scholarly journals No Increased Risk of Cataract in Immune Thrombocytopenia Adult Patients Treated with Eltrombopag. a French Nationwide Nested Case-Control Study

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2363-2363
Author(s):  
Margaux Lafaurie ◽  
Bérangère Baricault ◽  
Vincent Soler ◽  
Myriam Cassagne ◽  
Laurent Sailler ◽  
...  
Keyword(s):  
Risk Factors ◽  
Research Funding ◽  
Case Control Study ◽  
Case Control ◽  
Adult Patients ◽  
Cumulative Exposure ◽  
Increased Risk ◽  
Nested Case Control ◽  
Control Study

Background: In preclinical studies, eltrombopag has been associated to an increased incidence of cataract in mice and rats. No increased risk has been observed in randomized controlled trials in immune thrombocytopenia (ITP) patients. During the eltrombopag extension study EXTEND, 28/302 patients developed or worsened cataract, i.e. 9.3% of the patients over a median duration of exposure of 2.4 years. Of note, 79% of these 28 patients had at least another risk factor of cataract. Real-life studies assessing the risk of cataract in ITP adult patients exposed to eltrombopag are lacking. Aim: To assess the risk of cataract with eltrombopag in a nationwide cohort of primary ITP adults. Methods: The population was the cohort of all incident primary ITP adult patients (≥18 years) in France from June 2010 (date of eltrombopag marketing in France) to June 2017. This cohort was identified within the national health insurance database using a validated algorithm combining drug exposures and international classification of diseases, version 10 (ICD-10) diagnosis codes (FAITH cohort; NCT03429660). A nested case-control study was conducted within the cohort. Cases were patients who had a surgery for cataract after ITP onset, identified using appropriate codes. Up to five controls for each case were matched on age and sex. Index date was the date of cataract surgery for cases, and the date of cataract surgery of the corresponding case for controls. Two analyses were conducted: one considering the exposure to eltrombopag as ever vs. never exposed; another considering the cumulative exposure to eltrombopag, categorized by never exposed, a 1-365 Defined Daily Dose (DDD) exposure, and a ≥365 DDD exposure. Covariables were the presence of diabetes mellitus, cumulative exposure to corticosteroids considered in prednisone equivalence dosage (by quartiles), and the presence of ophthalmological risk factors of cataract (including previous ophthalmological surgery, glaucoma and other anterior chamber risk factors). Conditional logistic regression models were used to compute adjusted odds ratios (aOR) and their 95% confidence intervals (CI). Results: The cohort included 8,502 incident primary ITP adults. During the follow-up (31,590 patient-years in total; mean follow-up: 44.4 months), 1,097 patients were exposed to eltrombopag, including 310 with a cumulative exposure ≥365 DDDs. Overall, 573 patients had a surgery of cataract; incidence: 1.90/100 person-years (95% CI: 1.75-2.06). Fifty-seven cases occurred in patients ever exposed to eltrombopag; incidence: 1.50/100 person-years (95%CI: 1.15-1.94) in this subgroup. The nested case-control study included the 573 cases and 2699 controls. Median age was 75 years and 50% were women; the median duration of disease was 24.8 months in cases and 24.2 months in controls; 57 (9.9%) cases and 314 (11.6%) controls were exposed to eltrombopag before the index date; 14 (2.4%) and 68 (2.5%) patients had cumulative exposure to eltrombopag ≥365 DDDs, respectively. Cases were more frequently exposed to corticosteroids (83.4% vs. 75.7%), with a higher cumulative exposure to corticosteroids (median: 2800 vs. 2188 mg prednisone equivalent). Diabetes mellitus was present in 25.7% of cases vs. 25.1% of controls while ophthalmological risk factors were present in 5.4% and 2.8%, respectively. In the ever/never exposed analysis, the aOR for eltrombopag was 0.79 (95% CI: 0.58-1.07). In the cumulative exposure analysis, the aOR was 0.76 (95% CI: 0.54-1.08) in the 1-365 DDD group as compared with the never exposed group, and 0.88 (95% CI: 0.49-1.59) in the ≥365 DDD group as compared with the never exposed group. Conclusions: This nationwide pharmacoepidemiological study did not identify an increased risk of cataract in primary ITP adult patients exposed to eltrombopag. Disclosures Moulis: Novartis pharma: Research Funding, Speakers Bureau; Amgen pharma: Research Funding, Speakers Bureau; CSL Behring: Research Funding.

scholarly journals Risk Factors for Falls in Hospital In-Patients: A Prospective Nested Case Control Study

2019 ◽  
Vol 8 (5) ◽  
pp. 300-306 ◽  
Author(s):  
Zhila Najafpour ◽  
Zahra Godarzi ◽  
Mohammad Arab ◽  
Mehdi Yaseri
Keyword(s):  
Risk Factors ◽  
Length Of Stay ◽  
Case Control Study ◽  
Case Control ◽  
Patient Falls ◽  
Increased Risk ◽  
Risk Factors For Falls ◽  
Clinical Records ◽  
Nested Case Control ◽  
Control Study

Background: Patient falls are considered a challenge to the patient’s safety in hospitals, which, in addition to increasing the length of stay and costs, may also result in severe injuries or even the death of the patient. This study aims to investigate the associations between risk factors among fallers in comparison with the control group. Methods: A prospective nested case control study was performed on 185 patients who fell and 1141 controls were matched with the patients at risk of fall in the same ward and during the same time. This study was conducted in a university educational hospital in Tehran with 800 beds during a 9-month period. The data included demographics, comorbidities, admission details, types of medication, clinical conditions, and activities before or during the fall. The data was collected from clinical records, hospital information system, error reporting system and observations, and the interviews with the fallers, their families and care givers (physicians, nurses, etc). Data analysis was conducted through time-based matching using a multi-level analysis. Results: In a multilevel model including patient-related, medication, and care-related variables, the factors that were significantly associated with an increased risk of patient falls included: longer length of stay (odds ratio [OR] = 1.01; CI=0.32 to 0.73), using chemotherapy drugs, sedatives, anticonvulsants, benzodiazepines, and angiotensin-converting enzyme (ACE) inhibitors, visual acuity (OR=6.93; CI=4.22 to 11.38), balance condition (OR= 6.41; CI=4.51 to 9.11), manual transfer aid (OR=8.47; CI=5.65 to 12.69), urinary incontinence (OR= 8.47, CI= 5.65 to 12.69), and cancer (OR=2.86, CI=1.84-4.44). These factors were found to be associating with more odds for a falling accident among patients. Several characteristics such as fall history (OR=0.48; CI= 1.003 to 1.02), poly-pharmacy (OR=1.37, CI=00.85 to 2.2), stroke (OR=0.94, CI= 0.44 to 2.02), and nurse to patient ratio (incidence rate ratio=1.01, CI=0.01 to 0.03) were not significantly associated with falling in hospitals. Conclusion: It seems that a combination of both patient-related factors and history of medication should be considered. Moreover, modifiable clinical characteristics of patients such as vision improvement, provision of manual transfer aid, diabetes control, regular toilet program, and drug modification should be considered during the formulation of interventions.

scholarly journals Antiphospholipid antibodies predict imminent vascular events independently from other risk factors in a prospective cohort

2009 ◽  
Vol 101 (01) ◽  
pp. 100-107 ◽  
Author(s):  
Jeannine Kassis ◽  
Susan Solymoss ◽  
Lawrence Joseph ◽  
Patrick Belisle ◽  
Jerrold Levine ◽  
...  
Keyword(s):  
Risk Factors ◽  
Prospective Cohort ◽  
Antiphospholipid Antibodies ◽  
Case Control Study ◽  
Activated Protein C ◽  
Case Control ◽  
Vascular Events ◽  
Nested Case Control ◽  
Control Study

SummaryAntiphospholipid antibodies (aPL) are associated with vascular events, but the magnitude of this risk, alone, or in combination with other atherogenic and thrombophilic risk factors, remains unclear. A prospective cohort of 415 persons was studied for arterial and venous events (AE and VE) over a median time of 7.4 years. aPL and coagulation abnormalities were measured upon beginning of the study and annually for the first four years. Within the cohort, a nested case-control study was conducted to investigate the role of endothelial and inflammatory markers in predicting new vascular events. Forty-five individuals had new vascular events: 18 occurred during the first year of follow-up. The proportion of event-free survivors at eight years was 90% (95%CI = 87%, 94%) for aPL-negative and 72% (60%, 85%) for aPL-positive individuals, respectively. Predictors for new AE were previous AE (HR=5.7 [2.7, 12.0]), diabetes (5.6 [2.4, 13.2]), aPL positivity (2.6 ([1.2, 5.9]), and age (1.04 [1.01, 1.07]). New VE were predicted by previous VE (6.1 [1.9, 19.9]), anti-β2-glyco-protein I (aβ2GPI) positivity (5.8 [1.4, 24.1]), activated protein C resistance (APCR) (4.1 [1.1, 15.1]), and gender (3.7 [1.1, 12.9]). In the nested case-control study, similar predictors were observed for AE, while abnormal APCR (OR=5.5 [1.1, 26.6]) and elevated von Willebrand factor (vWF) (OR=5.0 [1.2, 19.8]) best predicted VE. We demonstrate that aPL independently predict new vascular events and discriminate between individuals with and without events in the first two years of follow-up, indicating that aPL are associated with a short-term risk of developing new and recurrent vascular events.

scholarly journals Standardized Incidence Rate, Risk and Survival Outcomes of Second Primary Malignancy Among Renal Cell Carcinoma Survivors: A Nested Case-Control Study

2021 ◽  
Vol 11 ◽  
Author(s):  
Zhixian Wang ◽  
Yisheng Yin ◽  
Jing Wang ◽  
Yunpeng Zhu ◽  
Xing Li ◽  
...  
Keyword(s):  
Risk Factors ◽  
Case Control Study ◽  
Case Control ◽  
Survival Outcomes ◽  
Second Primary ◽  
Second Primary Malignancy ◽  
Primary Malignancy ◽  
Nested Case Control ◽  
Control Study

PurposeSecond primary malignancy (SPM) is challenging for treatment and long-term survival. We sought to investigate the standardized incidence rate (SIR), risk factors, and survival outcomes for SPM after renal cell carcinoma (RCC) treatment.MethodA nested case-control study was designed, we identified all T1-4N0-1M0 RCC patients diagnosed between 2004 and 2015 in the Surveillance, Epidemiology, and End Results database and followed them for SPM diagnosis for up to 13 years. Patients with SPM diagnosis ≥6 months after treatment of primary T1-4N0-1M0 RCC were identified as the case cohort and SPM-free patients were the control cohort. SIRs and the excess risk were calculated. A competing risks and Cox model were used to evaluate the risk factors of SPM and overall survival (OS).ResultsA cohort of 6,204 RCC patients with SPM were matched with a control group of 31,020 RCC patients without SPM. The median time-to-SPM interval was 54.5 months in RCC patients with SPM diagnosis. Besides, an SPM of T3/4 or/and M1 stage diagnosis was positively associated with a longer time-to-SPM interval. SIR of SPM increased by follow-up time and decreased with age at diagnosis (Pfor all <0.001). SPM in the kidney had the highest SIR (54.6, P <0.001) among all SPMs. Prostate cancer (29.8%) in males and breast cancer (23.5%) in females were the most common SPM. Older age, black ethnicity, male sex, higher family income, papillary RCC, and lower TNM stage were significant risk factors for SPM diagnosis. The proportion of deaths from SPM exceeds that of deaths from RCC 3 years after the first RCC treatment. Patients with SPM and early time-to-SPM interval shortens the OS compared with SPM-free patients. The 5-year OS was 85.9% and 58.9% from the first RCC and the SPM diagnosis, respectively. Besides, patients with low-grade/early-stage SPM could benefit from aggressive surgical treatment for solid tumors.ConclusionsCollectively, our study described the epidemiological characteristics of SPM among RCC survivors and identified the independent predictors of the SPM diagnosis and its survival outcomes. This study highlights the importance of patient education and follow-up after the surgery for RCC.

scholarly journals Risk Factors for Postpartum Hemorrhage in a Thai–Myanmar Border Community Hospital: A Nested Case-Control Study

2021 ◽  
Vol 18 (9) ◽  
pp. 4633
Author(s):  
Waraporn Thepampan ◽  
Nuchsara Eungapithum ◽  
Krittai Tanasombatkul ◽  
Phichayut Phinyo
Keyword(s):  
Risk Factors ◽  
Pregnant Women ◽  
Postpartum Hemorrhage ◽  
Minority Groups ◽  
Case Control Study ◽  
Community Hospital ◽  
Case Control ◽  
Border Community ◽  
Nested Case Control ◽  
Control Study

Postpartum hemorrhage (PPH) is a common complication of pregnancy and a global public health concern. Even though PPH risk factors were extensively studied and reported in literature, almost all studies were conducted in non-Asian countries or tertiary care centers. Our study aimed to explore relevant risk factors for PPH among pregnant women who underwent transvaginal delivery at a Thai–Myanmar border community hospital in Northern Thailand. An exploratory nested case-control study was conducted to explore risk factors for PPH. Women who delivered transvaginal births at Maesai hospital from 2014 to 2018 were included. Two PPH definitions were used, which were ≥ 500 mL and 1000 mL of estimated blood loss within 24 h after delivery. Multivariable conditional logistic regression was used to identify significant risk factors for PPH and severe PPH. Of 4774 women with vaginal births, there were 265 (5.55%) PPH cases. Eight factors were identified as independent predictors for PPH and severe PPH: elderly pregnancy, minority groups, nulliparous, previous PPH history, BMI ≥ 35 kg/m2, requiring manual removal of placenta, labor augmentation, and fetal weight > 4000 gm. Apart from clinical factors, particular attention should be given to pregnant women who were minority groups as PPH risk significantly increased in this population.

scholarly journals Irritable bowel syndrome and Parkinson’s disease risk: register-based studies

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Bojing Liu ◽  
Arvid Sjölander ◽  
Nancy L. Pedersen ◽  
Jonas F. Ludvigsson ◽  
Honglei Chen ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Irritable Bowel Syndrome ◽  
Case Control Study ◽  
Case Control ◽  
Twin Registry ◽  
Increased Risk ◽  
Irritable Bowel ◽  
Nested Case Control ◽  
Control Study ◽  
Swedish Twin Registry

AbstractTo examine whether irritable bowel syndrome (IBS) was related to the future risk of Parkinson’s disease (PD), we conducted a nested case-control study in the Swedish total population including 56,564 PD cases identified from the Swedish Patient Register and 30 controls per case individually matched by sex and year of birth. Odds ratios (ORs) with 95% confidence intervals (CIs) for having a prior diagnosis of IBS were estimated using conditional logistic regression. We furthermore conducted a cohort study using the Swedish Twin Registry following 3046 IBS patients identified by self-reported abdominal symptoms and 41,179 non-IBS individuals. Through Cox proportional hazard models, we estimated hazard ratios (HRs) and 95% CIs for PD risk. In the nested case-control study, 253 (0.4%) PD cases and 5204 (0.3%) controls had a previous IBS diagnosis. IBS diagnosis was associated with a 44% higher risk of PD (OR = 1.44, 95% CI 1.27–1.63). Temporal relationship analyses showed 53% and 38% increased risk of PD more than 5 and 10 years after IBS diagnosis, respectively. In the cohort analysis based on the Swedish Twin Registry, there was no statistically significantly increased risk of PD related to IBS (HR = 1.25, 95% CI = 0.87–1.81). Our results suggest a higher risk of PD diagnosis after IBS. These results provide additional evidence supporting the importance of the gut–brain axis in PD.

scholarly journals Risk factors for suicidal tendency in people with epilepsy in China: a case–control study

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Mintao Lin ◽  
Jiani Chen ◽  
Sisi Li ◽  
Yingjie Qin ◽  
Xuruan Wang ◽  
...  
Keyword(s):  
Risk Factors ◽  
Low Income ◽  
Case Control Study ◽  
Univariate Analysis ◽  
Case Control ◽  
Conditional Inference ◽  
Suicidal Tendency ◽  
Patients With Epilepsy ◽  
Nested Case Control ◽  
Control Study

AbstractPeople with epilepsy (PWE) have an increased suicide prevalence. This study aimed to identify the risk factors for suicidal tendency among PWE in West China. A nested case–control study was designed in a cohort of patients with epilepsy (n = 2087). In total, 28 variates were calculated. In the univariate analysis, unemployment, low income, seizure frequency, seizure-free time, infectious or structural etiology, levetiracetam or phenobarbital use, anxiety, depression, and stigma were associated with suicidal tendency. A multivariate analysis indicated that unemployment (odds ratio [OR] 5.74, 95% confidence interval [CI] 2.13–15.48), levetiracetam use (OR 2.80, 95%CI 1.11–7.05), depression (C-NDDI-E score ≥ 13; OR 3.21, 95%CI 1.26–8.21), and stigma (SSCI score ≥ 16; OR 6.67, 95%CI 1.80–24.69) were independently associated with suicidal tendency. Conditional inference tree analysis indicated that SSCI and C-NDDI-E scores could effectively identify patients with suicidal tendency. Thus, this study suggests that unemployment, levetiracetam use, depression, and stigma are independent risk factors for suicidal tendency in PWE in China.

scholarly journals Inflammatory bowel disease in sub-Saharan Africa: a protocol of a prospective registry with a nested case–control study

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e039456
Author(s):  
Leolin Katsidzira ◽  
Wisdom F Mudombi ◽  
Rudo Makunike-Mutasa ◽  
Bahtiyar Yilmaz ◽  
Annika Blank ◽  
...  
Keyword(s):  
Risk Factors ◽  
Inflammatory Bowel Disease ◽  
Case Control Study ◽  
Alpha Diversity ◽  
Case Control ◽  
Sub Saharan Africa ◽  
Inflammatory Bowel ◽  
Sub Saharan ◽  
Nested Case Control ◽  
Control Study

IntroductionThe epidemiology of inflammatory bowel disease (IBD) in sub-Saharan Africa is poorly documented. We have started a registry to determine the burden, phenotype, risk factors, disease course and outcomes of IBD in Zimbabwe.Methods and analysisA prospective observational registry with a nested case–control study has been established at a tertiary hospital in Harare, Zimbabwe. The registry is recruiting confirmed IBD cases from the hospital, and other facilities throughout Zimbabwe. Demographic and clinical data are obtained at baseline, 6 months and annually. Two age and sex-matched non-IBD controls per case are recruited—a sibling or second-degree relative, and a randomly selected individual from the same neighbourhood. Cases and controls are interviewed for potential risk factors of IBD, and dietary intake using a food frequency questionnaire. Stool is collected for 16S rRNA-based microbiota profiling, and along with germline DNA from peripheral blood, is being biobanked. The estimated sample size is 86 cases and 172 controls, and the overall registry is anticipated to run for at least 5 years. Descriptive statistics will be used to describe the demographic and phenotypic characteristics of IBD, and incidence and prevalence will be estimated for Harare. Risk factors for IBD will be analysed using conditional logistic regression. For microbial analysis, alpha diversity and beta diversity will be compared between cases and controls, and between IBD phenotypes. Mann-Whitney U tests for alpha diversity and Adonis (Permutational Multivariate Analysis of Variance) for beta diversity will be computed.Ethics and disseminationEthical approval has been obtained from the Parirenyatwa Hospital’s and University of Zimbabwe’s research ethics committee and the Medical Research Council of Zimbabwe. Findings will be discussed with patients, and the Zimbabwean Ministry of Health. Results will be presented at scientific meetings, published in peer reviewed journals, and on social media.Trial registration numberNCT04178408.

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