Use Of Low-dose Acetylsalicylic Acid Research Articles

Angiotensin converting enzyme inhibitors related cough and associated medications

Introduction: Angiotensin-converting enzyme inhibitors (ACEi) are among the main anti-hypertensive medications. While they are generally well tolerated, dry cough is one of their important side effects, with a frequency of up to 10 percent. Medications that are associated with increased ACEi-related cough frequency are not well described. We wanted to evaluate medications that might have an effect on ACEi-related cough.
 Methods: This study was designed as a post-hoc analysis of our previously published study. Patients who were on ACEi were identified, and demographics, comorbidities, laboratory data, and medications were retrieved via electronic medical records. Patients who reported cough and whose cough ceased after ACEi withdrawal were defined as having an "ACEi-related cough." Patients were grouped according to their ACEi-related cough presence.
 Results: One hundred and twenty-one patients were included in the study, of whom 14 experienced ACEi-related coughs. All medications except for low-dose acetylsalicylic acid (ASA) and calcium channel blockers (CCB) were similar between the groups. Low-dose ASA use was significantly higher among patients who experienced ACEi-related cough (50% vs. 16.8%, p = 0.04). On the other hand, CCB use was associated with lower ACEi-related cough (7.7% vs. 35.5%, p = 0.03). Medications other than ASA and CCB, demographics, comorbidities, and laboratory data were similar across the groups.
 Discussion: ACEi-related cough risk is higher among patients on low-dose ASA and lower among patients on CCB. Further studies are needed to demonstrate if there is a “safe” acetylsalicylic acid dose that is not associated with ACEi-related cough.

Does the continuation of low-dose acetylsalicylic acid during the perioperative period of thyroidectomy increase the risk of cervical haematoma? A 1-year experience of two Italian centers.

A growing number of patients taking antiplatelet drugs, mainly low-dose acetylsalicylic acid (ASA) (75-150 mg/day), for primary or secondary prevention of thrombotic events, are encountered in every field of surgery. While the bleeding risk due to the continuation of these medications during the perioperative period has been adequately investigated in several surgical specialties, in thyroid surgery it still needs to be clarified. The main aim of this study was to assess the occurrence of cervical haematoma in patients receiving low-dose acetylsalicylic acid, specifically ASA 100 mg/day, during the perioperative period of thyroidectomy. Patients undergoing thyroidectomy in two high-volume thyroid surgery centers in Italy, between January 2021 and December 2021, were retrospectively analysed. Enrolled patients were divided into two groups: those not taking ASA were included in Group A, while those receiving this drug in Group B. Univariate analysis was performed to compare these two groups. Moreover, multivariate analysis was employed to evaluate the use of low-dose ASA as independent risk factor for cervical haematoma. A total of 412 patients underwent thyroidectomy during the study period. Among them, 29 (7.04%) were taking ASA. Based on the inclusion criteria, 351 patients were enrolled: 322 were included in Group A and 29 in Group B. In Group A, there were 4 (1.24%) cervical haematomas not requiring surgical revision of haemostasis and 4 (1.24%) cervical haematomas requiring surgical revision of haemostasis. In Group B, there was 1 (3.45%) cervical haematoma requiring surgical revision of haemostasis. At univariate analysis, no statistically significant difference was found between the two groups in terms of occurrence of cervical haematoma, nor of the other early complications of thyroidectomy. At multivariate analysis, the use of low-dose ASA did not prove to be an independent risk factor for cervical haematoma. Based on our findings, we believe that in patients receiving this drug, either for primary or secondary prevention of thrombotic events, its discontinuation during the perioperative period of thyroidectomy is not necessary.

The protective role of low-dose acetylsalicylic acid use and relation with inflammatory and thrombotic parameters on radial artery occlusion in patients undergoing elective transradial coronary angiography

Aim: Transradial angiography (TRA) is recommended in clinical practice; it is better than the transfemoral route to prevent site-related complications. Radial artery occlusion is one of the most seen significant complications after TRA. In the present study, the protective effect of low dose acetylsalicylic acid (ASA) use against the radial artery occlusion (RAO) and the predictive ability of some thrombotic and inflammatory factors for the development of RAO were investigated.
 Material and Method: One thousand two hundred fifty-four patients who planned for elective coronary angiography were screened to include transradial coronary angiography. The patients have grouped group I, who took ASA (100 mg) (n= 56), and group II (n= 51), who did not. Blood samples were taken immediately after sheath insertion and after the six hours of the sheath removal. The D-dimer and C-reactive protein values were analyzed between groups. In the first 24 hours after the procedure, the radial Doppler ultrasonography assessment was performed to detect RAO. Multivariable regression analysis was used to evaluate the independent risk factors for the TRA.
 Results: Eligible one hundred seven stable patients were included in the study. The demographic, laboratory and procedural characteristics were similar between the two groups (Table 2). TRA was statistically lower in Group I compared to Group II. (n=3 vs. n=22, p=.001). Multivariable regression analysis demonstrated that postprocedural higher D-dimer levels and non-ASA status were found to be the independent risk factors for RAO (OR (95% CI=1.235(1.014-1.582) p=.001, 5.534 (3.376-9.252), p .05).
 Conclusion: Preprocedural ASA use may have a protective role against the RAO. Pre- and post-procedural D-dimer levels can predict the thrombotic process in the early phase of the RAO.

Long-term low-dose acetylsalicylic use shows protective potential for the development of both vascular dementia and Alzheimer’s disease in patients with coronary heart disease but not in other individuals from the general population: results from two large cohort studies

BackgroundNo population-based cohort study investigated a potential inverse association between long-term low-dose acetylsalicylic acid (ASA) use and all-cause dementia and its two most common sub-types Alzheimer’s disease (AD) and vascular dementia (VD) so far.MethodsCox regression models with inverse probability of treatment weighting to model the underlying cardiovascular risk were used to assess the associations of low-dose ASA use with all-cause dementia, AD, and VD incidence in community-dwelling older adults from the German ESTHER study (N = 5258) and the UK Biobank (N = 305,394). Inclusion criteria were age of 55 years or older and completed drug assessment. Meta-analyses of the individual participant data from the two prospective cohort studies were performed.ResultsFour hundred seventy-six cases of all-cause dementia, 157 cases of AD, and 183 cases of VD were diagnosed over a median of 14.3 years of follow-up in ESTHER. In the UK Biobank, 5584 participants were diagnosed with all-cause dementia, 2029 with AD, and 1437 with VD over a median of 11.6 years. The meta-analysis of both cohorts revealed a weak reduction in hazards for all-cause dementia (hazard ratio (HR) [95% confidence interval (CI)]: 0.96 [0.93 to 0.99]). The strongest protective effect of low-dose ASA was observed in participants with coronary heart disease (CHD) in both cohorts, and a significant interaction was detected. In particular, in meta-analysis, a 31% reduction in hazard for AD, 69% for VD and 34% for all-cause dementia were observed (HR [95% CI]: 0.69 [0.59 to 0.80], 0.31 [0.27 to 0.35], 0.46 [0.42 to 0.50], respectively). Furthermore, compared to non-users, users of low-dose ASA for 10 years or longer (who likely use it because they have CHD or a related diagnosis putting them at an increased risk for cardiovascular events) demonstrated a strong protective effect on all dementia outcomes, especially for VD (HR [95% CI]: 0.48 [0.42 to 0.56]) whereas no protective associations were observed with shorter low-dose ASA use.ConclusionsThe protective potential of low-dose ASA for all-cause dementia, AD, and VD seems to strongly depend on pre-existing CHD and the willingness of patients to take it for a minimum of ten years.

Impact of Weight-Band Dosing of Tinzaparin for Venous Thromboembolism Prophylaxis on Persistent Wound Drainage in Adult Patients Undergoing Hip and Knee Arthroplasty.

Persistent wound drainage and venous thromboembolism (VTE) are potential complications of total joint arthroplasty, and these risks can be challenging to balance in clinical practice. Anecdotal observation has suggested that following joint arthroplasty, persistent wound drainage occurs more frequently with higher body weight and higher doses of tinzaparin when compared with lower body weight and lower doses of tinzaparin. The overall purpose of this study was to describe the impact of a tinzaparin weight-band dosing table for VTE prophylaxis on wound healing, thrombosis, and bleeding outcomes in patients undergoing total joint arthroplasty. This retrospective chart review included patients who underwent total hip or knee arthroplasty and received tinzaparin for thromboprophylaxis per their weight-banding category. The primary outcome was the incidence of persistent wound drainage. Secondary outcomes include the occurrence of VTE and clinically important bleeding during hospital admission. A total of 231 patients were included in the analysis. There was no significant difference in persistent wound drainage between the 3 weight categories, and there were no differences in rates of VTE or clinically important bleeding. Concurrent use of low-dose acetylsalicylic acid was associated with a 3-fold increased risk of persistent wound drainage (risk ratio = 3.35; 95% CI = 2.14-5.24; P = 0.00003). In joint arthroplasty patients, we observed no significant difference in rates of persistent wound drainage between various weight categories receiving different weight-banded doses of tinzaparin. Our results do not suggest that the current weight-band dosing table for tinzaparin needs to be adjusted to optimize patient outcomes.

Prevention of venous thromboembolic events occurring in myeloma patients treated with second-generation novel agents.

Thrombosis and neoplasms are strictly linked, and the diagnosis of a malignancy is a relevant risk factor for venous thromboembolism (VTE). In particular, between gammopathies, the VTE risk is known to be increased in both monoclonal gammopathy of uncertain significance and in multiple myeloma, with a 3- and 9-fold increase respectively, when compared to the general population. The risk appears to be further increased in patients treated with immunomodulating drugs, such as thalidomide, especially when in combination with dexamethasone or conventional cytotoxic chemotherapies, and lenalidomide. In 2008 the International Myeloma Working Group put out thrombosis prophylaxis recommendations for myeloma patients treated with IMiDs. Current recommendations for thromboprophylaxis suggest the use of low-dose acetylsalicylic acid in patients with low risk for thrombosis and therapeutic dose anticoagulation with LMWH or warfarin for high-risk patients. However, these recommendations have been frequently not followed in the clinical practice, due to various reasons that involve the patients' will, the level of evidence of the recommendations and some selection biases in the studies that were taken as basis for writing down the indications. The new direct oral anticoagulants have been preliminarily evaluated for the prophylaxis of thrombotic events in IMiDs-treated myelomas, being promising, even if more expensive. Currently, the most reliable tool for a correct thrombotic risk stratification appears to be the complete clinical and anamnestic evaluation of the myeloma patients added to a strong physician awareness of the evidences that the literature contains until now.

Prescription prevalence of low dose aspirin in primary prevention in the Spanish population, trends over time and associated factors

Background and objectiveThe use of low-dose acetylsalicylic acid (LD-ASA) in primary prevention is a matter of controversy, but its magnitude is unknown in Spain. The aim of the study was to estimate the proportion of patients who are prescribed LD-ASA for primary prevention and to identify their characteristics. MethodsIn a sample from the primary care database BIFAP we obtained the proportion of persons with prescriptions of LD-ASA over the period 2002–2015, excluding patients with any previous record of occlusive vascular disease, atrial fibrillation or cancer. The proportions were standardized to the Spanish population aged 40–99 years old. We identified the factors associated with the use of LD-ASA through a logistic regression and estimated its prevalence of use according to the presence of such factors. ResultsThe sample included 102,850 subjects; of which 6198 were users of LD-ASA. The standardized prevalence of prescription was 2.21% at the start of the period and 3.57% at the end, and increased with age. The factors with the strongest associations were diabetes (OR = 3.26; 95% CI:3.07−3.47), dyslipidaemia (OR = 2.08;1.96−2.21), heart failure (OR = 2.02;1.72−2.37), and hypertension (OR = 1.78;1.67−1.90). Among diabetic patients older than 70 years with hypertension and dyslipidaemia, the prevalence of LD-ASA prescription was 33.7%. ConclusionsThe prescription of LD-ASA for primary prevention in Spain over the study period was low in the general population, but high in older diabetic patients with additional risk factors. After years of controversy, it is time to realign the use of this drug in primary prevention according to recent guidelines.

Pregnancy with lupus erythematosus-an update

Current research in the field of systemic lupus erythematosus (SLE) and pregnancy focuses on predictors of adverse pregnancy outcomes, the safety and efficacy of hydroxychloroquine (HCQ) in pregnancy and the importance of preconception counselling. In particular, the prospective predictors of pregnancy outcome: biomarkers in antiphospholipid antibody syndrome and SLE (PROMISSE) study adds to the understanding of risk factors for adverse outcomes. There is increasing evidence of the numerous benefits associated with continuing HCQ treatment in pregnancy and for the use of low-dose acetylsalicylic acid in the prevention of preeclampsia. The European League Against Rheumatism (EULAR) has published evidence-based recommendations for the treatment of women with SLE and/or antiphospholipid syndrome before, during and after pregnancy. Rheumatologists caring for women with SLE should be familiar with the current state of knowledge in order to help optimize the management and thus the outcome of pregnancy in their patients.

Use of low-dose acetylsalicylic acid for cardiovascular disease prevention: A practical, stepwise approach for pharmacists.

Low-dose acetylsalicylic acid (ASA) is recommended in patients with established cardiovascular disease. However, the role of ASA in those without cardiovascular disease (i.e., primary prevention) is less clear, which has led to discordance among Canadian guidelines. In 2018, 3 double-blind, randomized controlled trials were published that evaluated ASA 100 mg daily versus placebo in patients without established cardiovascular disease. In the ASPREE trial, ASA did not reduce the risk of all-cause death, dementia, or persistent physical disability in patients ≥70 years of age but increased the risk of major bleeding. In the ARRIVE trial, ASA failed to lower the risk of a composite of cardiovascular events but increased any gastrointestinal bleeding in patients at intermediate risk of cardiovascular disease. In the ASCEND trial, ASA significantly reduced the primary composite cardiovascular outcome in patients with diabetes for a number needed to treat of 91 over approximately 7.4 years. Yet major bleeding was increased with ASA for a number needed to harm of 112. Therefore, in most situations, ASA should not be recommended for primary cardiovascular prevention. However, there are additional indications for ASA beyond cardiovascular disease. Thus, a sequential algorithm was developed based on contemporary evidence to help pharmacists determine the suitability of ASA in their patients and play an active role in educating their patients about the potential benefits (or lack thereof) and risks of ASA. Can Pharm J (Ott) 2020;153:xx-xx.

Prevalencia de prescripción del ácido acetilsalicílico a dosis bajas en prevención primaria en población española, evolución temporal y factores asociados

Background and objectiveThe use of low-dose acetylsalicylic acid (LD-ASA) in primary prevention is a matter of controversy, but its magnitude is unknown in Spain. The aim of the study was to estimate the proportion of patients who are prescribed LD-ASA for primary prevention and to identify their characteristics. MethodsIn a sample from the primary care database BIFAP we obtained the proportion of persons with prescriptions of LD-ASA over the period 2002-2015, excluding patients with any previous record of occlusive vascular disease, atrial fibrillation or cancer. The proportions were standardized to the Spanish population aged 40-99 years old. We identified the factors associated with the use of LD-ASA through a logistic regression and estimated its prevalence of use according to the presence of such factors. ResultsThe sample included 102,850 subjects; of which 6,198 were users of LD-ASA. The standardized prevalence of prescription was 2.21% at the start of the period and 3.57% at the end, and increased with age. The factors with the strongest associations were diabetes (OR=3.26; 95%CI: 3.07-3.47), dyslipidaemia (OR=2.08; 1.96-2.21), heart failure (OR=2.02; 1.72-2.37), and hypertension (OR=1.78; 1.67-1.90). Among diabetic patients older than 70 years with hypertension and dyslipidaemia, the prevalence of LD-ASA prescription was 33.7%. ConclusionsThe prescription of LD-ASA for primary prevention in Spain over the study period was low in the general population, but high in older diabetic patients with additional risk factors. After years of controversy, it is time to realign the use of this drug in primary prevention according to recent guidelines.

Management of Acute Coronary Syndromes

Management of Acute Coronary Syndromes

Conditioning on future exposure to define study cohorts can induce bias: the case of low-dose acetylsalicylic acid and risk of major bleeding.

BackgroundA principle of cohort studies is that cohort membership is defined by current rather than future exposure information. Pharmacoepidemiologic studies using existing databases are vulnerable to violation of this principle. We evaluated the impact of using data on future redemption of prescriptions to determine cohort membership, motivated by a published example seeking to emulate a “per-protocol” association between continuous versus never use of low-dose acetylsalicylic acid (ASA) and major bleeding (e.g., cerebral hemorrhage or gastrointestinal bleeding).Materials and methodsDanish medical registry data from 2004 to 2011 were used to construct two analytic cohorts. In Cohort 1, we used information about future redemption of low-dose ASA prescriptions to identify cohorts of continuous and never-ASA users. In Cohort 2, we identified ASA initiators and non-initiators using only contemporaneous data and censored follow-up for changes in use over time. We implemented propensity score-matched Poisson regression to evaluate associations between ASA use and major bleeding and estimated adjusted incidence rate differences (IRDs) per 1,000 person-years and ratios (IRRs) overall and stratified by time since initiation.ResultsAmong >6 million eligible Danish adults, we identified 403,693 low-dose ASA initiators (Cohort 2), of whom 189,150 were defined as continuous users (Cohort 1). Overall, IRDs and IRRs were similar across cohorts. However, the IRD for major bleeding in the first 90 days was substantially larger in Cohort 1 (IRD=25 per 1,000 person-years) compared with Cohort 2 (IRD=10 per 1,000 person-years).ConclusionUsing future medication redemption data to define baseline cohorts violates basic epidemiologic principles. Compared with an approach using only contemporaneous data to define cohorts, the approach based on future redemption data generated a substantially higher short-term association between low-dose ASA use and major bleeding on the absolute, but not the relative, scale possibly due to selection and immortal time biases.

UNIVERSAL APPROACH TO THE PREVENTION OF THE SYNDROME OF PATHOLOGICAL PREGNANCY

Aim - the purpose of the study is the development of a method for prevention of pathological pregnancy syndrome from the perspective of integral genesis, determined by morphological and functional abnormalities in the fetoplacental system, assessing the effectiveness of methodological standards of evidence-based medicine. Materials and methods. Prospective study of 435 women with high risk of decompensation of placental insufficiency was conducted. Depending on the method of prevention of gestational complications 4 groups were formed: 1st group included 145 pregnant women, who were prescribed dydrogesterone on the 6-20 weeks of gestation, and starting with the 21st week - highly-purified diosmin 600 mg as vasoprotective; in the 2nd group 118 women received a course of preventive treatment with low doses of acetylsalicylic acid; 3rd group included 102 patients who underwent a course of preventive monotherapy with magnesium; 4th group comprised 70 pregnant women who refused preventive treatment. A control group encompassed 30 healthy pregnant women. Dynamic survey included definition of markers of endothelial and hemostasiological dysfunction, vascular-platelet dysfunction elements, apoptosis, inflammatory response, total reactive capacity of the organism, magnesium and carbon dioxide concentrations; a hystostereometric study of placenta was conducted. Standards of evidence-based medicine were applied for the objectification of the effectiveness of the developed method. Results. Method of preventing great obstetric syndromes by successive appointment of progestogen dydrogesterone on the early stage of pregnancy followed by vasoprotective diosmin 600 mg in the 2nd half of pregnancy showed high efficiency (NNT 1.4 (95% CI 1.1 -1.7); OSH 5.3 (95% CI 4.7 -5.8), namely reducing pre-eclampsia by 93%, placental insufficiency with intrauterine growth restriction and/or chronic fetal hypoxia - 95%, preterm birth - 86%, and no premature abruption of normally situated placenta, severe forms of pre-eclampsia and placental insufficiency. Higher clinical effectiveness of the proposed method of prophylaxis of pathological pregnancy syndrome, compared to the use of low-dose acetylsalicylic acid and preparation of magnesium, can be explained by the normalizing effect of dydrogesterone and highly-purified diosmin 600 mg on the immune and biochemical homeostasis, apoptosis and angiogenesis, activation of endothelial and hemostasiological system, adaptive compensatory reactions in the placenta. Conclusion. The method of choice for the prevention of pathological pregnancy syndrome at high risk of fetoplacental system decompensation is the application of progestogen dydrogesterone and vasoprotective diosmin according to the developed method. The study revealed the potential of targeted selection of preventive methods depending on special needs of pregnant women.

Low-Dose Acetylsalicylic Acid Treatment and Impact on Short-Term Mortality in Staphylococcus aureus Bloodstream Infection: A Propensity Score-Matched Cohort Study.

Staphylococcus aureus bloodstream infection is associated with considerable mortality. Experimental models suggest a direct antistaphylococcal effect of acetylsalicylic acid, but evidence from human studies is scarce. We aimed to estimate the effect of low-dose acetylsalicylic acid therapy on mortality in bloodstream infections caused by S. aureus compared with Escherichia coli. Retrospective cohort study based on observational data from 838 and 602 episodes of S. aureus and E. coli bloodstream infection, respectively. Swiss tertiary referral center. Adult patients with S. aureus and E. coli bloodstream infection, respectively, categorized according to low-dose acetylsalicylic acid therapy as outpatient or inpatient before bacteremia. None. Thirty-day all-cause mortality was analyzed in a total of 314 propensity score-matched S. aureus bloodstream infection and in 268 E. coli bloodstream infection patients, respectively (1:1 match of low-dose acetylsalicylic acid users and nonusers). S. aureus bloodstream infection cases and controls were equally matched for relevant confounders except treatment with statins, which was strongly associated with a low-dose acetylsalicylic acid use (p < 0.001). At day 30, 12.1% of cases and 27.4% of controls had died (hazard ratio, 0.40; p < 0.001). Low-dose acetylsalicylic acid use was associated with a reduced 30-day all-cause mortality in multivariate analysis (hazard ratio, 0.38; 95% CI, 0.21-0.69; p = 0.001) of matched patients and also of the entire cohort (n = 689) after adjustment for the propensity score (hazard ratio, 0.58, 95% CI, 0.34-0.98; p = 0.04). In contrast, low-dose acetylsalicylic acid use was not associated with the primary endpoint in patients with E. coli bloodstream infection (hazard ratio, 0.78; 95% CI, 0.40-1.55; p = 0.8). Low-dose acetylsalicylic acid at the time of bloodstream infection was strongly associated with a reduced short-term mortality in patients with S. aureus bloodstream infection. Future studies are required to investigate if early low-dose acetylsalicylic acid is a suitable treatment in patients with S. aureus bloodstream infection.

Effects of Perioperative Acetyl Salicylic Acid on Clinical Outcomes in Patients Undergoing Craniotomy for Brain Tumor

To evaluate the safety of continuing acetyl salicylic acid (ASA) in patients undergoing brain tumor resection. Many patients are on antiplatelet agents that are withheld before elective neurosurgical procedures to reduce bleeding risk. Cessation of ASA in patients with cardiovascular disease is associated with a known increased risk of thrombotic events, especially in patients with coronary stents. The medical records of patients who underwent surgical resection of a brain tumor at the University of Florida from 2010 to 2014 were evaluated. The patients were separated into groups based on preoperative ASA use and whether or not it was stopped before surgery. Patients were evaluated for thrombotic complications, postoperative hemorrhage, estimated blood loss, length of hospital stay, and discharge disposition. Of the 452 patients analyzed, 368 patients were not on chronic ASA therapy, 55 patients had their ASA discontinued before surgery, and 28 patients were continued on ASA perioperatively. The patients on preoperative ASA were comparable on all collected demographic variables. There were no statistical differences detected between the groups for outcomes including bleeding complications, need for reoperation, or thrombotic complications. In this analysis, perioperative low dose ASA use was not associated with increased risk of perioperative complications.

Patterns in the use of low-dose acetylsalicylic acid and other therapies following upper gastrointestinal bleeding.

Anticoagulants and/or antiplatelet agents such as acetylsalicylic acid (ASA) are important in prevention of cardiovascular (CV) events, but may be associated with upper gastrointestinal bleeding (UGIB). However, discontinuing these agents may leave patients at risk of CV events. This study aimed to assess patterns of therapy after UGIB in routine clinical practice. The Health Improvement Network UK primary care database was used to identify a cohort of patients aged 40-84 years with a UGIB event between 2000 and 2007 (n = 2,036). Patients were followed up for 1 year from the recorded UGIB. Re-prescription rates for antithrombotics and drugs that can modify the risk of UGIB were estimated at 30, 90, 180, and 365 days. At 365 days, the re-prescription rate was 43 % for ASA, 66 % for warfarin, 69 % for clopidogrel, and 49 % for dipyridamole. The re-prescription rate of gastroprotective agents at 365 days for current users of histamine H2-receptor antagonists was 36 % and that of proton pump inhibitors (PPIs) was 97 %. In patients who were prescribed ASA before UGIB (n = 572), only 24 % were prescribed a PPI in the previous year. In patients who were prescribed ASA in the year after UGIB (n = 337), 92 % were prescribed a PPI. Antiplatelet use fell after UGIB events. In patients who were prescribed a PPI after a UGIB event, there was increased re-prescription of antiplatelet agents and antithrombotics.

Influence Of Concomitant NSAID Or ASA On The Efficacy and Safety Of Dabigatran Versus Warfarin For The Treatment Of Acute Venous Thromboembolism: A Pooled Analysis From RE-Cover and RE-Cover II

BackgroundIn two phase III trials, RE-COVER and RE-COVER II, dabigatran etexilate was as effective as warfarin for treatment of acute venous thromboembolism (VTE), with a lower risk of bleeding. However, some patients may already be taking non-steroidal anti-inflammatory drugs (NSAIDs) or acetylsalicylic acid (ASA), which can have antihemostatic effects. ObjectivesWe performed a prespecified subgroup analysis on pooled data from RE-COVER and RE-COVER II to investigate the efficacy and safety of dabigatran versus warfarin in patients with and without concomitant NSAIDs (half-life < 12 hours) or low-dose ASA. MethodsPatients with acute VTE received parenteral anticoagulation and were randomized to the addition of warfarin or warfarin-placebo for at least 5 days until the international normalized ratio (INR) was ≥ 2 at two consecutive measurements. This was followed (on discontinuation of parenteral therapy) by continued warfarin (target INR range 2.0–3.0) or dabigatran 150 mg twice daily (double-dummy; “oral only” treatment period) for 6 months. Concomitant use of ASA ≤ 100 mg/day or NSAIDs with a half-life ≤ 12 hours was permitted. Primary efficacy outcome: recurrent, symptomatic, objectively confirmed VTE, or VTE-related death from randomization (i.e., start of parenteral therapy plus either warfarin or warfarin-placebo) up to the end of the prespecified post-treatment follow-up. Safety: major bleeding events (MBEs), the composite of MBEs or clinically relevant bleeding events (CRBEs), and any bleeds, measured from the start of the double-dummy period (treatment with oral dabigatran or warfarin alone) up to the end of the 6-month study period. Thus, the safety analysis excludes events associated with parenteral therapy, either in combination with warfarin or with warfarin-placebo prior to commencing dabigatran treatment; it therefore compares dabigatran with warfarin at its full pharmacological potential. ResultsOverall, recurrent VTE or VTE-related death occurred in 68/2553 patients (2.7%) randomized to dabigatran and 62/2554 (2.4%) randomized to warfarin; hazard ratio (HR) 1.09 (95% confidence interval [CI] 0.77, 1.54). The Table shows event rates for dabigatran versus warfarin in subgroups with and without concomitant NSAIDs or low-dose ASA. Cox regression analysis showed no statistically significant interaction, indicating similar treatment effects regardless of presence or absence of these concomitant medications. Overall, MBEs were significantly less frequent with dabigatran than with warfarin during the oral only treatment (double dummy) period (HR 0.60; 95% CI 0.36, 0.99). Likewise, MBE/CRBE incidence overall was significantly lower with dabigatran versus warfarin overall (HR 0.56; 95% CI 0.45, 0.71). Results according to concomitant NSAID or low-dose ASA use at baseline are shown in the Table. There was no significant treatment interaction by concomitant medication status for either MBE or MBE/CRBE. Similarly, any bleeding events were significantly less frequent with dabigatran than with warfarin overall, and showed no treatment interaction by baseline NSAID or low-dose ASA use. ConclusionsThere was no apparent difference in recurrent VTE or VTE-related mortality across NSAID or low-dose ASA concomitant medication subgroups. The incidence of bleeding events was similar or numerically lower with dabigatran than with warfarin across subgroups. The results suggest that no increased bleeding risk exists when dabigatran is administered with NSAIDs with a half-life < 12 hours or low-dose ASA. Disclosures:Schulman:Bayer Healthcare: Consultancy, Honoraria, Research Funding; Boehringer Ingelheim: Consultancy, Honoraria, Research Funding. Off Label Use: Dabigatran etexilate is an oral direct thrombin inhibitor approved for the prevention of stroke in patients with atrial fibrillation and (outside the US) for prevention of venous thromboembolism in patients undergoing total hip or knee replacement. This presentation includes discussion of the following off-label use of dabigatran: treatment of venous thromboembolism. Eriksson:Boehringer Ingelheim: Consultancy; BMS: Consultancy; Pfizer: Consultancy. Goldhaber:Boehringer Ingelheim: Consultancy; Daiichi: Consultancy, Research Funding; BMS: Consultancy, Research Funding; Janssen: Consultancy; Merck: Consultancy; Pfizer: Consultancy; Portola: Consultancy; Sanofi-Aventis: Consultancy. Kakkar:Boehringer Ingelheim: Consultancy, Honoraria, Research Funding; Pfizer: Consultancy, Honoraria, Research Funding; BMS: Consultancy, Honoraria, Research Funding; Daiichi: Consultancy, Honoraria, Research Funding; Bayer: Consultancy, Honoraria, Research Funding; Sanofi: Consultancy, Honoraria, Research Funding; Eisai: Consultancy, Honoraria, Research Funding. Kearon:Bayer Healthcare Inc. : Consultancy; Boehringer Ingelheim (Canada) Ltd./Ltée : Consultancy. Schellong:Boehringer Ingelheim: Advisory Boards Other, Consultancy, Honoraria; Bayer Healthcare: Advisory Boards, Advisory Boards Other, Consultancy, Honoraria; BMS/Pfizer: Honoraria; Daiichi Sankyo: Advisory Boards, Advisory Boards Other, Honoraria. Feuring:Boehringer Ingelheim: Employment. Peter:Boehringer Ingelheim: Employment. Friedman:Boehringer Ingelheim: Employment.Table: Incidence of recurrent VTE/VTE-related deaths, MBEs, and MBEs/CRBEs in the dabigatran and warfarin groups by use of concomitant NSAID or ASA at baselineConcomitant medication statusVTE or VTE-related death Patients, n/N (%)MBEs Patients, n/N (%)MBEs or CRBEs Patients, n/N (%)DEWarfarinDEWarfarinDEWarfarinNSAID No52/1973 (2.6)51/2015 (2.5)18/1922 (0.9)35/1982 (1.8)87/1922 (4.5)163/1982 (8.2)NSAID Yes16/580 (2.8)11/539 (2.0)6/534 (1.1)5/480 (1.0)22/534 (4.1)26/480 (5.4)ASA No60/2294 (2.6)57/2340 (2.4)21/2163 (1.0)33/2227 (1.5)95/2163 (4.4)167/2227 (7.5)ASA Yes8/259 (3.1)5/214 (2.3)3/293 (1.0)7/235 (3.0)14/293 (4.8)22/235 (9.4)DE, dabigatran etexilate.

THU0067 Use of cardiovascular drugs in patients with RA, overall and in patients with a history of acute ischemic cardiac events

BackgroundData on increased cardiovascular disease (CV) risks in RA are abundant. Less is known about the use of therapeutic or prophylactic CV management in RA. Some studies report a lower...

The “Prometeo” Study

To implement an online, prospective collection of clinical data and outcome of patients with acute nonvariceal upper gastrointestinal bleeding (UGIB) in Italy ("Prometeo" study). Epidemiology, clinical features, and outcomes of nonvariceal UGIB are mainly known by retrospective studies and are probably changing. Data were collected by 13 Gastrointestinal Units in Italy from June 2006 to June 2007 (phase 1) and from December 2008 to December 2009 (phase 2): an interim analysis of data was performed between the 2 phases to optimize the online database. All the patients consecutively admitted for acute nonvariceal UGIB were enrolled. Demographic and clinical data were collected, a diagnostic endoscopy performed, with endoscopic hemostasis if indicated. One thousand four hundred thirteen patients (M=932, mean age±SD=66.5±15.8; F=481, mean age±SD=74.2±14.6) were enrolled. Comorbidities were present in 83%. 52.4% were treated with acetyl salicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs): only 13.9% had an effective gastroprotection. Previous episodes of UGIB were present in 13.3%. Transfusion were needed in 43.9%. Shock was present in 9.3%. Endoscopic diagnosis was made in 93.2%: peptic lesions were the main cause of bleeding (duodenal ulcer 36.2%, gastric ulcer 29.6%, gastric/duodenal erosions 10.9%). At endoscopy, Helicobacter pylori was searched in 37.2%, and found positive in 51.3% of tested cases. Early rebleeding was observed in 5.4%: surgery was required in 14.3% of them. Bleeding-related death occurred in 4.0%: at multivariate analysis, the risk of death was correlated with female sex [odds ratio (OR=2.19, P=0.0089)], presence of neoplasia (OR=2.70, P=0.0057) or multiple comorbidities (OR=5.04, P=0.0280), shock at admission (OR=4.55, P=0.0001), and early rebleeding (OR=1.47, P=0.004). Prometeo database has provided an up-to-date picture of acute nonvariceal UGIB in Italy: patients are elderly, predominantly males, and with important comorbidities. Gastroprotection is underutilized during NSAIDs treatment. With respect to previous studies, Prometeo shows a higher incidence of low-dose acetyl salicylic acid use and comorbidities, whereas no significant difference were found in other items (etiology of bleeding, NSAIDs use, need for endoscopic hemostasis, incidence of rebleeding, and overall mortality).

Management of Acute Coronary Syndromes

Management of Acute Coronary Syndromes