Association of Aspirin Use With Major Bleeding in Patients With and Without Diabetes

Berardis, Giorgia De; Lucisano, Giuseppe; D'Ettorre, A; Pellegrini, Fabio; Lepore, Vito; Tognoni, Gianni; Nicolucci, Antonio

doi:10.1001/jama.2012.5034

Cited by 211 publications

(155 citation statements)

References 37 publications

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“…37 A population-based study of aspirin-related bleeding showed that aspirin did not increase gastrointestinal bleeding even in patients with diabetes mellitus, although patients with diabetes mellitus had a higher rate of bleeding than those without diabetes mellitus. 38 In the JPAD2 study, long-term follow-up revealed that low-dose aspirin certainly increased the rate of gastrointestinal bleeding in patients with diabetes mellitus.…”

Section: Discussionmentioning

confidence: 99%

Low-Dose Aspirin for Primary Prevention of Cardiovascular Events in Patients With Type 2 Diabetes Mellitus

et al. 2017

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Background: The long-term efficacy and safety of low-dose aspirin for primary prevention of cardiovascular events in patients with type 2 diabetes mellitus are still inconclusive. Methods: The JPAD trial (Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes) was a randomized, open-label, standard care–controlled trial examining whether low-dose aspirin affected cardiovascular events in 2539 Japanese patients with type 2 diabetes mellitus and without preexisting cardiovascular disease. Patients were randomly allocated to receive aspirin (81 or 100 mg daily; aspirin group) or no aspirin (no-aspirin group) in the JPAD trial. After that trial ended in 2008, we followed up with the patients until 2015, with no attempt to change the previously assigned therapy. Primary end points were cardiovascular events, including sudden death, fatal or nonfatal coronary artery disease, fatal or nonfatal stroke, and peripheral vascular disease. For the safety analysis, hemorrhagic events, consisting of gastrointestinal bleeding, hemorrhagic stroke, and bleeding from any other sites, were also analyzed. The primary analysis was conducted for cardiovascular events among patients who retained their original allocation (a per-protocol cohort). Analyses on an intention-to-treat cohort were conducted for hemorrhagic events and statistical sensitivity. Results: The median follow-up period was 10.3 years; 1621 patients (64%) were followed up throughout the study; and 2160 patients (85%) retained their original allocation. Low-dose aspirin did not reduce cardiovascular events in the per-protocol cohort (hazard ratio, 1.14; 95% confidence interval, 0.91–1.42). Multivariable Cox proportional hazard model adjusted for age, sex, glycemic control, kidney function, smoking status, hypertension, and dyslipidemia showed similar results (hazard ratio, 1.04; 95% confidence interval, 0.83–1.30), with no heterogeneity of efficacy in subgroup analyses stratified by each of these factors (all interaction P >0.05). Sensitivity analyses on the intention-to-treat cohort yielded consistent results (hazard ratio, 1.01; 95% confidence interval, 0.82–1.25). Gastrointestinal bleeding occurred in 25 patients (2%) in the aspirin group and 12 (0.9%) in the no-aspirin group ( P =0.03), and the incidence of hemorrhagic stroke was not different between groups. Conclusions: Low-dose aspirin did not affect the risk for cardiovascular events but increased risk for gastrointestinal bleeding in patients with type 2 diabetes mellitus in a primary prevention setting. Clinical Trial Registration: URL: http://www.clinicaltrials.gov . Unique identifier: NCT00110448.

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Section: Discussionmentioning

confidence: 99%

Low-Dose Aspirin for Primary Prevention of Cardiovascular Events in Patients With Type 2 Diabetes Mellitus

et al. 2017

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“…El riesgo de hemorragia probablemente sea la RAM más frecuente y mejor documentada a través de los casos recogidos en la bibliografía (21)(22)(23)(24). En este estudio 5 pacientes refirieron tener antecedentes de úlcera y la utilización de medicamentos cuyo uso conjunto incrementa el riesgo de hemorragias, bien por daño directo o bien por afectar a la coagulación, como es el caso de los corticoides (5 casos), los inhibidores selectivos de la recaptación de serotonina (ISRS) (2 casos), los anticoagulantes (3 casos) o los trombolíticos (1 caso), además de los 19 que utilizaban otro AINE.…”

Section: Originalesunclassified

El farmacéutico, garante de la salud del paciente en la dispensación de ácido acetilsalicílico 500 mg

Núñez¹,

Benajas²,

Calle³

et al. 2014

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Alonso Núñez ML, Pérez Benajas A, Calle J, Eyaralar T. El farmacéutico, garante de la salud del paciente en la dispensación de ácido acetilsalicílico 500 mg Originales RESUMENIntroducción: La dispensación de medicamentos en España es responsabilidad del farmacéutico. En el caso de los medicamentos no sujetos a prescripción médica (MSP) es el farmacéutico el que asegura su buen uso y puede evitar la aparición de RAM. Uno de los MSP más conocidos es la Aspirina®, 500 mg de ácido acetilsalicílico (AAS). Este estudio pretende analizar las intervenciones farmacéuticas que se llevan a cabo al dispensar MSP con 500 mg de AAS.Material y métodos: 18 farmacias comunitarias participaron en este estudio observacional prospectivo. Desde junio de 2013 a junio de 2014 se documentaron todas las intervenciones realizadas a los pacientes que demandaron MSP con 500 mg de AAS y que estuvieran en alguna de las situaciones de riesgo para el consumo de estos medicamentos.Resultados: De las 3.355 demandas de MSP con 500 mg de AAS contabilizadas, los farmacéuticos intervinieron en 182 ocasiones (el 5,4% de las veces). Un 20% de las intervenciones estaban relacionadas con el tiempo de duración del tratamiento, un 24% con patologías en las que el uso de AAS está contraindicado, otro 24% con la alteración de pruebas analíticas y un 26% con la interacción con otros medicamentos.Discusión: El 5,4% de las veces que se demandó un MSP con 500 mg de AAS, la intervención del farmacéutico pudo evitar una RAM. Esto hace pensar si es apropiado el plantear que el ASS salga de la farmacia comunitaria. Planteamiento corroborado por el menor número de comunicaciones de RAM relacionadas con AAS de España en relación con el resto de Europa.The pharmacist as guarantor of patient health in the dispensation of acetylsalicylic acid 500 mg ABSTRACT Introduction: Pharmacists hold the responsibility for dispensing of medicines in Spain. When the medicine is an Over the Counter (OTC) one, the pharmacist ensures its good use and prevents the appearance of an ADR (adverse drug reaction). Aspirin® (500 mg of ASA) is one of the best known OTCs. This study analyses the pharmacist's interventions when 500mg ASA OTCs are dispensed.Material and methods: 18 community pharmacies took part in this prospective observational study. All interventions made by the pharmacists when patients, who demanded 500 mg ASA OTCs, where in a risky situation for its use, were documented from June 2013 to June 2014.Results: Pharmacists had to intervene 182 times out of the 3.355 ones a patient demanded a 500 mg ASA OTC (5.4% of the times). 20% of interventions where related to the length of treatment, 24% to pathologies where ASA was contraindicated, other 24% to lab tests alteration and 26% to drug-drug interactions.Discussion: Pharmacist intervention prevented an ADR for the patient 5.4% of the times a 500 mg ASA OTC was demanded at the pharmacy. This leads us to think carefully about the possibility of taking ASA out of the pharmacy. This fact is supported by the lower number of ADR notif...

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“…1,2 However, it also increases the risk of gastrointestinal bleeding, even at low doses. 1,3,4 The effect on stroke is mixed: Aspirin may slightly reduce the risk of ischemic strokes, but it also increases the less frequent hemorrhagic type. 1 Several systematic reviews, meta-analyses, and evidence-based clinical guidelines have quantified these effects and offered opinions about the utility of aspirin for primary prevention based on counts of the beneficial and detrimental events.…”

Section: Introductionmentioning

confidence: 99%

Effect of Including Cancer Mortality on the Cost-Effectiveness of Aspirin for Primary Prevention in Men

et al. 2013

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BACKGROUND: Recent data suggest that aspirin may be effective for reducing cancer mortality. OBJECTIVE: To examine whether including a cancer mortality-reducing effect influences which men would benefit from aspirin for primary prevention. DESIGN: We modified our existing Markov model that examines the effects of aspirin among middle-aged men with no previous history of cardiovascular disease or diabetes. For our base case scenario of 45-year-old men, we examined costs and life-years for men taking aspirin for 10 years compared with men who were not taking aspirin over those 10 years; after 10 years, we equalized treatment and followed the cohort until death. We compared our results depending on whether or not we included a 22 % relative reduction in cancer mortality, based on a recent meta-analysis. We discounted costs and benefits at 3 % and employed a third party payer perspective. MAIN MEASURE: Cost per quality-adjusted life year (QALY) gained. KEY RESULTS: When no effect on cancer mortality was included, aspirin had a cost per QALY gained of $22,492 at 5 % 10-year coronary heart disease (CHD) risk; at 2.5 % risk or below, no treatment was favored. When we included a reduction in cancer mortality, aspirin became cost-effective for men at 2.5 % risk as well (cost per QALY, $43,342). Results were somewhat sensitive to utility of taking aspirin daily; risk of death after myocardial infarction; and effects of aspirin on stroke, myocardial infarction, and sudden death. However, aspirin remained cost-saving or cost-effective (< $50,000 per QALY) in probabilistic analyses (59 % with no cancer effect included; 96 % with cancer effect) for men at 5 % risk. CONCLUSIONS: Including an effect of aspirin on cancer mortality influences the threshold for prescribing aspirin for primary prevention in men. If such an effect is real, many middle-aged men at low cardiovascular risk would become candidates for regular aspirin use.

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Association of Aspirin Use With Major Bleeding in Patients With and Without Diabetes

Cited by 211 publications

References 37 publications

Low-Dose Aspirin for Primary Prevention of Cardiovascular Events in Patients With Type 2 Diabetes Mellitus

Low-Dose Aspirin for Primary Prevention of Cardiovascular Events in Patients With Type 2 Diabetes Mellitus

El farmacéutico, garante de la salud del paciente en la dispensación de ácido acetilsalicílico 500 mg

Effect of Including Cancer Mortality on the Cost-Effectiveness of Aspirin for Primary Prevention in Men

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