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Sitagliptin AND pancreatitis

M B Rehman, B V Tudrej, J Soustre, M Buisson, P Archambault, D Pouchain, H Vaillant-Roussel, F Gueyffier, J-L Faillie, M-C Perault-Pochat, C Cornu, R Boussageon
BACKGROUND: Guidelines for type 2 diabetes (T2D) recommend reducing HbA1c through lifestyle interventions and glucose-lowering drugs (metformin, then combination with dipeptidyl peptidase-4 inhibitors [DPP-4Is] among other glucose-lowering drugs). However, no double-blind randomized clinical trial (RCT) compared with placebo has so far demonstrated that DDP-4Is reduce micro- and macrovascular complications in T2D. Moreover, the safety of DPP-4Is (with increased heart failure and acute pancreatitis) remains controversial...
October 10, 2016: Diabetes & Metabolism
Ivan Tkáč, Itamar Raz
OBJECTIVE: Data on the possible relationship of gliptin treatment to the incidence of acute pancreatitis have been controversial. The aim of the current study was to combine data on the incidence of acute pancreatitis from three large randomized controlled trials. RESEARCH DESIGN AND METHODS: Three trials designed to test cardiovascular safety and efficacy of add-on treatment with a gliptin were included in the analysis, as follows: SAVOR-TIMI 53 (saxagliptin), EXAMINE (alogliptin), and TECOS (sitagliptin)...
September 22, 2016: Diabetes Care
John B Buse, M Angelyn Bethel, Jennifer B Green, Susanna R Stevens, Yuliya Lokhnygina, Pablo Aschner, Carlos Raffo Grado, Tsvetalina Tankova, Julio Wainstein, Robert Josse, John M Lachin, Samuel S Engel, Keyur Patel, Eric D Peterson, Rury R Holman
OBJECTIVE: We evaluated the incidence of acute pancreatitis and pancreatic cancer in patients with type 2 diabetes and cardiovascular disease who were treated with sitagliptin, a dipeptidyl peptidase-4 inhibitor (DPP-4i). RESEARCH DESIGN AND METHODS: In the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS), a cardiovascular safety study of sitagliptin, all suspected cases of acute pancreatitis and pancreatic cancer were collected prospectively for 14,671 participants during a median follow-up time of 3 years, and were adjudicated blindly...
September 14, 2016: Diabetes Care
Melena D Bellin, Greg J Beilman, Ty B Dunn, Timothy L Pruett, David E R Sutherland, Srinath Chinnakotla, James S Hodges, Audrey Lane, Peggy Ptacek, K Louise Berry, Bernhard J Hering, Antoinette Moran
Insulin independence after total pancreatectomy and islet autotransplant (TPIAT) for chronic pancreatitis is limited by a high rate of post-procedure beta cell apoptosis. Endogenous GLP-1 and GIP, which are increased by DPP-4 inhibitor therapy (sitagliptin) may protect against beta cell apoptosis. To determine the effect of sitgalitpin after TPIAT, 83 adult TPIAT recipients were randomized to receive sitagliptin (n=54) or placebo (n=29) for 12 months after TPIAT. At 12 and 18 months after TPIAT, participants were assessed for insulin independence; metabolic testing was performed with mixed meal tolerance testing (MMTT) and frequent sample intravenous glucose tolerance testing (FSIVGTT)...
July 26, 2016: American Journal of Transplantation
Takehiro Kato, Katsumi Iizuka, Hiroyuki Niwa, Jun Takeda
Insulin antibodies sometimes cause glucose instability. A 52-year-old male patient was admitted to our department for the treatment of diabetes mellitus. From October 2003, he received insulin treatment for autoimmune pancreatitis and diabetes mellitus, but his hemoglobin A1c (HbA1c) levels gradually reached 8.0% (64 mmol/mol IFCC). In January 2010, insulin glargine and insulin aspart were introduced. In April 2010, the insulin antibody titre rose to >13.6 U/mL. In July 2010, treatment was changed to insulin glargine, metformin and miglitol...
2016: BMJ Case Reports
Sooyoung Shin, Hyunah Kim
BACKGROUND: A 2013 postmarketing study suggested a possible link between saxagliptin use and hospital admission for heart failure. Cardiovascular (CV) effects of sitagliptin, the most commonly prescribed antidiabetic in the same class as saxagliptin, have not been evaluated much in Asian patients with type 2 diabetes. This study sought to ascertain the CV safety of sitagliptin in Korean patients. METHODS: A retrospective cohort study of 4,860 patients who were classified into the sitagliptin and metformin groups was conducted using electronic patient data retrieved from a major tertiary care medical center in Korea...
2016: Therapeutics and Clinical Risk Management
Chia-Hsuin Chang, Jou-Wei Lin, Shu-Ting Chen, Mei-Shu Lai, Lee-Ming Chuang, Yi-Cheng Chang
To analyze the association between use of DPP-4 inhibitors and acute pancreatitis in high-risk type 2 diabetic patients. A retrospective nationwide cohort study was conducted using the Taiwan National Health Insurance claim database. The risk associated with sitagliptin was compared to that with acarbose, a second-line antidiabetic drug prescribed for patients with similar diabetes severity and with a known neutral effect on pancreatitis. Between January 1, 2009 and December 31, 2010, a total of 8526 sitagliptin initiators and 8055 acarbose initiators who had hypertriglyceridemia or prior hospitalization history for acute pancreatitis were analyzed for the risk of hospitalization due to acute pancreatitis stratified for baseline propensity score...
February 2016: Medicine (Baltimore)
C A Amritha, Punnagai Kumaravelu, D Darling Chellathai
INTRODUCTION: Among the oral anti-diabetic drugs, Dipeptidyl peptidase - 4(DPP-4) inhibitor is an emerging class of drugs. Inhibitors of DPP-4 enzyme like Sitagliptin and Vildagliptin have shown Anti-oxidant properties in many studies, both invivo and invitro. It has also been characterized as an apoptotic agent on pancreatic cancer cells. In the following study, Anticancer effect of DPP 4 inhibitors on colon cell lines (HT-29) using MTT assay- {3 -4, 5-dimethyl (thiazol - 2 -yl) -3, 5- dimethyl tetrazolium bromide} assay was elucidated...
December 2015: Journal of Clinical and Diagnostic Research: JCDR
Jindřich Špinar, Lenka Špinarová, Jiří Vítovec
The treatment of diabetes mellitus type 2 is effective, but still is not optimal. DPP4 inhibitors (gliptins) are a new group of peroral antidiabetic drugs. The third clinical mortality study with gliptins in patients with diabetes mellitus type 2 was finished in 2015. The studies are known under acronym TECOS, SAVOR and EXAMINE and the tested drugs are sitagliptin, saxagliptin and alogliptin. The studies included about 37,000 patients. The studies confirmed the cardiovascular safety of the DPP4 inhibitors, but the question about increased heart failure remains open...
November 2015: Vnitr̆ní Lékar̆ství
Mark M Smits, Lennart Tonneijck, Marcel H A Muskiet, Trynke Hoekstra, Mark H H Kramer, Indra C Pieters, Djuna L Cahen, Michaela Diamant, Daniël H van Raalte
INTRODUCTION: Incretin-based therapies, that is, glucagon-like peptide (GLP)-1 receptor agonists and dipeptidyl peptidase (DPP)-4 inhibitors, are relatively novel antihyperglycaemic drugs that are frequently used in type 2 diabetes management. Apart from glucose-lowering, these agents exhibit pleiotropic actions that may have favourable and unfavourable clinical consequences. Incretin-based therapies have been associated with heart rate acceleration, heart failure, acute renal failure and acute pancreatitis...
2015: BMJ Open
Chin-Hsiao Tseng
BACKGROUND: The risk of pancreatic cancer associated with incretin-based therapies is controversial. METHODS: This study retrospectively analysed the National Health Insurance database including patients with newly diagnosed type 2 diabetes mellitus at an age ≥ 25 years between 1999 and 2010. A total of 71 137 ever users of sitagliptin and 933 046 never users were followed for pancreatic cancer until 31 December 2011. A time-dependent approach was used to calculate incidence and estimate hazard ratios adjusted for propensity score using Cox regression...
January 2016: European Journal of Clinical Investigation
Christian Mangrum, Eric Rush, Vijay Shivaswamy
Maturity onset diabetes of the young (MODY) is a rare form of diabetes mellitus typically seen in young adults that results from pancreatic beta-cell dysfunction. MODY4 is a rare subtype caused by a PDX1 mutation. In this case, we present a nonobese 26-year-old male with polyuria and polydipsia. Lab work showed a blood glucose of 511 mg/dL, no ketones or antibodies (insulin, islet cell, and glutamic acid decarboxylase [GAD]), C-peptide of 1.6 ng/mL, and A1c 9.3%. Genetic analysis revealed a novel nonsense mutation in the PDX1 gene, consistent with MODY type 4...
2015: Clinical Medicine Insights. Endocrinology and Diabetes
Kuan-Fu Liao, Cheng-Li Lin, Shih-Wei Lai, Wen-Chi Chen
BACKGROUND: There is still lack of definite evidence to establish the association between sitagliptin use and acute pancreatitis. The study aimed to test this issue in Taiwan. METHODS: This case-control study was designed to analyze the database of the Taiwan National Health Insurance Program. There were 349 subjects with type 2 diabetes mellitus aged 20-84 with a first-attack of acute pancreatitis from 2009 to 2011 as the case group and 1116 randomly selected subjects with type 2 diabetes mellitus without acute pancreatitis as the control group...
January 2016: European Journal of Internal Medicine
Chin-Hsiao Tseng
PURPOSE: To evaluate the risk of acute pancreatitis hospitalization with sitagliptin use in patients with type 2 diabetes mellitus (T2DM). METHODS: This retrospective cohort analysis included newly diagnosed T2DM with onset age ≥25 years between 1999 and 2010 from the National Health Insurance database. Ever users (n = 89,800) and never users (n = 449,000) of sitagliptin were followed until end of 2011. A time-dependent approach was used to calculate event incidence and estimate hazard ratios adjusted for propensity score...
2015: Annals of Medicine
Kristin K Clemens, Eric McArthur, Jamie L Fleet, Irene Hramiak, Amit X Garg
BACKGROUND: The risk of pancreatitis with sitagliptin use in routine care remains to be established in older patients. We aimed to determine this risk in older adults who were newly prescribed sitagliptin versus an alternative hypoglycemic agent in the outpatient setting. METHODS: In a population-based retrospective cohort study in Ontario from 2010 until 2012 involving adults aged 66 years and older, we studied those who were newly prescribed sitagliptin or an alternative hypoglycemic agent...
April 2015: CMAJ Open
Elizabeth Osei, Susanne Fonville, Adrienne A M Zandbergen, Paul J A M Brouwers, Laus J M M Mulder, Hester F Lingsma, Diederik W J Dippel, Peter J Koudstaal, Heleen M den Hertog
BACKGROUND: Impaired glucose tolerance is present in one third of patients with a TIA or ischemic stroke and is associated with a two-fold risk of recurrent stroke. Metformin improves glucose tolerance, but often leads to side effects. The aim of this study is to explore the feasibility, safety, and effects on glucose metabolism of metformin and sitagliptin in patients with TIA or minor ischemic stroke and impaired glucose tolerance. We will also assess whether a slow increase in metformin dose and better support and information on this treatment will reduce the incidence of side effects in these patients...
2015: Trials
Kensuke Fukui, Hiroyuki Kawahito, Noriyuki Wakana, Masakazu Kikai, Kensuke Terada, Keita Yamamoto, Daisuke Irie, Taku Kato, Sonoko Miyagawa, Hiroyuki Yamada
INTRODUCTION: Dipeptidyl peptidase (DPP)-4 inhibitors, a novel oral anti-diabetic agents, exert a protective effect on pancreatic β-cell function in patients with type 2 diabetic mellitus (T2DM). However, their beneficial effect in hypertensive T2DM patients treated with angiotensin receptor blockers (ARBs) has not been investigated. METHODS: In this open-label multicenter randomized study, a total of 55 hypertensive T2DM patients treated with ARBs were randomly assigned to receive the DPP-4 inhibitor sitagliptin or sulfonylurea (SU)...
December 2015: Journal of the Renin-angiotensin-aldosterone System: JRAAS
Jennifer B Green, M Angelyn Bethel, Paul W Armstrong, John B Buse, Samuel S Engel, Jyotsna Garg, Robert Josse, Keith D Kaufman, Joerg Koglin, Scott Korn, John M Lachin, Darren K McGuire, Michael J Pencina, Eberhard Standl, Peter P Stein, Shailaja Suryawanshi, Frans Van de Werf, Eric D Peterson, Rury R Holman
BACKGROUND: Data are lacking on the long-term effect on cardiovascular events of adding sitagliptin, a dipeptidyl peptidase 4 inhibitor, to usual care in patients with type 2 diabetes and cardiovascular disease. METHODS: In this randomized, double-blind study, we assigned 14,671 patients to add either sitagliptin or placebo to their existing therapy. Open-label use of antihyperglycemic therapy was encouraged as required, aimed at reaching individually appropriate glycemic targets in all patients...
July 16, 2015: New England Journal of Medicine
R S Weinstock, B Guerci, G Umpierrez, M A Nauck, Z Skrivanek, Z Milicevic
AIMS: To compare the once-weekly glucagon-like peptide-1 (GLP-1) receptor dulaglutide with the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin after 104 weeks of treatment. METHODS: This AWARD-5 study was a multicentre, double-blind trial that randomized participants to dulaglutide (1.5 or 0.75 mg) or sitagliptin 100 mg for 104 weeks or placebo (reported separately) for 26 weeks. Change in glycated haemoglobin (HbA1c) concentration from baseline was the primary efficacy measure...
September 2015: Diabetes, Obesity & Metabolism
Jennifer E Bruin, Nelly Saber, Natalie Braun, Jessica K Fox, Majid Mojibian, Ali Asadi, Campbell Drohan, Shannon O'Dwyer, Diana S Rosman-Balzer, Victoria A Swiss, Alireza Rezania, Timothy J Kieffer
Human embryonic stem cell (hESC)-derived pancreatic progenitor cells effectively reverse hyperglycemia in rodent models of type 1 diabetes, but their capacity to treat type 2 diabetes has not been reported. An immunodeficient model of type 2 diabetes was generated by high-fat diet (HFD) feeding in SCID-beige mice. Exposure to HFDs did not impact the maturation of macroencapsulated pancreatic progenitor cells into glucose-responsive insulin-secreting cells following transplantation, and the cell therapy improved glucose tolerance in HFD-fed transplant recipients after 24 weeks...
April 14, 2015: Stem Cell Reports
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