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Gu W.,Ruijin Hospital Shanghai | Liang L.,Peoples Hospital of Liaoning Province | Wang S.,Linyi Peoples Hospital Linyi | Wang Y.,The First Affiliated Hospital of Baotou Medical College Baotou | And 10 more authors.
Journal of Diabetes | Year: 2016

Background: The aim of the present study was to explore the efficacy and safety of saxagliptin in a large Chinese population with type 2 diabetes mellitus (T2DM). Methods: In all, 1423 T2DM patients from 92 research centers, either drug naïve or uncontrolled by metformin, were enrolled in this single-arm cohort study; patients were treated with saxagliptin 5 mg once daily for 24 weeks. The primary efficacy endpoint was the change from baseline in HbA1c at 24 weeks in the per-protocol analysis set. Secondary endpoints included the proportion of patients achieving HbA1c <7% and changes from baseline in fasting plasma glucose (FPG) and 2-h postprandial plasma glucose (PPG) concentrations at 24 weeks. Safety endpoints included adverse events (AEs) and the incidence of hypoglycemia. Results: Among 1210 patients in the per-protocol analysis set, mean HbA1c, FPG and 2-h PPG decreased by 1.61±0.04%, 0.55±0.07 mmol/L, and 2.83±0.27 mmol/L, respectively, at week 24. The proportion of patients achieving HbA1c <7% was 44.1%. No new (previously unreported) AEs occurred. The incidence of serious AEs and hypoglycemia was low (1.8% and 1.2%, respectively). There were no significant differences in efficacy endpoints in subgroup analyses by age, creatinine clearance, body mass index, or treatment background. In elderly patients (≥65 years) and those with mild renal impairment (50 Source


Qian J.,Hospital 463 of PLA | Yang X.H.,Hospital 463 of PLA
Medicine (United States) | Year: 2015

Effect of aspirin (antiplatelet agents) in patients with peripheral artery disease (PAD) was still controversial. Varying studies reported varying results. Therefore, we did this meta-analysis to investigate if aspirin could reduce cardiovascular events in patients with PAD. A comprehensive literature search (PubMed, CCTR, Embase, Web of Science, CNKI, CBM-disc, and relevant websites) was conducted from 1990 to September 2014. The key search terms ("aspirin," "PAD," "peripheral arterial occlusive diseases," and "claudication") produced 9 high-quality randomized controlled trials (RCTs) of aspirin versus placebo/control. Mantel-Haenszel random-effects model was used to analysis of the 9 RCTs. The primary outcome was the cardiovascular events. Nine RCTs, composed of 9526 patients (4786 aspirin-treated and 4740 placebo or control-treated patients), were meta-analyzed. The results indicated that compared to placebo/control, aspirin could not significantly reduce the cardiovascular events (OR =0.81, 95% CI = 0.56-1.15). Moreover, aspirin could not produce better effect on prevention of nonfatal myocardial infarction (OR = 0.98, 95% CI = 0.52-1.84), nonfatal stroke (OR =0.89, 95% CI =0.69-1.14), cardiovascular death (OR =0.97, 95% CI =0.68-1.38), any death (OR = 1.05, 95% CI =0.85-1.30), and major bleeding (OR = 1.16, 95% CI =0.82-1.65) than placebo/control. But aspirin, as monotherapy therapy, did significantly reduce the risk of nonfatal stroke (OR = 0.42, 95% CI =0.21-0.84). Aspirin, as monotherapy or combination therapy, did not result in a significant decrease in the cardiovascular events. But aspirin, as mono-therapy therapy, did significantly reduce the risk of nonfatal stroke. Our conclusion might help clinicians in clinical treating PAD. Future studies are needed to draw firm conclusions about the clinical benefit and risks of aspirin and other antiplatelet agents. Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved. Source

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