Filtered By:
Condition: Heart Attack
Management: European Medicines Agency (EMA)

This page shows you your search results in order of date.

Order by Relevance | Date

Total 19 results found since Jan 2013.

Reply: Association between triple therapy and major adverse cardiovascular events in COPD patients
We thank P. Almagro and P. Martinez-Camblor for their interest in our work and for their salient comments. While we agree that there is no universally accepted definition of major adverse cardiovascular event (MACE), the US Food and Drug Administration (FDA) and the European Medicines Agency include nonfatal myocardial infarction and stroke as well as cardiovascular (CV) mortality in their MACE definition [1]. Importantly, this definition includes both haemorrhagic and ischaemic stroke [1–4]. In our study, we followed this classical "three-point" definition of MACE (including haemorrhagic strokes). While this definit...
Source: European Respiratory Journal - March 2, 2023 Category: Respiratory Medicine Authors: Yang, M.-J., Guo, S.-L., Sin, D. D. Tags: Correspondence Source Type: research

Janssen to Present the Strength and Promise of its Hematologic Malignancies Portfolio and Pipeline at ASH 2021
RARITAN, N.J., November 4, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that more than 45 company-sponsored abstracts, including 11 oral presentations, plus more than 35 investigator-initiated studies will be featured at the American Society of Hematology (ASH) Annual Meeting and Exposition. ASH is taking place at the Georgia World Congress Center in Atlanta and virtually from December 11-14, 2021.“We are committed to advancing the science and treatment of hematologic malignancies and look forward to presenting the latest research from our robust portfolio and pipeline during ASH...
Source: Johnson and Johnson - November 5, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Announces U.S. FDA Approval of PONVORY ™ (ponesimod), an Oral Treatment for Adults with Relapsing Multiple Sclerosis Proven Superior to Aubagio® (teriflunomide) in Reducing Annual Relapses and Brain Lesions
TITUSVILLE, N.J. – (March 19, 2021) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) approved PONVORY™ (ponesimod), a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, to treat adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.1,2,3 PONVORY™ offers MS patients superior efficacy in reducing annualized relapse rates compared to an established oral therapy and a proven safety profile backed by ove...
Source: Johnson and Johnson - March 19, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Clinical characteristics and outcomes of COMPASS eligible patients in France. An analysis from the REACH Registry.
CONCLUSION: The COMPASS therapeutic strategy in France appears to be applicable to more than half of CAD or PAD patients. This population appears at high residual risk of atherothrombotic events, and patients with polyvascular disease experienced the highest rate of events. PMID: 32778388 [PubMed - as supplied by publisher]
Source: Annales de Cardiologie et d'Angeiologie - August 6, 2020 Category: Cardiology Authors: Darmon A, Elbez Y, Bhatt DL, Abtan J, Mas JL, Cacoub P, Montalescot G, Billaut-Laden I, Ducrocq G, Steg PG Tags: Ann Cardiol Angeiol (Paris) Source Type: research

Cost-effectiveness analysis of apixaban compared to other direct oral anticoagulants for prevention of stroke in Austrian atrial fibrillation patients.
CONCLUSION: In patients with AF and an increased risk of stroke, prophylaxis with apixaban was highly cost-effective from the perspective of the Austrian health care system. PMID: 32700584 [PubMed - as supplied by publisher]
Source: Expert Review of Pharmacoeconomics and Outcomes Research - July 24, 2020 Category: Health Management Tags: Expert Rev Pharmacoecon Outcomes Res Source Type: research

A Post-Authorization Safety Study of Quetiapine as Antidepressant Treatment in Sweden: Nested Case –Control Analyses of Select Outcomes
ConclusionRisks for all-cause mortality, self-harm and suicide, and stroke in older patients may be higher among patients treated with quetiapine and antidepressant combination therapy.
Source: Drug Safety - December 16, 2019 Category: Drugs & Pharmacology Source Type: research

Design and rationale of the Edoxaban Treatment in routiNe clinical prActice for patients with Atrial Fibrillation in Europe (ETNA-AF-Europe) study
This study details the design of the Edoxaban Treatment in routiNe clinical prActice for patients with Atrial Fibrillation in Europe (ETNA-AF-Europe) study – a postauthorization observational study, which is part of the postapproval plan for edoxaban agreed with the European Medicines Agency. Methods The ETNA-AF-Europe study (Clinicaltrials.gov: NCT02944019) is a multicenter, prospective, observational study that enrolled 13 980 patients with atrial fibrillation treated with edoxaban from 852 sites across 10 European countries (Austria, Belgium, Germany, Ireland, Italy, the Netherlands, Portugal, Spain, Switzerland,...
Source: Journal of Cardiovascular Medicine - January 3, 2019 Category: Cardiology Tags: Research articles: Trial design Source Type: research

Androgens and cardiovascular risk: A series of case report in the French and Canadian pharmacovigilance databases.
CONCLUSION: Our study shows a very low report of cardiovascular effects under testosterone, all doubtful. Pending further studies, it seems reasonable to consider the cardiovascular risk of patients who are candidates for hormone therapy for age-related androgen deficiency. LEVEL OF EVIDENCE: 3. PMID: 29650456 [PubMed - as supplied by publisher]
Source: Progres en Urologie - April 15, 2018 Category: Urology & Nephrology Tags: Prog Urol Source Type: research

Amgen Receives Positive CHMP Opinion Recognizing That Repatha ® (evolocumab) Prevents Heart Attacks And Strokes
Recommended Label Includes New Indication Based on the Repatha Cardiovascular Outcomes Study (FOURIER) Amgen Continues to Work Closely With Payers on a Country-by-Country Basis to Ensure Access to Repatha for High-Risk Cardiovascular Patients THOUSAND OAKS, Calif., March 23, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion to include a new indication in the Repatha® (evolocumab) label for adults with established atherosclerotic cardiovascular disease (myocardial infarction, s...
Source: Amgen News Release - March 23, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Bayer submits application for marketing approval of rivaroxaban for patients with coronary or peripheral artery disease to European Medicines Agency (for specialized target groups only)
The rivaroxaban vascular dose, 2.5 mg twice daily plus aspirin 100 mg once daily, demonstrated a 24% reduction in the combined risk of stroke, cardiovascular death and heart attack / The application for marketing approval is based on the COMPASS study / If approved, the rivaroxaban vascular dose, 2.5 mg twice daily plus aspirin low dose once daily, will be the only non-vitamin K antagonist oral anticoagulant (NOAC) indicated for this patient population
Source: Bayer Company News - November 6, 2017 Category: Pharmaceuticals Source Type: news

Controversial Effects of Exogenous Testosterone on Cardiovascular Diseases
The use of testosterone (T) among men aged 40 years or older was increased more than 3 times from 0.81% in 2001 to 2.91% in 2011. Until recently, the majority of the studies did not show any increased cardiovascular (CV) risk by using T in male patients with hypogonadism. What is more, some studies had observed a protective effect of using T against CV diseases. However, in 2010, a randomized clinical trial (RCT) was intended to study the advantage of T gel in older men with limitations in mobility; the study was stopped due to unexpected high prevalence of CV adverse outcome. These findings were confirmed by 2 other studi...
Source: American Journal of Therapeutics - November 1, 2016 Category: Drugs & Pharmacology Tags: Original Articles Source Type: research

Cardiovascular Morbidity and Pure Red Cell Aplasia Associated With Epoetin Theta Therapy in Patients With Chronic Kidney Disease: A Prospective, Noninterventional, Multicenter Cohort Study.
Abstract PURPOSE: The European Medicines Agency recommends limiting the hemoglobin (Hb) concentration to 10 to 12 g/dL in adults with chronic kidney disease (CKD) receiving erythropoiesis-stimulating agents such as epoetin theta. This postauthorization study assessed the incidence and intensity of cardiovascular events, including ischemic stroke, in patients receiving epoetin theta for anemia associated with CKD. A secondary end point was adverse drug reactions, including pure red cell aplasia. METHODS: In this prospective, noninterventional, multinational cohort study, consecutive patients with advanced or e...
Source: Clinical Therapeutics - December 18, 2015 Category: Drugs & Pharmacology Authors: Lammerich A, Balcke P, Bias P, Mangold S, Wiesholzer M Tags: Clin Ther Source Type: research

Is platelet transfusion the solution to reverse platelet inhibition in patients on triple antiplatelet therapy?
Antiplatelet therapy is the cornerstone of secondary prevention against acute thrombotic events in patients with cardiovascular disease [1]. Health Organizations around the world recommend combination therapy with aspirin and a P2Y12 receptor inhibitor for up to one year following an acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI), and lifelong aspirin therapy thereafter [2]. Vorapaxar, a first-in-class novel protease-activated receptor (PAR)-1 antagonist, was approved in addition to standard antiplatelet therapy, to further reduce the risk of myocardial infarction (MI), stroke, cardiovascular dea...
Source: Thrombosis Research - October 30, 2015 Category: Hematology Authors: Marie Lordkipanidzé Source Type: research

New strategies for osteoporosis patients previously managed with strontium ranelate
The aim of this article is to describe potential alternatives to patients no longer eligible for management with strontium ranelate for osteoporosis according to the recommendations by the European Medicines Agency. A systematic search of Pubmed was done for papers on fracture efficacy of various treatments for osteoporosis, and potential harms especially in terms of cardiovascular events and stroke. The results showed that drugs more efficacious in terms of relative risk reduction of fractures than strontium ranelate were alendronate, risedronate, zoledronate, and denosumab. Raloxifene, as for strontium, may be associated...
Source: Therapeutic Advances in Musculoskeletal Disease - November 19, 2014 Category: Orthopaedics Authors: Vestergaard, P. Tags: Reviews Source Type: research

Protocol of the Febuxostat versus Allopurinol Streamlined Trial (FAST): a large prospective, randomised, open, blinded endpoint study comparing the cardiovascular safety of allopurinol and febuxostat in the management of symptomatic hyperuricaemia
Introduction Gout affects 2.5% of the UK's adult population and is now the most common type of inflammatory arthritis. The long-term management of gout requires reduction of serum urate levels and this is most often achieved with use of xanthine oxidase inhibitors, such as allopurinol. Febuxostat is the first new xanthine oxidase inhibitor since allopurinol and was licensed for use in 2008. The European Medicines Agency requested a postlicensing cardiovascular safety study of febuxostat versus allopurinol, which has been named the Febuxostat versus Allopurinol Streamlined trial (FAST). Methods and analysis FAST is a cardi...
Source: BMJ Open - July 10, 2014 Category: Journals (General) Authors: MacDonald, T. M., Ford, I., Nuki, G., Mackenzie, I. S., De Caterina, R., Findlay, E., Hallas, J., Hawkey, C. J., Ralston, S., Walters, M., Webster, J., McMurray, J., Perez Ruiz, F., Jennings, C. G., MacDonald, Ford, Nuki, Mackenzie, Hallas, Webster, Walte Tags: Open access, Cardiovascular medicine, Research methods Protocol Source Type: research