2020 Diabetes Guideline Data Supplement
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List of New Drugs Approved in India from 1991 to 2000
LIST OF NEW DRUGS APPROVED IN INDIA FROM 1991 TO 2000 S. No Name of Drug Pharmacological action/ Date of Indication Approval 1 Ciprofloxacin 0.3% w/v Eye Indicated in the treatment of February-1991 Drops/Eye Ointment/Ear Drop external ocular infection of the eye. 2 Diclofenac Sodium 1gm Gel March-1991 3 i)Cefaclor Monohydrate Antibiotic- In respiratory April-1991 250mg/500mg Capsule. infections, ENT infection, UT ii)Cefaclor Monohydrate infections, Skin and skin 125mg/5ml & 250mg/5ml structure infections. Suspension. iii)Cefaclor Monohydrate 100mg/ml Drops. iv)Cefaclor 187mg/5ml Suspension (For paediatric use). 4 Sheep Pox Vaccine (For April-1991 Veterinary) 5 Omeprazole 10mg/20mg Short term treatment of April-1991 Enteric Coated Granules duodenal ulcer, gastric ulcer, Capsule reflux oesophagitis, management of Zollinger- Ellison syndrome. 6 i)Nefopam Hydrochloride Non narcotic analgesic- Acute April-1991 30mg Tablet. and chronic pain, including ii)Nefopam Hydrochloride post-operative pain, dental 20mg/ml Injection. pain, musculo-skeletal pain, acute traumatic pain and cancer pain. 7 Buparvaquone 5% w/v Indicated in the treatment of April-1991 Solution for Injection (For bovine theileriosis. Veterinary) 8 i)Kitotifen Fumerate 1mg Anti asthmatic drug- Indicated May-1991 Tablet in prophylactic treatment of ii)Kitotifen Fumerate Syrup bronchial asthma, symptomatic iii)Ketotifen Fumerate Nasal improvement of allergic Drops conditions including rhinitis and conjunctivitis. 9 i)Pefloxacin Mesylate Antibacterial- In the treatment May-1991 Dihydrate 400mg Film Coated of severe infection in adults Tablet caused by sensitive ii)Pefloxacin Mesylate microorganism (gram -ve Dihydrate 400mg/5ml Injection pathogens and staphylococci). iii)Pefloxacin Mesylate Dihydrate 400mg I.V Bottles of 100ml/200ml 10 Ofloxacin 100mg/50ml & Indicated in RTI, UTI, May-1991 200mg/100ml vial Infusion gynaecological infection, skin/soft lesion infection. -
Computationally Guided Design of Dipeptidyl Peptidase-4 Inhibitors Lauren C
bioRxiv preprint doi: https://doi.org/10.1101/772137; this version posted September 18, 2019. The copyright holder for this preprint (which was not certified by peer review) is the author/funder. All rights reserved. No reuse allowed without permission. Computationally Guided Design of Dipeptidyl Peptidase-4 Inhibitors Lauren C. Reynolds1, Morgan P. Connolly2,3, Justin B. Siegel1,2,4* 1. Department of Chemistry, University of California Davis, Davis, California, United States of America 2. Genome Center, University of California Davis, Davis, California, United States of America 3. Microbiology Graduate Group, University of California Davis, Davis, California, United States of America 4. Department of Biochemistry and Molecular Medicine, University of California Davis, Davis, California, United States of America ABSTRACT: The Type 2 Diabetes Mellitus (T2DM) epidemic undoubtedly creates a need for the development of new phar- maceuticals. With the goal of generating new therapeutics for this disease, computational studies were conducted to design novel dipeptidyl peptidase-4 (DPP-4) inhibitors. Two candidates, generated by chemical intuition-driven design and bioiso- steric replacement, were found to have better docking scores than anagliptin, a currently available diabetes medication. INTRODUCTION debate in recent years for other gliptins as well. A recent Type 2 Diabetes Mellitus (T2DM) is dubbed the meta-analysis seems to suggest a possible increased pan- “epidemic of the 21st century”— affecting millions of pa- creatitis risk for sitagliptin -
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Katakami et al. Cardiovasc Diabetol (2020) 19:110 https://doi.org/10.1186/s12933-020-01079-4 Cardiovascular Diabetology ORIGINAL INVESTIGATION Open Access Tofoglifozin does not delay progression of carotid atherosclerosis in patients with type 2 diabetes: a prospective, randomized, open-label, parallel-group comparative study Naoto Katakami1,2* , Tomoya Mita3, Hidenori Yoshii4, Toshihiko Shiraiwa5, Tetsuyuki Yasuda6, Yosuke Okada7, Keiichi Torimoto7, Yutaka Umayahara8, Hideaki Kaneto9, Takeshi Osonoi10, Tsunehiko Yamamoto11, Nobuichi Kuribayashi12, Kazuhisa Maeda13, Hiroki Yokoyama14, Keisuke Kosugi15, Kentaro Ohtoshi16, Isao Hayashi17, Satoru Sumitani18, Mamiko Tsugawa19, Kayoko Ryomoto20, Hideki Taki21, Tadashi Nakamura22, Satoshi Kawashima23, Yasunori Sato24, Hirotaka Watada3 and Iichiro Shimomura1 on behalf of the UTOPIA study investigators Abstract Background: This study aimed to investigate the preventive efects of tofoglifozin, a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor, on atherosclerosis progression in type 2 diabetes (T2DM) patients without apparent cardiovascular disease (CVD) by monitoring carotid intima-media thickness (IMT). Methods: This prospective, randomized, open-label, blinded-endpoint, multicenter, parallel-group, comparative study included 340 subjects with T2DM and no history of apparent CVD recruited at 24 clinical units. Subjects were randomly allocated to either the tofoglifozin treatment group (n 169) or conventional treatment group using drugs other than SGLT2 inhibitors (n 171). Primary outcomes were changes= in mean and maximum common carotid IMT measured by echography during= a 104-week treatment period. Results: In a mixed-efects model for repeated measures, the mean IMT of the common carotid artery (mean- IMT-CCA), along with the right and left maximum IMT of the CCA (max-IMT-CCA), signifcantly declined in both the tofoglifozin ( 0.132 mm, SE 0.007; 0.163 mm, SE 0.013; 0.170 mm, SE 0.020, respectively) and the control group ( 0.140 mm,− SE 0.006; 0.190 mm,− SE 0.012; 0.190 mm,− SE 0.020, respectively). -
(Trulicity) Pen and the Semaglutide (Ozempic) Pen
Protocol H9X-MC-B021(b) Crossover Study Comparing Dulaglutide (Trulicity) Pen and the Semaglutide (Ozempic) Pen NCT03724981 Approval Date: 30-Nov-2018 H9X-MC-B021(b) Clinical Protocol Page 1 Protocol H9X-MC-B021(b): Crossover Study Comparing the Dulaglutide (Trulicity) Pen and the Semaglutide (Ozempic) Pen Confidential Information The information contained in this document is confidential and is intended for the use of clinical investigators. It is the property of Eli Lilly and Company or its subsidiaries and should not be copied by or distributed to persons not involved in the clinical investigation of dulaglutide (LY2189265), unless such persons are bound by a confidentiality agreement with Eli Lilly and Company or its subsidiaries. Note to Regulatory Authorities: This document may contain protected personal data and/or commercially confidential information exempt from public disclosure. Eli Lilly and Company requests consultation regarding release/redaction prior to any public release. In the United States, this document is subject to Freedom of Information Act (FOIA) Exemption 4 and may not be reproduced or otherwise disseminated without the written approval of Eli Lilly and Company or its subsidiaries. Dulaglutide (LY2189265) Eli Lilly and Company Indianapolis, Indiana USA 46285 Protocol Electronically Signed and Approved by Lilly on 07 Aug 2018 Amendment (a) Electronically Signed and Approved by Lilly on 11 Sep 2018 Amendment (b) Electronically Signed and Approved by Lilly on date below Approval Date: 30-Nov-2018 GMT LY2189265 H9X-MC-B021(b) Clinical Protocol Page 2 Table of Contents Section Page Protocol H9X-MC-B021(b): Crossover Study Comparing the Dulaglutide (Trulicity) Pen and the Semaglutide (Ozempic) Pen ............................................................1 Table of Contents........................................................................................................................2 1. -
(12) Patent Application Publication (10) Pub. No.: US 2006/0110428A1 De Juan Et Al
US 200601 10428A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2006/0110428A1 de Juan et al. (43) Pub. Date: May 25, 2006 (54) METHODS AND DEVICES FOR THE Publication Classification TREATMENT OF OCULAR CONDITIONS (51) Int. Cl. (76) Inventors: Eugene de Juan, LaCanada, CA (US); A6F 2/00 (2006.01) Signe E. Varner, Los Angeles, CA (52) U.S. Cl. .............................................................. 424/427 (US); Laurie R. Lawin, New Brighton, MN (US) (57) ABSTRACT Correspondence Address: Featured is a method for instilling one or more bioactive SCOTT PRIBNOW agents into ocular tissue within an eye of a patient for the Kagan Binder, PLLC treatment of an ocular condition, the method comprising Suite 200 concurrently using at least two of the following bioactive 221 Main Street North agent delivery methods (A)-(C): Stillwater, MN 55082 (US) (A) implanting a Sustained release delivery device com (21) Appl. No.: 11/175,850 prising one or more bioactive agents in a posterior region of the eye so that it delivers the one or more (22) Filed: Jul. 5, 2005 bioactive agents into the vitreous humor of the eye; (B) instilling (e.g., injecting or implanting) one or more Related U.S. Application Data bioactive agents Subretinally; and (60) Provisional application No. 60/585,236, filed on Jul. (C) instilling (e.g., injecting or delivering by ocular ion 2, 2004. Provisional application No. 60/669,701, filed tophoresis) one or more bioactive agents into the Vit on Apr. 8, 2005. reous humor of the eye. Patent Application Publication May 25, 2006 Sheet 1 of 22 US 2006/0110428A1 R 2 2 C.6 Fig. -
Supplementary Material
Supplementary material Table S1. Search strategy performed on the following databases: PubMed, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL). 1. Randomi*ed study OR random allocation OR Randomi*ed controlled trial OR Random* Control* trial OR RCT Epidemiological study 2. sodium glucose cotransporter 2 OR sodium glucose cotransporter 2 inhibitor* OR sglt2 inhibitor* OR empagliflozin OR dapagliflozin OR canagliflozin OR ipragliflozin OR tofogliflozin OR ertugliflozin OR sotagliflozin OR sergliflozin OR remogliflozin 3. 1 AND 2 1 Table S2. Safety outcomes of empagliflozin and linagliptin combination therapy compared with empagliflozin or linagliptin monotherapy in treatment naïve type 2 diabetes patients Safety outcome Comparator 1 Comparator 2 I2 RR [95% CI] Number of events Number of events / / total subjects total subjects i. Empagliflozin + linagliptin vs empagliflozin monotherapy Empagliflozin + Empagliflozin linagliptin monotherapy ≥ 1 AE(s) 202/272 203/270 77% 0.99 [0.81, 1.21] ≥ 1 drug-related 37/272 38/270 0% 0.97 [0.64, 1.47] AE(s) ≥ 1 serious AE(s) 13/272 19/270 0% 0.68 [0.34, 1.35] Hypoglycaemia* 0/272 5/270 0% 0.18 [0.02, 1.56] UTI 32/272 25/270 29% 1.28 [0.70, 2.35] Events suggestive 12/272 13/270 9% 0.92 [0.40, 2.09] of genital infection i. Empagliflozin + linagliptin vs linagliptin monotherapy Empagliflozin + Linagliptin linagliptin monotherapy ≥ 1 AE(s) 202/272 97/135 0% 1.03 [0.91, 1.17] ≥ 1 drug-related 37/272 17/135 0% 1.08 [0.63, 1.84] AE(s) ≥ 1 serious AE(s) 13/272 2/135 0% 3.22 [0.74, 14.07] Hypoglycaemia* 0/272 1/135 NA 0.17 [0.01, 4.07] UTI 32/272 12/135 0% 1.32 [0.70, 2.49] Events suggestive 12/272 4/135 0% 1.45 [0.47, 4.47] of genital infection RR, relative risk; AE, adverse event; UTI, urinary tract infection. -
Classification of Medicinal Drugs and Driving: Co-Ordination and Synthesis Report
Project No. TREN-05-FP6TR-S07.61320-518404-DRUID DRUID Driving under the Influence of Drugs, Alcohol and Medicines Integrated Project 1.6. Sustainable Development, Global Change and Ecosystem 1.6.2: Sustainable Surface Transport 6th Framework Programme Deliverable 4.4.1 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Due date of deliverable: 21.07.2011 Actual submission date: 21.07.2011 Revision date: 21.07.2011 Start date of project: 15.10.2006 Duration: 48 months Organisation name of lead contractor for this deliverable: UVA Revision 0.0 Project co-funded by the European Commission within the Sixth Framework Programme (2002-2006) Dissemination Level PU Public PP Restricted to other programme participants (including the Commission x Services) RE Restricted to a group specified by the consortium (including the Commission Services) CO Confidential, only for members of the consortium (including the Commission Services) DRUID 6th Framework Programme Deliverable D.4.4.1 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Page 1 of 243 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Authors Trinidad Gómez-Talegón, Inmaculada Fierro, M. Carmen Del Río, F. Javier Álvarez (UVa, University of Valladolid, Spain) Partners - Silvia Ravera, Susana Monteiro, Han de Gier (RUGPha, University of Groningen, the Netherlands) - Gertrude Van der Linden, Sara-Ann Legrand, Kristof Pil, Alain Verstraete (UGent, Ghent University, Belgium) - Michel Mallaret, Charles Mercier-Guyon, Isabelle Mercier-Guyon (UGren, University of Grenoble, Centre Regional de Pharmacovigilance, France) - Katerina Touliou (CERT-HIT, Centre for Research and Technology Hellas, Greece) - Michael Hei βing (BASt, Bundesanstalt für Straßenwesen, Germany). -
18512582.Pdf
European Heart Journal (2001) 22, 1938–1947 doi:10.1053/euhj.2001.2627, available online at http://www.idealibrary.com on The TRAPIST Study A multicentre randomized placebo controlled clinical trial of trapidil for prevention of restenosis after coronary stenting, measured by 3-D intravascular ultrasound P. W. Serruys1, D. P. Foley1, M. Pieper2, J. A. Kleijne3 and P. J. de Feyter1 on behalf of the TRAPIST investigators 1Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands; 2Heartcenter Bodensee, Kreuzlingen, Switzerland; and 3Cardialysis, Rotterdam, The Netherlands Background Studies have reported benefit of oral therapy significant difference between trapidil and placebo-treated with the phosphodiesterase inhibitor, trapidil, in reducing patients regarding in-stent neointimal volume (108·6 restenosis after coronary angioplasty. Coronary stenting is 95·6 mm3 vs 93·379·1 mm3; P=0·16) or % obstruction associated with improved late outcome compared with volume (3818% vs 3621%; P=0·32), in angiographic balloon angioplasty, but significant neointimal hyperplasia minimal luminal diameter at follow-up (1·630·61 mm vs still occurs in a considerable proportion of patients. The 1·740·69 mm; P=0·17), restenosis rate (31% vs 24%; aim of this study was to investigate the safety and efficacy P=0·24), cumulative incidence of major adverse cardiac of trapidil 200 mg in preventing in-stent restenosis. events at 7 months (22% vs 20%; P=0·71) or anginal complaints (30% vs 24%; P=0·29). Methods Patients with a single native coronary lesion requiring revascularization were randomized to placebo or Conclusion Oral trapidil 600 mg daily for 6 months did trapidil at least 1 h before, and continuing for 6 months not reduce in-stent hyperplasia or improve clinical outcome after, successful implantation of a coronary Wallstent. -
Pharmacokinetics of Omarigliptin, a Once-Weekly Dipeptidyl Peptidase-4 Inhibitor
Available online a t www.derpharmachemica.com ISSN 0975-413X Der Pharma Chemica, 2016, 8(12):292-295 CODEN (USA): PCHHAX (http://derpharmachemica.com/archive.html) Mini-review: Pharmacokinetics of Omarigliptin, a Once-weekly Dipeptidyl Peptidase-4 Inhibitor Nermeen Ashoush a,b aClinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, British University in Egypt, El- Sherouk city, Cairo 11837, Egypt. bHead of Health Economics Unit, Center for Drug Research and Development (CDRD), Faculty of Pharmacy, British University in Egypt, El-Sherouk city, Cairo 11837, Egypt. _____________________________________________________________________________________________ ABSTRACT The dipeptidyl peptidase-4 (DPP-4) inhibitors are novel oral hypoglycemic drugs which have been in clinical use for the past 10 years. The drugs are safe, weight neutral and widely prescribed. There are currently many gliptins approved by FDA, namely sitagliptin, vildagliptin, saxagliptin, linagliptin, alogliptin with several more in advanced stages of development. The gliptins may possess cardiovascular protective effects and their administration may promote β-cell survival; claims currently being evaluated in clinical and preclinical studies. The gliptins are an optional second-line therapy after metformin; they are generally well tolerated with low risk of hypoglycemia. The various compounds differ with respect to their pharmacokinetic properties; however, their clinical efficacy appears to be similar. The clinical differences between the various compounds -
200 Adverse Drug Reactions in a Southern Hospital in Taiwan 201
200 Adverse Drug Reactions in a southern hospital in Taiwan Yuhong Lin1 1Kaohsiung Veterans General Hospital Tainan Branch, Tainan City, Taiwan Objective: The aim of this study was to evaluate the adverse drug reactions (ADRs) reporting in a southern hospital in Taiwan. Methods: It was a retrospective study of ADRs reporting in 2016. We analysed ADRs which contain gender and age, occurring sources, Anatomical Therapeutic Chemical (ATC) classification of suspected drugs, management of ADRs and so on. Results: The study collected eighty-nine ADRs reported. Most of ADRs reported were occurring in outpatient department (87.6%). The average age of ADRs reported was 67.6 years. Majority of all ADRs reported were females (55.1%). According to ATC classification system, the major classification of suspected drugs were Sensory organs (32.6%). Among the adverse reactions, Dermatologic Effects (37.1%) were the major type of ADRs. Also, the major management of ADRs was to stop using the current suspected drug (46.1%). Conclusion: Certainly, ADRs reporting are still a very important information to healthcare professionals. As a result, we put all information of ADRs reported into medical system in our hospital and it will improve the safety of medication use. In case of prescribe the suspected medicines, it can remind doctor to think of information about patient's ADRs reported. No drugs is administered without risk. Therefore, all healthcare professionals should have a responsibility to their patients, who themselves are becoming more aware of problems -
Health Reports for Mutual Recognition of Medical Prescriptions: State of Play
The information and views set out in this report are those of the author(s) and do not necessarily reflect the official opinion of the European Union. Neither the European Union institutions and bodies nor any person acting on their behalf may be held responsible for the use which may be made of the information contained therein. Executive Agency for Health and Consumers Health Reports for Mutual Recognition of Medical Prescriptions: State of Play 24 January 2012 Final Report Health Reports for Mutual Recognition of Medical Prescriptions: State of Play Acknowledgements Matrix Insight Ltd would like to thank everyone who has contributed to this research. We are especially grateful to the following institutions for their support throughout the study: the Pharmaceutical Group of the European Union (PGEU) including their national member associations in Denmark, France, Germany, Greece, the Netherlands, Poland and the United Kingdom; the European Medical Association (EMANET); the Observatoire Social Européen (OSE); and The Netherlands Institute for Health Service Research (NIVEL). For questions about the report, please contact Dr Gabriele Birnberg ([email protected] ). Matrix Insight | 24 January 2012 2 Health Reports for Mutual Recognition of Medical Prescriptions: State of Play Executive Summary This study has been carried out in the context of Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross- border healthcare (CBHC). The CBHC Directive stipulates that the European Commission shall adopt measures to facilitate the recognition of prescriptions issued in another Member State (Article 11). At the time of submission of this report, the European Commission was preparing an impact assessment with regards to these measures, designed to help implement Article 11. -
CDR Clinical Review Report for Soliqua
CADTH COMMON DRUG REVIEW Clinical Review Report Insulin glargine and lixisenatide injection (Soliqua) (Sanofi-Aventis) Indication: adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (less than 60 units daily) alone or in combination with metformin. Service Line: CADTH Common Drug Review Version: Final (with redactions) Publication Date: January 2019 Report Length: 118 Pages Disclaimer: The information in this document is intended to help Canadian health care decision-makers, health care professionals, health systems leaders, and policy-makers make well-informed decisions and thereby improve the quality of health care services. While patients and others may access this document, the document is made available for informational purposes only and no representations or warranties are made with respect to its fitness for any particular purpose. The information in this document should not be used as a substitute for professional medical advice or as a substitute for the application of clinical judgment in respect of the care of a particular patient or other professional judgment in any decision-making process. The Canadian Agency for Drugs and Technologies in Health (CADTH) does not endorse any information, drugs, therapies, treatments, products, processes, or services. While care has been taken to ensure that the information prepared by CADTH in this document is accurate, complete, and up-to-date as at the applicable date the material was first published by CADTH, CADTH does not make any guarantees to that effect. CADTH does not guarantee and is not responsible for the quality, currency, propriety, accuracy, or reasonableness of any statements, information, or conclusions contained in any third-party materials used in preparing this document.