Literature DB >> 35731262

Scientific and ethical issues in add-on designs for antidiabetic drugs.

Lidia Staszewsky1, Silvio Garattini2.   

Abstract

This editorial describes the clinical trials related to antidiabetic drugs, most of them following an "add-on" design of where the new drug is added to metformin and the comparative arm is metformin plus placebo. Many drugs are already approved for therapy following this design; the authors believe that it is unethical to continue this trend because it makes it impossible to stratify the many antidiabetic drugs according to their efficacy and toxicity.
© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.

Entities:  

Keywords:  Add-on design; Antidiabetic drugs; Clinical trial; Type 2 diabetes

Mesh:

Substances:

Year:  2022        PMID: 35731262     DOI: 10.1007/s00228-022-03351-w

Source DB:  PubMed          Journal:  Eur J Clin Pharmacol        ISSN: 0031-6970            Impact factor:   3.064


  20 in total

Review 1.  The safety of thiazolidinediones.

Authors:  Keith G Tolman
Journal:  Expert Opin Drug Saf       Date:  2011-03-03       Impact factor: 4.250

Review 2.  Type 2 Diabetes Mellitus and Heart Failure: A Scientific Statement From the American Heart Association and the Heart Failure Society of America: This statement does not represent an update of the 2017 ACC/AHA/HFSA heart failure guideline update.

Authors:  Shannon M Dunlay; Michael M Givertz; David Aguilar; Larry A Allen; Michael Chan; Akshay S Desai; Anita Deswal; Victoria Vaughan Dickson; Mikhail N Kosiborod; Carolyn L Lekavich; Rozalina G McCoy; Robert J Mentz; Ileana L Piña
Journal:  Circulation       Date:  2019-06-06       Impact factor: 29.690

3.  Cardiovascular events and all-cause mortality in patients with type 2 diabetes treated with dipeptidyl peptidase-4 inhibitors: An extensive meta-analysis of randomized controlled trials.

Authors:  Edoardo Mannucci; Besmir Nreu; Chiara Montereggi; Benedetta Ragghianti; Marco Gallo; Andrea Giaccari; Matteo Monami
Journal:  Nutr Metab Cardiovasc Dis       Date:  2021-07-05       Impact factor: 4.222

4.  SGLT-2 inhibitors or GLP-1 receptor agonists for adults with type 2 diabetes: a clinical practice guideline.

Authors:  Sheyu Li; Per Olav Vandvik; Lyubov Lytvyn; Gordon H Guyatt; Suetonia C Palmer; René Rodriguez-Gutierrez; Farid Foroutan; Thomas Agoritsas; Reed A C Siemieniuk; Michael Walsh; Lawrie Frere; David J Tunnicliffe; Evi V Nagler; Veena Manja; Bjørn Olav Åsvold; Vivekanand Jha; Mieke Vermandere; Karim Gariani; Qian Zhao; Yan Ren; Emma Jane Cartwright; Patrick Gee; Alan Wickes; Linda Ferns; Robin Wright; Ling Li; Qiukui Hao; Reem A Mustafa
Journal:  BMJ       Date:  2021-05-11

5.  Sodium--glucose co-transporter-2 inhibitors for patients with diabetic and nondiabetic chronic kidney disease: a new era has already begun.

Authors:  Pantelis Sarafidis; Alberto Ortiz; Charles J Ferro; Jean-Michel Halimi; Reinhold Kreutz; Francesca Mallamaci; Giuseppe Mancia; Christoph Wanner
Journal:  J Hypertens       Date:  2021-06-01       Impact factor: 4.844

6.  Thiazolidinediones, alpha-glucosidase inhibitors, meglitinides, sulfonylureas, and hepatocellular carcinoma risk: A meta-analysis.

Authors:  Ashwini Arvind; Zoe N Memel; Lisa L Philpotts; Hui Zheng; Kathleen E Corey; Tracey G Simon
Journal:  Metabolism       Date:  2021-04-21       Impact factor: 13.934

7.  Class effect for SGLT-2 inhibitors: a tale of 9 drugs.

Authors:  Dario Giugliano; Katherine Esposito
Journal:  Cardiovasc Diabetol       Date:  2019-07-23       Impact factor: 9.951

8.  Sodium-glucose cotransporter protein-2 (SGLT-2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists for type 2 diabetes: systematic review and network meta-analysis of randomised controlled trials.

Authors:  Suetonia C Palmer; Britta Tendal; Reem A Mustafa; Per Olav Vandvik; Sheyu Li; Qiukui Hao; David Tunnicliffe; Marinella Ruospo; Patrizia Natale; Valeria Saglimbene; Antonio Nicolucci; David W Johnson; Marcello Tonelli; Maria Chiara Rossi; Sunil V Badve; Yeoungjee Cho; Annie-Claire Nadeau-Fredette; Michael Burke; Labib I Faruque; Anita Lloyd; Nasreen Ahmad; Yuanchen Liu; Sophanny Tiv; Tanya Millard; Lucia Gagliardi; Nithin Kolanu; Rahul D Barmanray; Rita McMorrow; Ana Karina Raygoza Cortez; Heath White; Xiangyang Chen; Xu Zhou; Jiali Liu; Andrea Flores Rodríguez; Alejandro Díaz González-Colmenero; Yang Wang; Ling Li; Surya Sutanto; Ricardo Cesar Solis; Fernando Díaz González-Colmenero; René Rodriguez-Gutierrez; Michael Walsh; Gordon Guyatt; Giovanni F M Strippoli
Journal:  BMJ       Date:  2021-01-13

9.  Safety of add-on sulfonylurea therapy in patients with type 2 diabetes using metformin: a population-based real-world study.

Authors:  Ingrid Hougen; Reid H Whitlock; Paul Komenda; Claudio Rigatto; Kristin K Clemens; Navdeep Tangri
Journal:  BMJ Open Diabetes Res Care       Date:  2021-12

10.  Cardiac and Kidney Benefits of Empagliflozin in Heart Failure Across the Spectrum of Kidney Function: Insights From EMPEROR-Reduced.

Authors:  Faiez Zannad; João Pedro Ferreira; Stuart J Pocock; Cordula Zeller; Stefan D Anker; Javed Butler; Gerasimos Filippatos; Sibylle Jenny Hauske; Martina Brueckmann; Egon Pfarr; Janet Schnee; Christoph Wanner; Milton Packer
Journal:  Circulation       Date:  2020-10-23       Impact factor: 29.690

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