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Article ; Online: Initiating Mineralocorticoid Antagonists for Longstanding Heart Failure With Reduced Ejection Fraction: Better Late Than Never?

Sauer, Andrew J / Hsia, Judith

Journal of the American College of Cardiology

2023 Volume 82, Issue 11, Page(s) 1092–1095

MeSH term(s)	Humans ; Mineralocorticoid Receptor Antagonists/pharmacology ; Mineralocorticoid Receptor Antagonists/therapeutic use ; Heart Failure/drug therapy
Chemical Substances	Mineralocorticoid Receptor Antagonists
Language	English
Publishing date	2023-08-29
Publishing country	United States
Document type	Editorial ; Comment
ZDB-ID	605507-2
ISSN	1558-3597 ; 0735-1097
ISSN (online)	1558-3597
ISSN	0735-1097
DOI	10.1016/j.jacc.2023.06.022
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Zs.A 1846: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 196: Show issues

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Article ; Online: Sex differences in guideline-directed medical therapy in 2021-22 among patients with peripheral artery disease.

Canonico, Mario Enrico / Hsia, Judith / Hess, Connie N / Bonaca, Marc P

Vascular medicine (London, England)

2023 Volume 28, Issue 3, Page(s) 233–235

MeSH term(s)	Humans ; Male ; Female ; Sex Characteristics ; Peripheral Arterial Disease/diagnosis ; Peripheral Arterial Disease/drug therapy ; Risk Factors
Language	English
Publishing date	2023-02-27
Publishing country	England
Document type	Letter
ZDB-ID	1311628-9
ISSN	1477-0377 ; 1358-863X
ISSN (online)	1477-0377
ISSN	1358-863X
DOI	10.1177/1358863X231155308
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Article ; Online: Medical Therapy for Secondary Prevention of Atherothrombotic Events in Peripheral Artery Disease.

Morrison, Justin T / Hsia, Judith / Bonaca, Marc P

Heart international

2021 Volume 15, Issue 1, Page(s) 14–19

Abstract: Patients with peripheral artery disease (PAD) are at risk for severe morbidity and mortality, including ischaemic-related events. Furthermore, there is heterogeneity within the PAD population, where the drivers of risk for cardiovascular and limb- ... ...

Abstract	Patients with peripheral artery disease (PAD) are at risk for severe morbidity and mortality, including ischaemic-related events. Furthermore, there is heterogeneity within the PAD population, where the drivers of risk for cardiovascular and limb-specific ischaemic events differ. Patients with PAD with concomitant coronary artery disease are at increased risk for cardiovascular ischaemic events, whereas patients with PAD with a prior history of lower-extremity revascularization are at increased risk for limb-specific ischaemic events. The current therapeutic challenge is identifying these risk factors to tailor therapy optimally for each patient. Additionally, the majority of our current medical therapeutics in patients with PAD have been shown to reduce atherothrombotic events, such as myocardial infarction, stroke and cardiovascular death, with a paucity of medical therapeutics specifically targeting a reduction in limb-specific ischaemic events. Over the past several years, there have been several contemporary clinical trials evaluating antithrombotic agents and their efficacy in reducing limb-specific ischaemic events. Specifically, rivaroxaban, with the addition of aspirin, has emerged as an efficacious therapeutic. In this article, we provide a review of the current clinical burden of PAD, the rationale behind current PAD medical therapeutics and the contemporary trials that have described the benefit of a novel therapeutic in PAD, rivaroxaban.
Language	English
Publishing date	2021-07-21
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2514156-9
ISSN	2036-2579 ; 2036-2579
ISSN (online)	2036-2579
ISSN	2036-2579
DOI	10.17925/HI.2021.15.1.14
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Article ; Online: Uptake of Newer Guideline-Directed Therapies in Heart Failure Patients With Diabetes or Chronic Kidney Disease.

Canonico, Mario Enrico / Hsia, Judith / Cannon, Christopher P / Bonaca, Marc P

JACC. Heart failure

2022 Volume 10, Issue 12, Page(s) 989–991

MeSH term(s)	Humans ; Heart Failure/complications ; Heart Failure/therapy ; Diabetes Mellitus ; Renal Insufficiency, Chronic/complications ; Renal Insufficiency, Chronic/therapy
Language	English
Publishing date	2022-11-09
Publishing country	United States
Document type	Letter
ZDB-ID	2705621-1
ISSN	2213-1787 ; 2213-1779
ISSN (online)	2213-1787
ISSN	2213-1779
DOI	10.1016/j.jchf.2022.09.013
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Article ; Online: Antithrombotic Prophylaxis with Rivaroxaban in Patients with Prehospital COVID-19: A Meta-analysis of Two Placebo-Controlled Trials.

Hsia, Judith / Spyropoulos, Alex C / Piazza, Gregory / Weng, Stephen / Dunne, Michael W / Lipardi, Concetta / Barnathan, Elliot S / Bonaca, Marc P

Thrombosis and haemostasis

2023

Abstract: Background: We conducted a prespecified meta-analysis of two randomized, placebo-controlled trials of rivaroxaban 10 mg daily in prehospital patients with acute coronavirus disease 2019 (COVID-19). Individually, the trials had limited power to detect a ...

Abstract	Background: We conducted a prespecified meta-analysis of two randomized, placebo-controlled trials of rivaroxaban 10 mg daily in prehospital patients with acute coronavirus disease 2019 (COVID-19). Individually, the trials had limited power to detect a treatment effect due to recruitment stopping ahead of plan. Material and methods: The statistical analysis plan for the meta-analysis was finalized before unblinding of PREVENT-HD, the larger of the two trials. Pooled risk ratios and pooled risk differences along with the two-sided 95% confidence intervals were calculated using random-effect models. Results: Rivaroxaban did not reduce the occurrence of either the primary prespecified endpoint, a composite of symptomatic arterial and venous thromboembolism, myocardial infarction, ischemic stroke, acute limb ischemia, all-cause hospitalization, and all-cause mortality (risk difference: 0.0044; 95% confidence interval: -0.0263, 0.0175; Conclusion: Although this meta-analysis does not support antithrombotic prophylaxis with rivaroxaban in a broad prehospital population with acute COVID-19, the prevention of arterial and venous thrombotic events among rivaroxaban-allocated patients is consistent with the known thromboprophylactic effect of the drug in medically ill patients.
Language	English
Publishing date	2023-12-21
Publishing country	Germany
Document type	Journal Article
ZDB-ID	518294-3
ISSN	2567-689X ; 0340-6245
ISSN (online)	2567-689X
ISSN	0340-6245
DOI	10.1055/a-2216-5848
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Article ; Online: PRO: Should aspirin be used in all women older than 65 years to prevent stroke?

Hsia, Judith

Preventive cardiology

2007 Volume 10 Suppl 4, Page(s) 6–11

Abstract: A number of studies have reported that aspirin is beneficial in the prevention of cardiovascular disease. A meta-analysis of data from 3 studies of the cardioprotective effect of aspirin in women has reported that use of aspirin reduces the risk of ... ...

Abstract	A number of studies have reported that aspirin is beneficial in the prevention of cardiovascular disease. A meta-analysis of data from 3 studies of the cardioprotective effect of aspirin in women has reported that use of aspirin reduces the risk of coronary events mainly by reducing the risk of ischemic stroke. Results of the Women's Health Study showed that although there is a risk of bleeding events with aspirin use, overall this risk is outweighed by the number of strokes prevented.
MeSH term(s)	Age Factors ; Aged ; Aspirin/adverse effects ; Aspirin/therapeutic use ; Cardiovascular Diseases/epidemiology ; Cardiovascular Diseases/prevention & control ; Cost of Illness ; Evidence-Based Practice ; Female ; Hemorrhage/chemically induced ; Humans ; Incidence ; Patient Selection ; Platelet Aggregation Inhibitors/adverse effects ; Platelet Aggregation Inhibitors/therapeutic use ; Primary Prevention ; Randomized Controlled Trials as Topic ; Recurrence ; Risk Factors ; Risk Reduction Behavior ; Secondary Prevention ; Stroke/epidemiology ; Stroke/prevention & control ; Treatment Outcome ; Women's Health
Chemical Substances	Platelet Aggregation Inhibitors ; Aspirin (R16CO5Y76E)
Language	English
Publishing date	2007-07-27
Publishing country	United States
Document type	Journal Article ; Meta-Analysis
ZDB-ID	2008427-4
ISSN	1751-7141 ; 1520-037X
ISSN (online)	1751-7141
ISSN	1520-037X
DOI	10.1111/j.1520-037x.2007.07267.x
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Zs.A 5173: Show issues

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Article ; Online: Randomized, Controlled Trial of a Digital Behavioral Therapeutic Application to Improve Glycemic Control in Adults With Type 2 Diabetes.

Hsia, Judith / Guthrie, Nicole L / Lupinacci, Paul / Gubbi, Ananda / Denham, Douglas / Berman, Mark A / Bonaca, Marc P

Diabetes care

2022 Volume 45, Issue 12, Page(s) 2976–2981

Abstract: Objective: To evaluate the efficacy and safety of a digital therapeutic application (app) delivering cognitive behavioral therapy (CBT) designed to improve glycemic control in patients with type 2 diabetes.: Research design and methods: Adults with ... ...

Abstract	Objective: To evaluate the efficacy and safety of a digital therapeutic application (app) delivering cognitive behavioral therapy (CBT) designed to improve glycemic control in patients with type 2 diabetes. Research design and methods: Adults with type 2 diabetes and an HbA1c of 7 to <11% were randomly assigned to receive access to a digital therapeutic app delivering CBT (BT-001) or a control app, both on top of standard of care management. CBT is an established form of psychological treatment that endeavors to identify and change unhelpful thinking patterns. The primary study end point was treatment group difference in mean HbA1c change from baseline to 90 days. Results: Among 669 randomly assigned subjects who completed app onboarding, the mean age was 58 years, BMI 35 kg/m2, 54% were female, 28% Black, and 16% Latino. Baseline HbA1c was 8.2 and 8.1% in the BT-001 and control groups, respectively. After 90 days of app access, change in HbA1c was -0.28% (95% CI -0.41, -0.15) in the BT-001 group and +0.11% (95% CI -0.02, 0.23) in the control group (treatment group difference 0.39%; P < 0.0001). HbA1c reduction paralleled exposure to the therapeutic intervention, assessed as the number of modules completed on the app (P for trend <0.0001). No adverse events in either group were attributed to app use and no adverse device effects reported. Conclusions: Patients randomly assigned to the BT-001 arm relative to the control arm had significantly lower HbA1c at 90 days. The digital therapeutic may provide a scalable treatment option for patients with type 2 diabetes.
MeSH term(s)	Adult ; Humans ; Female ; Middle Aged ; Male ; Diabetes Mellitus, Type 2/drug therapy ; Glycated Hemoglobin/analysis ; Glycemic Control ; Treatment Outcome ; Cognitive Behavioral Therapy
Chemical Substances	Glycated Hemoglobin A
Language	English
Publishing date	2022-09-30
Publishing country	United States
Document type	Randomized Controlled Trial ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	441231-x
ISSN	1935-5548 ; 0149-5992
ISSN (online)	1935-5548
ISSN	0149-5992
DOI	10.2337/dc22-1099
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Zs.A 1434: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 365: Show issues

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Article ; Online: Low-Dose Rivaroxaban Plus Aspirin in Patients With Peripheral Artery Disease Undergoing Lower Extremity Revascularization With and Without Concomitant Coronary Artery Disease: Insights From VOYAGER PAD.

Morrison, Justin T / Canonico, Mario Enrico / Anand, Sonia S / Patel, Manesh R / Debus, Eike Sebastian / Nehler, Mark R / Hess, Connie N / Hsia, Judith / Capell, Warren H / Muehlhofer, Eva / Haskell, Lloyd P / Berkowitz, Scott D / Bauersachs, Rupert M / Bonaca, Marc P

Circulation

2024 Volume 149, Issue 19, Page(s) 1536–1539

MeSH term(s)	Humans ; Peripheral Arterial Disease/drug therapy ; Peripheral Arterial Disease/surgery ; Rivaroxaban/therapeutic use ; Rivaroxaban/administration & dosage ; Aspirin/therapeutic use ; Aspirin/administration & dosage ; Coronary Artery Disease/drug therapy ; Coronary Artery Disease/surgery ; Lower Extremity/blood supply ; Male ; Factor Xa Inhibitors/therapeutic use ; Factor Xa Inhibitors/administration & dosage ; Platelet Aggregation Inhibitors/therapeutic use ; Platelet Aggregation Inhibitors/administration & dosage ; Female ; Aged ; Drug Therapy, Combination ; Middle Aged ; Treatment Outcome
Chemical Substances	Rivaroxaban (9NDF7JZ4M3) ; Aspirin (R16CO5Y76E) ; Factor Xa Inhibitors ; Platelet Aggregation Inhibitors
Language	English
Publishing date	2024-05-06
Publishing country	United States
Document type	Letter ; Research Support, Non-U.S. Gov't
ZDB-ID	80099-5
ISSN	1524-4539 ; 0009-7322 ; 0069-4193 ; 0065-8499
ISSN (online)	1524-4539
ISSN	0009-7322 ; 0069-4193 ; 0065-8499
DOI	10.1161/CIRCULATIONAHA.124.068080
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Article: Assessing drug risks and benefits: lessons from postmenopausal hormone therapy studies.

Hsia, Judith

Clinical breast cancer

2006 Volume 6 Suppl 2, Page(s) S65–70

Abstract: The issue of safety standards for new drugs remains unsettled. Limitations of biomarker or observational studies for assessing global safety and efficacy of postmenopausal hormone therapy are highlighted by contrast with randomized clinical trial results. ...

Abstract	The issue of safety standards for new drugs remains unsettled. Limitations of biomarker or observational studies for assessing global safety and efficacy of postmenopausal hormone therapy are highlighted by contrast with randomized clinical trial results. On the other hand, requiring large-scale, long-term outcome trials for every new drug might not be practical. Randomized trials with intermediate outcomes such as coronary angiography, coronary or carotid ultrasound, or coronary calcification present attractive alternatives. Trials with intermediate outcomes can be conducted with much smaller sample sizes and shorter duration, but the adequacy of these types of trials for assessment of safety and efficacy remains a topic of ongoing discussion in the scientific and regulatory communities.
MeSH term(s)	Aged ; Breast Neoplasms/etiology ; Drug Approval ; Hormone Replacement Therapy/adverse effects ; Humans ; Middle Aged ; Postmenopause ; Randomized Controlled Trials as Topic ; Risk Assessment ; Sample Size
Language	English
Publishing date	2006-03-28
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2106734-X
ISSN	1938-0666 ; 1526-8209
ISSN (online)	1938-0666
ISSN	1526-8209
DOI	10.3816/cbc.2006.s.006
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Article: Antithrombotic Prophylaxis with Rivaroxaban in Patients with Prehospital COVID-19: A Meta-analysis of Two Placebo-Controlled Trials

Hsia, Judith / Spyropoulos, Alex C. / Piazza, Gregory / Weng, Stephen / Dunne, Michael W. / Lipardi, Concetta / Barnathan, Elliot S. / Bonaca, Marc P.

Thrombosis and Haemostasis

2023

Abstract	Background: We conducted a prespecified meta-analysis of two randomized, placebo-controlled trials of rivaroxaban 10 mg daily in prehospital patients with acute coronavirus disease 2019 (COVID-19). Individually, the trials had limited power to detect a treatment effect due to recruitment stopping ahead of plan. Material and Methods: The statistical analysis plan for the meta-analysis was finalized before unblinding of PREVENT-HD, the larger of the two trials. Pooled risk ratios and pooled risk differences along with the two-sided 95% confidence intervals were calculated using random-effect models. Results: Rivaroxaban did not reduce the occurrence of either the primary prespecified endpoint, a composite of symptomatic arterial and venous thromboembolism, myocardial infarction, ischemic stroke, acute limb ischemia, all-cause hospitalization, and all-cause mortality (risk difference: 0.0044; 95% confidence interval: −0.0263, 0.0175; p = 0.69 for pooled risk difference) or the secondary endpoint of all-cause hospitalization ( p = 0.76). Although thrombotic events were infrequent, pooled analysis did reveal that rivaroxaban reduced arterial and venous thrombotic events (placebo 6 events, rivaroxaban 0 events; pooled risk difference: −0.0068; 95% confidence interval: −0.0132, −0.0006; p = 0.03). In the pooled studies, only one major bleeding event was observed in a rivaroxaban-allocated patient with no critical site or fatal bleeding events. Conclusion: Although this meta-analysis does not support antithrombotic prophylaxis with rivaroxaban in a broad prehospital population with acute COVID-19, the prevention of arterial and venous thrombotic events among rivaroxaban-allocated patients is consistent with the known thromboprophylactic effect of the drug in medically ill patients.
Keywords	COVID-19 ; clinical trial ; direct thrombin agent ; meta-analysis
Language	English
Publishing date	2023-11-23
Publisher	Georg Thieme Verlag KG
Publishing place	Stuttgart ; New York
Document type	Article
ZDB-ID	518294-3
ISSN	2567-689X ; 0340-6245
ISSN (online)	2567-689X
ISSN	0340-6245
DOI	10.1055/a-2216-5848
Database	Thieme publisher's database

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