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Total 105 results found since Jan 2013.

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

Sodium –Glucose Cotransporter-2 Inhibitors and Heart Failure Prevention in Type 2 Diabetes
In 2008, the European Medicines Agency and US Food and Drug Administration (FDA) issued industry guidance stating that all future novel glucose-lowering agent trials must undergo routine cardiovascular risk evaluation either before approval or as a post-marketing commitment.1 This mandated that all cardiovascular endpoint committees prospectively adjudicate all major adverse cardiovascular events, including cardiovascular death, non-fatal MI and stroke, occurring across Phase II and III diabetes trials.
Source: Radcliffe Cardiology - November 4, 2019 Category: Cardiology Authors: mehul Source Type: research

Diagnostic value of  alternative techniques to gadolinium-based contrast agents in MR neuroimaging—a comprehensive overview
AbstractGadolinium-based contrast agents (GBCAs) increase lesion detection and improve disease characterization for many cerebral pathologies investigated with MRI. These agents, introduced in the late 1980s, are in wide use today. However, some non-ionic linear GBCAs have been associated with the development of nephrogenic systemic fibrosis in patients with kidney failure. Gadolinium deposition has also been found in deep brain structures, although it is of unclear clinical relevance. Hence, new guidelines from the International Society for Magnetic Resonance in Medicine advocate cautious use of GBCA in clinical and resea...
Source: Insights into Imaging - August 22, 2019 Category: Radiology Source Type: research

Preventable Cases of Oral Anticoagulant-Induced Bleeding: Data From the Spontaneous Reporting System
Conclusion: Our findings describe the most reported risk factors for preventability of oral anticoagulant-induced bleedings. These factors may be useful for targeting interventions to improve pharmacovigilance activities in our regional territory and to reduce the burden of medication errors and inappropriate prescription. Introduction Oral anticoagulant therapy is widely used for the prevention of stroke and systemic embolism in patients with atrial fibrillation, or for the prevention and treatment of deep vein thrombosis and pulmonary embolism (Raj et al., 1994; Monaco et al., 2017). Oral anticoagulants can be di...
Source: Frontiers in Pharmacology - April 29, 2019 Category: Drugs & Pharmacology Source Type: research

Inappropriate non-vitamin  K antagonist oral anticoagulants prescriptions: be cautious with dose reductions.
CONCLUSION: An incorrect prescription occurred more often in the reduced-dose NOAC group. Clinical parameters such as renal function are often unknown whilst these are essential to determine the right NOAC and dose. PMID: 30949972 [PubMed - as supplied by publisher]
Source: Netherlands Heart Journal - April 3, 2019 Category: Cardiology Authors: Jacobs MS, van Hulst M, Campmans Z, Tieleman RG Tags: Neth Heart J 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

Edaravone: a new hope for deadly amyotrophic lateral sclerosis.
This article discusses the preclinical pharmacology, pharmacokinetics, safety profile, clinical studies and drug interactions of edaravone (Radicava) in ALS. PMID: 29998226 [PubMed - in process]
Source: Drugs of Today - July 13, 2018 Category: Drugs & Pharmacology Tags: Drugs Today (Barc) Source Type: research

Perceived Advantages and Disadvantages of Oral Anticoagulants, and the Trade-offs Patients Make in Choosing Anticoagulant Therapy and Adhering to Their Drug Regimen
Oral anticoagulant therapy (OAT) is proven to be highly effective for stroke prevention in patients suffering from atrial fibrillation (AF) [1,2]. Vitamin K antagonists (VKAs), particularly warfarin, which is the most commonly used VKA, have long been the standard of care to prevent AF-related stroke [3]. However, in recent years the European Medicines Agency has approved a number of direct oral anticoagulants (DOACs) as (possible) alternatives to VKAs. The perceived benefits of DOACs include their high efficacy and low risk of bleeding, the rapid onset/offset of action, fewer food and drug interactions, and predictable ph...
Source: Patient Education and Counseling - July 2, 2018 Category: International Medicine & Public Health Authors: Melissa C.W. Vaanholt, Marieke G.M. Weernink, Clemens von Birgelen, Catharina G.M. Groothuis-Oudshoorn, Maarten J. Ijzerman, Janine A. van Til 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

The Burden of Diabetes and the Chance of a Previous Stroke: Thrombolysis for Recurrent Stroke in Diabetics
Intravenous thrombolysis with recombinant tissue plasminogen activator is still not approved by the European Medicines Agency for patients with diabetes mellitus and previous stroke. We assessed functional benefit and potential risk of thrombolysis in patients with diabetes and previous stroke and the influence of age, preexisting diabetic damage, as well as acute and chronic hyperglycemia on outcome, symptomatic intracranial hemorrhage, and in-hospital mortality.
Source: Journal of Stroke and Cerebrovascular Diseases - February 3, 2018 Category: Neurology Authors: Alexandra Filipov, Anne D. Ebert, Eva Neumaier-Probst, Angelika Alonso Source Type: research

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