المؤلفون: Vistisen, Dorte, Carstensen, Bendix, Elisabetta, Patorno, Lanzinger, Stefanie, Tan, Elise Chia-Hui, Yabe, Daisuke, Kim, Dae Jung, Sheu, Wayne H.-H., Melzer-Cohen, Cheli, Holl, Reinhard W., Núñez, Júlio, Ha, Kyoung Hwa, Halvorsen, Sigrun, Langslet, Gisle, Karasik, Avraham, Nyström, Thomas, Niskanen, Leo, Guleria, Sonia, Klement, Riho, Carrasco, Marc, Foersch, Johannes, Shay, Christina, Koeneman, Lisette, Hoti, Fabian, Farsani, Soulmaz Fazeli, Khunti, Kamlesh, Zaccardi, Francesco, Subramanian, Anuradhaa, Nirantharakumar, Krishnarajah, Brodovicz, Kimberly, Zint, Kristina, Försch, Johannes, Rosenzweig, Doron, Lajer, Maria, Overgaard, Mikkel, Grip, Emilie Toresson, Söreskog, Emma, Gunnarsson, Joel, Karlsdotter, Kristina, Stenman, Lotta, Tuovinen, Mikko, Valveny, Neus, Casajust, Paula, Farmer, Ruth, Ternouth, Andrew, Ofstad, Anne Pernille, Nangaku, Masaomi, Node, Koichi, Taneda, Yusuke, Yasui, Atsutaka

المساهمون: Boehringer Ingelheim, Lilly Diabetes Alliance

المصدر: Cardiovascular Diabetology ; volume 22, issue 1 ; ISSN 1475-2840

مصطلحات موضوعية: Cardiology and Cardiovascular Medicine, Endocrinology, Diabetes and Metabolism

الوصف: Background Studies that have reported lower risk for cardiovascular outcomes in users of Sodium–Glucose Cotransporter-2 Inhibitors (SGLT-2i) are limited by residual cofounding and lack of information on prior cardiovascular disease (CVD). This study compared risk of cardiovascular events in patients within routine care settings in Europe and Asia with type 2 diabetes (T2D) initiating empagliflozin compared to dipeptidyl peptidase-4 inhibitors (DPP-4i) stratified by pre-existing CVD and history of heart failure (HF). Methods and results Adults initiating empagliflozin and DPP-4i in 2014–2018/19 from 11 countries in Europe and Asia were compared using propensity score matching and Cox proportional hazards regression to assess differences in rates of primary outcomes: hospitalisation for heart failure (HHF), myocardial infarction (MI), stroke; and secondary outcomes: cardiovascular mortality (CVM), coronary revascularisation procedure, composite outcome including HHF or CVM, and 3-point major adverse cardiovascular events (MACE: MI, stroke and CVM). Country-specific results were meta-analysed and pooled hazard ratios (HR) with 95% confidence intervals (CI) from random-effects models are presented. In total, 85,244 empagliflozin/DPP4i PS-matched patient pairs were included with overall mean follow-up of 0.7 years. Among those with pre-existing CVD, lower risk was observed for HHF (HR 0.74; 95% CI 0.64–0.86), CVM (HR 0.55; 95% CI 0.38–0.80), HHF or CVM (HR 0.57; 95% CI 0.48–0.67) and stroke (HR 0.79; 95% CI 0.67–0.94) in patients initiating empagliflozin vs DPP-4i. Similar patterns were observed among patients without pre-existing CVD and those with and without pre-existing HF. Conclusion These results from diverse patient populations in routine care settings across Europe and Asia demonstrate that initiation of empagliflozin compared to DPP-4i results in favourable cardioprotective effects regardless of pre-existing CVD or HF status.

الإتاحة: https://doi.org/10.1186/s12933-023-01963-9Test

المؤلفون: Rebordosa, Cristina, Farkas, Dóra Körmendiné, Montonen, Jukka, Laugesen, Kristina, Voss, Florian, Aguado, Jaume, Bothner, Ulrich, Rothman, Kenneth J, Zint, Kristina, Mines, Daniel, Ehrenstein, Vera

المصدر: Rebordosa , C , Farkas , D K , Montonen , J , Laugesen , K , Voss , F , Aguado , J , Bothner , U , Rothman , K J , Zint , K , Mines , D & Ehrenstein , V 2022 , ' Cardiovascular Events and All-Cause Mortality in Patients With Chronic Obstructive Pulmonary Disease Using Olodaterol and Other Long-Acting Beta2-Agonists ' , Pharmacoepidemiology and Drug Safety , vol. 31 , no. 8 , pp. 827-839 . https://doi.org/10.1002/pds.5432Test

مصطلحات موضوعية: Denmark, adrenergic beta-2 receptor agonists, cardiac arrhythmias, channelling, myocardial ischaemia, olodaterol, routinely collected health data

الوصف: Purpose: We examined the effect of olodaterol on the risk of myocardial ischaemia, cardiac arrhythmia, and all-cause mortality compared with use of other long-acting beta2-agonists (LABAs). Channelling bias was also explored. Methods: This Danish population-based cohort study used data linked from registries of hospital diagnoses, outpatient dispensings, and deaths. It included patients (aged ≥40 years) with a diagnosis of chronic obstructive pulmonary disease (COPD) who initiated olodaterol or another LABA. Using matching and propensity score (PS) stratification, we calculated adjusted incidence rate ratios (IRRs) using Poisson regression, followed by several additional analyses to evaluate and control channelling bias. Results: The IRRs of cardiac arrhythmias or myocardial ischaemia among users of olodaterol (n = 14 239) compared to users of other LABAs (n = 51 167) ranged from 0.96 to 1.65 in various analyses, although some estimates had low precision. Initial analysis suggested an increased risk for death with olodaterol compared with other LABAs (IRR, 1.63; 95% CI, 1.44–1.84). Because olodaterol prescribing was associated with COPD severity, the mortality association was attenuated by using different methods of tighter confounding control: the IRRs were 1.26 (95% CI, 0.97–1.64) among LABA-naïve LABA/LAMA users without recent COPD hospitalisation; 1.27 (95% CI, 1.03–1.57) in a population with additional trimming from the tails of the PS distribution; and 1.32 (95% CI, 1.19–1.48) after applying overlap-weights analysis. Conclusions: Olodaterol users had a similar risk for cardiac arrhythmias or myocardial ischaemia as other LABA users. The observed excess all-cause mortality associated with olodaterol use could be due to uncontrolled channelling bias.

وصف الملف: application/pdf

العلاقة: https://pure.au.dk/portal/da/publications/cardiovascular-events-and-allcause-mortality-in-patients-with-chronic-obstructive-pulmonary-disease-using-olodaterol-and-other-longacting-beta2agonistsTest(bab432a6-4da1-499a-8715-da136fb4e153).html

الإتاحة: https://doi.org/10.1002/pds.5432Test
https://pure.au.dk/portal/da/publications/cardiovascular-events-and-allcause-mortality-in-patients-with-chronic-obstructive-pulmonary-disease-using-olodaterol-and-other-longacting-beta2agonistsTest(bab432a6-4da1-499a-8715-da136fb4e153).html
https://pure.au.dk/ws/files/330384036/Pharmacoepidemiology_and_Drug_2022_Rebordosa_Cardiovascular_events_and_all_cause_mortality_in_patients_with_chronic.pdfTest

المؤلفون: Beier, Lea, Lu, Shihai, França, Lionel Riou, Marler, Sabrina, Lip, Gregory Y. H., Huisman, Menno V., Teutsch, Christine, Halperin, Jonathan L., Zint, Kristina, Diener, Hans-Christoph, Baker, Laurie, Ma, Chang-Sheng, Paquette, Miney, Bartels, Dorothee B., Dubner, Sergio J., Lyrer, Philippe, Senges, Jochen, Rothman, Kenneth J.

المصدر: Beier , L , Lu , S , França , L R , Marler , S , Lip , G Y H , Huisman , M V , Teutsch , C , Halperin , J L , Zint , K , Diener , H-C , Baker , L , Ma , C-S , Paquette , M , Bartels , D B , Dubner , S J , Lyrer , P , Senges , J & Rothman , K J 2022 , ' Evolution of antithrombotic therapy for patients with atrial fibrillation : The prospective global GLORIA-AF registry program ' ....

مصطلحات موضوعية: Administration, Oral, Anticoagulants/adverse effects, Atrial Fibrillation/chemically induced, Dabigatran/adverse effects, Fibrinolytic Agents/adverse effects, Humans, Registries, Stroke/chemically induced, Vitamin K

الوصف: OBJECTIVE: To assess baseline characteristics and antithrombotic treatment (ATT) prescription patterns in patients enrolled in the third phase of the GLORIA-AF Registry Program, evaluate predictors of treatment prescription, and compare results with phase II. METHODS: GLORIA-AF is a large, global, prospective registry program, enrolling patients with newly diagnosed nonvalvular atrial fibrillation (AF) at risk of stroke. Patients receiving dabigatran were followed for two years in phase II, and all patients were followed for 3 years in phase III. Phase II started when dabigatran became available; phase III started when the characteristics of patients receiving dabigatran became roughly comparable with those receiving vitamin K antagonists (VKAs). RESULTS: Between 2014 and 2016, 21,241 patients were enrolled in phase III. In total, 82% of patients were prescribed oral anticoagulation ([OAC]; 59.5% novel/nonvitamin K oral anticoagulants [NOACs], 22.7% VKAs). A further 11% of patients were prescribed antiplatelets without OAC and 7% were prescribed no ATT. A high stroke risk was the main driver of OAC prescription. Factors associated with prescription of VKA over NOAC included type of site, region, physician specialty, and impaired kidney function. CONCLUSION: Over the past few years, data from phase III of GLORIA-AF show that OACs have become the standard treatment option, with most newly diagnosed AF patients prescribed a NOAC. However, in some regions a remarkable proportion of patients remain undertreated. In comparison with phase II, more patients received NOACs in phase III while the prescription of VKA decreased. VKAs were preferred over NOACs in patients with impaired kidney function.

وصف الملف: application/pdf

العلاقة: https://vbn.aau.dk/da/publications/b741119e-881e-4fe6-9644-33b05ffb399aTest

الإتاحة: https://doi.org/10.1371/journal.pone.0274237Test
https://vbn.aau.dk/da/publications/b741119e-881e-4fe6-9644-33b05ffb399aTest
https://vbn.aau.dk/ws/files/490644140/Beier_et_al._2022_._Evolution_of_antithrombotic_therapy_for_patients_with_atrial_fibrillation_The_prospective_global_GLORIA_AF_registry_program.pdfTest
http://www.scopus.com/inward/record.url?scp=85139377485&partnerID=8YFLogxKTest

المؤلفون: van der Wall, Sake J, Teutsch, Christine, Dubner, Sergio J, Diener, Hans-Christoph, Halperin, Jonathan L, Ma, Chang Sheng, Rothman, Kenneth J, Paquette, Miney, Zint, Kristina, França, Lionel Riou, Lu, Shihai, Lip, Gregory Y H, Huisman, Menno V

المصدر: van der Wall , S J , Teutsch , C , Dubner , S J , Diener , H-C , Halperin , J L , Ma , C S , Rothman , K J , Paquette , M , Zint , K , França , L R , Lu , S , Lip , G Y H , Huisman , M V & GLORIA-AF Investigators 2021 , ' Anticoagulation Prescription and Outcomes in Relation to Renal Function in Patients with Atrial Fibrillation : Results from GLORIA-AF ' , TH Open , vol. 5 , no. 1 , pp. e35-e42 ....

مصطلحات موضوعية: atrial fibrillation, anticoagulation, dabigatran, renal function, stroke, bleeding

الوصف: Objective Anticoagulation management in patients with atrial fibrillation (AF) and impaired renal function is challenging. This study aimed to evaluate anticoagulation prescription patterns in relation to renal function and to describe 2-year clinical outcomes among dabigatran users. Methods Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF) is an international, prospective, and observational study program involving patients with newly diagnosed AF at risk for stroke. Prescription patterns were assessed by creatinine clearance (CrCl) at enrollment. Dabigatran users were followed for 2 years. Clinical outcomes were standardized for stroke and bleeding risk, based on CHA 2 DS 2 -VASc and HAS-BLED scores, with missing values imputed. Results Baseline CrCl values were available for 12,056 of 15,308 eligible patients (79%). With declining renal function, prescriptions increased for vitamin K antagonists (VKAs) and decreased for dabigatran (30-47% and 34-12%, respectively). The prescription of other non-vitamin K antagonists remained similar across CrCl groups (14-19%). In 4,873 dabigatran users, standardized stroke rates were low across all CrCl groups; 0.58/100 patient-years (95% confidence interval [CI]: 0.30-0.90) in CrCl ≥80 mL/min, 0.85 (95% CI: 0.48-1.21) in CrCl 50 to 79 mL/min, and 0.33 (95% CI: 0.06-1.11) in CrCl 30 to 49 mL/min. Similarly, major bleeding rates were low and numerically increased with declining renal function (0.68/100 patient-years, 95% CI: 0.39-1.03; 0.92, 95% CI: 0.58-1.32; and 1.26, 95% CI: 0.66-1.97, respectively). Conclusion In patients with AF, VKA prescriptions increased and dabigatran prescriptions decreased with declining renal function. Rates of stroke and major bleeding in dabigatran patients remained low across the categories of renal impairment.

وصف الملف: application/pdf

العلاقة: https://vbn.aau.dk/da/publications/cb3dd921-3f97-45a4-b75e-7c3a225ca2abTest

الإتاحة: https://doi.org/10.1055/s-0040-1722706Test
https://vbn.aau.dk/da/publications/cb3dd921-3f97-45a4-b75e-7c3a225ca2abTest
https://vbn.aau.dk/ws/files/405566797/van_der_Wall_et_al_2021_Anticoagulation_Prescription_and_Outcomes_in_Relation_to_Renal_Function_in_Patients_with_Atrial_Fibrillation.pdfTest

المؤلفون: Schellong, Sebastian, Ageno, Walter, Casella, Ivan B., Chee, Kok Han, Schulman, Sam, Singer, Daniel E., Desch, Marc, Tang, Wenbo, Voccia, Isabelle, Zint, Kristina, Goldhaber, Samuel Z.

المصدر: Seminars in Thrombosis and Hemostasis ; volume 48, issue 04, page 446-458 ; ISSN 0094-6176 1098-9064

الوصف: Isolated distal deep vein thrombosis (IDDVT) is presumed to be more benign than proximal DVT (PDVT) or pulmonary embolism (PE), suggesting a need for different management approaches. This subgroup analysis of the RE-COVERY DVT/PE global, observational study investigated patient characteristics, hospitalization details, and anticoagulant therapy in patients with IDDVT in real-world settings in 34 countries enrolled from January 2016 to May 2017. Data were analyzed descriptively according to the type and location of the index venous thromboembolism (VTE): IDDVT, PDVT ± distal DVT (DDVT), and PE ± DVT. Of the 6,095 eligible patients, 323 with DVT located outside the lower limb and no PE were excluded. Of the remaining 5,772 patients, 17.6% had IDDVT, 39.9% had PDVT ± DDVT, and 42.5% had PE ± DVT. IDDVT patients were younger and had fewer risk factors for VTE than the other groups. Other comorbidities were less frequent in the IDDVT group, except for varicose veins, superficial thrombophlebitis, and venous insufficiency. IDDVT patients were less likely to be diagnosed in an emergency department (22.3 vs. 29.7% for PDVT ± DDVT and 45.4% for PE ± DVT) or hospitalized for VTE (29.2 vs. 48.5% for PDVT ± DDVT and 75.0% for PE ± DVT). At hospital discharge or 14 days after diagnosis (whichever was later), non–vitamin K antagonist oral anticoagulants were the most commonly used anticoagulants (55.6% for IDDVT, 54.7% for PDVT ± DDVT, and 52.8% for PE ± DVT). Although differences in patient characteristics, risk factors, and clinical management were identified, anticoagulant treatment of IDDVT was almost equal to that of PDVT or PE. Prospective studies should investigate whether, in a global perspective, this is an appropriate use of anticoagulants.

الإتاحة: https://doi.org/10.1055/s-0041-1729169Test

المؤلفون: Kozieł, Monika, Mazurek, Michał, Teutsch, Christine, Diener, Hans-Christoph, Dubner, Sergio J., Halperin, Jonathan L., Ma, Chang-Sheng, Rothman, Kenneth J, Brandes, Axel, Paquette, Miney, Zint, Kristina, França, Lionel Riou, Lu, Shihai, Bartels, Dorothee B., Huisman, Menno V., Lip, Gregory Y H

المصدر: Kozieł , M , Mazurek , M , Teutsch , C , Diener , H-C , Dubner , S J , Halperin , J L , Ma , C-S , Rothman , K J , Brandes , A , Paquette , M , Zint , K , França , L R , Lu , S , Bartels , D B , Huisman , M V & Lip , G Y H 2020 , ' Persistence with Anticoagulation for Atrial Fibrillation : Report from the GLORIA-AF Phase III 1-Year Follow-up ' , Journal of Clinical Medicine , vol. 9 , ....

الوصف: Background: We aimed to assess the extent to which drug persistence is better with non-vitamin K antagonist oral anticoagulants (NOACs) than vitamin K antagonists (VKAs) in atrial fibrillation (AF) patients and to estimate the difference in therapy persistence depending on NOAC dosing regimen (once daily (QD) vs. twice daily (BID)). Methods: Consecutive patients were followed for 1 year in phase III of the GLORIA-AF registry. Drug persistence was defined as the use of OAC without any discontinuation in >30 days or switching to alternative therapy. Results: Among 21,109 eligible patients in phase III, 17,266 patients who were prescribed OAC at baseline and those who took ≥1 OAC dose were included. The 1-year proportion of patients receiving NOAC and VKA who persisted on treatment was 80% and 75%, respectively. The 1-year persistence with NOACs BID and NOACs QD was 81% and 80%, respectively. Female gender, hypertension, older age, alcohol use, permanent, asymptomatic, and minimally symptomatic AF were associated with better OAC persistence. Region, medication usage predisposing to bleeding, being a current smoker, treatment reimbursement, and proton pump inhibitors were associated with lower OAC persistence. Conclusions: Drug persistence was higher with NOACs (1-year persistence was 80%) than with VKAs (75%). There was little difference in 1-year persistence between NOAC dosing regimens.

وصف الملف: application/pdf

العلاقة: https://portal.findresearcher.sdu.dk/da/publications/f24d4c36-3978-41db-9785-345190842f49Test

الإتاحة: https://doi.org/10.3390/jcm9061969Test
https://portal.findresearcher.sdu.dk/da/publications/f24d4c36-3978-41db-9785-345190842f49Test
https://findresearcher.sdu.dk/ws/files/170700103/jcm_09_01969.pdfTest

المؤلفون: Paquette, Miney, França, Lionel Riou, Teutsch, Christine, Diener, Hans-Christoph, Lu, Shihai, Dubner, Sergio J, Ma, Chang Sheng, Rothman, Kenneth J, Zint, Kristina, Halperin, Jonathan L, Olshansky, Brian, Huisman, Menno V, Lip, Gregory Y H, Nieuwlaat, Robby

المصدر: Paquette , M , França , L R , Teutsch , C , Diener , H-C , Lu , S , Dubner , S J , Ma , C S , Rothman , K J , Zint , K , Halperin , J L , Olshansky , B , Huisman , M V , Lip , G Y H & Nieuwlaat , R 2020 , ' Dabigatran Persistence and Outcomes Following Discontinuation in Atrial Fibrillation Patients from the GLORIA-AF Registry ' , The American Journal of Cardiology , vol. 125 , no. 3 , pp. 383-391 . https://doi.org/10.1016/j.amjcard.2019.10.047Test

الوصف: Prospective studies evaluating persistence to nonvitamin K antagonist oral anticoagulants in patients with atrial fibrillation are needed to improve our understanding of drug discontinuation. The study objective was to evaluate if and when patients with newly diagnosed atrial fibrillation stop dabigatran treatment and to report outcomes following discontinuation. Patients prescribed dabigatran in diverse clinical practice settings were consecutively enrolled and followed for 2 years. Dabigatran persistence over time, reasons for discontinuation, and outcomes post discontinuation were assessed. Of 4,859 patients, aged 70.2 ± 10.4 years, 55.7% were male. Overall 2-year dabigatran persistence was 70.9% (95% confidence interval [CI] 69.6 to 72.2). Persistence probability was lower in the first 6-month period (83.7% [82.7 to 84.8]) than in subsequent periods for patients on dabigatran at the start of each period (6 to 12 months, 92.5% [91.6 to 93.3]; 12 to 18 months, 95.1% [94.3 to 95.8]; 18 to 24 months, 96.3% [95.6 to 96.9]). Of 1,305 patients (26.9%) who discontinued dabigatran, adverse events were reported as the reason for discontinuation in 457 (35.0%). Standardized stroke incidence rate post discontinuation (per 100 patient-years) in patients discontinuing without switching to another oral anticoagulant was 1.76 (95% CI 0.89 to 2.76) and 1.02 (95% CI 0.43 to 1.76) in those who switched, consistent with the expected benefit of remaining on treatment. Patients persistent with treatment at 1 year had >90% probability of remaining persistent at 2 years suggesting clinical interventions to improve persistence should be focused on the early period following treatment initiation.

وصف الملف: application/pdf

العلاقة: https://vbn.aau.dk/da/publications/3e5f40da-3111-4795-b65e-ecd0d457f97aTest

الإتاحة: https://doi.org/10.1016/j.amjcard.2019.10.047Test
https://vbn.aau.dk/da/publications/3e5f40da-3111-4795-b65e-ecd0d457f97aTest
https://vbn.aau.dk/ws/files/320784540/Open_Access_Article.pdfTest
http://www.scopus.com/inward/record.url?scp=85075839456&partnerID=8YFLogxKTest

المؤلفون: Dubner, Sergio J., Teutsch, Christine, Huisman, Menno V., Diener, Hans Christoph, Halperin, Jonathan, Rothman, Kenneth J., Ma, Chang Sheng, Chuquiure-Valenzuela, Eduardo, Bergler-Klein, Jutta, Zint, Kristina, Riou França, Lionel, Lu, Shihai, Paquette, Miney, Lip, Gregory Y.H.

المصدر: Dubner , S J , Teutsch , C , Huisman , M V , Diener , H C , Halperin , J , Rothman , K J , Ma , C S , Chuquiure-Valenzuela , E , Bergler-Klein , J , Zint , K , Riou França , L , Lu , S , Paquette , M & Lip , G Y H 2020 , ' Characteristics and 2-year outcomes of dabigatran treatment in patients with heart failure and atrial fibrillation : GLORIA-AF ' , ESC Heart Failure , vol. 7 , no. 5 , pp. 2679-2689 . https://doi.org/10.1002/ehf2.12857Test

مصطلحات موضوعية: Anticoagulation, Atrial fibrillation, Dabigatran, Heart failure, Major bleed, Stroke

الوصف: Aims: This study aimed to describe baseline characteristics of patients with atrial fibrillation (AF) at risk of stroke with and without history of heart failure (HF) and report 2-year outcomes in the dabigatran-treated subset of a prospective, global, observational study (GLORIA-AF). Methods and results: Newly diagnosed patients with AF and CHA 2 DS 2 -VASc score ≥ 1 were consecutively enrolled. Baseline characteristics were assessed by the presence or absence of HF diagnosis at enrolment. Incidence rates for outcomes in dabigatran-treated patients were estimated with and without standardization by stroke (excluding HF component) and bleeding risk scores. A total of 15 308 eligible patients were enrolled, including 15 154 with known HF status; of these, 3679 (24.0%) had been diagnosed with HF, 11 475 (75.0%) had not. Among 4873 dabigatran-treated patients, 1169 (24.0%) had HF, and 3658 (75.1%) did not; the risk of stroke was high (CHA 2 DS 2 -VASc score ≥ 2) for 94.3% of patients with HF and 85.8% without, while 6.0% and 7.0%, respectively, had a high bleeding risk (HAS-BLED ≥ 3). Incidence rates of all-cause death in dabigatran-treated patients with and without HF, standardized for CHA 2 DS 2 -VASc and HAS-BLED scores, were 4.76 vs. 1.80 per 100 patient years (py), with roughly comparable rates of stroke (0.82 vs. 0.60 per 100 py) and major bleeding (1.20 vs. 0.92 per 100 py). Conclusions: Patients with AF and history of HF may have greater disease burden at AF diagnosis and increased mortality rates vs. patients without HF. Stroke and major bleeding rates were roughly comparable between groups confirming the long-term safety and effectiveness of dabigatran in patients with HF.

وصف الملف: application/pdf

العلاقة: https://vbn.aau.dk/da/publications/28293eb7-57e6-455f-8f95-4a5873542bdfTest

الإتاحة: https://doi.org/10.1002/ehf2.12857Test
https://vbn.aau.dk/da/publications/28293eb7-57e6-455f-8f95-4a5873542bdfTest
https://vbn.aau.dk/ws/files/391799145/ehf2.12857.pdfTest
http://www.scopus.com/inward/record.url?scp=85087313480&partnerID=8YFLogxKTest

المؤلفون: Ageno, Walter, Casella, Ivan B., Chee, Kok Han, Schellong, Sebastian, Schulman, Sam, Singer, Daniel E., Desch, Marc, Tang, Wenbo, Voccia, Isabelle, Zint, Kristina, Goldhaber, Samuel Z.

المساهمون: Boehringer Ingelheim, Università degli Studi dell'Insubria

المصدر: Journal of Thrombosis and Thrombolysis ; volume 51, issue 3, page 561-570 ; ISSN 0929-5305 1573-742X

مصطلحات موضوعية: Cardiology and Cardiovascular Medicine, Hematology

الوصف: In randomized clinical trials (RCTs) of nonvitamin K antagonist oral anticoagulants (NOACs) for acute venous thromboembolism (VTE), ~ 12–13% of patients were elderly and ~ 26% had mild-to-moderate renal impairment. Observational studies are not restricted by the selection and treatment criteria of RCTs. In this ancillary analysis of the RE-COVERY DVT/PE global observational study, we aimed to describe patient characteristics, comorbidities, and anticoagulant therapy for subgroups of age (< or ≥ 75 years) and renal impairment (creatinine clearance [CrCl; estimated with Cockcroft–Gault formula] < 30 [severe], 30 to < 50 [moderate], 50 to < 80 [mild], ≥ 80 [normal] mL/min). Of 6095 eligible patients, 25.3% were aged ≥ 75 years; 38.2% (1605/4203 with CrCl values) had mild-to-moderate renal impairment. Comorbidities were more common in older patients (73.9% aged ≥ 75 vs. 58.1% < 75 years) and in those with mild or moderate versus no renal impairment (75.9%, 80.9%, and 59.3%, respectively). At hospital discharge or 14 days after diagnosis (whichever was later), most patients (53.7% and 55.1%, respectively) in both age groups received NOACs; 20.8% and 23.4%, respectively, received vitamin K antagonists, 19.0% and 21.8% parenteral therapy, 2.3% and 3.8% other anticoagulant treatments. Use of NOACs decreased with worsening renal impairment (none 58.5%, moderate 49.6%, severe 25.7%) and, in younger versus older patients with moderate renal impairment (33.1% vs. 56.1%). In routine practice, there are more elderly and renally impaired patients with VTE than represented in RCTs. Decreasing renal function, but not older age, was associated with less NOAC use. Clinical Trial Registration: http://www.clinicaltrials.govTest . Unique identifier: NCT02596230. Graphic abstract Decreasing renal function, particularly in the subgroup with CrCl < 30 mL/min, but not older age, was associated with less use of nonvitamin K antagonist oral anticoagulants (NOACs). Nevertheless, more than half of the older patients ...

الإتاحة: https://doi.org/10.1007/s11239-020-02239-9Test

المؤلفون: Schneeweiss, Sebastian, Gopalakrishnan, Chandrasekar, Bartels, Dorothee B., Franklin, Jessica M., Zint, Kristina, Kulldorff, Martin, Huybrechts, Krista F.

المصدر: Circulation: Cardiovascular Quality and Outcomes ; volume 12, issue 2 ; ISSN 1941-7713 1941-7705

الوصف: Background: The increasing availability of electronic healthcare data enables ongoing monitoring of the effectiveness and safety of newly marketed medications. We sought to demonstrate a 5-year prospective monitoring system of dabigatran for stroke prevention that may expedite discovery and allow ongoing evidence development. Methods and Results: Between 2011 and 2015, we conducted 9 sequential analyses of dabigatran versus warfarin users in a sequential cohort design in 2 US claims databases. Analyses 4 through 9 were prespecified, and analyses 1 through 3 were added subsequently using the same methodology. New users of anticoagulants with nonvalvular atrial fibrillation were followed until a study outcome of hospitalization for stroke (hemorrhagic and ischemic) or hospitalization for major hemorrhage (intracranial and extracranial). Hazard ratios and 95% CIs were estimated after 1:1 propensity score matching. Sequential analyses 1 through 3 on stroke prevention using data through June 2012 were limited by few events leading to wide CIs. As data accumulated the effect estimate in analysis 4 visually stabilized at a 25% risk reduction with increasingly narrower CIs (−46% to +9% in December 2012 and −42% to −2% in September 2015). Improved data-adaptive confounding adjustment with high-dimensional propensity score reached a stable state already at analysis 3 and was slightly closer to the randomized clinical trial finding (−39%). The risk of major hemorrhage was 28% lower in dabigatran initiators (−35% to −20%) a finding that was stable throughout analyses 2 to 9. Conclusions: Prospectively monitoring the effectiveness and safety of dabigatran for stroke prevention allowed for early insights with increasing precision over time.

الإتاحة: https://doi.org/10.1161/circoutcomes.118.005173Test