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Modifications to the Harmonized Tariff Schedule of the United States to Implement Changes to the Pharmaceutical Appendix
United States International Trade Commission Modifications to the Harmonized Tariff Schedule of the United States to Implement Changes to the Pharmaceutical Appendix USITC Publication 4208 December 2010 U.S. International Trade Commission COMMISSIONERS Deanna Tanner Okun, Chairman Irving A. Williamson, Vice Chairman Charlotte R. Lane Daniel R. Pearson Shara L. Aranoff Dean A. Pinkert Address all communications to Secretary to the Commission United States International Trade Commission Washington, DC 20436 U.S. International Trade Commission Washington, DC 20436 www.usitc.gov Modifications to the Harmonized Tariff Schedule of the United States to Implement Changes to the Pharmaceutical Appendix Publication 4208 December 2010 (This page is intentionally blank) Pursuant to the letter of request from the United States Trade Representative of December 15, 2010, set forth at the end of this publication, and pursuant to section 1207(a) of the Omnibus Trade and Competitiveness Act, the United States International Trade Commission is publishing the following modifications to the Harmonized Tariff Schedule of the United States (HTS) to implement changes to the Pharmaceutical Appendix, effective on January 1, 2011. Table 1 International Nonproprietary Name (INN) products proposed for addition to the Pharmaceutical Appendix to the Harmonized Tariff Schedule INN CAS Number Abagovomab 792921-10-9 Aclidinium Bromide 320345-99-1 Aderbasib 791828-58-5 Adipiplon 840486-93-3 Adoprazine 222551-17-9 Afimoxifene 68392-35-8 Aflibercept 862111-32-8 Agatolimod -
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. -
Renato Wilberto Zilli Eficácia Em Longo Prazo Das
RENATO WILBERTO ZILLI EFICÁCIA EM LONGO PRAZO DAS GLIFLOZINAS VERSUS GLIPTINAS NO TRATAMENTO DO DIABETES MELLITUS TIPO 2 APÓS FALÊNCIA DA METFORMINA COMO MONOTERAPIA: REVISÃO SISTEMÁTICA E METANÁLISE EM REDE Tese apresentada ao Programa de Ciências Médicas da Faculdade de Medicina da Universidade de São Paulo para obtenção do título de Doutor em Ciências. Área de Concentração: Processos Imunes e Infecciosos Orientador: Prof. Dr. Fabiano Pinheiro da Silva (Versão corrigida. Resolução CoPGr 6018/11, de 13 de outubro de 2011. A versão original está disponível na Biblioteca da FMUSP) São Paulo 2017 Dados Internacionais de Catalogação na Publicação (CIP) Preparada pela Biblioteca da Faculdade de Medicina da Universidade de São Paulo ©reprodução autorizada pelo autor Zilli, Renato Wilberto Eficácia em longo prazo das gliflozinas versus gliptinas no tratamento do diabetes mellitus tipo 2 após falência da metformina como monoterapia : revisão sistemática e metanálise em rede / Renato Wilberto Zilli ‐‐ São Paulo, 2017. Tese(doutorado)--Faculdade de Medicina da Universidade de São Paulo. Programa de Ciências Médicas. Área de concentração: Processos Imunes e Infecciosos. Orientador: Fabiano Pinheiro da Silva. Descritores: 1.Diabetes mellitus tipo 2 2.Metanálise 3.Terapia combinada 4.Falha de tratamento 5.Metformina 6.Inibidores da dipeptidil peptidase IV 7.Transportador 2 de glucose‐sódio/inibidores 8.Empagliflozina 9.Dapagliflozina 10.Saxagliptina USP/FM/DBD ‐302/17 Esta tese de doutorado está de acordo com as seguintes normas, em vigor no momento desta publicação: Referências: adaptado de International Committee of Medical Journals Editors (Vancouver). Guia de apresentação e dissertações, teses e monografias. Elaborado por Anneliese Cordeiro da Cunha, Maria Julia de A.L. -
Risk of Any Hypoglycemia with New Antihyperglycemic Agents in Patients with Type 2 Diabetes: a Systematic Review and Meta-Analysis
Risk of Any Hypoglycemia with New Antihyperglycemic Agents in Patients with Type 2 Diabetes: A Systematic Review and Meta-Analysis by Sanaz Kamalinia A thesis submitted in conformity with the requirements for the degree of Master of Science Institute of Medical Sciences University of Toronto © Copyright by Sanaz Kamalinia (2019) Risk of Any Hypoglycemia with New Antihyperglycemic Agents in Patients with Type 2 Diabetes: A Systematic Review and Meta- Analysis Sanaz Kamalinia Master of Science Institute of Medical Sciences University of Toronto 2019 Abstract Background : Evaluation of hypoglycemia risk relative to placebo with new antihyperglycemic agents (AHA) including the dipeptidyl peptidase-4 inhibitors (DPP4i), glucagon-like peptide-1 receptor agonists (GLP1RA) and sodium-glucose co-transporter- 2 inhibitors (SGLT2i) remains inconclusive. Objective: This systematic review and meta-analysis aimed to assess risk of any and severe hypoglycemia with new AHA relative to placebo by excluding studies with background sulfonylureas and insulin. Methods: Randomized, placebo-controlled studies, 12 weeks or greater in duration were considered for inclusion. Studies allowing background use of any other AHA, apart from metformin, were excluded. This study is registered with PROSPERO (CRD42018095458). Results: 141 studies included in the meta-analysis demonstrate that relative to placebo, risk of any and severe hypoglycemia did not significantly differ for any new AHA. ii Acknowledgments First and foremost, I wish to express my sincere gratitude to my program advisor committee members. To my supervisor Dr Tobe, thank you for accepting me as your student and presenting me with this challenge. I thoroughly enjoyed it. Especially given your positive words of encouragement and insightful guidance for every step of this journey. -
For the Use of a Registered Medical Practitioner Or a Hospital Or a Laboratory Only TENELIGLIPTIN, PIOGLITAZONE HYDROCHLORIDE AN
For the use of a Registered Medical Practitioner or a Hospital or a Laboratory only TENELIGLIPTIN, PIOGLITAZONE HYDROCHLORIDE AND PROLONGED RELEASE METFORMIN HYDROCHLORIDE TABLETS 1. THE DRUG SHOULD BE USED AT FIRST LINE OF THERAPY FOR DIABETES. 2. ADVICE FOR HEALTHCARE PROFESSIONALS • Patients with active bladder cancer or with a history of bladder cancer and those with uninvestigated haematuria should not receive pioglitazone. • Prescribers should review the safety and efficacy of pioglitazone in individuals after 3-6 month of treatment to ensure that only patients who are deriving benefit continue to be treated. Pioglitazone should be stopped in patients who do not respond adequately to treatment (e.g. reduction in Glycosylated haemoglobin HbA1C). • Before starting pioglitazone, the following known risk factors for development of bladder cancer should be assessed in individuals: age, current or past history of smoking, exposure to some occupational or chemotherapy agents such as cyclophosphamide, or previous irradiation of the pelvic region. • Use in elderly patients should be considered carefully before and during treatment because the risk of bladder cancer increases with age. Elderly patients should start on the lowest possible dose and be regularly monitored because of the risks of bladder cancer and heart failure associated with pioglitazone. COMPOSITION Each uncoated bilayered tablet contains: . 20 mg (InTeneligliptin Prolonged IP release .………………………..……………….. form) PioglitazoneMetformin Hydrochloride Hydrochloride IP IP …………………..…... equivalent to mg Pio . 15 mg .s Colour:glitazone Quinoline ………………………….…………………… Yellow Excipients ………………………….……………………..... q CLINICAL PHARMACOLOGY Biotenly®-MP contains three oral anti-hyperglycaemic drugs teneligliptin, pioglitazone and metformin hydrochloride used in the management of type-2 diabetes (NIDDM). MECHANISM OF ACTION/PHARMACODYNEMICS Teneligliptin is a DPP-4 inhibitor, which is believed to exert its actions in patients with type 2 diabetes by slowing the inactivation of incretin hormones. -
IJBCP International Journal of Basic & Clinical Pharmacology the Observational, Cross-Sectional Study of Drug Utilization
Print ISSN: 2319-2003 | Online ISSN: 2279-0780 IJBCP International Journal of Basic & Clinical Pharmacology DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20194771 Original Research Article The observational, cross-sectional study of drug utilization 90% and use of dipeptidyl peptidase-4 inhibitor in the patients with type 2 diabetes mellitus Prashant P. Shivgunde1*, Shantanu R. Joshi2, Archana D. Kodilkar1 1Department of University Research, Maharashtra ABSTRACT University of Health Sciences (MUHS), Mhasrul, Vani- Background: Diabetes is a chronic metabolic disease which affects the quality Dindori Road, Nashik, of life. It leads to multiple complications due to metabolic involvement. Out of Maharashtra, India multiple drugs used to treat diabetes, dipeptidyl peptidase 4 (DPP-4) inhibitors 2 Global Herbs Pharmaceuticals, are comparatively new drugs used for type-2-diabetes mellitus (DM) treatment. Pune-Satara Road, Pune, This study aimed to find out the drug utilization (DU) 90% and use of DPP-4 Maharashtra, India inhibitors in patients with type-2-DM. Methods: A prospective, cross-sectional, observational study was conducted at Received: 28 September 2019 a private healthcare clinic of an endocrinologist in Nashik. Type-2-DM patients Revised: 11 October 2019 of both sexes were selected and a total of 199 patients were enrolled in the Accepted: 14 October 2019 study. The consented patients were interviewed and prescription copies were collected. After studying them; statistical analysis was done and results and *Correspondence to: conclusions were drawn. Dr. Prashant P. Shivgunde, Results: Out of total prescribed drugs, 58.77% of drugs were anti-diabetics. It Email: prashantshivgunde@ was observed that the biguanides were most frequently (25.32%) prescribed gmail.com while the least prescribed drugs were meglitinide analogues (0.08%). -
Dipeptidyl Peptidase IV (DPP4) Inhibitors As Potential
Supporting Materials Drug repurposing: Dipeptidyl peptidase IV (DPP4) inhibitors as potential agents to treat SARS-CoV-2 (2019-nCov) infection Praveen P. N. Rao 1*, Amy Trinh Pham 1, Arash Shakeri 1, Amna El Shatshat 1, Yusheng Zhao 1, Rahul C. Karuturi 1 and Ahmed A. Hefny 1 School of Pharmacy, University of Waterloo, Health Sciences Campus, 200 University Ave West, Waterloo, Ontario N2L 3G1, Canada *Corresponding author Praveen P. N. Rao, School of Pharmacy, Health Sciences Campus, University of Waterloo, Waterloo, Ontario, Canada N2L 3G1, phone: 519-888-4567; ext: 21317; email: [email protected] Contents 1. Figure S1: Binding modes of DPP4 inhibitors anagliptin (A), alogliptin (B), trelagliptin (C) and sitagliptin (D) in the SARS-CoV-2 Mpro protomer 2. Figure S2: Binding modes of DPP4 inhibitors teneligliptin (A) and gosogliptin (B) in the SARS-CoV-2 Mpro protomer 3. Figure S3: Electrostatic surface potential map of SARS-CoV-2 Mpro protomer (A) and (B) dimer 4. Figure S4: Binding modes of DPP4 inhibitors gemigliptin, linagliptin and evogliptin in the MERS-CoV 3CLpro dimer 5. Figure S5: Pharmacophore model to design SARS-CoV-2 Mpro dimer inhibitors based on the docked poses of DPP4 inhibitors - gemigliptin, linagliptin and evogliptin 6. Figure S6: 2D Interaction map of linagliptin in the active sites of the serine protease DPP4 and cysteine protease SARS-CoV-2 Mpro 7. Table S1: Physicochemical properties of DPP4 inhibitors and the SARS-CoV-2 Mpro dimer inhibitor 1 1 Figure S1. Binding modes of DPP4 inhibitors anagliptin (A), alogliptin (B), trelagliptin (C) and sitagliptin (D) in the SARS-CoV-2 Mpro protomer (PDB ID: 6Y2F). -
Dipeptidyl Peptidase-4 Inhibitors and the Risk of Heart Failure: a Systematic Review and Meta-Analysis
CMAJ OPEN Research Dipeptidyl peptidase-4 inhibitors and the risk of heart failure: a systematic review and meta-analysis Subodh Verma MD PhD, Ronald M. Goldenberg MD, Deepak L. Bhatt MD MPH, Michael E. Farkouh MD MSc, Adrian Quan MPhil, Hwee Teoh PhD, Kim A. Connelly MBBS PhD, Lawrence A. Leiter MD, Jan O. Friedrich MD DPhil Abstract Background: Given recent discrepant results from randomized controlled trials (RCTs), we examined the totality of RCT evidence assessing the association between dipeptidyl peptidase-4 (DPP-4) inhibitors and heart failure. Methods: MEDLINE, Embase and ClinicalTrials.gov were searched without language restrictions to August 2016 for RCTs compar- ing DPP-4 inhibitors to placebo or no therapy for a period of 24 weeks or more. We included all heart failure outcomes when listed either as a serious adverse event or adverse event. Pooled analyses used random-effects. Results: We identified 100 RCTs (n = 79 867) — 3 large cardiovascular-safety RCTs (SAVOR-TIMI 53[saxagliptin]/n = 16 492, EXAMINE[alogliptin]/n = 5380, and TECOS[sitagliptin]/n = 14 735), and 97 smaller RCTs with a primary outcome that was usually change in glycated hemoglobin. Virtually all RCTs were high-quality, multicentre, placebo-controlled trials. A total of 96% (1192/1244) of heart failure events were prespecified, blindly adjudicated and required hospital admission. Pooled results suggested a 13% increase in heart failure (relative risk [RR] 1.13, 95% confidence interval [CI] 1.01–1.26, I2 = 0%; 32 RCTs, n = 54 640, 1244 events). When including only the 3 large RCTs, the increase was similar, but not significant (RR 1.14, 95% CI 0.97–1.32; 3 RCTs, n = 36 543, 1169 adjudicated events; number needed to harm 246) owing to heterogeneity (I2 = 42%), which lead to wider CIs, because SAVOR- TIMI 53 showed increased heart failure (RR 1.26, 95% CI 1.06–1.49) and TECOS showed no effect (RR 1.00, 95% CI 0.83–1.19). -
Meta-Analysis of 11 Heterogeneous Studies Regarding Dipeptidyl Peptidase 4 Inhibitor Add-On Therapy for Type 2 Diabetes Mellitus Patients Treated with Insulin
Hindawi Journal of Diabetes Research Volume 2020, Article ID 6321826, 12 pages https://doi.org/10.1155/2020/6321826 Research Article Meta-Analysis of 11 Heterogeneous Studies regarding Dipeptidyl Peptidase 4 Inhibitor Add-On Therapy for Type 2 Diabetes Mellitus Patients Treated with Insulin Katsuya Shibuki ,1,2 Shuji Shimada,1 and Takao Aoyama1 1Department of Pharmacy, Tokyo University of Science, 2641 Yamazaki, Noda 278-8510, Japan 2Clinical Research Center, Medical Hospital, Tokyo Medical and Dental University, 1-5-45 Yushima, Tokyo 113-8519, Japan Correspondence should be addressed to Katsuya Shibuki; [email protected] Received 6 April 2020; Revised 24 September 2020; Accepted 22 October 2020; Published 11 November 2020 Academic Editor: Daniela Foti Copyright © 2020 Katsuya Shibuki et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Background. Several clinical trials have addressed the therapeutic strategy of adding dipeptidyl peptidase 4 (DPP-4) inhibitors to the treatment of type 2 diabetes mellitus (DM) inadequately controlled by insulin therapy. However, there is a high degree of heterogeneity in these studies, and the cause of which has not been identified. Methods. We conducted a meta-analysis of randomized controlled trials, which compared the efficacy and safety of adding DPP-4 inhibitors or placebo to insulin therapy; the level of hemoglobin A1c (HbA1c) in the patients was >7.0%, and the duration of treatment was ≥8 weeks. We focused on the mean changes in HbA1c from the baseline (ΔHbA1c) and the incidence of hypoglycemia. -
(SGLT2) Inhibitors: a Systematic Review and Meta-Analysis
Open access Research BMJ Open: first published as 10.1136/bmjopen-2018-022577 on 1 February 2019. Downloaded from Comparative safety of the sodium glucose co-transporter 2 (SGLT2) inhibitors: a systematic review and meta-analysis Jennifer R Donnan,1 Catherine A Grandy,1 Eugene Chibrikov,1 Carlo A Marra,1,2 Kris Aubrey-Bassler,3 Karissa Johnston,1 Michelle Swab,3 Jenna Hache,1 Daniel Curnew,1 Hai Nguyen,1 John-Michael Gamble1,4 To cite: Donnan JR, Grandy CA, ABSTRACT Strengths and limitations of this study Chibrikov E, et al. Comparative Objective To estimate the association between the use safety of the sodium glucose of sodium glucose co-transporter-2 (SGLT2) inhibitors ► This study provides a comprehensive systematic co-transporter 2 (SGLT2) and postmarket harms as identified by drug regulatory inhibitors: a systematic review review of potential serious adverse events related agencies. and meta-analysis. BMJ Open to use of sodium glucose co-transporter-2 (SGLT2) Design We conducted a systematic review and meta- 2019;9:e022577. doi:10.1136/ inhibitors identified by drug regulatory agencies. analysis of randomised controlled trials (RCT). Six large bmjopen-2018-022577 ► This study considered select outcomes to provide databases were searched from inception to May 2018. focused attention on the issues concerning regula- ► Prepublication history and Random effects models were used to estimate pooled tors; however, this means that additional knowledge additional material for this relative risks (RRs). paper are available online. To of the clinical benefits and harms needs to be con- Intervention SGLT2 inhibitors, compared with placebo or view these files, please visit sidered before applying the results of this study. -
Comparison of Dapagliflozin and Teneligliptin in Nonalcoholic Fatty
Original Article ComparisonJCBNJournal0912-00091880-5086theKyoto,jcbn20-12910.3164/jcbn.20-129Original Society Japanof Article Clinical for Free Biochemistry Radical Research of and Nutrition Japandapagliflozin and teneligliptin in nonalcoholic fatty liver disease patients without type 2 diabetes mellitus: a prospective randomized study Hiroshi Tobita,1,2,* Tomotaka Yazaki,1,2 Masatoshi Kataoka,1,2 Satoshi Kotani,2 Akihiko Oka,2 Tsuyoshi Mishiro,2 Naoki Oshima,2 Kousaku Kawashima,2 Norihisa Ishimura,2 Kohji Naora,3 Shuichi Sato,4 and Shunji Ishihara2 1Division of Hepatology and 3Department of Pharmacy, Shimane University Hospital, 891 Enyacho, Izumo, Shimane 6938501, Japan 2Department of Internal Medicine II, Shimane University School of Medicine, 891 Enyacho, Izumo, Shimane 6938501, Japan 4Department of International Medicine, Izumo City General Medical Center, Izumo, Shimane 6938501, Japan (Received?? 10 August, 2020; Accepted 16 September, 2020; Published online 26 December, 2020) ThereCreativestrictedvidedCopyright2021This theare isuse, original anCommonsno opendistribution,© reports 2021 workaccess JCBNAttribution regarding is article andproperly reproduction distributed theLicense, cited. efficacy underwhichin ofany the sodiumglucose permitsmedium, terms ofunre- pro- the these patients.(9) cotransporter 2 inhibitor (SGLT2i) and dipeptidyl peptidase 4 Antidiabetic drugs are widely used for NAFLD patients with inhibitor (DPP4i) administrations in nonalcoholic fatty liver disease type 2 diabetes mellitus (T2DM).(10) Those include dipeptidyl -
Treatment with DPP-4I Anagliptin Or A-GI Miglitol Reduces IGT Development and the Expression of CVD Risk Factors in OLETF Rats
J Nutr Sci Vitaminol, 61, 313–321, 2015 Treatment with DPP-4I Anagliptin or a-GI Miglitol Reduces IGT Development and the Expression of CVD Risk Factors in OLETF Rats Chihiro IMAI1, Tomomi HARAZAKI1, Seiya INOUE1, Kazuki MOCHIZUKI1,2 and Toshinao GODA1,* 1 Laboratory of Nutritional Physiology, Graduate School of Integrated Pharmaceutical and Nutritional Sciences, University of Shizuoka, Shizuoka 422–8526, Japan 2 Laboratory of Food and Nutritional Sciences, Department of Local Produce and Food Sciences, Faculty of Life and Environmental Sciences, University of Yamanashi, Yamanashi 400–8510, Japan (Received November 26, 2014) Summary It has been reported that postprandial hyperglycemia from the pre-diabetic stage, especially from the impaired glucose tolerance (IGT) stage, is positively associated with subsequent incidences of cardiovascular diseases (CVD) and type 2 diabetes. In this study, we aimed to investigate whether treatment with a dipeptidyl peptidase-4 inhibitor (DPP-4I) or an a-glucosidase inhibitor (a-GI), either of which suppresses postprandial hyperglyce- mia, reduces the expression of CVD risk factors in an IGT animal model. A DPP-4I, ana- gliptin (1,200 ppm), or an a-GI, miglitol (600 ppm), in the diet was administered for 47 wk to Otsuka Long-Evans Tokushima Fatty (OLETF) rats, a model for spontaneously-developed type 2 diabetes, at the IGT stage. We examined whether each treatment reduced the expres- sion of CVD risk factors such as inflammatory cytokines/cytokine-like factors in peripheral leukocytes and adhesion molecules in the aortic tissues and circulation. Treatment with either drug reduced IGT development and repressed expression of the interleukin-1b, tumor necrosis factor-a, S100a9, and S100a11 genes in peripheral leukocytes in the fasting state at weeks 25 and 39.