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saxagliptin and heart failure

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https://www.readbyqxmd.com/read/28131656/integration-of-recent-evidence-into-management-of-patients-with-atherosclerotic-cardiovascular-disease-and-type-2-diabetes
#1
REVIEW
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, liraglutide, and semaglutide-the latter being under review for approval by the US Food and Drug Administration and the European Medicines Agency-should be preferentially used as second-line treatments in these patient populations, typically in addition to metformin...
January 25, 2017: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/28121469/savor-timi-to-sustain-6-a-critical-comparison-of-cardiovascular-outcome-trials-of-antidiabetic-drugs
#2
Awadhesh Kumar Singh, Ritu Singh
Since the inception of mandatory cardiovascular (CV) safety outcome trial (CVOT) promulgated by US FDA in 2008, seven trials have so far been published with three different classes of antidiabetic 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...
February 6, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28097882/antidiabetic-agents-and-cardiovascular-outcomes-in-patients-with-heart-diseases
#3
Judy W M Cheng, Hisham A Badreldin, Dhiren K Patel, Snehal H Bhatt
This article reviews evidence of benefits and risk of antidiabetic agents in cardiovascular (CV) outcomes, with a focus on medications approved by the FDA since 2008. Peer-reviewed articles were identified from MEDLINE and Current Content database (both 1966 to October 1, 2016) using the search terms insulin, metformin, rosiglitazone, pioglitazone, glyburide, glipizide, glimepiride, acarbose, miglitol, albiglutide, exenatide, liraglutide, lixisenatide, dulaglutide, pramlintide, meglitinide, alogliptin, linagliptin, saxagliptin, sitagliptin, canagliflozin, dapagliflozin, empagliflozin, colesevalam, bromocriptine, mortality, myocardial infarction (MI), heart failure, (HF) and stroke...
January 18, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/27844335/cardiovascular-safety-of-incretin-based-therapies-in-type-2-diabetes-systematic-review-of-integrated-analyses-and-randomized-controlled-trials
#4
REVIEW
Edoardo Mannucci, Matteo Monami
INTRODUCTION: Regulatory requirements mandate that new drugs for treatment of patients with type 2 diabetes mellitus (T2DM), such as dipeptidyl peptidase-4 (DPP-4) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists, are evaluated to show that they do not increase cardiovascular (CV) risk. METHODS: A systematic review was undertaken to evaluate the association between DPP-4 inhibitor and GLP-1 receptor agonist use and major adverse cardiac events (MACE)...
January 2017: Advances in Therapy
https://www.readbyqxmd.com/read/27835045/cardiovascular-outcomes-of-new-medications-for-type-2-diabetes
#5
Jennifer M Trujillo, Sara A Wettergreen, Wesley A Nuffer, Samuel L Ellis, Michael T McDermott
Cardiovascular (CV) disease remains the leading cause of death in people with diabetes, highlighting the importance of using treatment options that do not increase CV risk or possibly decrease CV outcomes. Since 2008, the Food and Drug Administration has required demonstration of CV safety for all new medications developed for the glycemic management of diabetes. Seven trials have been published that have established CV safety for three DPP-4 inhibitors (alogliptin, saxagliptin, and sitagliptin), three GLP-1 receptor agonists (liraglutide, lixisenatide, and semaglutide), and one sodium-glucose cotransporter-2 inhibitor (empagliflozin)...
December 2016: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/27681000/prognostic-implications-of-biomarker-assessments-in-patients-with-type-2-diabetes-at-high-cardiovascular-risk-a-secondary-analysis-of-a-randomized-clinical-trial
#6
Benjamin M Scirica, Deepak L Bhatt, Eugene Braunwald, Itamar Raz, Matthew A Cavender, KyungAh Im, Ofri Mosenzon, Jacob A Udell, Boaz Hirshberg, Pia S Pollack, Ph Gabriel Steg, Petr Jarolim, David A Morrow
Importance: Cardiac biomarkers provide insights into pathophysiologic processes and offer an attractive strategy for the assessment of cardiovascular risk. Objective: To assess the incremental prognostic value of biomarkers that reflect different pathophysiologic processes in patients with type 2 diabetes. Design, Setting, and Participants: The Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR)-Thrombolysis in Myocardial Infarction (TIMI) 53 is a randomized, double-blind, placebo-controlled clinical trial that evaluated the safety of saxagliptin vs placebo in 16 492 outpatients with type 2 diabetes with overt cardiovascular disease (CVD) or multiple risk factors...
December 1, 2016: JAMA Cardiology
https://www.readbyqxmd.com/read/27666017/cardiac-dpp-4-inhibition-by-saxagliptin-ameliorates-isoproterenol-induced-myocardial-remodeling-and-cardiac-diastolic-dysfunction-in-rats
#7
Junichi Ikeda, Naoya Kimoto, Tetsuya Kitayama, Shunji Kunori
Saxagliptin, a potent and selective DPP-4 inhibitor, is characterized by its slow dissociation from DPP-4 and its long half-life and is expected to have a potent tissue membrane-bound DPP-4-inhibitory effect in various tissues. In the present study, we examined the effects of saxagliptin on in situ cardiac DPP-4 activity. We also examined the effects of saxagliptin on isoproterenol-induced the changes in the early stage such as, myocardial remodeling and cardiac diastolic dysfunction. Male SD rats treated with isoproterenol (1 mg/kg/day via osmotic pump) received vehicle or saxagliptin (17...
September 2016: Journal of Pharmacological Sciences
https://www.readbyqxmd.com/read/27612317/cardiovascular-safety-trials-of-incretin-based-drugs-what-do-they-mean
#8
Daisuke Yabe, Yutaka Seino
Incretin-based dipeptidyl peptidase-4 inhibitors and glucagon-like peptide-1 receptor agonists are newer choices of antidiabetic medications that are now most widely used worldwide. Preclinical study results suggest that the two drugs potentially exert benefits to prevent onsets and/or progressions of diabetes-related complications, such as myocardial infarctions and strokes. Outcomes of five clinical trials to evaluate the cardiovascular (CV) safety of dipeptidyl peptidase-4 inhibitors and glucagon-like peptide-1 receptor agonist have been recently reported...
September 9, 2016: Journal of Diabetes Investigation
https://www.readbyqxmd.com/read/27538170/correction-risk-for-hospitalized-heart-failure-among-new-users-of-saxagliptin-sitagliptin-and-other-antihyperglycemic-drugs
#9
(no author information available yet)
No abstract text is available yet for this article.
August 16, 2016: Annals of Internal Medicine
https://www.readbyqxmd.com/read/27390991/saxagliptin-and-risk-of-heart-failure-hospitalization-concern-or-miscalculation
#10
Ana María Cebrián-Cuenca, Domingo Orozco-Beltrán, Jorge Navarro-Pérez, Josep Franch-Nadal, Julio Núñez-Villota, Luciano Consuegra-Sánchez
No abstract text is available yet for this article.
October 1, 2016: International Journal of Cardiology
https://www.readbyqxmd.com/read/27389437/no-increased-risk-of-hospitalization-for-heart-failure-for-patients-treated-with-dipeptidyl-peptidase-4-inhibitors-in-taiwan
#11
Chia-Hsuin Chang, Yi-Cheng Chang, Jou-Wei Lin, James L Caffrey, Li-Chiu Wu, Mei-Shu Lai, Lee-Ming Chuang
BACKGROUND: Saxagliptin has been reported to be associated with an increased risk of hospitalization for heart failure (HF). The objective of this study was to test whether the increased risk is drug specific or a class effect for dipeptidyl peptidase-4 (DPP-4) inhibitors. METHODS: Diabetic patients prescribed sitagliptin, saxagliptin, and vildagliptin between 2011 and 2013 were identified from Taiwan's National Health Insurance (NHI) claims database. The outcome of interest was the first hospitalization for HF...
October 1, 2016: International Journal of Cardiology
https://www.readbyqxmd.com/read/27373139/novel-antidiabetic-drugs-and-cardiovascular-risk-primum-non-nocere
#12
R C Bonadonna, C Borghi, A Consoli, M Volpe
AIMS: Diabetes treatments aim at preventing undesirable metabolic effects of hyperglycemia and at preventing/reducing tissue damage, including cardiovascular (CV) events. For approval, novel diabetes drugs undergo early systematic investigation to assess CV safety. This review provides an updated analysis of the results of recent studies examining novel diabetes medications and CV outcomes. DATA SYNTHESIS: The new regulatory guidelines enforce adjudication of all CV events when testing novel diabetes drugs...
September 2016: Nutrition, Metabolism, and Cardiovascular Diseases: NMCD
https://www.readbyqxmd.com/read/27347354/cardiovascular-safety-of-dipeptidyl-peptidase-4-inhibitors-recent-evidence-on-heart-failure
#13
Saumya Reddy Kankanala, Rafay Syed, Quan Gong, Boxu Ren, Xiaoquan Rao, Jixin Zhong
The cardiovascular safety of DPP4 inhibitors as a class, especially in regards to heart failure, has been questioned after the publication of first trials (SAVOR-TIMI 53 and EXAMINE) assessing the cardiovascular risks of DPP4 inhibitors alogliptin and sitagliptin in 2013. Although there were no increased risks in composite cardiovascular outcomes, the SAVOR-TIMI 53 trial reported a 27% increase in hospitalization for heart failure in diabetic patients who received the DPP4 inhibitor saxagliptin. There has been substantial increase in knowledge on the heart failure effect of DPP4 inhibition since 2013...
2016: American Journal of Translational Research
https://www.readbyqxmd.com/read/27210264/empa-reg-and-other-cardiovascular-outcome-trials-of-glucose-lowering-agents-implications-for-future-treatment-strategies-in-type-2-diabetes-mellitus
#14
Guntram Schernthaner, Marie Helene Schernthaner-Reiter, Gerit-Holger Schernthaner
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...
June 2016: Clinical Therapeutics
https://www.readbyqxmd.com/read/27195949/diabetes-mellitus-and-heart-failure-a-review-of-the-use-of-antidiabetic-medications-in-patients-with-heart-failure
#15
Marylene M Samia El Hayek, Maya F Beydoun, Sami Azar
Diabetes mellitus increases the mortality secondary to heart failure independent of hypertension and coronary artery disease. Several hypoglycemic agents are used to achieve glycemic control, of which several classes however still raise controversies in terms of safety in patients with concomitant heart failure: Metformin does not carry an increased risk of exacerbation in patients with stable heart failure, yet should be avoided in patients with unstable disease or chronic kidney disease. Sulfonylureas are neither associated with an increased mortality, nor do they seem to have deleterious effects on heart failure...
May 19, 2016: Minerva Endocrinologica
https://www.readbyqxmd.com/read/27110660/risk-for-hospitalized-heart-failure-among-new-users-of-saxagliptin-sitagliptin-and-other-antihyperglycemic-drugs-a-retrospective-cohort-study
#16
Sengwee Toh, Christian Hampp, Marsha E Reichman, David J Graham, Suchitra Balakrishnan, Frank Pucino, Jack Hamilton, Samuel Lendle, Aarthi Iyer, Malcolm Rucker, Madelyn Pimentel, Neesha Nathwani, Marie R Griffin, Nancy J Brown, Bruce H Fireman
BACKGROUND: Recent postmarketing trials produced conflicting results about the risk for hospitalized heart failure (hHF) associated with dipeptidyl peptidase-4 (DPP-4) inhibitors, creating uncertainty about the safety of these antihyperglycemic agents. OBJECTIVE: To examine the associations of hHF with saxagliptin and sitagliptin. DESIGN: Population-based, retrospective, new-user cohort study. SETTING: 18 health insurance and health system data partners in the U...
June 7, 2016: Annals of Internal Medicine
https://www.readbyqxmd.com/read/27106831/outcome-studies-and-safety-as-guide-for-decision-making-in-treating-patients-with-type-2-diabetes
#17
REVIEW
Avivit Cahn, Simona Cernea, Itamar Raz
Cardiovascular disease is the leading cause of mortality in patients with diabetes. Over the past 20 years multiple CV outcome studies have been conducted assessing the cardiovascular benefits of tight glycemic control or of particular glucose lowering agents. Improved glycemic control per-se failed to significantly reduce the risk of adverse cardiovascular outcomes in the short term, and it is only after >15 years that a reduction in adverse CV outcomes with tight glycemic control was perceived. Moreover tight glycemic control and increased attendant hypoglycemia led to increased mortality observed in the ACCORD trial...
March 2016: Reviews in Endocrine & Metabolic Disorders
https://www.readbyqxmd.com/read/27098966/saxagliptin-and-tadalafil-differentially-alter-cyclic-guanosine-monophosphate-cgmp-signaling-and-left-ventricular-function-in-aortic-banded-mini-swine
#18
Jessica A Hiemstra, Dong I Lee, Khalid Chakir, Manuel Gutiérrez-Aguilar, Kurt D Marshall, Pamela J Zgoda, Noelany Cruz Rivera, Daniel G Dozier, Brian S Ferguson, Denise M Heublein, John C Burnett, Carolin Scherf, Jan R Ivey, Gianmaria Minervini, Kerry S McDonald, Christopher P Baines, Maike Krenz, Timothy L Domeier, Craig A Emter
BACKGROUND: Cyclic guanosine monophosphate-protein kinase G-phosphodiesterase 5 signaling may be disturbed in heart failure (HF) with preserved ejection fraction, contributing to cardiac remodeling and dysfunction. The purpose of this study was to manipulate cyclic guanosine monophosphate signaling using the dipeptidyl-peptidase 4 inhibitor saxagliptin and phosphodiesterase 5 inhibitor tadalafil. We hypothesized that preservation of cyclic guanosine monophosphate cGMP signaling would attenuate pathological cardiac remodeling and improve left ventricular (LV) function...
April 20, 2016: Journal of the American Heart Association
https://www.readbyqxmd.com/read/27067162/dipeptidyl-peptidase-4-inhibitors-and-heart-failure-analysis-of-spontaneous-reports-submitted-to-the-fda-adverse-event-reporting-system
#19
E Raschi, E Poluzzi, A Koci, I C Antonazzo, G Marchesini, F De Ponti
BACKGROUND AND AIMS: We tested the possible association between dipeptidyl peptidase-4 inhibitors (DPP-4-I) use and heart failure (HF) occurrence by assessing the publicly available US-FDA Adverse Event Reporting System (FAERS). METHODS: FAERS data reporting HF and DPP-4-Is use in the period from the fourth quarter of 2006 through 2013 were extracted, using the Standardized MedDRA Query "Cardiac failure". Disproportionality (case/non-case method) was implemented by calculating Reporting Odds Ratios (RORs) with 95% Confidence Interval (CI): (1) exploratory analysis on the entire FAERS (using rosiglitazone as positive control); (2) consolidated analyses by therapeutic area (within antidiabetics), correcting for event- and drug-related competition bias and adjusting for co-reported drugs as confounders...
May 2016: Nutrition, Metabolism, and Cardiovascular Diseases: NMCD
https://www.readbyqxmd.com/read/27063427/-cardiovascular-safety-of-incretin-based-antidiabetic-treatment-results-of-completed-clinical-trials
#20
REVIEW
György Jermendy
Several randomized, controlled clinical trials were initiated some years ago in order to evaluate the cardiovascular safety of the new antidiabetic drugs in patients with type 2 diabetes due to requirements from regulatory bodies. Four trials with incretin-based drugs (saxagliptin, alogliptin, sitagliptin and lixisenatide) have been completed so far. Based on the primary outcome endpoints of these trials no cardiovascular risks were found with incretins in patients with type 2 diabetes. As for saxagliptin, the hospitalization for heart failure was investigated as a secondary endpoint, and an increased risk was observed in the respective trial; however, this observation was widely debated later in the literature...
April 17, 2016: Orvosi Hetilap
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