Yared Gurmu

Pegzilarginase for treatment of hyperargininemia in arginase 1 deficiency: FDA approval summary

Jennifer Evelyn Shields, Yared Gurmu

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Novel Clinical Trial Design With Stratum‐Specific Endpoints and Global Test Methods for Rare Diseases With Heterogeneous Clinical Manifestations

Emily R. Shives, Yared Gurmu, Wonyul Lee, Yan Wang

Many rare disease clinical trials are underpowered to detect a moderate treatment effect of an investigational product due to the limited number of participants available for the trials. In addition, given the complex, multisystemic nature of many rare diseases, it is challenging …

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Long‐Term Ticagrelor in Patients With Prior Coronary Stenting in the PEGASUS‐TIMI 54 Trial

Brian A. Bergmark, Deepak L. Bhatt, Philippe Gabríel Steg, Andrzej Budaj et autres

Background Coronary stent type and risk of stent thrombosis remain important factors affecting recommended duration of dual antiplatelet therapy. We investigated the efficacy and safety of long‐term ticagrelor in patients with prior coronary stenting enrolled in the PEGASUS‐TIMI 54 (Prevention of Cardiovascular …

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Efficacy and Safety of Sacubitril/Valsartan in High-Risk Patients in the PIONEER-HF Trial

David D. Berg, Marc D. Samsky, Eric J. Velazquez, Carol I. Duffy et autres

Background: In patients stabilized during hospitalization for acute decompensated heart failure (HF), initiation of sacubitril/valsartan compared with enalapril decreased the risk of cardiovascular death or rehospitalization for HF without increasing the risk of adverse events. It is unknown whether potentially high-risk subpopulations …

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Genetic Risk Score to Identify Risk of Venous Thromboembolism in Patients With Cardiometabolic Disease

Nicholas Marston, Giorgio E. M. Melloni, Yared Gurmu, Marc P. Bonaca et autres

Background: Venous thromboembolism (VTE) is a major cause of cardiovascular morbidity and mortality and has a known genetic contribution. We tested the performance of a genetic risk score for its ability to predict VTE in 3 cohorts of patients with cardiometabolic disease. …

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Clinical Application of a Novel Genetic Risk Score for Ischemic Stroke in Patients With Cardiometabolic Disease

Nicholas Marston, Parth N. Patel, Frederick Kamanu, Francesco Nordio et autres

Background: Genome-wide association studies have identified single-nucleotide polymorphisms that are associated with an increased risk of stroke. We sought to determine whether a genetic risk score (GRS) could identify subjects at higher risk for ischemic stroke after accounting for traditional clinical risk …

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Efficacy and Safety of Sacubitril/Valsartan by Dose Level Achieved in the PIONEER-HF Trial

David D. Berg, Eugene Braunwald, Adam D. DeVore, Anuradha Lala et autres

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Caffeinated Beverage Intake, Dyspnea With Ticagrelor, and Cardiovascular Outcomes: Insights From the PEGASUS‐TIMI 54 Trial

Remo H.M. Furtado, Ramkumar V. Venkateswaran, José Carlos Nicolau, Yared Gurmu et autres

Background A proposed cause of dyspnea induced by ticagrelor is an increase in adenosine blood levels. Because caffeine is an adenosine antagonist, it can potentially improve drug tolerability with regard to dyspnea. Furthermore, association between caffeine and cardiovascular events is of clinical …

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Gut Microbiota‐Dependent Trimethylamine N‐oxide and Cardiovascular Outcomes in Patients With Prior Myocardial Infarction: A Nested Case Control Study From the PEGASUS‐TIMI 54 Trial

Bariş Gencer, Xinmin S. Li, Yared Gurmu, Marc P. Bonaca et autres

Background Trimethylamine N‐oxide ( TMAO ) may have prothrombotic properties. We examined the association of TMAO quartiles with major adverse cardiovascular events ( MACE ) and the effect of TMAO on the efficacy of ticagrelor. Methods and Results PEGASUS ‐ TIMI 54 …

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The Effect of PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) Inhibition on the Risk of Venous Thromboembolism

Nicholas Marston, Yared Gurmu, Giorgio E. M. Melloni, Marc P. Bonaca et autres

Background: The relationship between cholesterol levels and risk of venous thromboembolism (VTE) is uncertain. We set out to determine the effect of PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibition on the risk of VTE, explore potential mechanisms, and examine the efficacy in …

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PERFORMANCE OF A NOVEL GENETIC RISK SCORE TO IDENTIFY RISK OF VENOUS THROMBOEMBOLISM IN PATIENTS WITH CARDIOMETABOLIC DISEASE

Nicholas Marston, Giorgio E. M. Melloni, Yared Gurmu, Christina Lee et autres

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Abstract 13838: Efficacy and Safety of Sacubitril/Valsartan in Acute Decompensated Heart Failure in High-Risk Patients in the PIONEER-HF Trial

David D. Berg, Eric J. Velazquez, Carol I. Duffy, Yared Gurmu et autres

Introduction: In pts stabilized during hospitalization (hosp) for acute decompensated heart failure (ADHF), initiation of sacubitril/valsartan (sac/val) compared with enalapril (enal) decreases the...