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Vildagliptin with metformin

Mahalingam Balakumar, Durai Prabhu, Chandrakumar Sathishkumar, Paramasivam Prabu, Namita Rokana, Ramesh Kumar, Srividhya Raghavan, Avinash Soundarajan, Sunita Grover, Virender Kumar Batish, Viswanathan Mohan, Muthuswamy Balasubramanyam
PURPOSE: Diabetes and obesity are characterized by glucose intolerance, fat deposition, inflammation, and dyslipidemia. Recent reports postulated that distinct gut microbiota alterations were observed in obese/diabetic subjects and modulating gut microbiota beneficially through specific probiotics could be a potential therapeutic option for type 2 diabetes/obesity. Therefore, we attempted to study the efficacy of probiotics of Indian gut origin (Lactobacillus plantarum MTCC5690 and Lactobacillus fermentum MTCC5689) along with a positive control, Lactobacillus rhamnosus (LGG) on glucose/lipid homeostasis in high-fat-diet-induced diabetic animal model...
October 18, 2016: European Journal of Nutrition
Alexandre Baptista, Inês Teixeira, Sónia Romano, António Vaz Carneiro, Julian Perelman
OBJECTIVE: To conduct a systematic review of cost-effectiveness, cost-utility, and cost-benefit studies of DPP-4 inhibitors for diabetes treatment versus other antidiabetics. METHODS: Three investigators searched the CRD York, Tufts CEA Registry, and MEDLINE databases through 2015. We reviewed all potentially relevant titles and abstracts, and screened full-text articles, according to inclusion criteria. We established a quality score for each study based on a 35-item list...
October 17, 2016: European Journal of Health Economics: HEPAC: Health Economics in Prevention and Care
Abhishek Anand
No abstract text is available yet for this article.
January 2016: Journal of the Association of Physicians of India
Ahmed A K Hassoun, Monira Al-Arouj, Mohamed Ibrahim
OBJECTIVE: To assess the effect of vildagliptin relative to sulfonylurea (SU) on hypoglycemic events, in Muslim patients from the Middle East with type 2 diabetes who fast during Ramadan. The primary endpoint was the proportion of patients with at least one hypoglycemic event (HE) during the fasting period. Secondary endpoints included change in weight, HbA1c levels, treatment adherence and overall safety. DESIGN AND METHODS: This multicenter, prospective, observational cohort study enrolled Muslim adult T2DM patients from Middle Eastern countries who received treatment with vildagliptin or SU as add on to metformin or monotherapy...
October 14, 2016: Current Medical Research and Opinion
Thomas Vanhove, Quinten Remijsen, Dirk Kuypers, Pieter Gillard
Post-transplant diabetes mellitus is a frequent complication of solid organ transplantation that generally requires treatment with lifestyle interventions and antidiabetic medication. A number of demonstrated and potential pharmacokinetic drug-drug interactions (DDIs) exist between commonly used immunosuppressants and antidiabetic drugs, which are comprehensively summarized in this review. Cyclosporine (CsA) itself inhibits the cytochrome P450 (CYP) 3A4 enzyme and a variety of drug transporters. As a result, it increases exposure to repaglinide and sitagliptin, will likely increase the exposure to nateglinide, glyburide, saxagliptin, vildagliptin and alogliptin, and could theoretically increase the exposure to gliquidone and several sodium-glucose transporter (SGLT)-2 inhibitors...
September 14, 2016: Transplantation Reviews
Rimke C Vos, Mariëlle Jp van Avendonk, Hanneke Jansen, Alexander N Goudswaard, Maureen van den Donk, Kees Gorter, Anneloes Kerssen, Guy Ehm Rutten
BACKGROUND: It is unclear whether people with type 2 diabetes mellitus on insulin monotherapy who do not achieve adequate glycaemic control should continue insulin as monotherapy or can benefit from adding oral glucose-lowering agents to the insulin therapy. OBJECTIVES: To assess the effects of insulin monotherapy compared with the addition of oral glucose-lowering agents to insulin monotherapy for people with type 2 diabetes already on insulin therapy and inadequate glycaemic control...
September 18, 2016: Cochrane Database of Systematic Reviews
Bo Ahrén, James E Foley
We hypothesized that the relative contribution of fasting plasma glucose (FPG) versus postprandial plasma glucose (PPG) to glycated haemoglobin (HbA1c) could be calculated using an algorithm developed by the A1c-Derived Average Glucose (ADAG) study group to make HbA1c values more clinically relevant to patients. The algorithm estimates average glucose (eAG) exposure, which can be used to calculate apparent PPG (aPPG) by subtracting FPG. The hypothesis was tested in a large dataset (comprising 17 studies) from the vildagliptin clinical trial programme...
2016: International Journal of Endocrinology
Eduardo Márquez-Rodríguez, Eduardo Brea-Andrea, Victoria Alejandro Rajmet-Hace, Javier Salinas-Salinas, Fabiola Mariño-Rojas
BACKGROUND: The multinational EDGE (Effectiveness of Diabetes control with vildaGliptin and vildagliptin/mEtformin) study assessed the effectiveness and tolerability of vildagliptin versus other oral antihyperglycemic drugs (OAD) when added to monotherapy in patients in the real-world setting. METHODS: Prospective, real-world observational study. The primary endpoint (PEP) was the proportion of patients achieving a reduction in HbA1c > 0.3% without peripheral edema, hypoglycemia, discontinuation, dueto gastrointestinal event, or weight gain > 5%...
July 2016: Gaceta Médica de México
Ahmed Ak Hassoun, Md Faruque Pathan, Rita C Medlej, Monira Alarouj, Inass Shaltout, Manoj S Chawla, Ditte Knap, Julius A Vaz
BACKGROUND: VIRTUE was a prospective, observational study assessing the effectiveness and safety of vildagliptin vs sulfonylureas (SUs) (both as monotherapy and in combination with metformin) in patients with type 2 diabetes mellitus who fasted during Ramadan. A post hoc analysis was carried out to assess the effect of treatment with/without metformin and age (<65 years or ≥65 years). PATIENTS AND METHODS: Patients were recruited from the Middle East and Asia...
2016: Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy
Mohamed Khattab, Khalifa Mahmoud, Inass Shaltout
INTRODUCTION: Fasting in patients with type 2 diabetes mellitus (T2DM) is associated with high risk of hypoglycemia. The aim of this study was to compare the effectiveness and safety of vildagliptin in T2DM patients fasting during Ramadan in a real-life setting in Egypt. METHODS: In this 16-week prospective and noninterventional study, data were collected up to 6 weeks before and after Ramadan fasting. Patients who had received vildagliptin or sulfonylurea (SU) either as dual therapy with metformin or as monotherapy were enrolled into the study...
September 2016: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
L-N Ji, C-Y Pan, J-M Lu, H Li, D-L Zhu, Q Li, Q-F Li, Y-D Peng, H-M Tian, C Yao, Z-G Zhao, L Wang, B-H Wang
AIMS: To compare the efficacy and safety of combination of vildagliptin and metformin therapy with metformin uptitration in Chinese patients with type 2 diabetes (T2DM) inadequately controlled with low-dose metformin. METHODS: In this 24-week prospective, randomized, multicentre, open-label study, patients with T2DM inadequately controlled with metformin ≤1000 mg daily were divided 1 : 1 : 1 : 1 into four prespecified subgroups based on age and body mass index (BMI)...
August 2016: Diabetes, Obesity & Metabolism
Michel Hermans, Luc Van Gaal, Ingrid Rézette, Evis Daci, Karen MacDonald, Kris Denhaerynck, Stefaan Vancayzeele, Lut De Meester, Andreas Clemens, Brian Yee, Ivo Abraham
AIMS: To evaluate the real-world effectiveness of vildagliptin and vildagliptin/metformin, combined with patient engagement, on glycemic outcomes. Patient engagement included both clinicians' engaging patients through education and counseling; and patients' self-engagement through disease awareness, lifestyle changes, and medication adherence. METHODS: Prospective, observational, open-label, multi-center, pharmacoepidemiologic study of type 2 diabetes mellitus (T2DM) patients treated de novo with vildagliptin or vildagliptin/metformin...
July 4, 2016: Primary Care Diabetes
H Brath, P M Paldánius, G Bader, W M Kolaczynski, P M Nilsson
OBJECTIVE: This post-hoc analysis of the EDGE (Effectiveness of Diabetes control with vildaGliptin and vildagliptin/mEtformin) study assessed inter-regional differences in baseline characteristics and response to treatment intensification with dual oral antidiabetes drugs (OADs) in patients with type 2 diabetes mellitus (T2DM). METHODS: Patients with T2DM inadequately controlled with first-line monotherapy were assigned to receive a dipeptidyl peptidase-4 (DPP-4) inhibitor, vildagliptin, or comparator OADs as add-on dual therapy...
2016: Nutrition & Diabetes
K M Prasanna Kumar, U Phadke, H Brath, A Gawai, P M Paldánius, C Mathieu
AIM: In this post hoc analysis of the EDGE study, we assessed the effectiveness and safety of vildagliptin versus other oral antidiabetes drugs (OADs) as add-on to first-line sulphonylurea (SU) therapy in patients who did not receive metformin in a real-life setting. METHODS: The primary endpoint was odds of achieving an HbA1c reduction of >0.3% without tolerability issues. Secondary endpoint was odds of achieving HbA1c <7.0% without hypoglycaemia or weight gain...
June 25, 2016: Primary Care Diabetes
Sivaporn Sivasinprasasn, Piangkwan Sa-Nguanmoo, Wanpitak Pongkan, Wasana Pratchayasakul, Siriporn C Chattipakorn, Nipon Chattipakorn
OBJECTIVE: Cardiac function was markedly compromised in obese insulin-resistant and estrogen-deprived rats. Metformin and dipeptidyl peptidase-4 inhibitor (vildagliptin) were reported to improve cardiac function in insulin-resistant rats. Their effects on the heart under estrogen-deprived conditions are, however, unknown. Therefore, the effects of metformin, vildagliptin, and estrogen on the cardiac function in estrogen-deprived insulin-resistant female rats were investigated. METHODS: Bilateral ovariectomized female rats (n = 48) were divided to be fed with either a normal diet (ND) or a high-fat diet (HFD) for 12 weeks...
August 2016: Menopause: the Journal of the North American Menopause Society
Oleg Baranov, Melanie Kahle, Carolyn F Deacon, Jens J Holst, Michael A Nauck
BACKGROUND: The present study was designed to directly compare clinical effects of vildagliptin and sitagliptin in patients with type 2 diabetes, with a special emphasis on incretin hormones and L-cell feedback inhibition induced by DPP-4 inhibition. PATIENTS/METHODS: 24 patients (12 diet/exercise, 12 on metformin) were treated, in randomized order, for 7-9 days , with either vildagliptin (50 mg b.i.d. = 100 mg/d), sitagliptin (100 mg q.d. in those on diet, 50 mg b...
June 14, 2016: Diabetes, Obesity & Metabolism
M García, M A Aranburu, I Palacios-Zabalza, U Lertxundi, C Aguirre
WHAT IS KNOWN AND OBJECTIVE: Bullous pemphigoid has been reported in association with gliptins. We describe a case, review the literature and analyse all cases of bullous pemphigoid recorded in the European pharmacovigilance database, EudraVigilance. CASE SUMMARY: A 74-year-old woman, treated with vildagliptin/metformin for 12 months, developed bullous pemphigoid, confirmed by skin biopsy. The symptoms resolved within 7 months after vildagliptin/metformin withdrawal...
June 2016: Journal of Clinical Pharmacy and Therapeutics
Helena Pelantová, Martina Bugáňová, Martina Holubová, Blanka Šedivá, Jana Zemenová, David Sýkora, Petra Kaválková, Martin Haluzík, Blanka Železná, Lenka Maletínská, Jaroslav Kuneš, Marek Kuzma
Metformin, vildagliptin and their combination are widely used for the treatment of diabetes, but little is known about the metabolic responses to these treatments. In the present study, NMR-based metabolomics was applied to detect changes in the urinary metabolomic profile of a mouse model of diet-induced obesity in response to these treatments. Additionally, standard biochemical parameters and the expression of enzymes involved in glucose and fat metabolism were monitored. Significant correlations were observed between several metabolites (e...
May 7, 2016: Molecular and Cellular Endocrinology
Shripad D Chitnis, Yi Han, Masayuki Yamaguchi, Sachiko Mita, Rong Zhao, Gangadhar Sunkara, Kenneth Kulmatycki
Metformin is the first-line pharmacotherapy choice for treating type-2 diabetes mellitus, alone or in combination with other antidiabetic drugs. During the development of immediate-release (IR) metformin containing novel fixed-dose combination (FDC) products, several health-authorities require sponsors to demonstrate bioequivalence between FDC products and the country-sourced metformin for market approval. Eight bioequivalence studies that compared metformin/vildagliptin FDC product (test) to metformin IR tablet sourced from various countries (reference) were conducted...
January 2016: Clinical Pharmacology in Drug Development
Jong Ho Kim, Sang Soo Kim, Hong Sun Baek, In Kyu Lee, Dong Jin Chung, Ho Sang Sohn, Hak Yeon Bae, Mi Kyung Kim, Jeong Hyun Park, Young Sik Choi, Young Il Kim, Jong Ryeal Hahm, Chang Won Lee, Sung Rae Jo, Mi Kyung Park, Kwang Jae Lee, In Joo Kim
BACKGROUND: We compared the efficacies of vildagliptin (50 mg twice daily) relative to pioglitazone (15 mg once daily) as an add-on treatment to metformin for reducing glycosylated hemoglobin (HbA1c) levels in Korean patients with type 2 diabetes. METHODS: The present study was a multicenter, randomized, active-controlled investigation comparing the effects of vildagliptin and pioglitazone in Korean patients receiving a stable dose of metformin but exhibiting inadequate glycemic control...
June 2016: Diabetes & Metabolism Journal
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