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Article ; Online: Dapagliflozin in Black and White Patients With Heart Failure Across the Ejection Fraction Spectrum.

Butt, Jawad H / Docherty, Kieran F / Claggett, Brian L / Desai, Akshay S / Fang, James C / Petersson, Magnus / Langkilde, Anna Maria / de Boer, Rudolf A / Cabrera Honorio, Jose Walter / Hernandez, Adrian F / Inzucchi, Silvio E / Kosiborod, Mikhail N / Køber, Lars / Lam, Carolyn S P / Martinez, Felipe A / Ponikowski, Piotr / Sabatine, Marc S / Vardeny, Orly / O'Meara, Eileen /

Saraiva, Jose F K / Shah, Sanjiv J / Vaduganathan, Muthiah / Jhund, Pardeep S / Solomon, Scott D / McMurray, John J V

JACC. Heart failure

2023 Volume 11, Issue 4, Page(s) 375–388

Abstract: Background: Black people have a higher incidence and prevalence of heart failure (HF) than White people, and once HF has developed, they may have worse outcomes. There is also evidence that the response to several pharmacologic therapies may differ ... ...

Abstract	Background: Black people have a higher incidence and prevalence of heart failure (HF) than White people, and once HF has developed, they may have worse outcomes. There is also evidence that the response to several pharmacologic therapies may differ between Black and White patients. Objectives: The authors sought to examine the outcomes and response to treatment with dapagliflozin according to Black or White race in a pooled analysis of 2 trials comparing dapagliflozin to placebo in patients with heart failure with reduced ejection fraction (DAPA-HF [Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure]) and heart failure with mildly reduced ejection fraction/heart failure with preserved ejection fraction (DELIVER [Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure]). Methods: Because most self-identified Black patients were enrolled in the Americas, the comparator group was White patients randomized in the same regions. The primary outcome was the composite of worsening HF or cardiovascular death. Results: Of the 3,526 patients randomized in the Americas, 2,626 (74.5%) identified as White and 381 (10.8%) as Black. The primary outcome occurred at a rate of 16.8 (95% CI: 13.8-20.4) in Black patients compared with 11.6 (95% CI: 10.6-12.7) per 100 person-years in White patients (adjusted HR: 1.27; 95% CI: 1.01-1.59). Compared with placebo, dapagliflozin decreased the risk of the primary endpoint to the same extent in Black (HR: 0.69; 95% CI: 0.47-1.02) and White patients (HR: 0.73 [95% CI: 0.61-0.88]; P Conclusions: The relative benefits of dapagliflozin were consistent in Black and White patients across the range of left ventricular ejection fraction, with greater absolute benefits in Black patients. (Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure [DAPA-HF]; NCT03036124; Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure [DELIVER]; NCT03619213).
MeSH term(s)	Humans ; Black People ; Heart Failure/drug therapy ; Stroke Volume ; Ventricular Function, Left ; White People ; Sodium-Glucose Transporter 2 Inhibitors/therapeutic use
Chemical Substances	dapagliflozin (1ULL0QJ8UC) ; Sodium-Glucose Transporter 2 Inhibitors
Language	English
Publishing date	2023-02-01
Publishing country	United States
Document type	Randomized Controlled Trial ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2705621-1
ISSN	2213-1787 ; 2213-1779
ISSN (online)	2213-1787
ISSN	2213-1779
DOI	10.1016/j.jchf.2022.11.014
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Article ; Online: Sacubitril-valsartan as a treatment for apparent resistant hypertension in patients with heart failure and preserved ejection fraction.

European heart journal

2021 Volume 42, Issue 36, Page(s) 3741–3752

Abstract: Aims: Patients with heart failure and preserved ejection fraction (HFpEF) frequently have difficult-to-control hypertension. We examined the effect of neprilysin inhibition on 'apparent resistant hypertension' in patients with HFpEF in the PARAGON-HF ... ...

Abstract	Aims: Patients with heart failure and preserved ejection fraction (HFpEF) frequently have difficult-to-control hypertension. We examined the effect of neprilysin inhibition on 'apparent resistant hypertension' in patients with HFpEF in the PARAGON-HF trial, which compared the effect of sacubitril-valsartan with valsartan. Methods and results: In this post hoc analysis, patients were categorized according to systolic blood pressure at the end of the valsartan run-in (n = 4795). 'Apparent resistant hypertension' was defined as systolic blood pressure ≥140 mmHg (≥135 mmHg if diabetes) despite treatment with valsartan, a calcium channel blocker, and a diuretic. 'Apparent mineralocorticoid receptor antagonist (MRA)-resistant' hypertension was defined as systolic blood pressure ≥140 mmHg (≥135 mmHg if diabetes) despite the above treatments and an MRA. The primary outcome in the PARAGON-HF trial was a composite of total hospitalizations for heart failure and death from cardiovascular causes. We examined clinical endpoints and the safety of sacubitril-valsartan according to the hypertension category. We also examined reductions in blood pressure from the end of valsartan run-in to Weeks 4 and 16 after randomization. Overall, 731 patients (15.2%) had apparent resistant hypertension and 135 (2.8%) had apparent MRA-resistant hypertension. The rate of the primary outcome was higher in patients with apparent resistant hypertension [17.3; 95% confidence interval (CI) 15.6-19.1 per 100 person-years] compared to those with a controlled systolic blood pressure (13.4; 12.7-14.3 per 100 person-years), with an adjusted rate ratio of 1.28 (95% CI 1.05-1.57). The reduction in systolic blood pressure at Weeks 4 and 16, respectively, was greater with sacubitril-valsartan vs. valsartan in patients with apparent resistant hypertension [-4.8 (-7.0 to -2.5) and 3.9 (-6.6 to -1.3) mmHg] and apparent MRA-resistant hypertension [-8.8 (-14.0 to -3.5) and -6.3 (-12.5 to -0.1) mmHg]. The proportion of patients with apparent resistant hypertension achieving a controlled systolic blood pressure by Week 16 was 47.9% in the sacubitril-valsartan group and 34.3% in the valsartan group [adjusted odds ratio (OR) 1.78, 95% CI 1.30-2.43]. In patients with apparent MRA-resistant hypertension, the respective proportions were 43.6% vs. 28.4% (adjusted OR 2.63, 95% CI 1.18-5.89). Conclusion: Sacubitril-valsartan may be useful in treating apparent resistant hypertension in patients with HFpEF, even in those who continue to have an elevated blood pressure despite treatment with at least four antihypertensive drug classes, including an MRA. Clinical trial registration: PARAGON-HF: ClinicalTrials.gov Identifier NCT01920711.
MeSH term(s)	Aminobutyrates/therapeutic use ; Angiotensin Receptor Antagonists/therapeutic use ; Biphenyl Compounds ; Double-Blind Method ; Drug Combinations ; Heart Failure/complications ; Heart Failure/drug therapy ; Humans ; Hypertension/complications ; Hypertension/drug therapy ; Neprilysin ; Stroke Volume ; Tetrazoles/therapeutic use ; Treatment Outcome ; Valsartan/therapeutic use
Chemical Substances	Aminobutyrates ; Angiotensin Receptor Antagonists ; Biphenyl Compounds ; Drug Combinations ; Tetrazoles ; Valsartan (80M03YXJ7I) ; Neprilysin (EC 3.4.24.11) ; sacubitril and valsartan sodium hydrate drug combination (WB8FT61183)
Language	English
Publishing date	2021-08-13
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	603098-1
ISSN	1522-9645 ; 0195-668X
ISSN (online)	1522-9645
ISSN	0195-668X
DOI	10.1093/eurheartj/ehab499
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Zs.A 1563: 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)
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Article ; Online: Anti-C5a antibody (vilobelimab) therapy for critically ill, invasively mechanically ventilated patients with COVID-19 (PANAMO): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial.

Vlaar, Alexander P J / Witzenrath, Martin / van Paassen, Pieter / Heunks, Leo M A / Mourvillier, Bruno / de Bruin, Sanne / Lim, Endry H T / Brouwer, Matthijs C / Tuinman, Pieter R / Saraiva, José F K / Marx, Gernot / Lobo, Suzana M / Boldo, Rodrigo / Simon-Campos, Jesus A / Cornet, Alexander D / Grebenyuk, Anastasia / Engelbrecht, Johannes M / Mukansi, Murimisi / Jorens, Philippe G /

Zerbib, Robert / Rückinger, Simon / Pilz, Korinna / Guo, Renfeng / van de Beek, Diederik / Riedemann, Niels C

The Lancet. Respiratory medicine

2022 Volume 10, Issue 12, Page(s) 1137–1146

Abstract: Background: Vilobelimab, an anti-C5a monoclonal antibody, was shown to be safe in a phase 2 trial of invasively mechanically ventilated patients with COVID-19. Here, we aimed to determine whether vilobelimab in addition to standard of care improves ... ...

Abstract	Background: Vilobelimab, an anti-C5a monoclonal antibody, was shown to be safe in a phase 2 trial of invasively mechanically ventilated patients with COVID-19. Here, we aimed to determine whether vilobelimab in addition to standard of care improves survival outcomes in this patient population. Methods: This randomised, double-blind, placebo-controlled, multicentre phase 3 trial was performed at 46 hospitals in the Netherlands, Germany, France, Belgium, Russia, Brazil, Peru, Mexico, and South Africa. Participants aged 18 years or older who were receiving invasive mechanical ventilation, but not more than 48 h after intubation at time of first infusion, had a PaO Findings: From Oct 1, 2020, to Oct 4, 2021, we included 368 patients in the ITT analysis (full analysis set; 177 in the vilobelimab group and 191 in the placebo group). One patient in the vilobelimab group was excluded from the primary analysis due to random assignment in error without treatment. At least one dose of study treatment was given to 364 (99%) patients (safety analysis set). 54 patients (31%) of 177 in the vilobelimab group and 77 patients (40%) of 191 in the placebo group died in the first 28 days. The all-cause mortality rate at 28 days was 32% (95% CI 25-39) in the vilobelimab group and 42% (35-49) in the placebo group (hazard ratio 0·73, 95% CI 0·50-1·06; p=0·094). In the predefined analysis without site-stratification, vilobelimab significantly reduced all-cause mortality at 28 days (HR 0·67, 95% CI 0·48-0·96; p=0·027). The most common TEAEs were acute kidney injury (35 [20%] of 175 in the vilobelimab group vs 40 [21%] of 189 in the placebo), pneumonia (38 [22%] vs 26 [14%]), and septic shock (24 [14%] vs 31 [16%]). Serious treatment-emergent adverse events were reported in 103 (59%) of 175 patients in the vilobelimab group versus 120 (63%) of 189 in the placebo group. Interpretation: In addition to standard of care, vilobelimab improves survival of invasive mechanically ventilated patients with COVID-19 and leads to a significant decrease in mortality. Vilobelimab could be considered as an additional therapy for patients in this setting and further research is needed on the role of vilobelimab and C5a in other acute respiratory distress syndrome-causing viral infections. Funding: InflaRx and the German Federal Government.
MeSH term(s)	Humans ; COVID-19/therapy ; SARS-CoV-2 ; Critical Illness/therapy ; Respiration, Artificial ; Treatment Outcome ; Antibodies, Monoclonal ; Double-Blind Method
Chemical Substances	vilobelimab (F5T0RF9ZJA) ; Antibodies, Monoclonal
Language	English
Publishing date	2022-09-07
Publishing country	England
Document type	Randomized Controlled Trial ; Multicenter Study ; Clinical Trial, Phase III ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2686754-0
ISSN	2213-2619 ; 2213-2600
ISSN (online)	2213-2619
ISSN	2213-2600
DOI	10.1016/S2213-2600(22)00297-1
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Article ; Online: Ticagrelor Versus Clopidogrel in Patients With STEMI Treated With Fibrinolysis: TREAT Trial.

Berwanger, Otavio / Lopes, Renato D / Moia, Diogo D F / Fonseca, Francisco A / Jiang, Lixin / Goodman, Shaun G / Nicholls, Stephen J / Parkhomenko, Alexander / Averkov, Oleg / Tajer, Carlos / Malaga, Germán / Saraiva, Jose F K / Guimaraes, Helio P / de Barros E Silva, Pedro G M / Damiani, Lucas P / Santos, Renato H N / Paisani, Denise M / Miranda, Tamiris A / Valeis, Nanci /

Piegas, Leopoldo S / Granger, Christopher B / White, Harvey D / Nicolau, Jose C

Journal of the American College of Cardiology

2019 Volume 73, Issue 22, Page(s) 2819–2828

Abstract: Background: The efficacy of ticagrelor in the long-term post-ST-segment elevation myocardial infarction (STEMI) treated with fibrinolytic therapy remains uncertain.: Objectives: The purpose of this study was to evaluate the efficacy of ticagrelor ... ...

Abstract	Background: The efficacy of ticagrelor in the long-term post-ST-segment elevation myocardial infarction (STEMI) treated with fibrinolytic therapy remains uncertain. Objectives: The purpose of this study was to evaluate the efficacy of ticagrelor when compared with clopidogrel in STEMI patients treated with fibrinolytic therapy. Methods: This international, multicenter, randomized, open-label with blinded endpoint adjudication trial enrolled 3,799 patients (age <75 years) with STEMI receiving fibrinolytic therapy. Patients were randomized to ticagrelor (180-mg loading dose, 90 mg twice daily thereafter) or clopidogrel (300- to 600-mg loading dose, 75 mg daily thereafter). The key outcomes were cardiovascular mortality, myocardial infarction, or stroke, and the same composite outcome with the addition of severe recurrent ischemia, transient ischemic attack, or other arterial thrombotic events at 12 months. Results: The combined outcome of cardiovascular mortality, myocardial infarction, or stroke occurred in 129 of 1,913 patients (6.7%) receiving ticagrelor and in 137 of 1,886 patients (7.3%) receiving clopidogrel (hazard ratio: 0.93; 95% confidence interval: 0.73 to 1.18; p = 0.53). The composite of cardiovascular mortality, myocardial infarction, stroke, severe recurrent ischemia, transient ischemic attack, or other arterial thrombotic events occurred in 153 of 1,913 patients (8.0%) treated with ticagrelor and in 171 of 1,886 patients (9.1%) receiving clopidogrel (hazard ratio: 0.88; 95% confidence interval: 0.71 to 1.09; p = 0.25). The rates of major, fatal, and intracranial bleeding were similar between the ticagrelor and clopidogrel groups. Conclusion: Among patients age <75 years with STEMI, administration of ticagrelor after fibrinolytic therapy did not significantly reduce the frequency of cardiovascular events when compared with clopidogrel. (Ticagrelor in Patients With ST Elevation Myocardial Infarction Treated With Pharmacological Thrombolysis [TREAT]; NCT02298088).
MeSH term(s)	Aged ; Cause of Death ; Clopidogrel/adverse effects ; Clopidogrel/therapeutic use ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; Female ; Humans ; Long-Term Care ; Male ; Middle Aged ; ST Elevation Myocardial Infarction/drug therapy ; ST Elevation Myocardial Infarction/mortality ; Survival Analysis ; Thrombolytic Therapy/methods ; Ticagrelor/adverse effects ; Ticagrelor/therapeutic use ; Treatment Outcome
Chemical Substances	Clopidogrel (A74586SNO7) ; Ticagrelor (GLH0314RVC)
Language	English
Publishing date	2019-03-18
Publishing country	United States
Document type	Clinical Trial, Phase III ; Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	605507-2
ISSN	1558-3597 ; 0735-1097
ISSN (online)	1558-3597
ISSN	0735-1097
DOI	10.1016/j.jacc.2019.03.011
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Article ; Online: Rivaroxaban in Patients with Atrial Fibrillation and a Bioprosthetic Mitral Valve.

Guimarães, Helio P / Lopes, Renato D / de Barros E Silva, Pedro G M / Liporace, Idelzuita L / Sampaio, Roney O / Tarasoutchi, Flávio / Hoffmann-Filho, Conrado R / de Lemos Soares Patriota, Rodrigo / Leiria, Tiago L L / Lamprea, Diana / Precoma, Dalton B / Atik, Fernando A / Silveira, Fabio S / Farias, Fabio R / Barreto, Diogo O / Almeida, Adail P / Zilli, Alexandre C / de Souza Neto, João D / Cavalcante, Margaret A /

Figueira, Fernando A M S / Kojima, Flávia C S / Damiani, Lucas / Santos, Renato H N / Valeis, Nanci / Campos, Viviane B / Saraiva, Jose F K / Fonseca, Francisco H / Pinto, Ibraim M / Magalhães, Carlos C / Ferreira, Joao F M / Alexander, John H / Pavanello, Ricardo / Cavalcanti, Alexandre B / Berwanger, Otavio

The New England journal of medicine

2020 Volume 383, Issue 22, Page(s) 2117–2126

Abstract: Background: The effects of rivaroxaban in patients with atrial fibrillation and a bioprosthetic mitral valve remain uncertain.: Methods: In this randomized trial, we compared rivaroxaban (20 mg once daily) with dose-adjusted warfarin (target ... ...

Abstract	Background: The effects of rivaroxaban in patients with atrial fibrillation and a bioprosthetic mitral valve remain uncertain. Methods: In this randomized trial, we compared rivaroxaban (20 mg once daily) with dose-adjusted warfarin (target international normalized ratio, 2.0 to 3.0) in patients with atrial fibrillation and a bioprosthetic mitral valve. The primary outcome was a composite of death, major cardiovascular events (stroke, transient ischemic attack, systemic embolism, valve thrombosis, or hospitalization for heart failure), or major bleeding at 12 months. Results: A total of 1005 patients were enrolled at 49 sites in Brazil. A primary-outcome event occurred at a mean of 347.5 days in the rivaroxaban group and 340.1 days in the warfarin group (difference calculated as restricted mean survival time, 7.4 days; 95% confidence interval [CI], -1.4 to 16.3; P<0.001 for noninferiority). Death from cardiovascular causes or thromboembolic events occurred in 17 patients (3.4%) in the rivaroxaban group and in 26 (5.1%) in the warfarin group (hazard ratio, 0.65; 95% CI, 0.35 to 1.20). The incidence of stroke was 0.6% in the rivaroxaban group and 2.4% in the warfarin group (hazard ratio, 0.25; 95% CI, 0.07 to 0.88). Major bleeding occurred in 7 patients (1.4%) in the rivaroxaban group and in 13 (2.6%) in the warfarin group (hazard ratio, 0.54; 95% CI, 0.21 to 1.35). The frequency of other serious adverse events was similar in the two groups. Conclusions: In patients with atrial fibrillation and a bioprosthetic mitral valve, rivaroxaban was noninferior to warfarin with respect to the mean time until the primary outcome of death, major cardiovascular events, or major bleeding at 12 months. (Funded by PROADI-SUS and Bayer; RIVER ClinicalTrials.gov number, NCT02303795.).
MeSH term(s)	Aged ; Anticoagulants/adverse effects ; Anticoagulants/therapeutic use ; Atrial Fibrillation/complications ; Atrial Fibrillation/drug therapy ; Atrial Fibrillation/mortality ; Bioprosthesis ; Cardiovascular Diseases/epidemiology ; Factor Xa Inhibitors/therapeutic use ; Female ; Hemorrhage/chemically induced ; Humans ; Male ; Middle Aged ; Mitral Valve ; Rivaroxaban/adverse effects ; Rivaroxaban/therapeutic use ; Single-Blind Method ; Stroke/prevention & control ; Warfarin/adverse effects ; Warfarin/therapeutic use
Chemical Substances	Anticoagulants ; Factor Xa Inhibitors ; Warfarin (5Q7ZVV76EI) ; Rivaroxaban (9NDF7JZ4M3)
Language	English
Publishing date	2020-11-14
Publishing country	United States
Document type	Comparative Study ; Equivalence Trial ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMoa2029603
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Article ; Online: A randomized clinical trial to evaluate the efficacy and safety of rivaroxaban in patients with bioprosthetic mitral valve and atrial fibrillation or flutter: Rationale and design of the RIVER trial.

Guimarães, Helio P / de Barros E Silva, Pedro G M / Liporace, Idelzuita L / Sampaio, Roney O / Tarasoutchi, Flávio / Paixão, Milena / Hoffmann-Filho, Conrado R / Patriota, Rodrigo / Leiria, Tiago L L / Lamprea, Diana / Precoma, Dalton B / Atik, Fernando A / Silveira, Fabio S / Farias, Fabio R / Barreto, Diogo O / Almeida, Adail P / Zilli, Alexandre C / de Souza Neto, João D / Cavalcante, Margaret A /

Figueira, Fernando A M S / Junior, Roque A / Moisés, Valdir A / Mesas, Cezar E / Ardito, Roberto V / Kalil, Paulo S A / Paiva, Maria S M O / Maldonado, Jaime G A / de Lima, Carlos E B / D'Oliveira Vieira, Ricardo / Laranjeira, Ligia / Kojima, Flávia / Damiani, Lucas / Nakagawa, Renato H / Dos Santos, Juliana R Y / Sampaio, Bruna S / Campos, Viviane B / Saraiva, Jose F K / Fonseca, Francisco H / Pinto, Ibraim M / Magalhães, Carlos C / Ferreira, Joao F M / Lopes, Renato D / Pavanello, Ricardo / Cavalcanti, Alexandre B / Berwanger, Otavio

American heart journal

2020 Volume 231, Page(s) 128–136

Abstract: The efficacy and safety of rivaroxaban in patients with bioprosthetic mitral valves and atrial fibrillation or flutter remain uncertain. DESIGN: RIVER was an academic-led, multicenter, open-label, randomized, non-inferiority trial with blinded outcome ... ...

Abstract	The efficacy and safety of rivaroxaban in patients with bioprosthetic mitral valves and atrial fibrillation or flutter remain uncertain. DESIGN: RIVER was an academic-led, multicenter, open-label, randomized, non-inferiority trial with blinded outcome adjudication that enrolled 1005 patients from 49 sites in Brazil. Patients with a bioprosthetic mitral valve and atrial fibrillation or flutter were randomly assigned (1:1) to rivaroxaban 20 mg once daily (15 mg in those with creatinine clearance <50 mL/min) or dose-adjusted warfarin (target international normalized ratio 2.0-30.); the follow-up period was 12 months. The primary outcome was a composite of all-cause mortality, stroke, transient ischemic attack, major bleeding, valve thrombosis, systemic embolism, or hospitalization for heart failure. Secondary outcomes included individual components of the primary composite outcome, bleeding events, and venous thromboembolism. SUMMARY: RIVER represents the largest trial specifically designed to assess the efficacy and safety of a direct oral anticoagulant in patients with bioprosthetic mitral valves and atrial fibrillation or flutter. The results of this trial can inform clinical practice and international guidelines.
MeSH term(s)	Humans ; Administration, Oral ; Aspirin/administration & dosage ; Atrial Fibrillation/complications ; Atrial Flutter/complications ; Bioprosthesis/adverse effects ; Brazil ; Cause of Death ; Creatinine/metabolism ; Embolism ; Factor Xa Inhibitors/administration & dosage ; Factor Xa Inhibitors/adverse effects ; Factor Xa Inhibitors/therapeutic use ; Heart Valve Prosthesis/adverse effects ; Hemorrhage/chemically induced ; Hospitalization ; Ischemic Attack, Transient ; Mitral Valve ; Rivaroxaban/administration & dosage ; Rivaroxaban/adverse effects ; Rivaroxaban/therapeutic use ; Sample Size ; Stroke ; Surgical Procedures, Operative ; Thrombosis/etiology ; Thrombosis/prevention & control ; Treatment Outcome ; Warfarin/administration & dosage ; Warfarin/adverse effects ; Warfarin/therapeutic use ; Equivalence Trials as Topic ; Multicenter Studies as Topic ; Randomized Controlled Trials as Topic
Chemical Substances	Aspirin (R16CO5Y76E) ; Creatinine (AYI8EX34EU) ; Factor Xa Inhibitors ; Rivaroxaban (9NDF7JZ4M3) ; Warfarin (5Q7ZVV76EI)
Language	English
Publishing date	2020-10-10
Publishing country	United States
Document type	Clinical Trial Protocol ; Journal Article
ZDB-ID	80026-0
ISSN	1097-6744 ; 0002-8703
ISSN (online)	1097-6744
ISSN	0002-8703
DOI	10.1016/j.ahj.2020.10.001
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Article ; Online: Ticagrelor vs Clopidogrel After Fibrinolytic Therapy in Patients With ST-Elevation Myocardial Infarction: A Randomized Clinical Trial.

Berwanger, Otavio / Nicolau, Jose C / Carvalho, Antonio C / Jiang, Lixin / Goodman, Shaun G / Nicholls, Stephen J / Parkhomenko, Alexander / Averkov, Oleg / Tajer, Carlos / Malaga, Germán / Saraiva, Jose F K / Fonseca, Francisco A / De Luca, Fábio A / Guimaraes, Helio P / de Barros E Silva, Pedro G M / Damiani, Lucas P / Paisani, Denise M / Lasagno, Camila M R / Candido, Carolina T /

Valeis, Nanci / Moia, Diogo D F / Piegas, Leopoldo S / Granger, Christopher B / White, Harvey D / Lopes, Renato D

JAMA cardiology

2017 Volume 3, Issue 5, Page(s) 391–399

Abstract: Importance: The bleeding safety of ticagrelor in patients with ST-elevation myocardial infarction treated with fibrinolytic therapy remains uncertain.: Objective: To evaluate the short-term safety of ticagrelor when compared with clopidogrel in ... ...

Abstract	Importance: The bleeding safety of ticagrelor in patients with ST-elevation myocardial infarction treated with fibrinolytic therapy remains uncertain. Objective: To evaluate the short-term safety of ticagrelor when compared with clopidogrel in patients with ST-elevation myocardial infarction treated with fibrinolytic therapy. Design, setting and participants: We conducted a multicenter, randomized, open-label with blinded end point adjudication trial that enrolled 3799 patients (younger than 75 years) with ST-segment elevation myocardial infarction receiving fibrinolytic therapy in 152 sites from 10 countries from November 2015 through November 2017. The prespecified upper boundary for noninferiority for bleeding was an absolute margin of 1.0%. Interventions: Patients were randomized to ticagrelor (180-mg loading dose, 90 mg twice daily thereafter) or clopidogrel (300-mg to 600-mg loading dose, 75 mg daily thereafter). Patients were randomized with a median of 11.4 hours after fibrinolysis, and 90% were pretreated with clopidogrel. Main outcomes and measures: The primary outcome was thrombolysis in myocardial infarction (TIMI) major bleeding through 30 days. Results: The mean (SD) age was 58.0 (9.5) years, 2928 of 3799 patients (77.1%) were men, and 2177 of 3799 patients (57.3%) were white. At 30 days, TIMI major bleeding had occurred in 14 of 1913 patients (0.73%) receiving ticagrelor and in 13 of 1886 patients (0.69%) receiving clopidogrel (absolute difference, 0.04%; 95% CI, -0.49% to 0.58%; P < .001 for noninferiority). Major bleeding defined by the Platelet Inhibition and Patient Outcomes criteria and by the Bleeding Academic Research Consortium types 3 to 5 bleeding occurred in 23 patients (1.20%) in the ticagrelor group and in 26 patients (1.38%) in the clopidogrel group (absolute difference, -0.18%; 95% CI, -0.89% to 0.54; P = .001 for noninferiority). The rates of fatal (0.16% vs 0.11%; P = .67) and intracranial bleeding (0.42% vs 0.37%; P = .82) were similar between the ticagrelor and clopidogrel groups, respectively. Minor and minimal bleeding were more common with ticagrelor than with clopidogrel. The composite of death from vascular causes, myocardial infarction, or stroke occurred in 76 patients (4.0%) treated with ticagrelor and in 82 patients (4.3%) receiving clopidogrel (hazard ratio, 0.91; 95% CI, 0.67-1.25; P = .57). Conclusions and relevance: In patients younger than 75 years with ST-segment elevation myocardial infarction, delayed administration of ticagrelor after fibrinolytic therapy was noninferior to clopidogrel for TIMI major bleeding at 30 days. Trial registration: clinicaltrials.gov Identifier: NCT02298088.
MeSH term(s)	Aged ; Clopidogrel/adverse effects ; Clopidogrel/therapeutic use ; Female ; Fibrinolytic Agents/therapeutic use ; Hemorrhage/chemically induced ; Humans ; Male ; Middle Aged ; Myocardial Infarction/drug therapy ; Ticagrelor/adverse effects ; Ticagrelor/therapeutic use
Chemical Substances	Fibrinolytic Agents ; Clopidogrel (A74586SNO7) ; Ticagrelor (GLH0314RVC)
Language	English
Publishing date	2017-11-10
Publishing country	United States
Document type	Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ISSN	2380-6591
ISSN (online)	2380-6591
DOI	10.1001/jamacardio.2018.0612
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Article: Efficacy, safety and tolerability of sildenafil in Brazilian hypertensive patients on multiple antihypertensive drugs.

Albuquerque, Denilson C / Miziara, Lineu J / Saraiva, Jose F K / Rodrigues, Ulisses S / Ribeiro, Artur B / Wajngarten, Mauricio

International braz j urol : official journal of the Brazilian Society of Urology

2005 Volume 31, Issue 4, Page(s) 342–53; discussion 354–5

Abstract: Objective: To evaluate the efficacy, safety and tolerability of sildenafil among Brazilian patients with hypertension treated with combinations of anti-hypertensive drugs.: Materials and methods: One hundred twenty hypertensive men aged 30 to 81 ... ...

Abstract	Objective: To evaluate the efficacy, safety and tolerability of sildenafil among Brazilian patients with hypertension treated with combinations of anti-hypertensive drugs. Materials and methods: One hundred twenty hypertensive men aged 30 to 81 years old under treatment with 2 or more anti-hypertensive drugs and with erectile dysfunction (ED) lasting for at least 6 months were enrolled at 7 research centers in Brazil. Patients were randomized to receive treatment with either sildenafil or placebo taken 1 hour before sexual intercourse (initial dose of 50 mg, adjusted to 25 mg or 100 mg according to efficacy and toxicity). During the following 8 weeks, patients were evaluated regarding vital signs, adverse events, therapeutic efficacy, satisfaction with treatment and use of concurrent medications. Results: The primary evaluation of efficacy, which was based on responses to questions 3 and 4 of the International Index of Erectile Function, showed significant differences regarding treatment with sildenafil (p = 0.0002 and p < 0.0001, respectively). In the assessment of global efficacy, 87% of the patients treated with sildenafil reported improved erections, as compared with 37% of patients given placebos (p < 0.0001). The other secondary evaluations supported the results favoring sildenafil. The most frequent adverse events among patients treated with sildenafil were headaches (11.4%), vasodilation (11.4%) and dyspepsia (6.5%). There were no significant changes in blood pressure measurements in both groups. Conclusion: Sildenafil is efficacious and safe for the treatment of hypertensive patients with ED who receive concurrent combinations of anti-hypertensive drugs.
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Antihypertensive Agents/therapeutic use ; Brazil ; Drug Therapy, Combination ; Erectile Dysfunction/complications ; Erectile Dysfunction/drug therapy ; Follow-Up Studies ; Humans ; Hypertension/complications ; Hypertension/drug therapy ; Male ; Middle Aged ; Patient Satisfaction ; Piperazines/adverse effects ; Piperazines/therapeutic use ; Purines ; Sildenafil Citrate ; Sulfones ; Treatment Outcome ; Vasodilator Agents/adverse effects ; Vasodilator Agents/therapeutic use
Chemical Substances	Antihypertensive Agents ; Piperazines ; Purines ; Sulfones ; Vasodilator Agents ; Sildenafil Citrate (BW9B0ZE037)
Language	English
Publishing date	2005-08-29
Publishing country	Brazil
Document type	Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	2206649-4
ISSN	1677-5538
ISSN	1677-5538
DOI	10.1590/s1677-55382005000400008
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