scholarly journals Stopping 5-aminosalicylates in patients with ulcerative colitis starting biologic therapy does not increase the risk of adverse clinical outcomes: analysis of two nationwide population-based cohorts

Gut ◽  
2018 ◽  
Vol 68 (6) ◽  
pp. 977-984 ◽  
Author(s):  
Ryan C Ungaro ◽  
Berkeley N Limketkai ◽  
Camilla Bjørn Jensen ◽  
Kristine Højgaard Allin ◽  
Manasi Agrawal ◽  
...  

ObjectiveThe benefit of continuing 5-aminosalicylate (5-ASA) in patients with ulcerative colitis (UC) who initiate anti-tumour necrosis factor-alpha (anti-TNF) biologics is unknown. We aimed to compare clinical outcomes in patients with UC already on 5-ASA who started anti-TNF and then either stopped or continued 5-ASA.DesignOur primary outcome was any adverse clinical event defined as a composite of new corticosteroid use, UC-related hospitalisation or surgery. We used two national databases: the United States (US) Truven MarketScan health claims database and the Danish health registers. Patients with UC who started anti-TNF after having been on oral 5-ASA for at least 90 days were included. Patients were classified as stopping 5-ASA if therapy was discontinued within 90 days of starting anti-TNF. We performed multivariable Cox regression models controlling for demographics, clinical factors and healthcare utilisation. Adjusted HRs (aHR) with 95% CI are reported comparing stopping 5-ASA with continuing 5-ASA.ResultsA total of 3589 patients with UC were included (2890 US and 699 Denmark). Stopping 5-ASA after initiating anti-TNF was not associated with an increased risk of adverse clinical events in the U.S. cohort (aHR 1.04; 95% CI 0.90 to 1.21, p=0.57) nor in the Danish cohort (aHR 1.09; 95% CI 0.80 to 1.49, p=0.60). Results were similar in sensitivity analyses investigating concomitant immunomodulator use and duration of 5-ASA treatment before initiating anti-TNF.ConclusionIn two national databases, stopping 5-ASA in patients with UC starting anti-TNF therapy did not increase the risk of adverse clinical events. These results should be validated in a prospective clinical trial.

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Wanbing He ◽  
Xiaorong Shu ◽  
Enyi Zhu ◽  
Bingqing Deng ◽  
Yongqing Lin ◽  
...  

Abstract Background Proton pump inhibitors (PPIs) are frequently prescribed to patients with coronary heart disease (CHD) under antiplatelet therapy to prevent gastrointestinal (GI) bleeding. However, its clinical impact is still under debate, especially in Asian population. This study was undertaken to explore the effects of concurrent use of clopidogrel and PPIs on the clinical outcomes in Chinese patients with CHD in secondary prevention. Methods A single-center retrospective study was conducted in 638 patients with CHD on consecutive clopidogrel therapy for at least 1 year. After 18-month follow-up, adverse clinical events were collected. Cox regression was used to calculate hazard ratios (HR) and 95% confidence interval (CI) for the effect of PPI use on the outcomes. A total of 638 patients were recruited from 2014 to 2015 in this study, among whom 201 were sustained PPI users, 188 were intermittent PPI users and the remaining 249 were non-PPI users. Results Compared with sustained PPI users, intermittent use of PPIs was associated with a lower risk of stroke, major adverse cardiac events (MACE) and net adverse clinical event (NACE) (stroke: adjusted HR: 0.109, 95% CI 0.014–0.878, p = 0.037; MACE: adjusted HR: 0.293, 95% CI 0.119–0.722; p = 0.008; NACE: adjusted HR: 0.357, 95% CI 0.162–0.786, p = 0.011). Subgroup analysis further revealed the benefit of intermittent PPI use was significant in male CHD patients over 60 years old, with hypertension or chronic kidney disease, and undergoing percutaneous coronary intervention during hospitalization. Conclusion The current findings suggest that the intermittent concurrent use of PPIs and clopidogrel is not associated with an increased risk of 18-month adverse clinical outcomes, and intermittent use of PPIs is associated with a lower rate of MACE and NACE.


2019 ◽  
Vol 188 (8) ◽  
pp. 1484-1492 ◽  
Author(s):  
Stella Koutros ◽  
Jay H Lubin ◽  
Barry I Graubard ◽  
Aaron Blair ◽  
Patricia A Stewart ◽  
...  

Abstract We extended the mortality follow-up of a cohort of 25,460 workers employed at 8 acrylonitrile (AN)-producing facilities in the United States by 21 years. Using 8,124 deaths and 1,023,922 person-years of follow-up, we evaluated the relationship between occupational AN exposure and death. Standardized mortality ratios (SMRs) based on deaths through December 31, 2011, were calculated. Work histories and monitoring data were used to develop quantitative estimates of AN exposure. Hazard ratios were estimated by Cox proportional hazards regression. All-cause mortality and death from total cancer were less than expected compared with the US population. We observed an excess of death due to mesothelioma (SMR = 2.24, 95% confidence interval (CI): 1.39, 3.42); no other SMRs were elevated overall. Cox regression analyses revealed an elevated risk of lung and bronchial cancer (n = 808 deaths; for >12.1 ppm-year vs. unexposed, hazard ratio (HR) = 1.43, 95% CI: 1.13, 1.81; P for trend = 0.05), lagged 10 years, that was robust in sensitivity analyses adjusted for smoking and co-exposures including asbestos. Death resulting from bladder cancer (for >2.56 ppm vs. unexposed, lagged 10-year HR = 2.96, 95% CI: 1.38, 6.34; P for trend = 0.02) and pneumonitis (for >3.12 ppm-year vs. unexposed, HR = 4.73, 95% CI: 1.42, 15.76; P for trend = 0.007) was also associated with AN exposure. We provide additional evidence of an association between AN exposure and lung cancer, as well as possible increased risk for death due to bladder cancer and pneumonitis.


Author(s):  
Marcela R. Entwistle ◽  
Donald Schweizer ◽  
Ricardo Cisneros

Abstract Purpose This study investigated the association between dietary patterns, total mortality, and cancer mortality in the United States. Methods We identified the four major dietary patterns at baseline from 13,466 participants of the NHANES III cohort using principal component analysis (PCA). Dietary patterns were categorized into ‘prudent’ (fruits and vegetables), ‘western’ (red meat, sweets, pastries, oils), ‘traditional’ (red meat, legumes, potatoes, bread), and ‘fish and alcohol’. We estimated hazard ratios for total mortality, and cancer mortality using Cox regression models. Results A total of 4,963 deaths were documented after a mean follow-up of 19.59 years. Higher adherence to the ‘prudent’ pattern was associated with the lowest risk of total mortality (5th vs. 1st quintile HR 0.90, 95% CI 0.82–0.98), with evidence that all-cause mortality decreased as consumption of the pattern increased. No evidence was found that the ‘prudent’ pattern reduced cancer mortality. The ‘western’ and the ‘traditional’ patterns were associated with up to 22% and 16% increased risk for total mortality (5th vs. 1st quintile HR 1.22, 95% CI 1.11–1.34; and 5th vs. 1st quintile HR 1.16, 95% CI 1.06–1.27, respectively), and up to 33% and 15% increased risk for cancer mortality (5th vs. 1st quintile HR 1.33, 95% CI 1.10–1.62; and 5th vs. 1st quintile HR 1.15, 95% CI 1.06–1.24, respectively). The associations between adherence to the ‘fish and alcohol’ pattern and total mortality, and cancer mortality were not statistically significant. Conclusion Higher adherence to the ‘prudent’ diet decreased the risk of all-cause mortality but did not affect cancer mortality. Greater adherence to the ‘western’ and ‘traditional’ diet increased the risk of total mortality and mortality due to cancer.


Nutrients ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 874
Author(s):  
Yoshikuni Obata ◽  
Naoya Kakutani ◽  
Shintaro Kinugawa ◽  
Arata Fukushima ◽  
Takashi Yokota ◽  
...  

Malnutrition is highly prevalent in patients with heart failure (HF), but the precise impact of dietary energy deficiency on HF patients’ clinical outcomes is not known. We investigated the associations between inadequate calorie intake and adverse clinical events in 145 stable outpatients with chronic HF who had a history of hospitalization due to worsening HF. To assess the patients’ dietary pattern, we used a brief self-administered diet-history questionnaire (BDHQ). Inadequate calorie intake was defined as <60% of the estimated energy requirement. In the total chronic HF cohort, the median calorie intake was 1628 kcal/day. Forty-four patients (30%) were identified as having an inadequate calorie intake. A Kaplan–Meier analysis revealed that the patients with inadequate calorie intake had significantly worse clinical outcomes including all-cause death and HF-related hospitalization during the 1-year follow-up period versus those with adequate calorie intake (20% vs. 5%, p < 0.01). A multivariate logistic regression analysis showed that inadequate calorie intake was an independent predictor of adverse clinical events after adjustment for various factors that may influence patients’ calorie intake. Among patients with chronic HF, inadequate calorie intake was associated with an increased risk of all-cause mortality and rehospitalization due to worsening HF. However, our results are preliminary and larger studies with direct measurements of dietary calorie intake and total energy expenditure are needed to clarify the intrinsic nature of this relationship.


2015 ◽  
Vol 33 (21) ◽  
pp. 2376-2383 ◽  
Author(s):  
Anna E. Coghill ◽  
Meredith S. Shiels ◽  
Gita Suneja ◽  
Eric A. Engels

Purpose Despite advances in the treatment of HIV, HIV-infected people remain at increased risk for many cancers, and the number of non–AIDS-defining cancers is increasing with the aging of the HIV-infected population. No prior study has comprehensively evaluated the effect of HIV on cancer-specific mortality. Patients and Methods We identified cases of 14 common cancers occurring from 1996 to 2010 in six US states participating in a linkage of cancer and HIV/AIDS registries. We used Cox regression to examine the association between patient HIV status and death resulting from the presenting cancer (ascertained from death certificates), adjusting for age, sex, race/ethnicity, year of cancer diagnosis, and cancer stage. We included 1,816,461 patients with cancer, 6,459 (0.36%) of whom were HIV infected. Results Cancer-specific mortality was significantly elevated in HIV-infected compared with HIV-uninfected patients for many cancers: colorectum (adjusted hazard ratio [HR], 1.49; 95% CI, 1.21 to 1.84), pancreas (HR, 1.71; 95% CI, 1.35 to 2.18), larynx (HR, 1.62; 95% CI, 1.06 to 2.47), lung (HR, 1.28; 95% CI, 1.17 to 1.39), melanoma (HR, 1.72; 95% CI, 1.09 to 2.70), breast (HR, 2.61; 95% CI, 2.06 to 3.31), and prostate (HR, 1.57; 95% CI, 1.02 to 2.41). HIV was not associated with increased cancer-specific mortality for anal cancer, Hodgkin lymphoma, or diffuse large B-cell lymphoma. After further adjustment for cancer treatment, HIV remained associated with elevated cancer-specific mortality for common non–AIDS-defining cancers: colorectum (HR, 1.40; 95% CI, 1.09 to 1.80), lung (HR, 1.28; 95% CI, 1.14 to 1.44), melanoma (HR, 1.93; 95% CI, 1.14 to 3.27), and breast (HR, 2.64; 95% CI, 1.86 to 3.73). Conclusion HIV-infected patients with cancer experienced higher cancer-specific mortality than HIV-uninfected patients, independent of cancer stage or receipt of cancer treatment. The elevation in cancer-specific mortality among HIV-infected patients may be attributable to unmeasured stage or treatment differences as well as a direct relationship between immunosuppression and tumor progression.


Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Abdulla Damluji ◽  
Conrad Macon ◽  
Mohammed Al-Damluji ◽  
Arieh Fox ◽  
George R Marzouka ◽  
...  

Introduction: We sought to investigate the association between hemoglobin (Hgb) changes in patients with ADHF (with and without PACs) to mortality and clinical outcomes. Methods: We examined 433 patients enrolled in the Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE) trial. Change of Hgb (g/dL) was defined as at least 1 (g/dL) drop by hospital discharge. Quartiles of % change of Hgb (g/dL) were calculated. We used multivariable Cox regression analysis to evaluate the effect Hgb change on mortality and composite end points of death, cardiac re-hospitalization, or cardiac transplant. Results: Of the 433 patients, 324 (75%) had baseline and discharge Hgb available for analysis. Of those, 64 (20%) had at least 1 (g/dL) drop of Hgb by time of discharge. Patients in the Hgb drop group were older than those without Hgb changes (59 vs. 55, p = 0.011). There were no baseline differences in gender, race, and etiology of HF between groups. Compared to patients without Hgb changes, patients with Hgb drop had lower systolic BP (99 vs. 106, p = 0.017), lower sodium (136 vs. 137, p =0.025), higher BUN (37 vs. 26, p <0.001), and higher Creatinine (1.6 vs. 1.3, p <0.001), respectively. Higher Hgb drop was observed in the PACs (vs. no PACs) randomized arm of the trial (2 g/dL: PACs 10% versus 3%, p =0.010; 3 g/dL: PACs 5% versus 0%, p =0.005). After adjustments, higher in-hospital Hgb was associated with lower mortality (HR 0.79, p =0.003). In addition, patients in the Hgb drop group had increased risk of mortality (Adjusted HR 2.38, p =0.003) and composite endpoints (Adjusted HR 1.43, p =0.055). PACs insertion was not associated with adverse clinical outcomes by quartiles of % change of hemoglobin (Mortality: Q1: HR 0.80, p 0.601, Q2 HR 0.79, p = 0.706, Q3 HR 0.34, p =0.101, Q4 HR 2.23, p =0.357). Conclusion: In-hospital decrease in Hgb is independently associated with increased long-term mortality and adverse cardiovascular events in severe HF. The ideal Hgb levels in ADHF patients should be investigated and the insertion of PACs to direct therapy should be weighed against bleeding risks.


Author(s):  
Philip S Wells ◽  
Anthonie W Lensing ◽  
Lloyd Haskell ◽  
Bennett Levitan ◽  
François Laliberté ◽  
...  

Background: The EINSTEIN-extension trial (EINSTEIN-EXT) found that continued treatment with rivaroxaban for an additional 6 or 12 months (versus placebo) after the initial 6-12 months of anticoagulation significantly reduced the risk of recurrent venous thromboembolism (VTE) with a small increased risk of major bleeding (none was fatal or in a critical site). This study aimed to assess the cost impact of rivaroxaban vs. placebo based on EINSTEIN-EXT recurrent VTE and bleed rates. Methods: Total costs were calculated as the sum of drug and clinical event costs, and compared between cohorts from a US managed care perspective. Treatment duration and event rates were obtained from EINSTEIN-EXT. Drug costs were based on wholesale acquisition costs. Cost estimates for clinical events (i.e., recurrent VTE, major bleeding, clinically relevant nonmajor bleeding, and mortality) were determined based on a targeted literature review. Results were examined over a ± 20% range of each cost component in a one-way sensitivity analysis approach. Results: Total cost per person was $1,161 lower for rivaroxaban (vs. placebo) in the base case, with lower cost of clinical events fully offsetting drug costs (Figure 1). The difference in recurrent DVT alone (-$3,102) was greater than drug cost ($3,025). Total cost of rivaroxaban remained lower than placebo in sensitivity analyses. Conclusions: Rivaroxaban is associated with lower total costs compared to placebo in VTE patients who had completed 6 to 12 months of VTE treatment.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Prakash Acharya ◽  
Farhad Sami ◽  
Omar Al-Taweel ◽  
Sagar Ranka ◽  
Brianna Stack ◽  
...  

Introduction: Acute pericarditis accounts for one in every twenty emergency department visits for chest pain and a majority of these patients get admitted to a hospital. However, apart from small studies, there is a lack of data regarding the incidence and predictors of readmissions in these patients. Methodology: A secondary analysis of the Nationwide Readmission Database for years 2016-2017 was performed. Patients who were admitted with a primary diagnosis of acute pericarditis in the first six months of each year were identified based on International Classification of Diseases (ICD-10), Clinical Modification codes, and were followed for 180 days. A multivariate cox-regression model was utilized to delineate the predictors of pericarditis related readmissions. Results: A total of 21,115 patients were admitted with a primary diagnosis of acute pericarditis. The mean age was 53.3+19 years and 60.83% were males. About 23% of patients had pericardial effusion or tamponade and 19.4% of patients presenting with pericarditis required pericardiocentesis. The mortality rate during index admission was 3.21% and the mean length of stay was 6.4+9 days. The rate of all-cause readmission was 30.8% within 180 days, of which 23.8% were pericarditis related. The mean time to readmission for pericarditis was 37.7+41 days. Females were at higher risk of readmission for pericarditis [OR 1.66, CI (1.38-1.99), p<0.001] after adjustment for multiple variables (including connective tissue disease, congestive heart failure and malignancy). Presence of comorbidities like diabetes mellitus [HR 1.21, CI(1.01-1.45), p=0.04], obesity [HR 1.27, CI(1.05-1.54), p=0.01], and chronic lung disease [HR 1.32, CI(1.12-1.57), p=0.001] also increased risk of pericarditis related readmissions. Moreover, the length of index hospitalization was significantly higher in patients with pericarditis related readmissions [5.4+6 vs1.6+5 days, p<0.001]. Conclusion: Even though the mortality during index admission in patients admitted with pericarditis is low, about 1 in every 3 patients will be readmitted within 180 days. While females account for a minority of initial admissions for pericarditis, their risk of readmission is significantly higher.


Neurology ◽  
2019 ◽  
Vol 92 (24) ◽  
pp. e2735-e2742 ◽  
Author(s):  
Mao-Hsuan Huang ◽  
Chih-Ming Cheng ◽  
Kai-Lin Huang ◽  
Ju-Wei Hsu ◽  
Ya-Mei Bai ◽  
...  

ObjectiveTo evaluate the risk of Parkinson disease (PD) among patients with bipolar disorder (BD).MethodsUsing the Taiwan National Health Insurance Research Database, we examined 56,340 patients with BD and 225,360 age- and sex-matched controls between 2001 and 2009 and followed them to the end of 2011. Individuals who developed PD during the follow-up period were identified.ResultsPatients with BD had a higher incidence of PD (0.7% vs 0.1%, p < 0.001) during the follow-up period than the controls. A Cox regression analysis with adjustments for demographic data and medical comorbid conditions revealed that patients with BD were more likely to develop PD (hazard ratio [HR] 6.78, 95% confidence interval [CI] 5.74–8.02) than the control group. Sensitivity analyses after exclusion of the first year (HR 5.82, 95% CI 4.89–6.93) or first 3 years (HR 4.42; 95% CI 3.63–5.37) of observation showed consistent findings. Moreover, a high frequency of psychiatric admission for manic/mixed and depressive episodes was associated with an increased risk of developing PD.ConclusionPatients with BD had a higher incidence of PD during the follow-up period than the control group. Manic/mixed and depressive episodes were associated with an elevated likelihood of developing PD. Further studies are necessary to investigate the underlying pathophysiology between BD and PD.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e16760-e16760
Author(s):  
Moataz Ellithi ◽  
Mohamed A. Abdallah ◽  
Mahum Shahid ◽  
Isaak Ailts ◽  
Kate Waligoske ◽  
...  

e16760 Background: Pancreatic adenocarcinoma represents the fourth leading cause of cancer-related death in the United States. A majority of patients have locally advanced or metastatic disease at the time of diagnosis. For many years, gemcitabine monotherapy was the standard of care for advanced disease, until recent studies demonstrated survival benefits for FOLFIRINOX (5-FU, leucovorin, irinotecan, and oxaliplatin) and Gem/nab-P (gemcitabine/nab-paclitaxel). In this study, we evaluated the clinical outcomes in patients with metastatic pancreatic adenocarcinoma in a single health system before and after the incorporation of these newer treatments into practice. Methods: A retrospective study of metastatic pancreatic adenocarcinoma patients diagnosed between January 2009 to December 2018 with follow up until December 2019. Overall survival (OS) and progression-free survival (PFS) were calculated using Kaplan-Meier survival analysis. Univariate and multivariable Cox regression analyses were used to explore predictors of survival. Results: 394 patients were diagnosed with metastatic pancreatic adenocarcinoma at Sanford Health hospitals during the study period. There was no statistically significant difference in OS between the cohort diagnosed between 2009-2013 compared to 2014-2018, with median OS of 4.7 and 3.6 months respectively; in those receiving at least one line of chemotherapy, the median OS was 6.7 and 7.3 months. While subgroup analysis of all study population based on the type of first-line chemotherapy showed improved survival with FOLFIRINOX and Gem/nabP as compared to gemcitabine monotherapy [10.7, 6.9, 4 months respectively] (Wilcoxon Test of Homogeneity of Survival Curves p = 0.0002). Univariate and multivariate Cox regression analysis of all study data revealed that at the time of the diagnosis, age (HR: 1.021, p = 0.0013), ECOG performance status > 1 (HR: 3.47, p = 0.0001), serum albumin (HR: 0.708, p = 0.0002), Neutrophil-to-Lymphocytes ratio (HR: 1.076, p≤0.0001) and platelets-to-lymphocyte ratio (HR: 0.998, p = 0.0031) were predictors of survival. Conclusions: Although newer treatments appear to offer improved survival for eligible patients, overall outcomes for metastatic pancreatic adenocarcinoma in this cohort were similar before and after the incorporation of newer treatment regimens. Further advances in the treatment and early detection of pancreatic cancer are needed to improve clinical outcomes.


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