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https://www.readbyqxmd.com/read/28421983/comparative-study-between-multivariate-and-univariate-analysis-of-two-antidiabetic-combinations
#1
Maha F Abdel-Ghany, Omar Abdel-Aziz, Miriam F Ayad, Mariam M Tadros
New multivariate and univariate methods were developed for the analysis of two novel gliptin combinations by manipulating the zero-order and ratio spectra of empagliflozin and linagliptin in combination, with application on Glyxambi(®) tablets, and of alogliptin and pioglitazone in combination, with application on Oseni(®) tablets. Linearity ranges for chemometric approaches using principal component regression and partial least-squares were found to be 2–10, 2.5–12.5, 5–15, and 5–25 μg/mL for empagliflozin, linagliptin, alogliptin, and pioglitazone, respectively, whereas the respective linearity ranges for the spectrophotometric approaches were found to be 5–15, 2–12, 5–15, and 5–15 μg/mL...
April 18, 2017: Journal of AOAC International
https://www.readbyqxmd.com/read/28420699/erratum-alogliptin-a-dipeptidyl-peptidase-4-inhibitor-prevents-the-progression-of-carotid-atherosclerosis-in-patients-with-type-2-diabetes-the-study-of-preventive-effects-of-alogliptin-on-diabetic-atherosclerosis-spead-a-diabetes-care-2016-39-139-148
#2
Tomoya Mita, Naoto Katakami, Hidenori Yoshii, Tomio Onuma, Hideaki Kaneto, Takeshi Osonoi, Toshihiko Shiraiwa, Keisuke Kosugi, Yutaka Umayahara, Tsunehiko Yamamoto, Hiroki Yokoyama, Nobuichi Kuribayashi, Hideaki Jinnouchi, Masahiko Gosho, Iichiro Shimomura, Hirotaka Watada
No abstract text is available yet for this article.
April 18, 2017: Diabetes Care
https://www.readbyqxmd.com/read/28408925/combination-therapy-with-a-sodium-glucose-cotransporter-2-inhibitor-and-a-dipeptidyl-peptidase-4-inhibitor-additively-suppresses-macrophage-foam-cell-formation-and-atherosclerosis-in-diabetic-mice
#3
Michishige Terasaki, Munenori Hiromura, Yusaku Mori, Kyoko Kohashi, Hideki Kushima, Makoto Ohara, Takuya Watanabe, Olov Andersson, Tsutomu Hirano
Dipeptidyl peptidase-4 inhibitors (DPP-4is), in addition to their antihyperglycemic roles, have antiatherosclerotic effects. We reported that sodium-glucose cotransporter 2 inhibitors (SGLT2is) suppress atherosclerosis in a glucose-dependent manner in diabetic mice. Here, we investigated the effects of combination therapy with SGLT2i and DPP-4i on atherosclerosis in diabetic mice. SGLT2i (ipragliflozin, 1.0 mg/kg/day) and DPP-4i (alogliptin, 8.0 mg/kg/day), either alone or in combination, were administered to db/db mice or streptozotocin-induced diabetic apolipoprotein E-null (Apoe(-/-) ) mice...
2017: International Journal of Endocrinology
https://www.readbyqxmd.com/read/28402902/cardiovascular-outcome-studies-with-incretin-based-therapies-comparison-between-dpp-4-inhibitors-and-glp-1-receptor-agonists
#4
REVIEW
André J Scheen
Dipeptidyl peptidase-4 inhibitors (DPP-4is) and glucagon-like peptide-1 receptor agonists (GLP-1RAs) represent two distinct classes of incretin-based therapies used for the treatment of type 2 diabetes. Non-inferiority versus placebo was shown in large prospective cardiovascular outcome trials in patients with high cardiovascular risk: SAVOR-TIMI 53 (saxagliptin), EXAMINE (alogliptin), and TECOS (sitagliptin); ELIXA (lixisenatide), LEADER (liraglutide) and SUSTAIN 6 (semaglutide). The promises raised by meta-analyses of phase 2-3 trials with DPP-4is were non confirmed as no cardiovascular protection could be evidenced...
March 25, 2017: Diabetes Research and Clinical Practice
https://www.readbyqxmd.com/read/28323503/add-on-dpp-4-inhibitor-alogliptin-alone-or-in-combination-with-pioglitazone-improved-%C3%AE-cell-function-and-insulin-sensitivity-in-metformin-treated-pcos
#5
Mojca Jensterle, Katja Goricar, Andrej Janez
PURPOSE: Impaired β-cell function remains unaddressed in PCOS. The aim of the study was to evaluate whether dipeptidyl peptidase-4 (DPP-4) inhibitor alogliptin (ALO) alone or in combination with pioglitazone (PIO) improves β-cell function along with insulin resistance (IR) in metformin (MET) treated obese women with PCOS with persistent IR. MATERIALS AND METHODS: In 12-week randomized study, ALO 25 mg QD (n=15) or ALO 25 mg QD and PIO 30 mg QD (n=15) was added to MET 1000 mg BID in PCOS women (aged 34...
March 21, 2017: Endocrine Research
https://www.readbyqxmd.com/read/28303056/fixed-dose-combination-of-alogliptin-pioglitazone-improves-glycemic-control-in-japanese-patients-with-type-2-diabetes-mellitus-independent-of-body-mass-index
#6
Chie Aoki, Kunihiro Suzuki, Hisamoto Kuroda, Masaaki Sagara, Masanori Shimizu, Kikuo Kasai, Yoshimasa Aso
This study investigated the effects of switching from combination therapy with either alogliptin (Alo) or pioglitazone (Pio) to fixed-dose combination therapy (FDCT) with alogliptin and pioglitazone (Alo-Pio FDCT). The usefulness and efficacy of Alo-Pio FDCT were investigated. A total of 50 outpatients with type 2 diabetes mellitus (T2DM) treated with Alo and 47 outpatients with T2DM treated with Pio were switched to Alo-Pio FDCT, and its efficacy and usefulness were evaluated. Significant improvements were observed in hemoglobinA1c (HbA1c), alanine transaminase (ALT), and γ-glutamyl transpeptidase (GGT) levels after switching to Alo-Pio FDCT for 16 weeks in both groups...
February 2017: Nagoya Journal of Medical Science
https://www.readbyqxmd.com/read/28291655/the-cardiovascular-safety-trials-of-dpp-4-inhibitors-glp-1-agonists-and-sglt2-inhibitors
#7
REVIEW
Matthew H Secrest, Jacob A Udell, Kristian B Filion
In this paper, we review the results of large, double-blind, placebo-controlled randomized trials mandated by the US Food and Drug Administration to examine the cardiovascular safety of newly-approved antihyperglycemic agents in patients with type 2 diabetes. The cardiovascular effects of dipeptidyl peptidase-4 (DPP-4) inhibitors remain controversial: while these drugs did not reduce or increase the risk of primary, pre-specified composite cardiovascular outcomes, one DPP-4 inhibitor (saxagliptin) increased the risk of hospitalization for heart failure in the overall population; another (alogliptin) demonstrated inconsistent effects on heart failure hospitalization across subgroups of patients, and a third (sitagliptin) demonstrated no effect on heart failure...
April 2017: Trends in Cardiovascular Medicine
https://www.readbyqxmd.com/read/28275958/comparative-effectiveness-of-adding-alogliptin-to-metformin-plus-sulfonylurea-with-other-dpp-4-inhibitors-in-type-2-diabetes-a-systematic-review-and-network-meta-analysis
#8
REVIEW
Stephen Kay, Amanda Strickson, Jorge Puelles, Ross Selby, Eugene Benson, Keith Tolley
INTRODUCTION: Alogliptin is an oral antihyperglycemic agent that is a selective inhibitor of the enzyme dipeptidyl peptidase-4 (DPP-4), approved for the treatment of type 2 diabetes mellitus (T2DM). There currently exists no comparative data to support the use of alogliptin in combination with metformin (met) and sulfonylurea (SU). A decision-focused network meta-analysis (NMA) was performed to compare the relative efficacy and safety of alogliptin 25 mg once daily to other DPP-4 inhibitors as part of a triple therapy regimen for patients inadequately controlled on metformin and SU dual therapy...
April 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28246236/serial-measurement-of-high-sensitivity-troponin-i-and-cardiovascular-outcomes-in-patients-with-type-2-diabetes-mellitus-in-the-examine-trial
#9
Matthew A Cavender, William B White, Petr Jarolim, George L Bakris, William C Cushman, Stuart Kupfer, Qi Gao, Cyrus R Mehta, Faiez Zannad, Christopher P Cannon, David A Morrow
Background -We sought to describe the relationship between changes in high-sensitivity cardiac troponin I (hsTnI) and cardiovascular (CV) outcomes. Methods -The Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care (EXAMINE) was a phase IIIb clinical outcomes trial designed to evaluate the CV safety of alogliptin, a non-selective dipeptidyl peptidase 4 (DPP-4) inhibitor. Patients with type 2 diabetes mellitus (T2DM), glycated hemoglobin between 6.5%-11% (or 7%-11% if they were on insulin), and a recent acute coronary syndrome (between 15-90 days prior to randomization) were eligible for the trial...
February 28, 2017: Circulation
https://www.readbyqxmd.com/read/28197977/interpreting-cardiovascular-endpoints-in-trials-of-antihyperglycemic-drugs
#10
REVIEW
Himika Chawla, Nikhil Tandon
In view of the significant cardiovascular (CV) morbidity and mortality in patients with type 2 diabetes mellitus, and concerns raised about the CV safety of some glucose-lowering drugs, the US Food and Drug Administration (FDA) issued guidance for the industry in 2008 to demonstrate CV safety for the approval of all new antihyperglycemic drugs. Seven randomized controlled trials involving around 60,000 participants have been completed so far and have demonstrated the CV safety of dipeptidyl peptidase 4 inhibitors (saxagliptin, alogliptin and sitagliptin), glucagon-like peptide-1 receptor agonists (lixisenatide, liraglutide and semaglutide) and a sodium-glucose co-transporter 2 inhibitor (empagliflozin) in patients with type 2 diabetes...
February 14, 2017: American Journal of Cardiovascular Drugs: Drugs, Devices, and Other Interventions
https://www.readbyqxmd.com/read/28195387/baseline-adiponectin-concentration-and-clinical-outcomes-among-patients-with-diabetes-and-recent-acute-coronary-syndrome-in-the-examine-trial
#11
Brian A Bergmark, Christopher P Cannon, William B White, Petr Jarolim, Yuyin Liu, Marc P Bonaca, Faiez Zannad, David A Morrow
INTRODUCTION: Adiponectin is a pleiotropic adipocytokine with a strong inverse (protective) association with obesity, diabetes, and cardiovascular outcomes in stable patients. However, this relationship may be reversed in the setting of acute coronary syndrome (ACS). Given this possible complex relationship, we investigated adiponectin and cardiovascular (CV) outcomes in patients with diabetes and recent ACS. MATERIALS AND METHODS: We analyzed baseline adiponectin concentration and CV outcomes in 5,213 patients with type 2 diabetes enrolled 15-90 days (median 45 days) after ACS in the EXAMINE trial of alogliptin vs placebo...
February 14, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28151518/-type-2-diabetes-treatment-and-cardiovascular-risk-what-can-we-learn-from-trials
#12
Agostino Consoli, Fabrizio Febo
Diabetes treatment should include drugs with absolutely no adverse effects toward cardiovascular risk. Indeed, it would be advisable to use drugs with intrinsic protective effect against the risk of cardiovascular events. Intervention trials aiming at demonstrating a protective cardiovascular effect of very tight glucose control have produced controversial results. It is commonly perceived, however, that early intervention with safe treatment strategies is likely to be beneficial. In regard to safety, in the attempt to firmly establish cardiovascular safety of new drugs for diabetes, Government Authorities have mandated that cardiovascular safety trials need to be performed for all new drugs registered for diabetes treatment...
December 2016: Giornale Italiano di Cardiologia
https://www.readbyqxmd.com/read/28131656/integration-of-recent-evidence-into-management-of-patients-with-atherosclerotic-cardiovascular-disease-and-type-2-diabetes
#13
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...
May 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
#14
REVIEW
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...
April 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28118775/renoprotective-effects-of-a-dipeptidyl-peptidase-4-inhibitor-in-a-mouse-model-of-progressive-renal-fibrosis
#15
Takahiro Uchida, Takashi Oda, Hidehito Matsubara, Atsushi Watanabe, Hanako Takechi, Naoki Oshima, Yutaka Sakurai, Hiroo Kumagai
Although the effects of dipeptidyl peptidase 4 (DPP-4) inhibitors beyond their hypoglycemic action have been reported, whether these inhibitors have renoprotective effects in nondiabetic chronic kidney disease (CKD) is unclear. We examined the therapeutic effects of DPP-4 inhibition in mice with unilateral ureteral obstruction (UUO), a nondiabetic model of progressive renal fibrosis. After UUO surgery, mice were administered either the DPP-4 inhibitor alogliptin or a vehicle by oral gavage once a day for 10 days...
November 2017: Renal Failure
https://www.readbyqxmd.com/read/28118563/analytical-stability-indicating-methods-for-alogliptin-in-tablets-by-lc-cad-and-lc-uv
#16
Charise Dallazem Bertol, Maria Tereza Friedrich, Graciela Carlos, Pedro Eduardo Froehlich
Stability-indicating LC methods using a UV detector and a charged aerosol detector (CAD) simultaneously were validatedfor the assessment of alogliptin (ALG) in tablets. The analysis was performed on a C<sub>8</sub> column (250 × 4.6 mm, 5 μm) at a flow of 0.8 mL/min, using acetonitrile-10 mM ammonium acetate buffer (pH 3.5; 90 + 10, v/v) as mobile phase and UV detection at 275 nm. Validation followed the International Conference on Harmonization guidelines. The method was linear over the range of 25-200 μg/mL...
December 15, 2016: Journal of AOAC International
https://www.readbyqxmd.com/read/28097882/antidiabetic-agents-and-cardiovascular-outcomes-in-patients-with-heart-diseases
#17
Judy W M Cheng, Hisham A Badreldin, Dhiren K Patel, Snehal H Bhatt
INTRODUCTION: This article reviews evidence of the benefits and risk of antidiabetic agents in cardiovascular (CV) outcomes, with a focus on medications approved by the FDA since 2008. STUDY SELECTION: Peer-reviewed articles were identified from MEDLINE and Current Content databases (both 1966 to 1 October 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...
February 15, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/28075066/efficacy-and-safety-of-fixed-dose-combination-therapy-alogliptin-plus-metformin-in-asian-patients-with-type-2-diabetes-a-phase-3-trial
#18
Linong Ji, Ling Li, Jian Kuang, Tao Yang, Dong-Jun Kim, Azidah A Kadir, Chien-Ning Huang, Douglas Lee
This study evaluated the efficacy and safety of 26 weeks of twice-daily (BID) alogliptin + metformin fixed-dose combination (FDC) therapy in Asian patients with type 2 diabetes. Patients aged 18 to 75 years with hemoglobin A1c (HbA1c) of 7.5% to 10.0% after ≥2 months of diet and exercise and a 4-week placebo run-in were enrolled. Eligible patients were randomized (1:1:1:1) to placebo, alogliptin 12.5 mg BID, metformin 500 mg BID or alogliptin 12.5 mg plus metformin 500 mg FDC BID. The primary endpoint was change in HbA1c from baseline to end of treatment (Week 26)...
January 11, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28058763/relationship-of-glycated-haemoglobin-and-reported-hypoglycaemia-to-cardiovascular-outcomes-in-patients-with-type-2-diabetes-and-recent-acute-coronary-syndrome-events-the-examine-trial
#19
Simon R Heller, Richard M Bergenstal, William B White, Stuart Kupfer, George L Bakris, William C Cushman, Cyrus R Mehta, Steven E Nissen, Craig A Wilson, Faiez Zannad, Yuyin Liu, Noah M Gourlie, Christopher P Cannon
AIMS: To investigate relationships between glycated haemoglobin (HbA1c) and reported hypoglycaemia and risk of major adverse cardiovascular events (MACE). METHODS: The EXAMINE trial randomized 5380 patients with type 2 diabetes (T2DM) and a recent acute coronary syndrome (ACS) event, in 49 countries, to double-blind treatment with alogliptin or placebo in addition to standard of care. We used Cox proportional hazards models to analyse relationships among MACE, HbA1c levels and hypoglycaemic events...
January 6, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/27999883/the-pharmacokinetics-and-pharmacodynamics-of-alogliptin-in-children-adolescents-and-adults-with-type-2-diabetes-mellitus
#20
RANDOMIZED CONTROLLED TRIAL
Caroline Dudkowski, Max Tsai, Jie Liu, Zhen Zhao, Eric Schmidt, Jeannie Xie
PURPOSE: The aim of this study is to determine the pharmacokinetics (PK) and pharmacodynamics (PD) of a single 12.5- or 25-mg dose of alogliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, in pediatric (children and adolescents) and adult subjects with type 2 diabetes mellitus (T2DM). METHODS: A randomized, open-label, multicenter study was conducted in pediatric and adult subjects. Subjects in two pediatric groups (children and adolescents) were randomized 1:1 to receive a single oral dose of alogliptin 12...
March 2017: European Journal of Clinical Pharmacology
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