scholarly journals Less statin associated adverse events after initiation of pitavastatin compared with atorvastatin and rosuvastatin

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
J L Lin ◽  
P S Chen ◽  
Y H Li
Keyword(s):  
Adverse Events ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Moderate Intensity ◽  
Study Endpoint ◽  
Research Database ◽  
Private Company ◽  
Increased Risk

Abstract Background Statin associated adverse events (SAAEs), including hepatitis, myopathy and new onset diabetes mellitus (NODM), are major reasons that prevent the use of statins. We compared the risk of SAAEs among the commonly used statins to see if SAAEs were similar among the statins. Methods We retrieved data from the Taiwan National Health Insurance Research Database. From January 2013 to December 2017, all statin-treated patients without diabetes at baseline were enrolled. We classified eligible patients into pitavastatin (2–4mg/day), moderate-intensity statin (MIS [atorvastatin 10–20 mg/day or rosuvastatin 5–10 mg/day]), and high-intensity statin group (HIS [atorvastatin ≥40 mg/day and rosuvastatin ≥20mg/day]). The study endpoint is a composite of safety events, including hepatitis, myopathy, and NODM. All patients were followed-up for at least one year until December 2018. We used propensity score to balance the baseline differences between the 3 statin groups (N=50935 in each group). Results After a mean follow up time of 3.08 years, the safety events occurred in 5014 patients in pitavastatin group (9.84%), 5542 in MIS group (10.88%), and 5343 in HIS group (10.49%). Multivariate Cox proportional hazards model showed that MIS and HIS statins were associated with a higher risk of safety events compared with pitavastatin (adjusted hazard ratio [aHR] 1.122, 95% confidence interval [CI] 1.08–1.17 for MIS and aHR 1.056, 95% CI 1.02–1.10 for HIS). Most events were NODM, with 4818 events in pitavastatin (9.46%), 5284 in MIS (10.37%), and 5113 in HIS group (10.04%). Multivariate Cox proportional hazard analysis showed higher risk of NODM in MIS (adjusted HR 1.111, 95% CI 1.07–1.16) and HIS (aHR 1.050, 95% CI 1.01–1.10) compared with pitavastatin. Time-varying HR analysis showed increased risk of NODM with use of all these statins for more than 1 year compared with non-statin users. Conclusions Pitavastatin was associated with a lower risk of SAAEs, especially NODM, compared with atorvastatin and rosuvastatin. FUNDunding Acknowledgement Type of funding sources: Private company. Main funding source(s): Orient EuroPharma Co., Ltd.

scholarly journals Risk of pleural empyema in patients with schizophrenia: a nationwide propensity-matched cohort study in Taiwan

BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e021187 ◽  
Author(s):  
Te-Chun Shen ◽  
Chia-Hung Chen ◽  
Yu-Jhen Huang ◽  
Cheng-Li Lin ◽  
Ting-Chang Chang ◽  
...  
Keyword(s):  
Cohort Study ◽  
Propensity Scores ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Pleural Empyema ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Research Database ◽  
Increased Risk ◽  
Comparison Cohort

ObjectiveThoracic infection and pneumonia are prevalent in patients with schizophrenia; however, it is unclear whether patients with schizophrenia are at an increased risk of developing pleural empyema.DesignA retrospective cohort study with propensity-matched cohorts with and without schizophrenia.SettingUsing the National Health Insurance Research Database of Taiwan.ParticipantsWe identified 55 888 patients with schizophrenia newly diagnosed in 2000–2011 and same number of individuals without schizophrenia as the comparison cohort, frequency matched by propensity scores estimated using age, sex, occupation, income, urbanisation, year of diagnosis and comorbidities.Primary outcome measuresWe assessed incident pleural empyema by the end of 2011 and used the Cox proportional hazards model to calculate the schizophrenia cohort to comparison cohort HR of pleural empyema.ResultsThe overall incidence of pleural empyema was 2.44-fold greater in the schizophrenia cohort than in the comparison cohort (4.39vs1.80 per 10 000 person-years), with an adjusted HR of 2.87(95% CI 2.14 to 3.84). Stratified analyses by age, sex, occupation, income, urbanisation and comorbidity revealed significant hazards for pleural empyema associated with schizophrenia in all subgroups.ConclusionsPatients with schizophrenia are at an increased risk of developing pleural empyema and require greater attention and appropriate support.

scholarly journals Elevated plasma growth and differentiation factor 15 predicts incident anemia in older adults aged 60 years and older

2020 ◽  
Author(s):  
Yuko Yamaguchi ◽  
Marta Zampino ◽  
Toshiko Tanaka ◽  
Stefania Bandinelli ◽  
Yusuke Osawa ◽  
...  
Keyword(s):  
Older Adults ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Differentiation Factor ◽  
Hazards Model ◽  
Increased Risk ◽  
The Relationship

Abstract Background Anemia is common in older adults and associated with greater morbidity and mortality. The causes of anemia in older adults have not been completely characterized. Although elevated circulating growth and differentiation factor 15 (GDF-15) has been associated with anemia in older adults, it is not known whether elevated GDF-15 predicts the development of anemia. Methods We examined the relationship between plasma GDF-15 concentrations at baseline in 708 non-anemic adults, aged 60 years and older, with incident anemia during 15 years of follow-up among participants in the Invecchiare in Chianti (InCHIANTI) Study. Results During follow-up, 179 (25.3%) participants developed anemia. The proportion of participants who developed anemia from the lowest to highest quartile of plasma GDF-15 was 12.9%, 20.1%, 21.2%, and 45.8%, respectively. Adults in the highest quartile of plasma GDF-15 had an increased risk of developing anemia (Hazards Ratio 1.15, 95% Confidence Interval 1.09, 1.21, P<.0001) compared to those in the lower three quartiles in a multivariable Cox proportional hazards model adjusting for age, sex, serum iron, soluble transferrin receptor, ferritin, vitamin B12, congestive heart failure, diabetes mellitus, and cancer. Conclusions Circulating GDF-15 is an independent predictor for the development of anemia in older adults.

scholarly journals Blood eosinophils on hospital admission for COPD exacerbation do not predict the recurrence of moderate and severe relapses

2021 ◽  
Vol 7 (1) ◽  
pp. 00543-2020
Author(s):  
Balázs Csoma ◽  
András Bikov ◽  
Ferenc Tóth ◽  
György Losonczy ◽  
Veronika Müller ◽  
...  
Keyword(s):  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Forced Expiratory Volume ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Full Blood Count ◽  
Rank Test ◽  
Severe Exacerbation ◽  
Increased Risk ◽  
Exacerbation Of Copd

Background and objectiveThe relationship between hospitalisation with an eosinophilic acute exacerbation of COPD (AE-COPD) and future relapses is unclear. We aimed to explore this association by following 152 patients for 12 months after hospital discharge or until their first moderate or severe flare-up.MethodsPatients hospitalised with AE-COPD were divided into eosinophilic and non-eosinophilic groups based on full blood count results on admission. All patients were treated with a course of systemic corticosteroid. The Cox proportional hazards model was used to study the association with the time to first re-exacerbation; a generalised linear regression model was applied to identify clinical variables related to the recurrence of relapses.ResultsWe did not find a difference in the time to the next moderate or severe exacerbation between the eosinophilic (≥2% of total leukocytes and/or ≥200 eosinophils·µL−1, n=51, median (interquartile range): 21 (10–36) weeks) and non-eosinophilic groups (n=101, 17 (9–36) weeks, log-rank test: p=0.63). No association was found when other cut-off values (≥3% of total leukocytes and/or ≥300 eosinophils·µL−1) were used for the eosinophilic phenotype. However, the higher number of past severe exacerbations, a lower forced expiratory volume in 1 s (FEV1) at discharge and higher pack-years were related to shorter exacerbation-free time. According to a subgroup analysis (n=73), 48.1% of patients with initial eosinophilic exacerbations had non-eosinophilic relapses on readmission.ConclusionsOur data do not support an increased risk of earlier recurring moderate or severe relapses in patients hospitalised with eosinophilic exacerbations of COPD. Eosinophilic severe exacerbations present a variable phenotype.

Abstract WP79: Choice Of Treatment And Effect On Hemorrhage Rates Of Unruptured Intracranial Aneurysms

Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
James Torner ◽  
Jie Zhang ◽  
David Piepgras ◽  
John Huston ◽  
Irene Meissner ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Interventional Procedure ◽  
Careful Consideration ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Unruptured Intracranial Aneurysms ◽  
Increased Risk

INTRODUCTION: The decision regarding whether to perform an interventional procedure as a strategy to prevent hemorrhage of an unruptured intracranial aneurysm (UIA) requires careful consideration of procedural risk and the UIA natural history. No randomized trial data are available. The International Study of Unruptured Intracranial Aneurysms (ISUIA) included a prospective cohort, examining hemorrhage risk and treatment risk. Hypothesis: The purpose of this analysis was to compare the factors related to treatment selection and determination of the number of hemorrhages prevented. Methods: Patients were allocated into the initial treatment and untreated cohorts based upon observation or treatment practices in 61 centers from 1991-1998. 1691 patients were in the observational cohort, 471 were in the endovascular cohort and 1917 patients were in the surgical cohort. The cohorts were followed for a median follow-up of 9.2 years. Outcomes were determined prospectively and with central review. The data were grouped together and analyzed to determine treatment decisions. A Cox proportional hazards model predicting hemorrhage developed in the observation cohort and was applied to the surgery and endovascular cohorts across the follow-up period. Results: Significant baseline variable differences between treated and observed patients were aneurysm size, symptoms, age, prior SAH group, geographical region, treatment percentage, aneurysm daughter sacs or multiple lobes, and history of hypertension, smoking and myocardial infarction. Aneurysm site and family history were not significant. Site, size, and aspirin use were significant predictors of hemorrhage. Long-term the predicted hemorrhage rates were 6.7% at 5 years and 8.0% at 10 years in the surgery group and 8.1% and 9.6% for the endovascular group, respectively. For comparison the rates in the observed cohort were 4.1% and 4.8%, respectively. Conclusions: Decisions for treatment are influenced by patient characteristics such as age and medical history, aneurysm characteristics such as size and morphology and center and regional practices. Patients in the treated cohorts were at moderately increased risk for hemorrhage compared to those in the observed cohort.

Associations of Endometriosis and Hormone Therapy With Risk of Hyperlipidemia

2020 ◽  
Author(s):  
Cherry Yin-Yi Chang ◽  
Chih-Hsin Muo ◽  
Yi-Chun Yeh ◽  
Chung-Yen Lu ◽  
William Wu-Chou Lin ◽  
...  
Keyword(s):  
Hormone Therapy ◽  
Structural Model ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Marginal Structural Model ◽  
Bilateral Oophorectomy ◽  
Hazards Model ◽  
Increased Risk

Abstract Using claims data from the universal health insurance program of Taiwan, we conducted a retrospective cohort study to investigate whether endometriosis and hormone therapy are associated with the risk of developing hyperlipidemia. We selected 9,155 women aged 20–55 years with endometriosis diagnosed during the period 2000–2013 and 212,641 women without endometriosis with a median follow-up time of 7 years. Among patients with endometriosis, 86% of cases were identified on the basis of diagnosis codes with an ultrasound claim, and 14% were defined by diagnostic laparoscopy or surgical treatments. In a Cox proportional hazards model, the adjusted hazard ratio was 1.30 (95% confidence interval (CI): 1.19, 1.41) for all women, 1.04 (95% CI: 0.81, 1.32) for women under 35 years of age, 1.17 (95% CI: 1.03, 1.32) for women aged 35–44 years, and 1.34 (95% CI: 1.18, 1.52) for women aged 45–54 years. Hysterectomy and/or bilateral oophorectomy accounted for 46.9% of the association between endometriosis and hyperlipidemia, and hormone therapy accounted for 21.6%. Among women with endometriosis, the marginal structural model approach adjusting for time-varying hysterectomy/bilateral oophorectomy showed no association between use of hormone medications and risk of hyperlipidemia. We concluded that women with endometriosis are at increased risk of hyperlipidemia; use of hormone therapy by these women was not independently associated with the development of hyperlipidemia.

Predictive Value of First Posttreatment Imaging Using Standardized Reporting in Head and Neck Cancer

2019 ◽  
Vol 161 (6) ◽  
pp. 978-985 ◽  
Author(s):  
Derek Hsu ◽  
Falgun H. Chokshi ◽  
Patricia A. Hudgins ◽  
Suprateek Kundu ◽  
Jonathan J. Beitler ◽  
...  
Keyword(s):  
Treatment Failure ◽  
Head And Neck ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Strong Association ◽  
Treatment Completion ◽  
Tertiary Hospital ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Increased Risk

Objective The Neck Imaging Reporting and Data System (NI-RADS) is a standardized numerical reporting template for surveillance of head and neck squamous cell carcinoma (HNSCC). Our aim was to analyze the accuracy of NI-RADS on the first posttreatment fluorodeoxyglucose positron emission tomography/contrast-enhanced computed tomography (PET/CECT). Study Design Retrospective cohort study. Setting Academic tertiary hospital. Subject and Methods Patients with HNSCC with a 12-week posttreatment PET/CECT interpreted using the NI-RADS template and 9 months of clinical and radiologic follow-up starting from treatment completion between June 2014 and July 2016 were included. Treatment failure was defined as positive tumor confirmed by biopsy or Response Evaluation Criteria in Solid Tumors criteria. Cox proportional hazards models were performed. Results This study comprised 199 patients followed for a median of 15.5 months after treatment completion (25% quartile, 11.8 months; 75% quartile, 20.2 months). The rates of treatment failure increased with each incremental increase in NI-RADS category from 1 to 3 (4.3%, 9.1%, and 42.1%, respectively). A Cox proportional hazards model demonstrated a strong association between NI-RADS categories and treatment failure at both primary and neck sites (hazard ratio [HR], 2.60 and 5.22, respectively; P < .001). In the smaller treatment subgroup analysis, increasing NI-RADS category at the primary site in surgically treated patients and treatment failure did not achieve statistically significant association (HR, 0.88; P = .82). Conclusion Increasing NI-RADS category at the baseline posttreatment PET/CECT is strongly associated with increased risk of treatment failure in patients with HNSCC.

scholarly journals Hyperlipidemia and Statins Use for the Risk of New Diagnosed Sarcopenia in Patients with Chronic Kidney: A Population-Based Study

2020 ◽  
Vol 17 (5) ◽  
pp. 1494 ◽  
Author(s):  
Min-Hua Lin ◽  
She-Yu Chiu ◽  
Pei-Hsuan Chang ◽  
Yu-Liang Lai ◽  
Pau-Chung Chen ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Population Based ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Research Database ◽  
Newly Diagnosed ◽  
Hazards Model

Background: Previous research found that statins, in addition to its efficiency in treating hyperlipidemia, may also incur adverse drug reactions, which mainly include myopathies and abnormalities in liver function. Aim: This study aims to assess the risk for newly onset sarcopenia among patients with chronic kidney disease using statins. Material and Method: In a nationwide retrospective population-based cohort study, 75,637 clinically confirmed cases of chronic kidney disease between 1997 and 2011were selected from the National Health Insurance Research Database of Taiwan. The selection of the chronic kidney disease cohort included a discharge diagnosis with chronic kidney disease or more than 3 outpatient visits with the diagnosis of chronic kidney disease found within 1 year. After consideration of patient exclusions, we finally got a total number of 67,001 cases of chronic kidney disease in the study. The Cox proportional hazards model was used to perform preliminary analysis on the effect of statins usage on the occurrence of newly diagnosed sarcopenia; the Cox proportional hazards model with time-dependent covariates was conducted to take into consideration the individual temporal differences in medication usage, and calculated the hazard ratio (HR) and 95% confidence interval after controlling for gender, age, income, and urbanization. Results: Our main findings indicated that patients with chronic kidney disease who use statins seem to effectively prevent patients from occurrences of sarcopenia, high dosage of statins seem to show more significant protective effects, and the results are similar over long-term follow-up. In addition, the risk for newly diagnosed sarcopenia among patients with lipophilic statins treatment was lower than that among patients with hydrophilic statins treatment. Conclusion: It seems that patients with chronic kidney disease could receive statin treatment to reduce the occurrence of newly diagnosed sarcopenia. Additionally, a higher dosage of statins could reduce the incidence of newly diagnosed sarcopenia in patients with chronic kidney disease.

scholarly journals Arthritis Increases the Risk for Fractures — Results from the Women’s Health Initiative

2011 ◽  
Vol 38 (8) ◽  
pp. 1680-1688 ◽  
Author(s):  
NICOLE C. WRIGHT ◽  
BRIAN T. WALITT ◽  
CHARLES B. EATON ◽  
ZHAO CHEN ◽  
Keyword(s):  
Hip Fracture ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Spinal Fractures ◽  
Fracture Prevention ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Hazards Model ◽  
Increased Risk ◽  
Clinical Fractures

Objective.To examine the relationship between arthritis and fracture.Methods.Women were classified into 3 self-reported groups at baseline: no arthritis (n = 83,295), osteoarthritis (OA; n = 63,402), and rheumatoid arthritis (RA; n = 960). Incident fractures were self-reported throughout followup. Age-adjusted fracture rates by arthritis category were generated, and the Cox proportional hazards model was used to test the association between arthritis and fracture.Results.After an average of 7.80 years, 24,137 total fractures were reported including 2559 self-reported clinical spinal fractures and 1698 adjudicated hip fractures. For each fracture type, age-adjusted fracture rates were highest in the RA group and lowest in the nonarthritic group. After adjustment for several covariates, report of arthritis was associated with increased risk for spine, hip, and any clinical fractures. Compared to the nonarthritis group, the risk of sustaining any clinical fracture in the OA group was HR 1.09 (95% CI 1.05, 1.13; p < 0.001) and HR 1.49 (95% CI 1.26, 1.75; p < 0.001) in the RA group. The risk of sustaining a hip fracture was not statistically increased in the OA group (HR 1.11; 95% CI 0.98, 1.25; p = 0.122) compared to the nonarthritis group; however, the risk of hip fracture increased significantly (HR 3.03; 95% CI 2.03, 4.51; p < 0.001) in the RA group compared to the nonarthritis group.Conclusion.The increase in fracture risk confirms the importance of fracture prevention in patients with RA and OA.

scholarly journals Multiple immune-related adverse events and anti-tumor efficacy: real-world data on various solid tumors

2020 ◽  
Author(s):  
Keitaro Shimozaki ◽  
Yasutaka Sukawa ◽  
Noriko Beppu ◽  
Isao Kurihara ◽  
Shigeaki Suzuki ◽  
...  
Keyword(s):  
Retrospective Study ◽  
Adverse Events ◽  
Real World ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Checkpoint Inhibitors ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
University Hospital ◽  
Real World Data

Abstract Background Immune checkpoint inhibitors have been approved for various types of cancer; however, they cause a broad spectrum of immune-related adverse events (irAEs). The association between the development of irAEs and the clinical benefit remains uncertain. We aimed to evaluate the association of irAEs and the treatment efficacy in the real-world practice. Methods We conducted a retrospective study on patients with recurrent or metastatic non-small cell lung cancer, melanoma, renal cell carcinoma, or gastric cancer who received anti-PD-1/PD-L1 antibodies (nivolumab, pembrolizumab, or atezolizumab) at the Keio University Hospital between September 2014 and January 2019. We recorded treatment-related AEs from medical records and graded them using the Common Terminology Criteria for Adverse Events version 4. We performed an overall survival (OS) analysis using a Cox proportional hazards model. Results Among 212 patients eligible for this study, 108 experienced irAEs and 42 developed multiple irAEs. OS in patients with multiple irAEs was significantly longer than that in patients with single irAE (42.3 months vs. 18.8 months; hazard ratio [HR], 0.48; 95% confidence interval [CI], 0.25–0.93; P = 0.03). Moreover, OS from the development of a second irAE in those with multiple irAEs was longer than that from the development of the first irAE in patients with single irAEs (median OS, 26.9 months vs. 17.7 months, respectively; HR, 0.59; 95% CI, 0.30–1.14; P = 0.11). Conclusions Our single-center retrospective study revealed a remarkable tendency associating the development of multiple irAEs with favorable prognoses.

scholarly journals Survival of Captive Chimpanzees: Impact of Location and Transfers

2016 ◽  
Author(s):  
Michael S. Lauer
Keyword(s):  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Premature Mortality ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Hazards Model ◽  
Increased Risk ◽  
Random Survival Forests ◽  
Survival Forests

AbstractTo inform the retirement of NIH-owned chimpanzees, we analyzed the outcomes of 764 NIH-owned chimpanzees that were located at various points in time in at least one of 4 specific locations. All chimpanzees considered were alive and at least 10 years of age on January 1, 2005; transfers to a federal sanctuary began a few months later. During a median follow-up of just over 7 years, there were 314 deaths. In a Cox proportional hazards model that accounted for age, sex, and location (which was treated as a time-dependent covariate), age and sex were strong predictors of mortality, but location was only marginally predictive. Among 273 chimpanzees who were transferred to the federal sanctuary, we found no material increased risk in mortality in the first 30 days after arrival. During a median follow-up at the sanctuary of 3.5 years, age was strongly predictive of mortality, but other variables – sex, season of arrival, and ambient temperature on the day of arrival – were not predictive. We confirmed our regression findings using random survival forests. In summary, in a large cohort of captive chimpanzees, we find no evidence of materially important associations of location of residence or recent transfer with premature mortality.

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