer of care. There is evidence of the need to train nurses to better identify adverse drug reactions so that they can act on these events avoiding the worsening of the individual.

scholarly journals Fuzzy Comprehensive Evaluation Assistant 3D-QSAR of Environmentally Friendly FQs to Reduce ADRs

2019 ◽  
Vol 16 (17) ◽  
pp. 3161 ◽  
Author(s):  
Ren ◽  
Wang ◽  
Xu ◽  
Li ◽  
Han
Keyword(s):  
Adverse Drug Reactions ◽  
Comprehensive Evaluation ◽  
Metabolic Activation ◽  
Fuzzy Comprehensive Evaluation ◽  
3D Qsar ◽  
New Drugs ◽  
Drug Reactions ◽  
Improved Method ◽  
Biological Studies

Most studies on adverse drug reactions (ADRs) of fluoroquinolones (FQs) have focused on the mechanisms of single ADRs, and no quantitative structure–activity relationship (QSAR) method studies have been carried out that combine several ADRs of FQs. In this study, an improved three-dimensional (3D) QSAR method was established using fuzzy comprehensive evaluation. This method could simultaneously consider three common ADRs of FQs using molecular parameters. The improved method could comprehensively predict three ADRs of FQs and provide direction for the development of new drugs with lower ADRs than the originals. According to the improved method, 48 derivatives with lower ADRs (decreased by 4.86% to 50.92%) were designed from pazufloxacin. Three derivatives with a higher genotoxicity, higher photodegradation, and lower bioconcentration than pazufloxacin were selected using the constructed QSAR methods of the FQs. Finally, three traditional 3D-QSAR methods of single ADR were constructed to validate the improved method. The improved method was reasonable, with a relative error range of 0.96% to 4.30%. This study provides valuable reference data and will be useful for the development of strategies to produce new drugs with few ADRs. In the absence of complementary biological studies of these adverse drug reactions, the results reported here may be quite divergent from those found in humans or experimental animals in vivo. One major reason for this is that many adverse drug reactions are dependent upon enzyme-catalyzed metabolic activation (toxication) or on non-enzymatic conversion to toxic products and are not due to the parent drug moiety.

The Influence of Primary Care Prescribing Rates for New Drugs on Spontaneous Reporting of Adverse Drug Reactions

Drug Safety ◽  
2007 ◽  
Vol 30 (4) ◽  
pp. 357-366 ◽  
Author(s):  
Richard C Clark ◽  
Simon R J Maxwell ◽  
Sheena Kerr ◽  
Melinda Cuthbert ◽  
Duncan Buchanan ◽  
...  
Keyword(s):  
Primary Care ◽  
Adverse Drug Reactions ◽  
Spontaneous Reporting ◽  
New Drugs ◽  
Drug Reactions

scholarly journals Association of Rehabilitation Intensity for Stroke and Risk of Hospital Readmission

2015 ◽  
Vol 95 (12) ◽  
pp. 1660-1667 ◽  
Author(s):  
A. Williams Andrews ◽  
Dongmei Li ◽  
Janet K. Freburger
Keyword(s):  
Confidence Interval ◽  
Acute Care ◽  
Hospital Readmission ◽  
Proportional Hazards ◽  
Cohort Analysis ◽  
Hospital Readmissions ◽  
Illness Severity ◽  
Cox Proportional Hazards ◽  
Hazard Ratio ◽  
Increased Risk

Background Little is known about the use of rehabilitation in the acute care setting and its impact on hospital readmissions. Objective The objective of this study was to examine the association between the intensity of rehabilitation services received during the acute care stay for stroke and the risk of 30-day and 90-day hospital readmission. Design A retrospective cohort analysis of all acute care hospitals in Arkansas and Florida was conducted. Methods Patients (N=64,065) who were admitted for an incident stroke in 2009 or 2010 were included. Rehabilitation intensity was categorized as none, low, medium-low, medium-high, or high based on the sum and distribution of physical therapy, occupational therapy, and speech therapy charges within each hospital. Cox proportional hazards regression was used to estimate hazard ratios, controlling for demographic characteristics, illness severity, comorbidities, hospital variables, and state. Results Relative to participants who received the lowest intensity therapy, those who received higher-intensity therapy had a decreased risk of 30-day readmission. The risk was lowest for the highest-intensity group (hazard ratio=0.86; 95% confidence interval=0.79, 0.93). Individuals who received no therapy were at an increased risk of hospital readmission relative to those who received low-intensity therapy (hazard ratio=1.30; 95% confidence interval=1.22, 1.40). The findings were similar, but with smaller effects, for 90-day readmission. Furthermore, patients who received higher-intensity therapy had more comorbidities and greater illness severity relative to those who received lower-intensity therapy. Limitations The results of the study are limited in scope and generalizability. Also, the study may not have adequately accounted for all potentially important covariates. Conclusions Receipt of and intensity of rehabilitation therapy in the acute care of stroke is associated with a decreased risk of hospital readmission.

Attention-deficit hyperactivity disorder increases the risk of deliberate self-poisoning: A population-based cohort

2014 ◽  
Vol 29 (8) ◽  
pp. 523-527 ◽  
Author(s):  
I.-C. Chou ◽  
C.-C. Lin ◽  
F.-C. Sung ◽  
C.-H. Kao
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Regression Model ◽  
Attention Deficit ◽  
Cohort Analysis ◽  
Cox Proportional Hazards ◽  
Emergency Department Visits ◽  
Rank Test ◽  
Study Cohort ◽  
Parental Occupation ◽  
Hyperactivity Disorder

AbstractBackgroundChildren with attention-deficit hyperactivity disorder (ADHD) may suffer marked impairment in early adulthood, increasing their risk for serious self-harmful behaviors. Deliberate self-poisoning (DSP) is the most common form of deliberate self-harm. An association may exist between ADHD diagnosis and subsequent DSP events. The purpose of study was to determine whether children and adolescents with ADHD are at a greater risk for DSP than are age-matched controls.MethodsClaims data from the Taiwan National Health Insurance Database were used to conduct a retrospective cohort analysis of emergency department visits. The study cohort contained 3685 patients with ADHD (< 8 years old). Each ADHD patient was frequency matched based on sex, age, urbanization, parental occupation, and index year to 10 control patients without ADHD. A Cox proportional-hazards regression model was used to estimate the risk of DSP in the ADHD and comparison cohorts.ResultsThe risk of developing DSP was significantly higher in the ADHD cohort than in the comparison cohort (P < .0001 for log-rank test). After adjusting for potential confounders, the regression model showed that the ADHD patients were at a 4.65-fold greater risk of developing DSP than the control patients were (HR = 4.65, 95% CI: 2.41–8.94).ConclusionChildren with ADHD are at greater risk of developing DSP. Identifying risk factors of DSP is crucial efforts to implement prevention strategies. The identification of the underlying cause of increased DSP among ADHD patients warrants further investigation.

Survival in male breast cancer (MaBC) over the past three decades.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 569-569
Author(s):  
Jose Pablo Leone ◽  
Rachel A. Freedman ◽  
Julieta Leone ◽  
Michael J. Hassett ◽  
Sara M. Tolaney ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Breast Cancer Mortality ◽  
Cox Proportional Hazards ◽  
Hazard Ratio ◽  
Rank Test ◽  
Cancer Specific Survival ◽  
Cox Models ◽  
The Past ◽  
Significant Difference ◽  
Over Time

569 Background: Breast cancer mortality in women has declined significantly over the past several years. In men, it is unclear whether survival has changed over time. The aim of this study was to evaluate changes in breast cancer-specific survival (BCSS) and overall survival (OS) in MaBC over the past three decades. Methods: We evaluated men diagnosed with breast cancer between 1988 and 2017, with known cause of death reported in the Surveillance, Epidemiology, and End Results registry. Patients were categorized into 3 groups by year of diagnosis: 1988-1997, 1998-2007 and 2008-2017. BCSS and OS were estimated by Kaplan-Meier and differences between groups were compared by log-rank test. Cox proportional hazards regression was used to evaluate the independent association of tumor and patient characteristics with BCSS and OS. Results: We included 8,412 men diagnosed between 1988-1997 (N = 1,033), 1998-2007 (N = 2,938) and 2008-2017 (N = 4,441). Median age for the overall population and within each decade of diagnosis was 68 years. Median follow-up was 23.6 years, 14.3 years and 4.5 years in periods 1988-1997, 1998-2007 and 2008-2017, respectively. Overall, BCSS at 5 years was 83.5%, 83.6% and 84.3% in periods 1988-1997, 1998-2007 and 2008-2017, respectively; p = 0.8. There was no significant difference in BCSS between the three periods of diagnosis within each stage of breast cancer (stage I, II, III and IV). Among all patients, OS at 5 years was 64.7%, 67.2% and 69.3% in periods 1988-1997, 1998-2007 and 2008-2017, respectively; p = 0.01. In multivariate Cox models, older age at diagnosis, black race, grade 3 disease, increasing stage, hormone receptor negative status and no surgery were all independently associated with worse BCSS and OS. In these adjusted Cox models, each additional year of diagnosis had no significant association with BCSS (hazard ratio, 1.0; 95% CI, 0.99 – 1.01; p = 0.78), and a significant improvement in OS (hazard ratio, 0.99; 95% CI, 0.98 – 0.99; p = 0.01). Conclusions: Over the past three decades, there has been no significant improvement in BCSS in MaBC. The changes in OS over time suggest increasing life expectancy. Efforts to improve BCSS in MaBC are warranted.

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