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https://www.readbyqxmd.com/read/29331436/jetstream-atherectomy-system-treatment-of-femoropopliteal-arteries-results-of-the-post-market-jet-registry
#1
William A Gray, Lawrence A Garcia, Ali Amin, Nicolas W Shammas
OBJECTIVES: To report on procedural, safety, and effectiveness outcomes of real-world practice with the Jetstream rotational atherectomy system for treatment of femoropopliteal artery lesions. BACKGROUND: Safety and effectiveness of treatment with the Jetstream device has been demonstrated in clinical trials, but outcomes during real-world clinical practice have yet to be examined. METHODS: 241 patients (66% male, mean age 67years, 41% diabetes; Rutherford 1-3) with de novo or restenotic (non-stent) femoropopliteal lesions ≥4cm in length were recruited...
December 27, 2017: Cardiovascular Revascularization Medicine: Including Molecular Interventions
https://www.readbyqxmd.com/read/29331269/clinical-benefits-of-autologous-haematopoietic-stem-cell-transplantation-in-type-1-diabetes-patients
#2
B Gu, H Miao, J Zhang, J Hu, W Zhou, W Gu, W Wang, G Ning
Type 1 diabetes (T1D) is characterized by severe damage to pancreas islet function through immunological attack; therefore, it is also called 'insulin-dependent diabetes'. The present study aimed to evaluate the safety and clinical efficacy of autologous haematopoietic stem cell transplantation (AHSCT) in adolescent patients with newly diagnosed T1D. A phase-II prospective, parallel-assignment, non-randomized trial was conducted from March 2008 to December 2011 with 40 T1D patients, of whom 20 received AHSCT therapy and 20 were treated only with insulin injections...
December 22, 2017: Diabetes & Metabolism
https://www.readbyqxmd.com/read/29322605/declare-timi-58-participants-baseline-characteristics
#3
Itamar Raz, Ofri Mosenzon, Marc P Bonaca, Avivit Cahn, Eri T Kato, Michael G Silverman, Deepak L Bhatt, Lawrence A Leiter, Darren K McGuire, John Wilding, Ingrid Am Gause-Nilsson, Anna Maria Langkilde, Peter A Johansson, Marc S Sabatine, Stephen D Wiviott
BACKGROUND: Cardiovascular (CV) outcome trials with new glucose lowering agents (GLA) are designed to prove CV safety in high CV risk populations. However, the level of CV risk differs greatly among trials, which may influence comparability and generalizability of results. AIM: We describe baseline characteristics of participants randomized in the Dapagliflozin Effect on CardiovascuLAR Events (DECLARE-TIMI 58) trial, the pivotal study to assess CV outcomes with dapagliflozin...
January 11, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29320889/the-cardiovascular-effect-of-incretin-based-therapies-among-type-2-diabetes-a-systematic-review-and-network-meta-analysis
#4
Shanshan Wu, Andrea Cipriani, Zhirong Yang, Jun Yang, Ting Cai, Yang Xu, Xiaochi Quan, Yuan Zhang, Sanbao Chai, Feng Sun, Siyan Zhan
OBJECTIVE: To evaluate the comparative cardiovascular safety of incretin-based therapies in patients with type 2 diabetes mellitus (T2DM). METHODS: Medline, Embase, the Cochrane Library and www.clinicaltrials.gov were searched for randomized controlled trials (RCTs) with duration≥12 weeks. Network meta-analysis was performed, followed by subgroup analysis and meta-regression. The Grading of Recommendations Assessment, Development and Evaluation system was used to assess the quality of evidence...
January 10, 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29318219/extending-metformin-use-in-diabetic-kidney-disease-a-pharmacokinetic-study%C3%A2-in%C3%A2-stage-4-diabetic-nephropathy
#5
Ajith Munasinghe Dissanayake, Mark Christopher Wheldon, Jafar Ahmed, Christopher John Hood
Introduction: Metformin use in advanced chronic kidney disease is controversial. This study sought to examine the pharmacokinetics, safety, and efficacy of low-dose metformin in patients with type 2 diabetes and stage 4 chronic kidney disease. Methods: In this open-label, phase I trial, 3 consecutive cohorts (1, 2, and 3) of 6 patients each were recruited to receive 250-, 500-, or 1000-mg once-daily doses of metformin, respectively. All patients underwent a first-dose pharmacokinetic profile and weekly trough metformin concentrations for the duration of 4 weeks of daily therapy...
July 2017: KI Reports
https://www.readbyqxmd.com/read/29317332/safety-and-efficacy-of-sodium-glucose-cotransporter-2-sglt2-inhibitors-in-type-1-diabetes-a-systematic-review-and-meta-analysis
#6
REVIEW
Dana El Masri, Samiran Ghosh, Linda A Jaber
AIMS: Sodium-glucose cotransporter 2 (SGLT2) inhibitors are currently FDA approved for the management of type 2 diabetes. Our objective was to review the available evidence of the effects of SGLT2 inhibitors on HbA1c, body weight, and total daily insulin dose, as well as their safety profile in patients with type 1 diabetes. METHODS: Four randomized controlled trials (RCTs) were identified by conducting a systematic search of PubMed, Embase, Web of Science, Scopus and Cochrane library databases through August 2017...
January 6, 2018: Diabetes Research and Clinical Practice
https://www.readbyqxmd.com/read/29316236/long-term-safety-and-efficacy-of-tofogliflozin-add-on-to-insulin-in-patients-with-type-2-diabetes-results-from-a-52-week-multicenter-randomized-double-blind-open-label-extension-phase-4-study-in-japan-j-step-ins
#7
Yasuo Terauchi, Masahiro Tamura, Masayuki Senda, Ryoji Gunji, Kohei Kaku
AIMS: To evaluate the long-term safety and efficacy of tofogliflozin as an add-on treatment to insulin over 52 weeks. MATERIALS AND METHODS: This 52-week, multicenter, Phase 4 study consisted of a 16-week, randomized, double-blind, placebo-controlled phase and a 36-week open label extension phase (NCT02201004). Japanese patients with type 2 diabetes mellitus aged 20-75 years with suboptimal glycemic control (7.5%-10.5%) on insulin monotherapy (basal-bolus, bolus, premix [low and high], and basal) or on combination therapy of basal insulin and dipeptidyl peptidase-4 inhibitor were eligible for participation...
January 5, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29316176/effect-of-prandial-treatment-timing-adjustment-based-on-continuous-glucose-monitoring-in-patients-with-type-2-diabetes-uncontrolled-on-once-daily-basal-insulin-a-randomized-phase-iv-study
#8
Jacob Ilany, Hamad Bhandari, Dan Nabriski, Yoel Toledano, Noa Konvalina, Ohad Cohen
OBJECTIVE: To evaluate the glycemic control achieved by prandial once daily insulin glulisine injection timing adjustment based on continuous glucose monitoring sensor in comparison to once daily insulin glulisine injection before breakfast in type 2 diabetes patients uncontrolled on once daily basal insulin glargine. RESEARCH DESIGN AND METHODS: This was a 24-week open-label, randomized-controlled, multicenter trial. At the end of 8 weeks of basal insulin optimization period, patients with HbA1c ≥ 7...
January 8, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29316137/have-we-really-demonstrated-the-cardiovascular-safety-of-antihyperglycemic-drugs-rethinking-the-concepts-of-macrovascular-and-microvascular-disease-in-type-2-diabetes
#9
REVIEW
Milton Packer
A primary goal of the treatment of type 2 mellitus is the prevention of morbidity and mortality due to cardiovascular disease. However, antihyperglycemic drugs have the capacity to cause deleterious effects on the circulation, a risk that is not adequately reflected by the endpoints selected for emphasis in large-scale clinical trials that are designed to evaluate cardiovascular safety. The primary endpoint of the large-scale studies mandated by regulatory authorities focuses only on 3-4 events that depict only a limited view of the circulatory system...
January 5, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29314715/outcomes-of-endoscopic-and-microscopic-transsphenoidal-surgery-on-non-functioning-pituitary-adenomas-a-systematic-review-and-meta-analysis
#10
Shi-Yuan Yu, Qiu Du, Si-Yuan Yao, Ke-Nan Zhang, Jian Wang, Zhe Zhu, Xiao-Bing Jiang
Both microscopic and endoscopic transsphenoidal surgery are effective approaches for nonfunctioning pituitary adenomas. The issue on the comparison of their efficacy and safety remains inconsistent. A thorough search of the literatures (PubMed, EMBASE, MEDLINE) were performed up to March 2017. Studies reporting outcomes of microscopic or endoscopic transsphenoidal surgery on nonfunctioning pituitary adenomas were included. A meta-analysis was performed focusing on the early stage and long term outcomes. The final search yielded 19 eligible studies enrolling 3847 patients, 389 of them underwent microscopic approach and 3458 of them with endoscopic approach...
January 4, 2018: Journal of Cellular and Molecular Medicine
https://www.readbyqxmd.com/read/29314506/efficacy-and-safety-of-sitagliptin-in-elderly-patients-with-type%C3%A2-2-diabetes-mellitus
#11
Motoko Tago, Jun-Ichi Oyama, Yoshiko Sakamoto, Aya Shiraki, Fumi Uchida, Atsuko Chihara, Hideo Ikeda, Shigetaka Kuroki, Shigeki Gondo, Taketo Iwamoto, Yasufumi Uchida, Koichi Node
AIM: The aim of the present study was to assess the efficacy and safety of sitagliptin in elderly patients with type 2 diabetes mellitus. METHODS: A total of 188 patients were enrolled who had type 2 diabetes mellitus with poor glycemic profiles (hemoglobin A1c [HbA1c] ≥6.2%). Patients were assigned to one of three age groups (<65, 65-74 and ≥75 years) and received 50-100 mg of sitagliptin daily for 12 months. Changes in HbA1c classified by age and body mass index (BMI) were assessed in addition to physiological parameters...
January 4, 2018: Geriatrics & Gerontology International
https://www.readbyqxmd.com/read/29313576/pharmacological-reperfusion-therapy-with-tenecteplase-in-7-668-indian-patients-with-st-elevation-myocardial-infarction-a-real-world-indian-experience
#12
S S Iyengar, Tiny Nair, Jagdish Hiremath, Anjan Lal Dutta, Uday Jadhav, V K Katyal, Dayanand Kumbla, Immaneni Sathyamurthy, R K Jain, M Srinivasan, Prasant Kr Sahoo
Objective: This real-world, observational, prescription event monitoring study was conducted to evaluate safety and efficacy of indigenous tenecteplase (TNK-tPA) in Indian patients presenting with ST elevation myocardial infarction (STEMI). Methods: This is a multi-centric, observational, prescription event monitoring study. Data was collected for 7,668 patients from 1,307 investigator sites across India from January 2011 to February 2016. Results: Overall, 76...
September 2017: Journal of the Association of Physicians of India
https://www.readbyqxmd.com/read/29313282/ertugliflozin-and-sitagliptin-co-initiation-in-patients-with-type-2-diabetes-the-vertis-sita-randomized-study
#13
Sam Miller, Tania Krumins, Haojin Zhou, Susan Huyck, Jeremy Johnson, Gregory Golm, Steven G Terra, James P Mancuso, Samuel S Engel, Brett Lauring
INTRODUCTION: Ertugliflozin is an oral sodium-glucose cotransporter 2 inhibitor that is being developed to treat type 2 diabetes mellitus (T2DM). This study assessed the efficacy and safety of co-initiation of ertugliflozin and sitagliptin compared with placebo in patients with T2DM inadequately controlled on diet and exercise. METHODS: In this phase III, randomized, double-blind, multicenter, placebo-controlled 26-week study (NCT02226003), patients with T2DM and glycated hemoglobin (HbA1c) 8...
January 8, 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/29305825/slender-transradial-iliac-artery-stenting-using-a-4-5%C3%A2-french-guiding-sheath
#14
Norihiko Shinozaki, Takashi Minowa, Tsutomu Murakami, Yohei Ohno, Masataka Nakano, Toshiharu Fujii, Gaku Nakazawa, Fuminobu Yoshimachi, Yuji Ikari
We previously reported safety and usefulness of transradial iliac artery stenting using 6 Fr guiding sheath. However, radial artery occlusion was a major limitation of this procedure. We analyzed the safety and utility of slender transradial iliac artery stenting using a 4.5 Fr guiding sheath to prevent radial artery occlusion. We performed transradial iliac artery stenting in left radial artery, using a 4.5 Fr sheath incorporating a shaft length of 110 cm, for 34 lesions in 29 patients. Transradial intervention was attempted at the discretion of the operator...
January 5, 2018: Cardiovascular Intervention and Therapeutics
https://www.readbyqxmd.com/read/29305402/metformin-treatment-in-patients-with-type-2-diabetes-and-chronic-kidney-disease-stages-3a-3b-or-4
#15
Jean-Daniel Lalau, Farshad Kajbaf, Youssef Bennis, Anne-Sophie Hurtel-Lemaire, Frans Belpaire, Marc E De Broe
OBJECTIVE: This study was conducted to define a safe, effective dose regimen for metformin in moderate and severe chronic kidney disease (CKD; stages 3A/3B and 4, respectively), after the lifting of restrictions on metformin use in patients with diabetes with moderate-to-severe CKD in the absence of prospective safety and efficacy studies. RESEARCH DESIGN AND METHODS: Three complementary studies were performed: 1) a dose-finding study in CKD stages 1-5, in which blood metformin concentrations were evaluated during a 1-week period after each dose increase; 2) a 4-month metformin treatment study for validating the optimal metformin dose as a function of the CKD stage (3A, 3B, and 4), with blood metformin, lactate, and HbA1c concentrations monitored monthly; and 3) an assessment of pharmacokinetic parameters after the administration of a single dose of metformin in steady-state CKD3A, 3B, and 4...
January 5, 2018: Diabetes Care
https://www.readbyqxmd.com/read/29305175/an-overview-of-anti-diabetic-plants-used-in-gabon-pharmacology-and-toxicology
#16
REVIEW
B Bading Taika, M Bouckandou, A Souza, H P Bourobou Bourobou, L MacKenzie, L Lione
ETHNOPHARMACOLOGICAL RELEVANCE: The management of diabetes mellitus management in African communities, especially in Gabon, is not well established as more than 60% of population rely on traditional treatments as primary healthcare. The aim of this review was to collect and present the scientific evidence for the use of medicinal plants that are in currect by Gabonese traditional healers to manage diabetes or hyperglycaemia based here on the pharmacological and toxicological profiles of plants with anti-diabetic activity are presented in order to promote their therapeutic value, ensure a safer use by population and provide some bases for further study on high potential plants reviewed...
January 2, 2018: Journal of Ethnopharmacology
https://www.readbyqxmd.com/read/29304731/safety-tolerability-and-pharmacodynamics-of-apical-sodium-dependent-bile-acid-transporter-inhibition-with-volixibat-in-healthy-adults-and-patients-with-type-2-diabetes-mellitus-a-randomised-placebo-controlled-trial
#17
Renger G Tiessen, Ciara A Kennedy, Bradley T Keller, Nancy Levin, Lisette Acevedo, Bronislava Gedulin, Andre A van Vliet, Alejandro Dorenbaum, Melissa Palmer
BACKGROUND: Pathogenesis in non-alcoholic steatohepatitis (NASH) involves abnormal cholesterol metabolism and hepatic accumulation of toxic free cholesterol. Apical sodium-dependent bile acid transporter (ASBT) inhibition in the terminal ileum may facilitate removal of free cholesterol from the liver by reducing recirculation of bile acids (BAs) to the liver, thereby stimulating new BA synthesis from cholesterol. The aim of this phase 1 study in adult healthy volunteers (HVs) and patients with type 2 diabetes mellitus (T2DM) was to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ASBT inhibition with volixibat (SHP626; formerly LUM002)...
January 5, 2018: BMC Gastroenterology
https://www.readbyqxmd.com/read/29304527/is-there-a-preferred-stroke-prevention-strategy-for-diabetic-patients-with-non-valvular-atrial-fibrillation-comparing-warfarin-dabigatran-and-rivaroxaban
#18
Chih-Cheng Hsu, Pai-Feng Hsu, Shih-Hsien Sung, Shih-Te Tu, Ben-Hui Yu, Chi-Jung Huang, Hao-Min Cheng
BACKGROUND:  The prevalence of diabetes is growing, and diabetes is an independent risk factor for both atrial fibrillation (AF) and stroke. However, the relative effectiveness and safety of different oral anticoagulants for diabetic patients with non-valvular AF remain unclear. We aimed to compare thromboembolic events, bleeding and mortality in diabetic AF patients treated with rivaroxaban, dabigatran and warfarin. METHODS AND RESULTS:  Diabetic AF patients taking dabigatran (n = 322), rivaroxaban (n = 320) or warfarin (n = 1,899) were identified from the nationwide diabetes pay-for-performance program (n = 814,465) in Taiwan...
January 2018: Thrombosis and Haemostasis
https://www.readbyqxmd.com/read/29304513/nonvitamin-k-antagonist-oral-anticoagulants-use-in-patients-with-atrial-fibrillation-and-bioprosthetic-heart-valves-prior-surgical-valve-repair-a-multicenter-clinical-practice-experience
#19
Vincenzo Russo, Emilio Attena, Carmine Mazzone, Francesca Esposito, Valentina Parisi, Ciro Bancone, Anna Rago, Gerardo Nigro, Raffaele Sangiuolo, Antonio D' Onofrio
This is an observational study to investigate the efficacy and safety of nonvitamin K antagonist oral anticoagulants (NOACs) in atrial fibrillation (AF) patients with bioprosthetic valves or prior surgical valve repair in clinical practice. A total of 122 patients (mean age: 74.1 ± 13.2; 54 females) with bioprosthetic heart valve or surgical valve repair and AF treated with NOACs were included in the analysis. The mean CHA2DS2-VASc (Congestive heart failure, Hypertension, Age >75 years, Diabetes mellitus, prior Stroke or transient ischemic attack, Vascular disease) and HAS-BLED (Hypertension, Abnormal renal and liver function, Stroke, Bleeding, Labile INR [international normalized ratio], Elderly, Drugs or alcohol) score values were 3...
January 5, 2018: Seminars in Thrombosis and Hemostasis
https://www.readbyqxmd.com/read/29303009/dyslipidaemia-in-the-elderly-to-treat-or-not-to-treat
#20
Niki Katsiki, Genovefa Kolovou, Pablo Perez-Martinez, Dimitri P Mikhailidis
The elderly population (i.e. aged ≥ 65 years) is increasing worldwide. Ageing is associated with a higher incidence and prevalence of cardiovascular disease (CVD). Areas covered: The prevalence of CVD risk factors including type 2 diabetes mellitus, hypertension and dyslipidaemia also increases with advancing age, contributing to the higher absolute CVD risk observed in the elderly. The present narrative review comments on the associations of dyslipidaemia with CVD as well as the effects of lifestyle measures and lipid-lowering drugs on lipids and CVD risk with a special focus on the elderly population...
January 5, 2018: Expert Review of Clinical Pharmacology
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