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https://www.readbyqxmd.com/read/29468916/the-safety-of-gliptins-updated-data-in-2018
#1
André J Scheen
Dipeptidyl peptidase-4 inhibitors (DPP-4is) are generally considered as glucose-lowering agents with a safe profile in type 2 diabetes. Areas covered: An updated review of recent safety data from randomised controlled trials, observational studies, meta-analyses, pharmacovigilance reports regarding alogliptin, linagliptin, saxagliptin, sitagliptin, and vildagliptin, with a special focus on risks of hypoglycaemia, pancreatitis and pancreatic cancer, major cardiovascular events, hospitalisation for heart failure and other new safety issues, such as bone fractures and arthralgia...
February 22, 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29450684/application-and-impact-of-run-in-studies
#2
Michael Fralick, Jerry Avorn, Jessica M Franklin, Abdurrahman Abdurrob, Aaron S Kesselheim
BACKGROUND: A run-in phase is often employed prior to randomization in a clinical trial to exclude non-adherent patients, placebo responders, active drug non-responders, or patients who do not tolerate the active drug. This may impact the generalizability of trial results. OBJECTIVE: To determine if clinical outcomes differed between randomized controlled trials with run-in phases compared with randomized controlled trials of the same medication without run-in phases...
February 15, 2018: Journal of General Internal Medicine
https://www.readbyqxmd.com/read/29446523/safety-and-tolerability-of-dapagliflozin-saxagliptin-and-metformin-in-combination-post-hoc-analysis-of-concomitant-add-on-versus-sequential-add-on-to-metformin-and-of-triple-versus-dual-therapy-with-metformin
#3
Stefano Del Prato, Julio Rosenstock, Ricardo Garcia-Sanchez, Nayyar Iqbal, Lars Hansen, Eva Johnsson, Hungta Chen, Chantal Mathieu
The safety of triple oral therapy with dapagliflozin plus saxagliptin plus metformin, versus dual therapy with dapagliflozin or saxagliptin plus metformin, was compared in a post hoc analysis of three randomized trials of sequential or concomitant add-on of dapagliflozin and saxagliptin to metformin. In the concomitant add-on trial, patients with type 2 diabetes on stable metformin received dapagliflozin 10 mg/day plus saxagliptin 5 mg/day. In sequential add-on trials, patients on metformin plus either saxagliptin 5 mg/day or dapagliflozin 10 mg/day received add-on dapagliflozin 10 mg/day or saxagliptin 5 mg/day, respectively...
February 15, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29394350/blood-pressure-and-cardiovascular-outcomes-in-patients-with-diabetes-and-high-cardiovascular-risk
#4
Brian A Bergmark, Benjamin M Scirica, Ph Gabriel Steg, Christina L Fanola, Yared Gurmu, Ofri Mosenzon, Avivit Cahn, Itamar Raz, Deepak L Bhatt
Aims: Optimal blood pressure for prevention of cardiovascular (CV) events in patients with Type 2 diabetes mellitus (T2DM) remains uncertain and there is concern for increased risk with low diastolic blood pressure (DBP). This study analysed the association between blood pressure and CV outcomes in high-risk patients with T2DM. Methods and results: Patients with T2DM and elevated CV risk were enrolled in the Saxagliptin Assessment of Vascular Outcomes Recorded in patients with diabetes mellitus-Thrombolysis in Myocardial Infarction 53 trial...
January 31, 2018: European Heart Journal
https://www.readbyqxmd.com/read/29364549/dipeptidyl-peptidase-4-inhibitors-and-heart-failure-exacerbation-in-the-veteran-population-an-observational-study
#5
Michael R Cobretti, Benjamin Bowman, Ted Grabarczyk, Emily Potter
OBJECTIVES: The dipeptidyl peptidase-4 inhibitors (DPP-4 inhibitors) are effective modulators of fasting and postprandial hyperglycemia in patients with type 2 diabetes mellitus (T2DM). In 2013 the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus-Thrombolysis in Myocardial Infarction 53 (SAVOR-TIMI 53) clinical trial found an increased risk of heart failure exacerbation, as a secondary outcome, among patients treated with saxagliptin. This study examines the safety of DPP-4 inhibitors as a class in T2DM in relation to risk of heart failure exacerbations...
January 24, 2018: Pharmacotherapy
https://www.readbyqxmd.com/read/29359260/clinical-impact-of-oral-antidiabetic-medications-in-heart-failure-patients
#6
REVIEW
Alberto Palazzuoli, Elena Ceccarelli, Gaetano Ruocco, Ranuccio Nuti
Heart failure (HF) is a common complication in patients with type 2 diabetes and it is closely associated with high morbidity and mortality rate. The incidence of cardiovascular events in patients with diabetes is related to high levels of glycemia, expressed by increase of HbA1c levels. However, there is little evidence to indicate that glycemic control can reduce the incidence of HF events in this population. Recently, several new antidiabetic drugs have been proposed although the exact clinical impact on heart failure occurrence and deterioration is under debate...
January 23, 2018: Heart Failure Reviews
https://www.readbyqxmd.com/read/29241903/effect-of-dipeptidyl-peptidase-4-inhibitors-on-heart-failure-a-network-meta-analysis
#7
COMPARATIVE STUDY
Wen-Qin Guo, Lang Li, Qiang Su, Wei-Ran Dai, Zi-Liang Ye
BACKGROUND: Previous meta-analyses evaluating the effectiveness of individual dipeptidyl peptidase-4 (DPP-4) inhibitors on the risk of heart failure (HF) were limited because of the small number of trials with direct comparisons between two treatments. METHODS: A Bayesian network meta-analysis was performed to investigate the relationship between DPP-4 inhibitors and the risk of HF in patients with type-2 diabetes mellitus. The primary outcome was the occurrence of HF or hospital admission for HF...
December 2017: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/29239764/treatment-choices-for-the-glycaemic-management-of-patients-with-type-2-diabetes-and-chronic-kidney-disease-analysis-of-the-sail-patient-linked-dataset
#8
Thinzar Min, Gareth I Davies, Sam Rice, James Chess, Jeffrey W Stephens
AIMS: Chronic kidney disease (CKD) is common in type 2 diabetes and limits the treatment choices for glycaemic control. Our aim was to examine real-world prescribing for managing hyperglycaemia in the presence of CKD. METHODS: The SAIL (Secure Anonymised Information Linkage) databank was used to examine prescribing during the period from the 1st of January to 30th December 2014. CKD was defined as:- none or mild CKD, eGFR ≥60mL/min/1.73m2; moderate CKD eGFR <60mL/min/1...
November 23, 2017: Diabetes & Metabolic Syndrome
https://www.readbyqxmd.com/read/29231750/concordance-with-prescribing-information-dosage-recommendations-for-dipeptidyl-peptidase-4-inhibitors-among-type-2-diabetes-mellitus-patients-with-moderate-to-severe-chronic-kidney-disease
#9
Huan Huang, Sharash Shetty, Elise Bauer, Kathleen Lang
OBJECTIVE: To estimate the proportion of patients with moderate to severe chronic kidney disease (CKD) whose initial DPP4-i dosage was concordant with prescribing information (label) recommendations in the United States. METHODS: Adult patients with T2DM who initiated a DPP4-i (linagliptin, sitagliptin, saxagliptin) between Jan 1, 2011 and Jun 30, 2014 were identified using electronic medical records and administrative claims, with index date being the date of first observed DPP4-i treatment...
December 12, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/29230196/saxagliptin-induces-%C3%AE-cell-proliferation-through-increasing-stromal-cell-derived-factor-1%C3%AE-in-vivo-and-in-vitro
#10
Chun-Jun Li, Bei Sun, Qian-Hua Fang, Min Ding, Yun-Zhi Xing, Li-Ming Chen, De-Min Yu
Dipeptidyl peptidase-4 inhibitors, such as saxagliptin, have been reported to have beneficial effects on β-cell function, but the specific underlying mechanism remains unclear. Stromal cell-derived factor-1α (SDF-1α), a chemokine produced in multiple organs, has been considered as a crucial regulator in promoting β-cell survival. Here, we speculate that SDF-1α might mediate the effect of saxagliptin on improving β-cell function. After 12-week saxagliptin treatment in high-fat diet/streptozotocin-induced diabetic rats, significant improvement in pancreas insulin secretion capacity evaluated by hyperglycemia clamp and increased β-cell to α-cell areas ratio were observed...
2017: Frontiers in Endocrinology
https://www.readbyqxmd.com/read/29214305/cardiovascular-outcomes-according-to-urinary-albumin-and-kidney-disease-in-patients-with-type-2-diabetes-at-high-cardiovascular-risk-observations-from-the-savor-timi-53-trial
#11
Benjamin M Scirica, Ofri Mosenzon, Deepak L Bhatt, Jacob A Udell, Ph Gabriel Steg, Darren K McGuire, KyungAh Im, Estella Kanevsky, Christina Stahre, Mikaela Sjöstrand, Itamar Raz, Eugene Braunwald
Importance: An elevated level of urinary albumin to creatinine ratio (UACR) is a marker of renal dysfunction and predictor of kidney failure/death in patients with type 2 diabetes. The prognostic use of UACR in established cardiac biomarkers is not well described. Objective: To evaluate whether UACR offers incremental prognostic benefit beyond risk factors and established plasma cardiovascular biomarkers. Design, Setting, and Participants: The Saxagliptin Assessment of Vascular Outcomes Recorded in Patients With Diabetes Mellitus-Thrombolysis in Myocardial Infarction (SAVOR-TIMI) 53 study was performed from May 2010 to May 2013 and evaluated the safety of saxagliptin vs placebo in patients with type 2 diabetes with overt cardiovascular disease or multiple risk factors...
December 6, 2017: JAMA Cardiology
https://www.readbyqxmd.com/read/29206832/the-effects-of-dipeptidyl-peptidase-4-inhibitors-on-bone-fracture-among-patients-with-type-2-diabetes-mellitus-a-network-meta-analysis-of-randomized-controlled-trials
#12
Jun Yang, Chao Huang, Shanshan Wu, Yang Xu, Ting Cai, Sanbao Chai, Zhirong Yang, Feng Sun, Siyan Zhan
AIM: The association between dipeptidyl peptidase-4 inhibitors (DPP-4is), a class of anti-diabetes, and bone fracture in patients with type 2 diabetes mellitus (T2DM) is unknown. This meta-analysis aimed to systematically evaluate the effects of DPP-4is on bone fracture in T2DM patients. METHODS: We searched the Cochrane Library, Embase, Medline and ClinicalTrials.gov from inception through April 28th, 2016 to identify randomized controlled trials (RCTs) that compared DPP-4is with placebo or other anti-diabetes in T2DM patients...
2017: PloS One
https://www.readbyqxmd.com/read/29176433/drug-updates-and-approvals-2017-in-review
#13
Geoffrey Mospan, Cortney Mospan, Shayna Vance, Alyssa Bradshaw, Kalyn Meosky, Kirklin Bowles
In 2017, the FDA approved several new drugs for use in primary care. This article highlights the following new drugs: brodalumab (Siliq), dapagliflozin and saxagliptin (Qtern), dupilumab (Dupixent), oxymetazoline (Rhofade), safinamide (Xadago), and sarilumab (Kevzara).
December 15, 2017: Nurse Practitioner
https://www.readbyqxmd.com/read/29163166/saxagliptin-attenuates-albuminuria-by-inhibiting-podocyte-epithelial-to-mesenchymal-transition-via-sdf-1%C3%AE-in-diabetic-nephropathy
#14
Yun-Peng Chang, Bei Sun, Zhe Han, Fei Han, Shao-Lan Hu, Xiao-Yu Li, Mei Xue, Yang Yang, Li Chen, Chun-Jun Li, Li-Ming Chen
The dipeptidyl peptidase-4 (DPP-4) inhibitor saxagliptin has been found to reduce progressive albuminuria, but the exact mechanism of inhibition is unclear. Podocyte epithelial-to-mesenchymal transition (EMT) has emerged as a potential pathway leading to proteinuria in diabetic nephropathy (DN). Stromal cell-derived factor-1α (SDF-1α), one of the substrates of DPP-4, can activate the protein kinase A pathway and subsequently inhibit its downstream effector, transforming growth factor-β1 (TGF-β1), which induces podocyte EMT...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/29144061/saxagliptin-add-on-therapy-in-chinese-patients-with-type-2-diabetes-inadequately-controlled-by-insulin-with-or-without-metformin-results-from-the-super-study-a-randomized-double-blind-placebo-controlled-trial
#15
Yingli Chen, Xiaomin Liu, Quanmin Li, Jianhua Ma, Xiaofeng Lv, Lixin Guo, Changjiang Wang, Yongquan Shi, Yanbing Li, Eva Johnsson, Mei Wang, June Zhao, Linong Ji
This prospective, multicentre, phase 3 study (NCT02104804) evaluated the efficacy and safety of saxagliptin add-on therapy in Chinese patients with type 2 diabetes inadequately controlled by insulin ± metformin. Patients with glycated haemoglobin (HbA1c) 7.5%-10.5% and fasting plasma glucose (FPG) <270 mg/dL on stable insulin therapy (20-150 U/day) were randomized (1:1) to saxagliptin 5 mg once daily (N = 232) or placebo (N = 230) for 24 weeks, stratified by metformin use. The primary efficacy measure was change in HbA1c...
November 16, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29122893/prospective-postmarketing-surveillance-of-acute-myocardial-infarction-in-new-users-of-saxagliptin-a-population-based-study
#16
Sengwee Toh, Marsha E Reichman, David J Graham, Christian Hampp, Rongmei Zhang, Melissa G Butler, Aarthi Iyer, Malcolm Rucker, Madelyn Pimentel, Jack Hamilton, Samuel Lendle, Bruce H Fireman
OBJECTIVE: The cardiovascular safety of saxagliptin, a dipeptidyl-peptidase 4 inhibitor, compared with other antihyperglycemic treatments is not well understood. We prospectively examined the association between saxagliptin use and acute myocardial infarction (AMI). RESEARCH DESIGN AND METHODS: We identified patients aged ≥18 years, starting from the approval date of saxagliptin in 2009 and continuing through August 2014, using data from 18 Mini-Sentinel data partners...
November 9, 2017: Diabetes Care
https://www.readbyqxmd.com/read/29113790/the-persistent-inhibitory-properties-of-saxagliptin-on-renal-dipeptidyl-peptidase-4-studies-with-hk-2-cells-in%C3%A2-vitro-and-normal-rats-in%C3%A2-vivo
#17
Masako Uchii, Mariko Sakai, Yuhei Hotta, Satoshi Saeki, Naoya Kimoto, Akinori Hamaguchi, Tetsuya Kitayama, Shunji Kunori
Saxagliptin, a potent and selective DPP-4 inhibitor, exhibits a slow dissociation from DPP-4. We investigated the sustained effects of saxagliptin on renal DPP-4 activity in a washout study using renal tubular (HK-2) cells, and in a pharmacodynamic study using normal rats. In HK-2 cells, the inhibitory potency of saxagliptin on DPP-4 activity persisted after washout, while that of sitagliptin was clearly reduced. In normal rats, a single treatment of saxagliptin or sitagliptin inhibited the plasma DPP-4 activity to similar levels...
October 23, 2017: Journal of Pharmacological Sciences
https://www.readbyqxmd.com/read/28984487/dapagliflozin-and-saxagliptin-tablets-for-adults-with-type-2-diabetes
#18
André J Scheen
Saxagliptin (a dipeptidyl peptidase-4 inhibitor, DPP-4i) and dapagliflozin (a sodium-glucose cotransporter type 2 inhibitor, SGLT2i) improve glucose control in type 2 diabetes (T2D) through different potentially complementary mechanisms, thus offering the opportunity for a combined therapy. Area covered: The characteristics of the saxagliptin/dapagliflozin combination are analysed, focusing on: 1) pharmacokinetic and pharmacodynamic properties; 2) efficacy and safety in phase III trials with concurrent and sequential add-on therapy; and 3) potential use in clinical practice, including in special populations (cardiovascular disease, heart failure, chronic kidney disease, elderly)...
October 18, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28977602/dipeptidyl-peptidase-4-inhibition-with-saxagliptin-ameliorates-angiotensin-ii-induced-cardiac-diastolic-dysfunction-in-male-mice
#19
Scott M Brown, Cassandra E Smith, Alex I Meuth, Maloree Khan, Annayya R Aroor, Hannah M Cleeton, Gerald A Meininger, James R Sowers, Vincent G DeMarco, Bysani Chandrasekar, Ravi Nistala, Shawn B Bender
Activation of the renin-angiotensin-aldosterone system is common in hypertension and obesity and contributes to cardiac diastolic dysfunction, a condition for which no treatment currently exists. In light of recent reports that antihyperglycemia incretin enhancing dipeptidyl peptidase (DPP)-4 inhibitors exert cardioprotective effects, we examined the hypothesis that DPP-4 inhibition with saxagliptin (Saxa) attenuates angiotensin II (Ang II)-induced cardiac diastolic dysfunction. Male C57BL/6J mice were infused with either Ang II (500 ng/kg/min) or vehicle for 3 weeks receiving either Saxa (10 mg/kg/d) or placebo during the final 2 weeks...
October 1, 2017: Endocrinology
https://www.readbyqxmd.com/read/28966696/comparing-adoption-of-breakthrough-and-me-too-drugs-among-medicare-beneficiaries-a-case-study-of-dipeptidyl-peptidase-4-inhibitors
#20
Inmaculada Hernandez, Yuting Zhang
PURPOSE: "Me-too" drugs are new pharmaceuticals with the mechanism of action of an existing drug and are considered less innovative than breakthrough drugs. The objective of this study was to evaluate whether the adoption patterns of the breakthrough drug sitagliptin and the "me-too" drug saxagliptin differed; and to assess whether the patterns differed between Medicare stand-alone (PDP) and Medicare-Advantage Part D (MA-PD) plans. METHODS: Pharmacy claims from a 5% random sample of Medicare Part D beneficiaries were used to identify all prescriptions filled for sitagliptin (breakthrough drug) and saxagliptin ("me-too" drug) between October 1, 2006 and December 31, 2011...
June 2017: Journal of Pharmaceutical Innovation
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