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Drug: Victoza
Management: Food and Drug Administration (FDA)

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Total 10 results found since Jan 2013.

Spotlight on Antidiabetic Agents with Cardiovascular or Renoprotective Benefits.
Authors: Madievsky R Abstract Type 2 diabetes mellitus often goes hand in hand with cardiovascular and renal comorbidities. Stroke, myocardial infarction, heart failure, and chronic kidney disease are high-risk complications of type 2 diabetes that contribute to morbidity and mortality. Recent clinical trials have uncovered evidence that certain antidiabetic agents may confer cardiovascular and/or renal benefits such as reduced cardiovascular and all-cause mortality and reduced need for renal replacement therapy. Two landmark trials in particular, EMPA-REG OUTCOME (Empagliflozin, Cardiovascular Outcomes, and Mortal...
Source: The Permanente journal - September 21, 2018 Category: General Medicine Tags: Perm J Source Type: research

Integrating cardioprotective glucose-lowering medications into clinical practice
Patients with type 2 diabetes suffer from both microvascular and macrovascular complications. Optimal glycemic control is well known to reduce the microvascular complications of retinopathy, nephropathy, and neuropathy. However, despite having multiple classes of antidiabetes medications, we have not been able to favorably affect the cardiovascular (CV) complications of diabetes, which cause considerable morbidity and premature CV mortality in patients with diabetes. The recent publication of the EMPA-REG Outcome and the LEADER studies demonstrating favorable CV outcomes with empagliflozin and liraglutide have led to a dec...
Source: Cardiovascular Endocrinology - February 19, 2018 Category: Cardiology Tags: Review articles Source Type: research

Victoza (liraglutide) is Approved to Reduce the Risk of Three Major Adverse Cardiovascular Events in Type 2 Diabetes Patients
PLAINSBORO, N.J., Aug. 25, 2017 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved a new indication for Victoza (liraglutide) to reduce the risk of major adverse cardiovascular (CV) events, heart attack, stroke and CV death, in...
Source: Drugs.com - New Drug Approvals - August 25, 2017 Category: Drugs & Pharmacology Source Type: news

GLP-1R as a Target for the Treatment of Diabetic Retinopathy: Friend or Foe?
Glucagon-like peptide 1 receptor (GLP-1R) agonists are increasingly being used as treatment for type 2 diabetes. Since the U.S. Food and Drug Administration published recommendations about the cardiovascular safety of new antidiabetes therapies for treating type 2 diabetes in 2008, the results of two outstanding clinical trials using GLP-1R agonists addressing this issue (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results—A Long Term Evaluation [LEADER] and Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes [SUSTAIN-6]) ...
Source: Diabetes - May 22, 2017 Category: Endocrinology Authors: Simo, R.; Hernandez, C. Tags: Perspectives in Diabetes Source Type: research

Integration of recent evidence into management of patients with atherosclerotic cardiovascular disease and type 2 diabetes
Publication date: Available online 26 January 2017 Source:The Lancet Diabetes & Endocrinology Author(s): Eberhard Standl, Oliver Schnell, Darren K McGuire, Antonio Ceriello, Lars Rydén Cardiovascular outcome trials of antihyperglycaemic drugs and non-statin LDL-cholesterol-lowering drugs in patients with type 2 diabetes who have, or who are at high risk of, atherosclerotic cardiovascular disease have provided new evidence that has substantially affected the management of cardiovascular risk in these patients. On the basis of proven cardiovascular and renal benefit, the antihyperglycaemic drugs empagliflozin, lira...
Source: The Lancet Diabetes and Endocrinology - January 25, 2017 Category: Endocrinology Source Type: research

SAVOR-TIMI to SUSTAIN-6: A critical comparison of cardiovascular outcome trials of anti-diabetic drugs.
Abstract INTRODUCTION: Since the inception of mandatory cardiovascular (CV) safety outcome trial (CVOT) promulgated by US Food and Drug Administration in 2008, seven trials have so far been published with three different classes of anti-diabetic drugs in type 2 diabetes mellitus (T2DM). This mini-review aims to critically analyse these CVOTs in terms of different outcomes achieved. Areas covered: An electronic search pertaining to the subject was conducted till September 2016. The three CVOT conducted with saxagliptin, alogliptin and sitagliptin respectively, found them to be CV-neutral. However, both saxagliptin ...
Source: Pharmacological Reviews - January 24, 2017 Category: Drugs & Pharmacology Authors: Singh AK, Singh R Tags: Expert Rev Clin Pharmacol Source Type: research

EMPA-REG and Other Cardiovascular Outcome Trials of Glucose-lowering Agents: Implications for Future Treatment Strategies in Type 2 Diabetes Mellitus.
Abstract During the last decade, the armamentarium for glucose-lowering drugs has increased enormously by the development of DPP-4 inhibitors, GLP-1 receptor agonists and SGLT2 inhibitors, allowing individualization of antidiabetic therapy for patients with type 2 diabetes (T2DM). Some combinations can now be used without an increased risk for severe hypoglycemia and weight gain. Following a request of the US Food and Drug Administration, many large cardiovascular (CV) outcome studies have been performed in patients with longstanding disease and established CV disease. In the majority of CV outcome studies, CV ris...
Source: Clinical Therapeutics - May 18, 2016 Category: Drugs & Pharmacology Authors: Schernthaner G, Schernthaner-Reiter MH, Schernthaner GH Tags: Clin Ther Source Type: research

Pharmacologic Approaches to Weight Management: Recent Gains and Shortfalls in Combating Obesity
This article reviews recent literature in the field of Obesity Medicine and highlights important findings from clinical trials. Future directions in the pharmacologic management of obesity are presented along with new diabetes medications that promote weight loss and reduce cardiovascular mortality.
Source: Current Atherosclerosis Reports - May 14, 2016 Category: Cardiology Source Type: research

Evolution of Pharmacological Obesity Treatments: Focus on Adverse Side‐Effect Profiles
ABSTRACT Pharmacotherapy directed toward reducing body weight may provide benefits for both curbing obesity and lowering the risk of obesity‐associated co‐morbidities. However, many weight loss medications have been withdrawn from the market due to serious adverse effects. Examples include pulmonary hypertension (aminorex), cardiovascular toxicity, e.g. flenfluramine‐induced valvopathy, stroke (phenylpropanolamine), excess non‐fatal cardiovascular events (sibutramine), and neuro‐psychiatric issues (rimonabant ‐ approved in Europe, but not in the US). This negative experience has helped mold the current drug dev...
Source: Diabetes, Obesity and Metabolism - March 1, 2016 Category: Endocrinology Authors: Andrew J. Krentz, Ken Fujioka, Marcus Hompesch Tags: REVIEW ARTICLE Source Type: research

Cardiovascular safety of albiglutide in the Harmony programme: a meta-analysis
Publication date: Available online 11 August 2015 Source:The Lancet Diabetes & Endocrinology Author(s): Miles Fisher, Mark C Petrie, Philip D Ambery, Jill Donaldson, John J V McMurray, June Ye Background Albiglutide is a glucagon-like peptide-1 receptor agonist, a new class of drugs used to treat type 2 diabetes. We did a prospective meta-analysis of the cardiovascular safety of albiglutide as stipulated by the US Food and Drug Administration recommendations for the assessment of new treatments for diabetes. Methods We did a meta-analysis of eight phase 3 trials and one phase 2b trial in which patients wer...
Source: The Lancet Diabetes and Endocrinology - August 12, 2015 Category: Endocrinology Source Type: research