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Increased major bleeding incidence in atrial fibrillation patients with apixaban: a review of Japanese post-marketing surveillance studies of direct oral anticoagulants
AbstractLarge-scaled post-marketing surveillance studies (PMSSs) of 4 direct oral anticoagulants (DOACs) for stroke prevention in non-valvular atrial fibrillation (AF) were conducted since 2011 in Japan, and the results of the last one have recently been published. Each reported a more than acceptable ischemic stroke prevention. The major bleeding rates were also acceptably low and comparable to each other in the PMSSs of dabigatran (J-dabigatran), rivaroxaban (XAPASS), and edoxaban (ETNA-AF-Japan). However, the incidence in PMSS of apixaban (STANDARD) was more than double the others. This finding appeared to contradict th...
Source: European Journal of Clinical Pharmacology - April 25, 2023 Category: Drugs & Pharmacology Source Type: research

In Brief: Tegaserod (Zelnorm) Returns
Date: May 6, 2019 Issue #:  1571Summary:  Tegaserod maleate(Zelnorm), a 5-HT4 receptor partial agonist that increases gastrointestinal (GI) motility, was approved by the FDA in 2002 for short-term treatment of irritable bowel syndrome with constipation (IBS-C) in women and in 2004 for treatment of chronic idiopathic constipation (CIC) in adults<65 years old.In 2007, the manufacturer (Novartis) complied with an FDA request to stop marketing the drug based on an unpublished retrospective analysis of clinical trials in IBS-C and other GI motility disorders that showed a higher rate of ischemic ...
Source: The Medical Letter - April 26, 2019 Category: Drugs & Pharmacology Authors: admin Tags: Constipation irritable bowel syndrome Motegrity prucalopride Resotran Tegaserod Zelnorm Source Type: research

Cardiovascular Disease in Gout and the  Protective Effect of Treatments Including Urate-Lowering Therapy
AbstractCardiovascular disease affects more than 90 million Americans. Recent studies support an increased cardiovascular disease risk in inflammatory conditions, such as gout. Increased serum urate levels, or hyperuricemia, are a precursor to gout. Data from meta-analyses have shown hyperuricemia to be linked to hypertension and coronary heart disease. Similarly, gout has been associated with an increased risk of myocardial infarction, cerebrovascular accidents, and death from cardiovascular disease in randomized clinical trials. Urate-lowering therapy reduces serum urate and may decrease systemic inflammation, generation...
Source: Drugs - March 12, 2019 Category: Drugs & Pharmacology Source Type: research

Novel anticoagulants for stroke prevention in atrial fibrillation: safety issues in the elderly.
Abstract Vitamin K antagonists (VKAs) are the most widely used anticoagulants for stroke prevention in patients with atrial fibrillation (AF). Recently, the US FDA approved three novel anticoagulants that work through inhibition of coagulation cascade independent of Vitamin K-dependent enzymatic reactions and, therefore, should have less food-drug interactions. Since AF is a disease of the aging heart, it is important to assess safety and efficacy of these new anticoagulants in elderly patients. We reviewed age-related changes in pharmacokinetics and pharmacodynamics observed with senescence and the effects of the...
Source: Pharmacological Reviews - November 1, 2013 Category: Drugs & Pharmacology Authors: Strunets A, Mirza M, Sra J, Jahangir A Tags: Expert Rev Clin Pharmacol Source Type: research

The new oral anticoagulants in atrial fibrillation: Once daily or twice daily?
Abstract The new anticoagulants (NOACs) tested for prevention or treatment of venous thromboembolism (VTE), stroke prevention in atrial fibrillation (AF), and acute coronary syndromes (ACS) differ in bioavailability, metabolism, route of excretion and interaction with other drugs, but have remarkably similar pharmacokinetics, with very similar half lives. However the choice of dosing regimens in different clinical conditions has been different for the various NOACs, and has been established on the basis of widely different considerations, including the clinical setting (venous versus arterial thrombosis), the indi...
Source: Vascular Pharmacology - July 18, 2013 Category: Drugs & Pharmacology Authors: Renda G, De Caterina R Tags: Vascul Pharmacol Source Type: research

FDA approves alogliptin for type 2 diabetes as three separate preparations
Source: FDA Area: News The FDA has approved alogliptin for the treatment of type 2 diabetes as three separate preparations: alogliptin monotherapy; alogliptin in combination with metformin; and alogliptin in combination with pioglitazone.   Alogliptin stimulates insulin release following meals and was shown to be safe and effective as monotherapy in 14 clinical trials involving approximately 8,500 patients with type 2 diabetes.  Alogliptin monotherapy reduced glycosylated haemoglobin (HBA1c) by 0.4 to 0.6% compared to placebo following 26 weeks of treatment.   The FDA has requested additional data ...
Source: NeLM - News - January 28, 2013 Category: Drugs & Pharmacology Source Type: news