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Bromocriptine-QR therapy for the management of type 2 diabetes mellitus: developmental basis and therapeutic profile summary.
Authors: Raskin P, Cincotta AH Abstract An extended series of studies indicate that endogenous phase shifts in circadian neuronal input signaling to the biological clock system centered within the hypothalamic suprachiasmatic nucleus (SCN) facilitates shifts in metabolic status. In particular, a diminution of the circadian peak in dopaminergic input to the peri-SCN facilitates the onset of fattening, insulin resistance and glucose intolerance while reversal of low circadian peak dopaminergic activity to the peri-SCN via direct timed dopamine administration to this area normalizes the obese, insulin resistant, gluco...
Source: Expert Review of Endocrinology and Metabolism - August 2, 2018 Category: Endocrinology Tags: Expert Rev Endocrinol Metab Source Type: research

Composite Primary End Points in Cardiovascular Outcomes Trials Involving Type 2 Diabetes Patients: Should Unstable Angina Be Included in the Primary End Point?
Reductions in cardiovascular (CV) outcomes in recently reported trials, along with the recent approval by the U.S. Food and Drug Administration of an additional indication for empagliflozin to reduce the risk of CV death in type 2 diabetes patients with evidence of CV disease, have renewed interest in CV outcome trials (CVOTs) of glucose-lowering drugs. Composite end points are a pragmatic necessity in CVOTs to ensure that sample size and duration of follow-up remain reasonable. Combining clinical outcomes into a composite end point increases the numbers of events ascertained and thus statistical power and precision. Histo...
Source: Diabetes Care - August 22, 2017 Category: Endocrinology Authors: Marx, N.; McGuire, D. K.; Perkovic, V.; Woerle, H.-J.; Broedl, U. C.; von Eynatten, M.; George, J. T.; Rosenstock, J. Tags: Perspectives in Care Source Type: research

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

Survival and cardiovascular events in men treated with testosterone replacement therapy: an intention-to-treat observational cohort study
Publication date: Available online 7 May 2016 Source:The Lancet Diabetes & Endocrinology Author(s): Christopher J D Wallis, Kirk Lo, Yuna Lee, Yonah Krakowsky, Alaina Garbens, Raj Satkunasivam, Sender Herschorn, Ronald T Kodama, Patrick Cheung, Steven A Narod, Robert K Nam Background Conflicting evidence exists for the association between testosterone replacement therapy and mortality and cardiovascular events. The US Food and Drug Administration recently cautioned that testosterone replacement therapy might increase risk of heart attack and stroke, based on evidence from studies with short treatment d...
Source: The Lancet Diabetes and Endocrinology - May 7, 2016 Category: Endocrinology 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

Insights From Cardiovascular Outcome Trials with Novel Antidiabetes Agents: What Have We Learned? An Industry Perspective
Abstract Owing to the close association of cardiovascular (CV) disease with type 2 diabetes and the uncertainty surrounding the CV safety of antidiabetes agents, in 2008 the Food and Drug Administration issued guidance for the demonstration of CV safety for new antidiabetes drugs. Recently the results from CV outcomes trials of three dipeptidyl peptidase-4 (DPP-4) inhibitors and a glucagon-like peptide-1 receptor agonist have been reported. The Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR) trial, the Examination of Cardiovascular Outcomes with Alogliptin versus St...
Source: Current Diabetes Reports - September 14, 2015 Category: Endocrinology 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