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      Two-year assessment of the efficacy and safety of sitagliptin in elderly patients with type 2 diabetes: Post hoc analysis of the ASSET-K study

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          Abstract

          Background

          There have only been a few reports about use of dipeptidyl peptidase 4 (DPP-4) inhibitors in elderly patients with type 2 diabetes mellitus (T2DM), suggesting that the safety of these agents has not been sufficiently demonstrated. We performed a comparative review of the efficacy and safety of sitagliptin for Japanese patients with T2DM managed in the real-world clinical setting.

          Methods

          An age-stratified analysis was performed of 831 patients who were treated with sitagliptin for 2 years. Parameters assessed included the hemoglobin A 1c (HbA 1c), body weight, serum creatinine, and adverse events. HbA 1c and the incidence of hypoglycemia were also evaluated in patients treated with sitagliptin and a sulfonylurea (SU), who were divided into three age groups (<65 years, 65–74 years, and ≥75 years).

          Results

          Comparison of glycemic control parameters, laboratory values, and adverse events revealed significant improvement of HbA 1c, casual postprandial plasma glucose, and fasting plasma glucose in each age group with no change in body weight. Serum creatinine increased significantly in all age groups. Hypoglycemia only occurred in patients who received combined treatment with an SU and sitagliptin, and there was no age-related difference in its incidence.

          Conclusions

          HbA 1c was improved by 2 years of sitagliptin therapy in all three age groups, and age did not seem to influence the incidence of hypoglycemic events. These results confirm the efficacy and safety of sitagliptin in patients ≥ 75 years old, suggesting that it is also useful for treating elderly patients with T2DM.

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          Most cited references27

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          Systematic review of type 1 and type 2 diabetes mellitus and risk of fracture.

          The authors conducted a systematic review of published data on the association between diabetes mellitus and fracture. The authors searched MEDLINE through June 2006 and examined the reference lists of pertinent articles (limited to studies in humans). Summary relative risks and 95% confidence intervals were calculated with a random-effects model. The 16 eligible studies (two case-control studies and 14 cohort studies) included 836,941 participants and 139,531 incident cases of fracture. Type 2 diabetes was associated with an increased risk of hip fracture in both men (summary relative risk (RR) = 2.8, 95% confidence interval (CI): 1.2, 6.6) and women (summary RR = 2.1, 95% CI: 1.6, 2.7). Results were consistent between studies of men and women and between studies conducted in the United States and Europe. The association between type of diabetes and hip fracture incidence was stronger for type 1 diabetes (summary RR = 6.3, 95% CI: 2.6, 15.1) than for type 2 diabetes (summary RR = 1.7, 95% CI: 1.3, 2.2). Type 2 diabetes was weakly associated with fractures at other sites, and most effect estimates were not statistically significant. These findings strongly support an association between both type 1 and type 2 diabetes and increased risk of hip fracture in men and women.
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            Pharmacology, Physiology, and Mechanisms of Action of Dipeptidyl Peptidase-4 Inhibitors

            Abstract Dipeptidyl peptidase-4 (DPP4) is a widely expressed enzyme transducing actions through an anchored transmembrane molecule and a soluble circulating protein. Both membrane-associated and soluble DPP4 exert catalytic activity, cleaving proteins containing a position 2 alanine or proline. DPP4-mediated enzymatic cleavage alternatively inactivates peptides or generates new bioactive moieties that may exert competing or novel activities. The widespread use of selective DPP4 inhibitors for the treatment of type 2 diabetes has heightened interest in the molecular mechanisms through which DPP4 inhibitors exert their pleiotropic actions. Here we review the biology of DPP4 with a focus on: 1) identification of pharmacological vs physiological DPP4 substrates; and 2) elucidation of mechanisms of actions of DPP4 in studies employing genetic elimination or chemical reduction of DPP4 activity. We review data identifying the roles of key DPP4 substrates in transducing the glucoregulatory, anti-inflammatory, and cardiometabolic actions of DPP4 inhibitors in both preclinical and clinical studies. Finally, we highlight experimental pitfalls and technical challenges encountered in studies designed to understand the mechanisms of action and downstream targets activated by inhibition of DPP4.
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              Glucose tolerance status and risk of dementia in the community: the Hisayama study.

              We investigated the association between glucose tolerance status defined by a 75-g oral glucose tolerance test (OGTT) and the development of dementia. A total of 1,017 community-dwelling dementia-free subjects aged ≥60 years who underwent the OGTT were followed up for 15 years. Outcome measure was clinically diagnosed dementia. The age- and sex-adjusted incidence of all-cause dementia, Alzheimer disease (AD), and vascular dementia (VaD) were significantly higher in subjects with diabetes than in those with normal glucose tolerance. These associations remained robust even after adjustment for confounding factors for all-cause dementia and AD, but not for VaD (all-cause dementia: adjusted hazard ratio [HR] = 1.74, 95% confidence interval [CI] = 1.19 to 2.53, p = 0.004; AD: adjusted HR = 2.05, 95% CI = 1.18 to 3.57, p = 0.01; VaD: adjusted HR = 1.82, 95% CI = 0.89 to 3.71, p = 0.09). Moreover, the risks of developing all-cause dementia, AD, and VaD significantly increased with elevated 2-hour postload glucose (PG) levels even after adjustment for covariates, but no such associations were observed for fasting plasma glucose (FPG) levels: compared with those with 2-hour PG levels of <6.7 mmol/L, the multivariable-adjusted HRs of all-cause dementia and AD significantly increased in subjects with 2-hour PG levels of 7.8 to 11.0 mmol/L or over, and the risk of VaD was significantly higher in subjects with levels of ≥11.1 mmol/L. Our findings suggest that diabetes is a significant risk factor for all-cause dementia, AD, and probably VaD. Moreover, 2-hour PG levels, but not FPG levels, are closely associated with increased risk of all-cause dementia, AD, and VaD.
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                Author and article information

                Contributors
                umecli@mta.biglobe.ne.jp
                kubota@sj8.so-net.ne.jp
                nrcbd536@ybb.ne.jp
                rankana@kanamori-cl.jp
                matoba-clinic@po1.dti2.ne.jp
                jin-clinic@nifty.com
                fminagawa-endo@umin.ac.jp
                UIH45876@nifty.com
                e36m3kotaro@nifty.com
                sksym-1404@nifty.com
                QYF11710@nifty.com
                kaneshiro-diabetes-c@jcom.home.ne.jp
                markune@ka2.so-net.ne.jp
                kaneshi@rf6.so-net.ne.jp
                hoshinocl@pure.ocn.ne.jp
                miya1@space.ocn.ne.jp
                nminami@gmail.com
                mjob9949-mnet@yahoo.co.jp
                nsasai@d3.dion.ne.jp
                kmyajp@yahoo.co.jp
                t2kawata@marianna-u.ac.jp
                mokubo@mokubo-clinic.jp
                miyairinaka@feel.ocn.ne.jp
                h_takeda@ka2.so-net.ne.jp
                s.honda@silverwing.jp
                qq3966cd@etude.ocn.ne.jp
                moto-cli@za2.so-net.ne.jp
                inaho474@ab.auone-net.jp
                naka@tomei.or.jp
                y2tanaka@marianna-u.ac.jp
                terauchi@yokohama-cu.ac.jp
                ikuro@matsuba-web.com
                Journal
                BMC Endocr Disord
                BMC Endocr Disord
                BMC Endocrine Disorders
                BioMed Central (London )
                1472-6823
                3 July 2015
                3 July 2015
                2015
                : 15
                : 34
                Affiliations
                [ ]Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan
                [ ]Division of Metabolism and Endocrinology, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Japan
                [ ]Department of Endocrinology and Diabetes, Yokohama City University Medical Center, Yokohama, Japan
                Article
                33
                10.1186/s12902-015-0033-2
                4490678
                26137940
                eb342f8a-48ae-44d4-bba9-95ff51c53325
                © Umezawa et al. 2015

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 10 March 2015
                : 22 June 2015
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2015

                Endocrinology & Diabetes
                type 2 diabetes,sitagliptin,elderly patients,dipeptidyl peptidase 4 inhibitor,sulfonylurea,hypoglycemia

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