1. Unravelling the utility of modern sulfonylureas from cardiovascular outcome trials and landmark trials: expert opinion from an international panel
- Author
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Ansumali Joshi, Aly Ahmed Abdel Rahim, Shyaminda Kahandawa, Shreeparna Ghosh, Deepak Khandelwal, Dinesh Kumar, Gagan Priya, A. Shaheed, M. Chawla, Hikmat Permana, R. N. Mehrotra, Sanjay Kalra, Debmalya Sanyal, Khalid Shaikh, Manilka Sumanathilaka, Parag Shah, Sarita Bajaj, Pradeep Krishna Shrestha, V D Deshmukh, A K Das, Sambit Das, Sruti Chandrasekaran, Ahmed Al-Ani, Wiam I. Hussein, M. D. Fariduddin, Tiny Nair, Dina Shrestha, Fatimah Eliana, and Abbas Orabi
- Subjects
medicine.medical_specialty ,RD1-811 ,Context (language use) ,Disease ,Review Article ,030204 cardiovascular system & hematology ,Outcome (game theory) ,Food and drug administration ,03 medical and health sciences ,Cardiovascular outcome trials ,0302 clinical medicine ,medicine ,Diseases of the circulatory (Cardiovascular) system ,Humans ,030212 general & internal medicine ,Intensive care medicine ,Expert Testimony ,Pharmaceutical industry ,business.industry ,Type 2 Diabetes Mellitus ,Modern sulfonylureas ,Expert group ,Sulfonylurea Compounds ,Treatment Outcome ,Cardiovascular Diseases ,Expert opinion ,RC666-701 ,Surgery ,Cardiosafe ,Cardiology and Cardiovascular Medicine ,business - Abstract
Aim The primary objective of this review is to develop practice-based expert group opinions on the cardiovascular (CV) safety and utility of modern sulfonylureas (SUs) in cardiovascular outcome trials (CVOTs). Background The United States Food and Drug Administration issued new guidance to the pharmaceutical industry in 2008 regarding the development of new antihyperglycemic drugs. The guidance expanded the scope for the approval of novel antihyperglycemic drugs by mandating CVOTs for safety. A few long-term CVOTs on dipeptidyl peptidase 4 inhibitors, glucagon-like peptide 1 receptor agonists, and sodium-glucose cotransporter 2 inhibitors have been completed, while others are ongoing. SUs, which constitute one of the key antihyperglycemic agents used for the management of type 2 diabetes mellitus (T2DM), have been used as comparator agents in several CVOTs. However, the need for CVOTs on modern SUs remains debatable. In this context, a multinational group of endocrinologists convened for a meeting and discussed the need for CVOTs of modern SUs to evaluate their utility in the management of patients with T2DM. At the meeting, CVOTs of modern SUs conducted to date and the hypotheses derived from the results of these trials were discussed. Review results The expert group analyzed the key trials emphasizing the CV safety of modern SUs and also reviewed the results of various CVOTs in which modern SUs were used as comparators. Based on literature evidence and individual clinical insights, the expert group opined that modern SUs are cardiosafe and that since they have been used as comparators in other CVOTs, CVOTs of SUs are not required. Conclusion Modern SUs can be considered a cardiosafe option for the management of patients with diabetes mellitus and CV disease; thus CVOTs among individuals with T2DM are not required.
- Published
- 2019