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1.
Pharmacoepidemiol Drug Saf ; 33(6): e5816, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38773801

RESUMO

BACKGROUND: Antisecretory drugs are commonly prescribed with clopidogrel-based dual antiplatelet therapy (DAPT) to prevent gastrointestinal bleeding in high-risk patients after percutaneous coronary intervention (PCI). However, omeprazole and esomeprazole (inhibiting proton pump inhibitors [PPIs]) may increase cardiovascular event rates on co-administration with clopidogrel. This study aimed to examine trends in the use of antisecretory agents in patients administered clopidogrel-based DAPT and the concomitant use of clopidogrel and inhibiting PPIs. METHODS: We used National Inpatient Sample data compiled by the Health Insurance Review & Assessment Service from 2009 to 2020. Further, we identified patients who were prescribed clopidogrel-based DAPT after PCI and investigated the concomitant use of antisecretory agents with clopidogrel. To verify the annual trend of drug utilization, we used the Cochran-Armitage trend test. RESULTS: From 2009 to 2020, the percentage of H2 receptor antagonist users decreased steadily (from 82.5% in 2009 to 25.3% in 2020); instead, the percentage of PPI users increased (from 23.7% in 2009 to 82.0% in 2020). The use of inhibiting PPI also increased (from 4.2% in 2009 to 30.7% in 2020). Potassium competitive acid blockers (P-CABs) were rarely used before 2019; however, in 2020, it accounted for 7.8% of the antisecretory users. CONCLUSIONS: Our study demonstrates that the use of inhibiting PPIs increased steadily in patients administered clopidogrel-based DAPT therapy. This is a major concern since the concomitant use of inhibiting PPIs with clopidogrel could increase the risk of cardiovascular events.


Assuntos
Clopidogrel , Hemorragia Gastrointestinal , Intervenção Coronária Percutânea , Inibidores da Agregação Plaquetária , Inibidores da Bomba de Prótons , Humanos , Clopidogrel/administração & dosagem , Clopidogrel/uso terapêutico , Clopidogrel/efeitos adversos , Intervenção Coronária Percutânea/efeitos adversos , Inibidores da Agregação Plaquetária/administração & dosagem , Inibidores da Agregação Plaquetária/uso terapêutico , Inibidores da Agregação Plaquetária/efeitos adversos , Inibidores da Bomba de Prótons/administração & dosagem , Inibidores da Bomba de Prótons/uso terapêutico , Masculino , Feminino , Idoso , Pessoa de Meia-Idade , Hemorragia Gastrointestinal/induzido quimicamente , Hemorragia Gastrointestinal/epidemiologia , Hemorragia Gastrointestinal/prevenção & controle , Terapia Antiplaquetária Dupla/métodos , Esomeprazol/administração & dosagem , Esomeprazol/uso terapêutico , Omeprazol/administração & dosagem , Omeprazol/uso terapêutico , Omeprazol/efeitos adversos , Interações Medicamentosas , Quimioterapia Combinada , Antagonistas dos Receptores H2 da Histamina/administração & dosagem , Antagonistas dos Receptores H2 da Histamina/uso terapêutico
2.
Crit Pathw Cardiol ; 23(2): 58-72, 2024 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-38781079

RESUMO

OBJECTIVE: To verify the incidence of bleeding events in patients on ongoing anticoagulant treatment in the real world and compare the results of different reversal or repletion strategies currently available for pharmacological treatment. METHODS: Patients managed in the emergency department (ED) with major bleeding events, on ongoing anticoagulation were stratified according to bleeding site and reversal or repletion therapy with andexanet alfa (ADX), idarucizumab (IDA), prothrombin complex concentrate (PCC), and vitamin K (Vit-K). ENDPOINT: Death at 30 days was compared in the subgroups with cerebral hemorrhage (CH) and gastrointestinal (GI) bleeding. RESULTS: Of the 809,397 visits in the years 2022-2023 at 6 EDs in the northwestern health district of Tuscany, 5372 patients with bleeding events were considered; 3740 were excluded due to minor bleeding or propensity score matching. Of the remaining 1632 patients with major bleeding, 548 on ongoing anticoagulation were enrolled; 334 received reversal or repletion agents. Patients with CH (n = 176) and GI bleeding (n = 108) represented the primary analysis cohorts in the study's strategic treatment assessment. Overall, 30-day survival of patients on ongoing aFXa treatment receiving on-label ADX versus off-label PCC showed a relative increase of 71%, while 30-day survival of patients on ongoing aFII receiving on-label IDA versus off-label PCC showed a relative increase of 30%; no substantial difference was found when comparing on-label PCC combined with Vit-K versus off-label Vit-K alone. Indeed, patients undergoing on-label ADX or IDA showed a statistically significant difference over off-label PCC (ADX vs. PCC: n = 15, events = 4, mean ± SD 82.50 ± 18.9, vs. 49, 13, 98.82 ± 27, respectively; analysis of variance [ANOVA] variance 8627; P < 0.001; posthoc test diff 32, 95% confidence interval: 28-35; P < 001; IDA vs. PCC: 20, 5, 32.29 ± 15.0 vs. 2, 1, 28.00 ± 0.0, respectively; ANOVA 1484; P < 0.001; posthoc test -29, -29 -29, respectively; P = n.d.). On-label PCC combined with Vit-K showed overall a slight statistically significant difference versus off-label Vit-K alone (52, 16, 100.58 ± 22.6 vs. 53, 11, 154.62 ± 29.8, respectively; ANOVA 310; P < 0.02; posthoc test 4, 0.7-7.2, respectively; P < 0.02). Data were confirmed in the group of patients with CH (ADX vs. PCC: n = 13, events = 3, mean ± SD 91.55 ± 18.6 vs. 78, 21, 108.91 ± 20.9, respectively; ANOVA variance 10,091, F = 261; P < 0.001; posthoc difference test 36, 95% confidence interval: 30-41; P < 0.001; IDA vs. PCC: 10, 2, 4.50 ± 2.5 vs. 78, 21, 108.91 ± 20.9, respectively; ANOVA 16,876,303, respectively; P < 0.001; posthoc test 41, 34-47, respectively; P < 0.001). On-label PCC combined with Vit-K showed an overall slight statistically significant difference compared with off-label Vit-K alone (P < 0.01 and P < 0.001 in the subgroups of CH and GI bleeding). CONCLUSIONS: Patients undergoing specific reversal therapy with on-label ADX or IDA, when treated with aFXa or aFII anticoagulants, respectively, showed statistically elevated differences in 30-day death compared with off-label repletion therapy with PCC. Overall, 30-day survival of patients on ongoing aFXa or aFII receiving on-label reversal therapy with ADX or IDA compared with off-label PCC repletion agents showed an increase of 71% and 30%, respectively.


Assuntos
Anticoagulantes , Fatores de Coagulação Sanguínea , Serviço Hospitalar de Emergência , Humanos , Masculino , Feminino , Idoso , Itália/epidemiologia , Fatores de Coagulação Sanguínea/uso terapêutico , Anticoagulantes/uso terapêutico , Anticoagulantes/efeitos adversos , Proteínas Recombinantes/uso terapêutico , Anticorpos Monoclonais Humanizados/uso terapêutico , Vitamina K/antagonistas & inibidores , Pessoa de Meia-Idade , Inibidores do Fator Xa/uso terapêutico , Inibidores do Fator Xa/efeitos adversos , Idoso de 80 Anos ou mais , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Estudos Retrospectivos , Hemorragia Gastrointestinal/induzido quimicamente , Hemorragia Gastrointestinal/epidemiologia , Incidência , Hemorragia Cerebral/induzido quimicamente , Hemorragia Cerebral/epidemiologia , Hemorragia Cerebral/tratamento farmacológico , Hemorragia Cerebral/mortalidade , Resultado do Tratamento , Fator Xa
3.
BMC Gastroenterol ; 24(1): 177, 2024 May 21.
Artigo em Inglês | MEDLINE | ID: mdl-38773435

RESUMO

BACKGROUND: Although proton pump inhibitors (PPIs) or potassium-competitive acid blocker (PCAB) are useful in peptic ulcer prevention, their efficacy in preventing other gastrointestinal bleeding remains unclear. This study aimed to identify the status of gastrointestinal bleeding in the modern era when PPIs are widely used. METHODS: This study included patients who underwent percutaneous coronary intervention (PCI) between 2018 and 2019 at two high-volume centers. Patients were categorized based on whether they experienced gastrointestinal bleeding within 2 years of PCI into groups A (patients who experienced gastrointestinal bleeding within 2 years after PCI) and B (patients who did not experience gastrointestinal bleeding). RESULTS: Groups A and B included 21 (4.1%) and 494 (95.9%) patients, respectively (a total of 515 patients). Age at the initial PCI (77.8±2.4 and 72.0±0.5 years in groups A and B, respectively; p = 0.02), weight (53.8±3.2 and 61.8±0.7 kg in groups A and B, respectively; p = 0.01), and concomitant warfarin use (14.3% and 2.0% in groups A and B, respectively; p = 0.0005) were significantly different between the groups. The high bleeding risk rate (90.5% and 47.6% in groups A and B, respectively; p = 0.0001) was significantly different between the groups. A total of 95.9% of patients were taking PPIs or PCAB without significant differences between the groups. However, only one patient, who was taking steroids, had a gastric ulcer during PCAB treatment. CONCLUSIONS: Acid-related upper gastrointestinal bleeding is largely controlled by PPIs in post-PCI patients. Furthermore, the risk factors for non-acid-related bleeding include older age, lower weight, and concomitant warfarin use.


Assuntos
Hemorragia Gastrointestinal , Isquemia Miocárdica , Intervenção Coronária Percutânea , Inibidores da Bomba de Prótons , Humanos , Inibidores da Bomba de Prótons/uso terapêutico , Inibidores da Bomba de Prótons/efeitos adversos , Masculino , Feminino , Hemorragia Gastrointestinal/induzido quimicamente , Hemorragia Gastrointestinal/epidemiologia , Hemorragia Gastrointestinal/prevenção & controle , Idoso , Isquemia Miocárdica/complicações , Estudos Retrospectivos , Fatores de Risco
4.
Sci Rep ; 14(1): 9688, 2024 04 27.
Artigo em Inglês | MEDLINE | ID: mdl-38678096

RESUMO

Gastrointestinal (GI) bleeding control is critical in elderly patients with atrial fibrillation (AF) receiving oral anticoagulants (OAC). This subgroup analysis aimed to clarify the actual state and significance of GI bleeding in elderly non-valvular AF (NVAF) patients. We evaluated the incidence and risk factors of GI bleeding during the 2-year follow-up and examined the GI bleeding impact on mortality. Of the 32,275 patients in the ANAFIE Registry, 1139 patients (3.5%) experienced GI bleeding (incidence rate, 1.92 events per 100 person-years; mean follow-up, 1.88 years); 339 upper and 760 lower GI bleeding events occurred. GI bleeding risk factors included age ≥ 85 years, body mass index ≥ 25.0 kg/m2, prior major bleeding, hyperuricaemia, heart failure, P-glycoprotein inhibitor use, GI disease, and polypharmacy (≥ 5 drugs). No significant differences in GI bleeding risk were found between direct OAC (DOAC) vs warfarin users (adjusted hazard ratios [95% confidence interval], 1.01 [0.88-1.15]). The 1-year post-GI bleeding mortality rate was numerically higher in patients with upper (19.6%) than lower GI bleeding (8.9%). In elderly Japanese NVAF patients, this large-scale study found no significant difference in GI bleeding risk between DOAC vs. warfarin users or 1-year mortality after upper or lower GI bleeding.


Assuntos
Anticoagulantes , Fibrilação Atrial , Hemorragia Gastrointestinal , Sistema de Registros , Humanos , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/complicações , Masculino , Feminino , Idoso de 80 Anos ou mais , Hemorragia Gastrointestinal/epidemiologia , Hemorragia Gastrointestinal/induzido quimicamente , Hemorragia Gastrointestinal/etiologia , Idoso , Anticoagulantes/efeitos adversos , Anticoagulantes/uso terapêutico , Fatores de Risco , Incidência , Varfarina/efeitos adversos
5.
EBioMedicine ; 103: 105130, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38653188

RESUMO

BACKGROUND: Active surveillance pharmacovigilance is an emerging approach to identify medications with unanticipated effects. We previously developed a framework called pharmacopeia-wide association studies (PharmWAS) that limits false positive medication associations through high-dimensional confounding adjustment and set enrichment. We aimed to assess the transportability and generalizability of the PharmWAS framework by using medical claims data to reproduce known medication associations with Clostridioides difficile infection (CDI) or gastrointestinal bleeding (GIB). METHODS: We conducted case-control studies using Optum's de-identified Clinformatics Data Mart Database of individuals enrolled in large commercial and Medicare Advantage health plans in the United States. Individuals with CDI (from 2010 to 2015) or GIB (from 2010 to 2021) were matched to controls by age and sex. We identified all medications utilized prior to diagnosis and analysed the association of each with CDI or GIB using conditional logistic regression adjusted for risk factors for the outcome and a high-dimensional propensity score. FINDINGS: For the CDI study, we identified 55,137 cases, 220,543 controls, and 290 medications to analyse. Antibiotics with Gram-negative spectrum, including ciprofloxacin (aOR 2.83), ceftriaxone (aOR 2.65), and levofloxacin (aOR 1.60), were strongly associated. For the GIB study, we identified 450,315 cases, 1,801,260 controls, and 354 medications to analyse. Antiplatelets, anticoagulants, and non-steroidal anti-inflammatory drugs, including ticagrelor (aOR 2.81), naproxen (aOR 1.87), and rivaroxaban (aOR 1.31), were strongly associated. INTERPRETATION: These studies demonstrate the generalizability and transportability of the PharmWAS pharmacovigilance framework. With additional validation, PharmWAS could complement traditional passive surveillance systems to identify medications that unexpectedly provoke or prevent high-impact conditions. FUNDING: U.S. National Institute of Diabetes and Digestive and Kidney Diseases.


Assuntos
Clostridioides difficile , Infecções por Clostridium , Hemorragia Gastrointestinal , Farmacovigilância , Humanos , Infecções por Clostridium/epidemiologia , Infecções por Clostridium/etiologia , Infecções por Clostridium/tratamento farmacológico , Estudos de Casos e Controles , Masculino , Hemorragia Gastrointestinal/induzido quimicamente , Hemorragia Gastrointestinal/epidemiologia , Hemorragia Gastrointestinal/etiologia , Feminino , Idoso , Pessoa de Meia-Idade , Antibacterianos/efeitos adversos , Antibacterianos/uso terapêutico , Estados Unidos/epidemiologia , Fatores de Risco , Adulto , Idoso de 80 Anos ou mais
6.
Viruses ; 16(3)2024 03 14.
Artigo em Inglês | MEDLINE | ID: mdl-38543817

RESUMO

BACKGROUND: Cytomegalovirus (CMV) gastrointestinal (GI) diseases impact both immunocompromised and immunocompetent individuals, yet comprehensive studies highlighting the differences between these groups are lacking. METHODS: In this retrospective study (January 2000 to July 2022) of 401 patients with confirmed CMV GI diseases, we categorized them based on immunological status and compared manifestations, treatments, outcomes, and prognostic factors. RESULTS: The immunocompromised patients (n = 193) showed older age, severe illnesses, and higher comorbidity rates. GI bleeding, the predominant manifestation, occurred more in the immunocompetent group (92.6% vs. 63.6%, p = 0.009). Despite longer antiviral therapy, the immunocompromised patients had higher in-hospital (32.2% vs. 18.9%, p = 0.034) and overall mortality rates (91.1% vs. 43.4%, p < 0.001). The independent factors influencing in-hospital mortality in the immunocompromised patients included GI bleeding (OR 5.782, 95% CI 1.257-26.599, p = 0.024) and antiviral therapy ≥ 14 days (OR 0.232, 95% CI 0.059-0.911, p = 0.036). In the immunocompetent patients, age (OR 1.08, 95% CI 1.006-1.159, p = 0.032), GI bleeding (OR 10.036, 95% CI 1.183-85.133, p = 0.035), and time to diagnosis (OR 1.029, 95% CI 1.004-1.055, p = 0.021) were significant prognostic factors, with the age and diagnosis time cut-offs for survival being 70 years and 31.5 days, respectively. CONCLUSIONS: GI bleeding is the most common manifestation and prognostic factor in both groups. Early diagnosis and effective antiviral therapy can significantly reduce in-hospital mortality.


Assuntos
Infecções por Citomegalovirus , Gastroenteropatias , Humanos , Citomegalovirus , Estudos Retrospectivos , Infecções por Citomegalovirus/diagnóstico , Infecções por Citomegalovirus/tratamento farmacológico , Infecções por Citomegalovirus/epidemiologia , Gastroenteropatias/diagnóstico , Gastroenteropatias/epidemiologia , Gastroenteropatias/tratamento farmacológico , Hemorragia Gastrointestinal/epidemiologia , Hospedeiro Imunocomprometido , Antivirais/uso terapêutico
7.
Sci Rep ; 14(1): 5107, 2024 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-38429364

RESUMO

Acute gastric bleeding (AGB) is a common and potentially serious complication in patients with gastrointestinal disorders. Nursing interventions play a critical role in the management of acute gastric bleeding, but their impact on clinical outcomes is not well understood. The aim of this retrospective analysis was to evaluate the impact of nursing interventions on clinical outcomes in patients with acute gastric bleeding. A retrospective review of medical records was conducted for 220 patients with acute gastric bleeding who were admitted to the hospital between February 2022 and February 2023. Patients were divided into two groups based on whether or not they received nursing interventions during their hospital stay. Clinical outcomes, including length of hospital stay, blood transfusion requirements, and mortality rates, were compared between the two groups using descriptive statistics and logistic regression analysis. Of the 220 patients included in the study, 168 (76.4%) received nursing interventions during their hospital stay. Patients who received nursing interventions had a significantly shorter length of hospital stay (mean = 7.2 days, SD = 2.1) compared to those who did not receive nursing interventions (mean = 10.5 days, SD = 3.4, p < 0.001). Additionally, the 90-day mortality rate was lower in the group receiving professional nursing interventions (4.2% vs. 15.4%, p = 0.010). Fewer patients who received nursing interventions required blood transfusions (33.3% vs. 65.2%, p < 0.001) and mortality rates were lower (6.7% vs. 20.8%, p = 0.04). Multivariate logistic regression analysis suggested that professional nursing intervention was a protective factor for postoperative rebleeding in patients with gastric hemorrhage (OR 0.727, 95% CI 0.497-0.901, P < 0.001). The results of this retrospective analysis suggest that nursing interventions are associated with improved clinical outcomes in patients with acute gastric bleeding. The implementation of nursing interventions, such as individualized care plans, monitoring and evaluation, and patient education, should be encouraged to optimize patient outcomes in this population. Further research is needed to identify the most effective nursing interventions and to evaluate their cost-effectiveness.


Assuntos
Transfusão de Sangue , Hemorragia Gastrointestinal , Humanos , Estudos Retrospectivos , Hemorragia Gastrointestinal/epidemiologia
8.
J Pak Med Assoc ; 74(2): 224-228, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38419217

RESUMO

Objective: To determine different aetiologies and outcomes of upper gastrointestinal bleeding in hospitalised patients. METHODS: The retrospective cohort study was conducted at the Aga Khan University Hospital, Karachi, and comprised data from December 2019 to April 2021 related to adult patients of either gender with nongastrointestinal illnesses who developed bleeding at least 24 hours after admission. Data was reviewed for clinical characteristics, cause of bleeding and clinical outcome. Data was analysed using SPSS 23. RESULTS: Among 47,337 hospitalised patients, upper gastrointestinal bleeding was identified in 147(0.3%); 98 (66.7%) males and 49 (33.3%) females. The overall mean age was 62.73±14.81 years (range 20-95 years). Of the total, 125(85%) presented with overt bleeding and 22(15%) with a drop in haemoglobin level. There were 34(23%) patients on aspirin, 36(24%) on dual anti-platelets, 41(28%) on therapeutic anticoagulation, and 81(55%) on prophylactic anticoagulation. There were 7(5%) patients having a history of non-steroidal anti-inflammatory drugs (NSAIDs), and 12(8%) were on steroids. In terms of associated medical conditions, pneumonia, stroke, and acute coronary syndrome were commonly seen with frequency of 29.9%, 8.1% and 7.4% respectively. Overall, 36(24.4%) patients underwent endoscopy, 8(5.4%) had therapeutic measures to control bleeding, 14(9.5%) had bleeding for >48 hours, 89(60.5%) were stepped up to special care. Mortality was seen in 36(24.5%) cases. CONCLUSIONS: Hospital acquired gastrointestinal bleeding was found to be uncommon, and there were several risk factors for such bleeding events.


Assuntos
Endoscopia Gastrointestinal , Hemorragia Gastrointestinal , Adulto , Masculino , Feminino , Humanos , Adulto Jovem , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Estudos Retrospectivos , Centros de Atenção Terciária , Hemorragia Gastrointestinal/epidemiologia , Hemorragia Gastrointestinal/etiologia , Hemorragia Gastrointestinal/terapia , Fatores de Risco , Endoscopia Gastrointestinal/efeitos adversos , Anticoagulantes/efeitos adversos , Anti-Inflamatórios não Esteroides/efeitos adversos
9.
BMJ Open ; 14(2): e074608, 2024 Feb 29.
Artigo em Inglês | MEDLINE | ID: mdl-38423766

RESUMO

OBJECTIVES: This study aimed to assess the internal law and time trend of hospitalisation for oesophagogastric variceal bleeding (EGVB) in cirrhosis and develop an effective model to predict the trend of hospitalisation time. DESIGN: We used a time series covering 72 months to analyse the hospitalisation for EGVB in cirrhosis. The number of inpatients in the first 60 months was used as the training set to establish the autoregressive integrated moving average (ARIMA) model, and the number over the next 12 months was used as the test set to predict and observe their fitting effect. SETTING AND DATA: Case data of patients with EGVB between January 2014 and December 2019 were collected from the Affiliated Hospital of Southwest Medical University. OUTCOME MEASURES: The number of monthly hospitalised patients with EGVB in our hospital. RESULTS: A total of 877 patients were included in the analysis. The proportion of EGVB in patients with cirrhosis was 73% among men and 27% among women. The peak age at hospitalisation was 40-60 years. The incidence of EGVB varied seasonally with two peaks from January to February and October to November, while the lowest number was observed between April and August. Time-series analysis showed that the number of inpatients with EGVB in our hospital increased annually. The sequence after the first-order difference was a stationary series (augmented Dickey-Fuller test p=0.02). ARIMA (0,1,0) (0,1,1)12 with a minimum Akaike Information Criterion value of 260.18 could fit the time trend of EGVB inpatients and had a good short-term prediction effect. The root mean square error and mean absolute error were 2.4347 and 1.9017, respectively. CONCLUSIONS: The number of hospitalised patients with EGVB at our hospital is increasing annually, with seasonal changes. The ARIMA model has a good prediction effect on the number of hospitalised patients with EGVB in cirrhosis.


Assuntos
Varizes Esofágicas e Gástricas , Pacientes Internados , Masculino , Humanos , Feminino , Adulto , Pessoa de Meia-Idade , Varizes Esofágicas e Gástricas/epidemiologia , Varizes Esofágicas e Gástricas/terapia , Universidades , Previsões , Hemorragia Gastrointestinal/epidemiologia , Hemorragia Gastrointestinal/etiologia , Hemorragia Gastrointestinal/terapia , Hospitalização , Cirrose Hepática/complicações , Cirrose Hepática/terapia , Hospitais , Incidência , Modelos Estatísticos , China/epidemiologia
10.
Pharmacoepidemiol Drug Saf ; 33(2): e5749, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38362655

RESUMO

PURPOSE: Pharmacy chains can differ with respect to the characteristics of their patient populations as well as their nonprescription products, services, and practices, and thus may serve as a surrogate for potential unmeasured confounding in observational studies of prescription drugs. This study evaluates whether a single-source drug can have different patient outcomes based on the dispensing pharmacy chain. METHODS: Separate analyses for two anticoagulant drugs, rivaroxaban and apixaban, were conducted using Medicare Fee-for-Service claims evaluating the association between dispensing pharmacy chain and outcomes of acute myocardial infarction, ischemic stroke, intracranial hemorrhage, gastrointestinal (GI) bleeding, all-cause mortality, and major GI bleeding. Inverse probability of treatment weighting (IPTW) was used to balance baseline covariates across pharmacy chain cohorts, and outcome association was assessed with a Cox Proportional Hazards model. RESULTS: We observed no differences in outcomes across pharmacy chains for apixaban recipients. Rivaroxaban recipients from pharmacy chain C, however, had lower rates of GI bleeding (adjusted HR 0.83; 95% CI 0.69-1.00) and ischemic stroke (adjusted HR 0.57; 95% CI 0.38-0.87) as compared to chain A in primary analyses with a 3-day grace period. The results moved closer to the null when 14- and 30-day grace periods were implemented. CONCLUSIONS: These results suggest that dispensing pharmacy chains may have the potential to act as a confounder of associations between drug exposure and outcome in some observational studies. Additional studies of potential confounding by pharmacy chain are needed. Further evaluation of potential pharmacy chain effects on safe use would be of value.


Assuntos
Fibrilação Atrial , AVC Isquêmico , Acidente Vascular Cerebral , Idoso , Humanos , Estados Unidos , Anticoagulantes/efeitos adversos , Rivaroxabana/efeitos adversos , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/prevenção & controle , Acidente Vascular Cerebral/complicações , Dabigatrana/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Medicare , Hemorragia Gastrointestinal/induzido quimicamente , Hemorragia Gastrointestinal/epidemiologia , AVC Isquêmico/tratamento farmacológico , Piridonas/uso terapêutico , Estudos Retrospectivos
11.
Clin Gastroenterol Hepatol ; 22(5): 981-993.e11, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38184099

RESUMO

BACKGROUND & AIMS: In patients with atrial fibrillation (AF) receiving direct oral anticoagulant (DOAC), upper gastrointestinal bleeding (UGIB) is a serious complication. There are limited data on the benefit of preventive proton pump inhibitor (PPI) use to reduce the risk of UGIB in DOAC users. METHODS: We included patients with AF receiving DOAC from 2015 to 2020 based on the Korean Health Insurance Review and Assessment database. The propensity score (PS) weighting method was used to compare patients with PPI use and those without PPI use. The primary outcome was hospitalization for UGIB. Weighted hazard ratios (HRs) and corresponding 95% confidence intervals (CIs) were evaluated using the Cox proportional hazards regression model. RESULTS: A total of 165,624 patients were included (mean age: 72.2 ± 10.8 years; mean CHA2DS2-VASc score: 4.3 ± 1.8; mean HAS-BLED score: 3.3 ± 1.2). Among them, 99,868 and 65,756 were in the non-PPI group and PPI group, respectively. During a median follow-up of 1.5 years, the PPI group was associated with lower risks of hospitalization for UGIB and UGIB requiring red blood cell transfusion than non-PPI group (weighted HR, 0.825; 95% CI, 0.761-0.894 and 0.798; 95% CI, 0.717-0.887, respectively, both P < .001). The benefits of PPI on the risk of hospitalization for UGIB were greater in those with older age (≥75 years), higher HAS-BLED score (≥3), prior GIB history, and concomitant use of antiplatelet agent (all P-for-interaction < .1). Low-dose PPI was consistently associated with a lower risk of significant UGIB by 43.6-49.3% (P < .001). CONCLUSIONS: In this large Asian cohort of patients with AF on DOAC, PPI co-therapy is beneficial for reducing the risk of hospitalization for UGIB, particularly in high-risk patients.


Assuntos
Fibrilação Atrial , Hemorragia Gastrointestinal , Inibidores da Bomba de Prótons , Humanos , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/complicações , Inibidores da Bomba de Prótons/administração & dosagem , Inibidores da Bomba de Prótons/uso terapêutico , Inibidores da Bomba de Prótons/efeitos adversos , Masculino , Feminino , Idoso , Hemorragia Gastrointestinal/induzido quimicamente , Hemorragia Gastrointestinal/epidemiologia , Hemorragia Gastrointestinal/prevenção & controle , República da Coreia , Pessoa de Meia-Idade , Idoso de 80 Anos ou mais , Anticoagulantes/efeitos adversos , Anticoagulantes/administração & dosagem , Anticoagulantes/uso terapêutico , Hospitalização/estatística & dados numéricos , Estudos de Coortes , Administração Oral , Estudos Retrospectivos
12.
Am J Med Sci ; 367(4): 259-267, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38278359

RESUMO

BACKGROUND: Massive gastrointestinal bleeding is a life-threatening condition without a well-established definition. We aimed to analyze the characteristics, risk factors, and outcomes of patients with massive upper gastrointestinal bleeding. METHODS: Our study analyzed a prospective registry of patients admitted between 2013 and 2020 with variceal and non-variceal causes. Severe bleeding was defined as ongoing bleeding requiring transfusion of more than 2 units of packed red blood cells within 24 hours, accompanied by signs of shock. The main outcomes were 30-day and 6-month mortality, rebleeding within 7 days, persistent bleeding, and severe complications during admission. RESULTS: Out of 1213 patients, 171 had massive gastrointestinal bleeding, with a predominance of males. The massive bleeding group had higher rates of chronic kidney disease, cirrhosis, in-patient status, disseminated malignancy, alcoholism, and ASA score ≥3. All major outcomes, including 30-day mortality, 6-month mortality, rebleeding, persistent bleeding, and severe complications, were more common in the massive bleeding group. Multivariate logistic regression identified inpatient status, systemic diseases, malignancy, active bleeding in endoscopy, and severe complications as risk factors for massive bleeding and mortality. CONCLUSIONS: Inpatient status and comorbidities, especially systemic diseases, and malignancies, were associated with a higher risk of massive bleeding. Mortality was linked to chronic kidney disease, cirrhosis, severe comorbidities, and alcohol consumption. We observed increased 6-months mortality, probably related to a health status in which gastrointestinal bleeding heralded poor outcomes, some of them potentially preventable. Innovative healthcare interventions, such as Emergency Department-based intermediate care areas or Intensive Care Units, and multidisciplinary follow-up, could potentially improve survival.


Assuntos
Varizes Esofágicas e Gástricas , Neoplasias , Insuficiência Renal Crônica , Masculino , Humanos , Feminino , Hemorragia Gastrointestinal/epidemiologia , Hemorragia Gastrointestinal/etiologia , Hemorragia Gastrointestinal/diagnóstico , Fatores de Risco , Cirrose Hepática/complicações , Endoscopia Gastrointestinal , Insuficiência Renal Crônica/complicações
13.
J Am Heart Assoc ; 13(3): e032272, 2024 Feb 06.
Artigo em Inglês | MEDLINE | ID: mdl-38293966

RESUMO

BACKGROUND: There are limited data on the efficacy and safety of direct oral anticoagulants (DOACs) in patients with atrial fibrillation with significant tricuspid regurgitation (TR), which can lead to hepatic dysfunction and intestinal malabsorption. We aimed to compare the efficacy and safety of DOACs and warfarin for patients with atrial fibrillation with significant (moderate to severe) TR. METHODS AND RESULTS: A total of 1215 patients with significant TR and atrial fibrillation who were treated with warfarin (N=491) or DOACs (N=724) were retrospectively analyzed. The primary outcomes were ischemic stroke, systemic embolic events, and hospitalization for major bleeding. The secondary outcomes were intracranial hemorrhage, hospitalization for gastrointestinal bleeding, all-cause mortality, and a composite outcome. The median follow-up duration was 2.4 years. In the inverse probability treatment weighting-adjusted cohort, DOACs and warfarin had a similar risk for ischemic stroke and systemic embolic events (adjusted hazard ratio [aHR], 0.95 [95% CI, 0.67-1.36]; P=0.79) and major bleeding (aHR, 0.78 [95% CI, 0.57-1.06]; P=0.11). For the secondary outcomes, relative to warfarin, DOACs had a lower risk of intracranial hemorrhage and the composite outcome, and a comparable risk for gastrointestinal bleeding and all-cause mortality. In the subgroup analysis, the effects of DOACs on ischemic stroke and systemic embolic events were comparable to the effects of warfarin, even in patients with inferior vena cava plethora (increased right atrial pressure) or severe TR. CONCLUSIONS: In this study, relative to warfarin, DOACs demonstrated comparable efficacy for ischemic stroke and systemic embolic events and major bleeding, with a lower intracranial hemorrhage risk in patients with significant TR and atrial fibrillation, indicating their effectiveness and safety.


Assuntos
Fibrilação Atrial , Embolia , AVC Isquêmico , Acidente Vascular Cerebral , Insuficiência da Valva Tricúspide , Humanos , Varfarina/efeitos adversos , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/tratamento farmacológico , Inibidores do Fator Xa/uso terapêutico , Anticoagulantes/efeitos adversos , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Estudos Retrospectivos , Insuficiência da Valva Tricúspide/complicações , Embolia/epidemiologia , Embolia/etiologia , Embolia/prevenção & controle , AVC Isquêmico/tratamento farmacológico , Hemorragias Intracranianas/induzido quimicamente , Hemorragia Gastrointestinal/induzido quimicamente , Hemorragia Gastrointestinal/epidemiologia , Administração Oral
14.
Rev Med Virol ; 34(1): e2509, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-38282392

RESUMO

Upper gastrointestinal bleeding (UGIB) in COVID-19 presents challenges in patient management. Existing studies lack comprehensive review due to varied designs, samples, and demographics. A meta-analysis can provide valuable insights into the incidence, features, and outcomes of UGIB in COVID-19. A comprehensive literature search was carried out using several databases. We considered all appropriate observational studies from all over the world. Mantel-Haenszel odds ratios and associated 95% confidence intervals (CIs) were produced to report the overall effect size using random effect models. Besides, Random effects models were used to calculate the overall pooled prevalence. Funnel plots, Egger regression tests, and Begg-Mazumdar's rank correlation test were used to appraise publication bias. Data from 21 articles consisting of 26,933 COVID-19 patients were considered. The pooled estimate of UGIB prevalence in patients admitted with COVID-19 across studies was 2.10% (95% CI, 1.23-3.13). Similarly, the overall pooled estimate for severity, mortality, and rebleeding in COVID-19 patients with UGIB was 55% (95% CI, 37.01-72.68), 29% (95% CI, 19.26-40.20) and 12.7% (95% CI, 7.88-18.42) respectively. Further, UGIB in COVID-19 patients was associated with increased odds of severity (OR = 3.52, 95% CI 1.80-6.88, P = 0.001) and mortality (OR = 2.16, 95% CI 1.33-3.51, P = 0.002) compared with patients without UGIB. No significant publication bias was evident in the meta-analysis. The results of our study indicate that UGIB in individuals with COVID-19 is linked to negative outcomes such as severe illness, higher mortality rates, and an increased risk of re-bleeding. These findings highlight the significance of identifying UGIB as a significant complication in COVID-19 cases and emphasise the importance of timely clinical assessment and proper treatment.


Assuntos
COVID-19 , Humanos , COVID-19/complicações , COVID-19/epidemiologia , Prevalência , Hemorragia Gastrointestinal/epidemiologia , Hemorragia Gastrointestinal/etiologia , Hemorragia Gastrointestinal/terapia , Hospitalização , Incidência
15.
Int J Clin Pharmacol Ther ; 62(1): 29-36, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37942928

RESUMO

OBJECTIVES: This study aimed to explore the risk factors of hypoglycemia in patients with gastrointestinal bleeding caused by somatostatin for injection and to establish a prediction model based on logistic regression combined with receiver operating characteristic (ROC) curve. MATERIALS AND METHODS: This retrospective study analyzed patients diagnosed with gastrointestinal bleeding and treated with somatostatin from January 2022 to May 2023 and collected hypoglycemic events. Univariate and multivariate logistic regression analysis were used to determine the independent influencing factors of somatostatin-induced hypoglycemia, and a prediction model was established. ROC analysis was used to evaluate the prediction model. RESULTS: A total of 331 patients were enrolled in this study, and 42 patients developed hypoglycemic events. Age and co-infection were found to be significant risk factors for hypoglycemia in patients with gastrointestinal bleeding induced by somatostatin. Binary logistic regression fitting established the hypoglycemia prediction model Logit (P) = -4.125+0.053Yage+1.366Yco-infection (co-infection: Xco-infection = 1, non-co-infection: Xno co-infection = 0), Hosmer-Lemeshow test results showed that the model had a good fit (χ2 = 10.552, df = 8, p = 0.228), and the AUC of the prediction model to predict the risk of hypoglycemia caused by somatostatin in patients with gastrointestinal bleeding was 0.744 (95% CI: 0.653 - 0.835, p < 0.001), the sensitivity was 57.14%, and the specificity was 93.77%. CONCLUSION: Among adult patients with gastrointestinal bleeding treated with somatostatin for injection, our study found that age and co-infection were significant risk factors for somatostatin-induced hypoglycemia in this patient population, and the fitted models had high predictive value in predicting the occurrence of hypoglycemia.


Assuntos
Coinfecção , Hipoglicemia , Adulto , Humanos , Estudos Retrospectivos , Fatores de Risco , Curva ROC , Hipoglicemia/induzido quimicamente , Hipoglicemia/epidemiologia , Hemorragia Gastrointestinal/induzido quimicamente , Hemorragia Gastrointestinal/diagnóstico , Hemorragia Gastrointestinal/epidemiologia , Hipoglicemiantes , Somatostatina/efeitos adversos
16.
J Heart Lung Transplant ; 43(4): 604-614, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38065237

RESUMO

BACKGROUND: Gastrointestinal bleeding (GIB) results in frequent hospitalizations and impairs quality of life in durable left ventricular assist device (LVAD) recipients. Anticipation of these events before implantation could have important implications for patient selection and management. METHODS: The study population included all adult HeartMate 3 (HM3) primary LVAD recipients enrolled in the STS Intermacs registry from January 2017 to December 2020. Using multivariable modeling methodologies, we investigated the relationships between preimplantation characteristics and postimplant bleeding, bleeding and death, and additional bleeding episodes on subsequent bleeding episodes and created a risk score to predict the likelihood of post-LVAD GIB based solely on preimplantation factors. RESULTS: Of 6,425 patients who received an HM3 LVAD, 1,010 (15.7%) patients experienced GIB. Thirteen preimplantation factors were independent predictors of post-LVAD GIB. A risk score was created from these factors and calculated for each patient. By 3 years postimplant, GIB occurred in 11%, 26%, and 43% of low-, medium- and high-risk patients, respectively. Experiencing 1 post-LVAD GIB event was associated with an increased risk for further GIB events, with 33.9% of patients experiencing at least 1 recurrence. While post-LVAD GIB was associated with mortality, there was no relationship between number of GIB events and death. CONCLUSIONS: The Michigan Bleeding Risk Model is a simple tool, which facilitates the prediction of post-LVAD GIB in HM3 recipients using 13 preimplant variables. The implementation of this tool may help in the risk stratification process and may have therapeutic and clinical implications in HM3 LVAD recipients.


Assuntos
Insuficiência Cardíaca , Coração Auxiliar , Adulto , Humanos , Insuficiência Cardíaca/cirurgia , Michigan/epidemiologia , Coração Auxiliar/efeitos adversos , Qualidade de Vida , Estudos Retrospectivos , Hemorragia Gastrointestinal/epidemiologia , Hemorragia Gastrointestinal/etiologia
17.
Korean J Intern Med ; 39(2): 261-271, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38092556

RESUMO

BACKGROUND/AIMS: Mucoprotective agents, such as eupatilin, are often prescribed to prevent gastrointestinal (GI) bleeding in addition to an acid suppressant despite the absence of a large-scale study. We evaluated the additional effect of eupatilin on the prevention of GI bleeding in both the upper and lower GI tract in concomitant aspirin and acid suppressant users using the nationwide database of national claims data from the Korean National Health Insurance Service (NHIS). METHODS: An aspirin cohort was constructed using the NHIS claims data from 2013 to 2020. Patients who manifested with hematemesis, melena, or hematochezia were considered to have GI bleeding. A Cox proportional hazards regression model was used to determine the risk factors for GI bleeding associated with the concomitant use of GI drugs and other covariates among aspirin users. RESULTS: Overall, a total of 432,208 aspirin users were included. The concurrent use of an acid suppressant and eupatilin (hazard ratio [HR] = 0.85, p = 0.016, vs. acid suppressant only) was a statistically significant preventive factor for GI bleeding. Moreover, a more than 3-month duration (HR = 0.88, p = 0.030) of acid suppressant and eupatilin prescription (vs. acid suppressant only) was a statistically significant preventive factor for GI bleeding. CONCLUSION: Eupatilin administration for ≥ 3 months showed additional preventive effect on GI bleeding in concomitant aspirin and acid suppressant users. Thus, cotreatment with eupatilin with a duration of 3 months or longer is recommended for reducing GI bleeding among aspirin plus acid suppressant users.


Assuntos
Aspirina , Hemorragia Gastrointestinal , Humanos , Aspirina/efeitos adversos , Hemorragia Gastrointestinal/induzido quimicamente , Hemorragia Gastrointestinal/epidemiologia , Hemorragia Gastrointestinal/prevenção & controle , Flavonoides , Fármacos Gastrointestinais , Fatores de Risco , Anti-Inflamatórios não Esteroides/efeitos adversos
18.
ANZ J Surg ; 94(4): 708-713, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38059545

RESUMO

BACKGROUND: Acute lower gastrointestinal bleeding (LGIB) is a common reason for hospital admission. However, the majority resolve spontaneously and only a minority require inpatient intervention. We aimed to describe the epidemiology and aetiology of acute LGIB admissions in our institution. We also aimed to validate the Oakland Score, which can identify patients at low risk of adverse outcome from LGIB, in our population and determine the proportion who could have safely avoided admission. METHODS: Using the prospective, validated Otago Clinical Audit database (DIVA), we searched for adult patients admitted to Dunedin Hospital with a primary diagnosis of LGIB between January 2013 and December 2020. We retrieved data to calculate the Oakland Score and details of inpatient treatment from the electronic patient record. We excluded patients admitted electively, admissions related to inflammatory bowel disease, and those with upper gastrointestinal bleeding. RESULTS: We identified 761 patients of which 501 met inclusion criteria (56% male, median age 76 years, 82% NZ European). Overall, 72% were managed with observation or diagnostic endoscopy, 32% received blood products, and 7% required haemostatic intervention to control bleeding. The area under the receiver operating characteristic curve for the Oakland Score was 0.85 (95% CI, 0.81-0.89). A cut-off score of ≤10 predicted a 95% probability of safely avoiding admission. This equates to saving 30 bed-days annually. CONCLUSION: The majority of patients admitted with LGIB are managed conservatively. The Oakland Score could be used as a stratification tool to safely reduce the admission rate.


Assuntos
Hemorragia Gastrointestinal , Alta do Paciente , Adulto , Humanos , Masculino , Idoso , Feminino , Estudos Prospectivos , Nova Zelândia/epidemiologia , Medição de Risco , Hemorragia Gastrointestinal/diagnóstico , Hemorragia Gastrointestinal/epidemiologia , Hemorragia Gastrointestinal/etiologia , Doença Aguda , Hospitais , Estudos Retrospectivos
19.
J Clin Gastroenterol ; 58(5): 440-446, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-37341702

RESUMO

GOALS: We aim to explore the relationship between the use of proton pump inhibitors (PPIs) and upper gastrointestinal bleeding (UGIB). We develop a nomogram model to predict mortality in critically ill stroke patients. STUDY: This is a retrospective study based on the MIMIC IV database. We extracted clinical information including demographic data, comorbidities, and laboratory indicators. Univariate and multivariable logistic regressions were used to assess and identify risk factors for the occurrence of UGIB and for the in-hospital mortality of critically ill stroke patients. The resulting model was used to construct a nomogram for predicting in-hospital mortality. RESULTS: Five thousand seven hundred sixteen patients from the MIMIC-IV database were included in our analysis. UGIB occurred in 109 patients (1.9%), whereas the PPI use rate was as high as 60.6%. Chronic liver disease, sepsis, shock, anemia, and increased level of urea nitrogen were independent risk factors for the occurrence of UGIB in severe stroke patients. We identified age, heart failure, shock, coagulopathy, mechanical ventilation, continuous renal replacement therapy, antiplatelet drugs, anticoagulation, simplified acute physiology score-II, and Glasgow coma score as independent risk factors for in-hospital mortality in severe stroke patients. The C-index for the final nomograms was 0.852 (95% confidence interval: 0.840, 0.864). CONCLUSIONS: We found that the overall rate of UGIB in severe stroke patients is low, whereas the rate of PPI usage is high. In our study, PPI was not identified as a risk factor for the occurrence of UGIB and UGIB was not associated with all-cause mortality. More clinical trials are needed to evaluate the benefits of using PPI in critically ill stroke patients.


Assuntos
Estado Terminal , Acidente Vascular Cerebral , Humanos , Estudos Retrospectivos , Hemorragia Gastrointestinal/epidemiologia , Hemorragia Gastrointestinal/etiologia , Fatores de Risco , Prognóstico , Acidente Vascular Cerebral/complicações
20.
Int J Urol ; 31(2): 139-143, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-37847117

RESUMO

OBJECTIVES: Rectal bleeding is a common complication of transrectal ultrasound-guided prostate biopsy (TRPB). Massive rectal bleeding after TRPB can be life threatening. We initiated proctoscopy after TRPB to clarify the incidence of rectal bleeding and evaluated the usefulness of proctoscopy for controlling bleeding after TRPB. MATERIALS: Two hundred and fifty six patients who underwent TRPB were included in the study. TRPB was performed under local anesthesia. Post-biopsy, we performed a proctoscopy to evaluate the degree of rectal bleeding at four levels (G0, no bleeding; G1, traces; G2, venous bleeding requiring hemostasis; and G3, massive venous bleeding or arterial bleeding). Once the bleeding site on the rectal wall was identified, a gauze tampon was placed at the bleeding site and compressed for a few minutes. A second proctoscopy was performed to confirm complete hemostasis, after which the TRPB was terminated. RESULTS: Proctoscopy revealed that the degree of bleeding was G0 in 27 cases, G1 in 104 cases, G2 in 116 cases, and G3 in nine cases. Rectal bleeding that required hemostasis (G2 and G3) was observed in 125 of 256 cases (48.3%). Among the 125 cases, bleeding was stopped by compression in 121 cases; in the remaining four cases, bleeding continued despite compression and was stopped by suturing of the bleeding site. Suturing was performed by urologists, and none of the 256 patients had problematic posterior hemorrhage. CONCLUSIONS: Proctoscopy enables precise and effective pressure hemostasis. Moreover, suturing hemostasis under direct vision can be performed in cases in which pressure hemostasis is difficult. Continued proctoscopy allays urologists' fear of post-TRPB rectal bleeding.


Assuntos
Proctoscopia , Próstata , Masculino , Humanos , Próstata/diagnóstico por imagem , Próstata/cirurgia , Próstata/patologia , Proctoscopia/efeitos adversos , Reto , Biópsia/efeitos adversos , Hemorragia Gastrointestinal/diagnóstico , Hemorragia Gastrointestinal/epidemiologia , Hemorragia Gastrointestinal/etiologia
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