PMID- 32423565 OWN - NLM STAT- MEDLINE DCOM- 20210120 LR - 20210120 IS - 2213-3763 (Electronic) IS - 0019-4832 (Print) IS - 0019-4832 (Linking) VI - 72 IP - 1 DP - 2020 Jan-Feb TI - Unravelling the utility of modern sulfonylureas from cardiovascular outcome trials and landmark trials: expert opinion from an international panel. PG - 7-13 LID - S0019-4832(20)30001-8 [pii] LID - 10.1016/j.ihj.2020.01.001 [doi] AB - 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. CI - Copyright (c) 2020 Cardiological Society of India. Published by Elsevier B.V. All rights reserved. FAU - Kalra, S AU - Kalra S AD - Department of Endocrinology, Bharti Hospital and BRIDE, Karnal, Haryana, India. Electronic address: brideknl@gmail.com. FAU - Ghosh, S AU - Ghosh S AD - Department of Endocrinology and Metabolism, IPGMER, Kolkata, West Bengal, India. FAU - Das, A K AU - Das AK AD - Department of Endocrinology & Medicine, Pondicherry Institute of Medical Sciences, Puducherry, India. FAU - Nair, T AU - Nair T AD - Dept. of Cardiology, PRS Hospital, Trivandrum, Kerala, India. FAU - Bajaj, S AU - Bajaj S AD - Department of Endocrinology, MLN Medical College, Allahabad, Uttar Pradesh, India. FAU - Priya, G AU - Priya G AD - Department of Endocrinology, Fortis Hospital, Chandigarh, Punjab, India. FAU - Mehrotra, R N AU - Mehrotra RN AD - Department of Endocrinology, Apollo Hospitals, Jubilee Hills, Hyderabad, India. FAU - Das, S AU - Das S AD - Department of Endocrinology, Apollo Hospitals in Bhubaneswar, India. FAU - Shah, P AU - Shah P AD - Department of Endocrinology and Diabetes Gujarat Endocrine Centre, Ahmedabad, India. FAU - Deshmukh, V AU - Deshmukh V AD - Department of Endocrinology, Deshmukh Clinic and Research Centre, Pune, Maharashtra. FAU - Chawla, M AU - Chawla M AD - Department of Diabetology, Lina Diabetes Care and Mumbai Diabetes Research Centre, Mumbai, India. FAU - Sanyal, D AU - Sanyal D AD - Department of Endocrinology, KPC Medical College, Kolkata, West Bengal. FAU - Chandrasekaran, S AU - Chandrasekaran S AD - Department of Endocrinology & Diabetes, Dr. Rela Institute of Medical Science (RIMC), Chennai, Tamil Nadu, India. FAU - Khandelwal, D AU - Khandelwal D AD - Department of Endocrinology & Diabetes, Maharaja Agrasen Hospital, New Delhi, India. FAU - Joshi, A AU - Joshi A AD - Department of Endocrinology & Diabetes, Bhaktivedanta Hospital and Research Institute, Mumbai, India. FAU - Eliana, F AU - Eliana F AD - Department of Internal Medicine, Faculty of Medicine, YARSI University, Jakarta, Indonesia. FAU - Permana, H AU - Permana H AD - Department of Internal Medicine, Faculty of Medicine, Padjadjaran University, Bandung, Indonesia. FAU - Fariduddin, M D AU - Fariduddin MD AD - Department of Endocrinology of Bangabandhu Sheikh, Mujib Medical University, Dhaka, Bangladesh. FAU - Shrestha, P K AU - Shrestha PK AD - Department of Internal Medicine, Tribhuwan University Teaching Hospital, Kathmandu, Nepal. FAU - Shrestha, D AU - Shrestha D AD - Department of Endocrinologist, Norvic International Hospital Kathmandu, Nepal. FAU - Kahandawa, S AU - Kahandawa S AD - Department of Endocrinology, Teaching Hospital Karapitiya, Sri Lanka. FAU - Sumanathilaka, M AU - Sumanathilaka M AD - Department of Endocrinology, National Hospital of Sri Lanka, Colombo, Sri Lanka. FAU - Shaheed, A AU - Shaheed A AD - Department of Internal Medicine, Indira Gandhi Memorial Hospital, Male, Maldives. FAU - Rahim, A A AU - Rahim AA AD - Department of Diabetes and Metabolism, Alexandria University, Alexandria, Egypt. FAU - Orabi, A AU - Orabi A AD - Department of Internal Medicine, Faculty of Medicine, Zagazig University, Zagazig, Egypt. FAU - Al-Ani, A AU - Al-Ani A AD - Department of Internal Medicine, Hamad General Hospital, Doha, Qatar. FAU - Hussein, W AU - Hussein W AD - Department of Endocrinology & Diabetes, Royal Hospital, Bahrain. FAU - Kumar, D AU - Kumar D AD - Department of Endocrinology, NMC Specialty Hospital, Abu Dhabi. FAU - Shaikh, K AU - Shaikh K AD - Department of Diabetes, Faculty of Internal Medicine, Royal Oman Police Hospital, Muscat, Oman. LA - eng PT - Journal Article PT - Review DEP - 20200113 PL - India TA - Indian Heart J JT - Indian heart journal JID - 0374675 RN - 0 (Sulfonylurea Compounds) SB - IM MH - Cardiovascular Diseases/*drug therapy MH - *Expert Testimony MH - Humans MH - Sulfonylurea Compounds/*therapeutic use MH - Treatment Outcome PMC - PMC7231843 OTO - NOTNLM OT - Cardiosafe OT - Cardiovascular outcome trials OT - Modern sulfonylureas EDAT- 2020/05/20 06:00 MHDA- 2021/01/21 06:00 PMCR- 2021/01/01 CRDT- 2020/05/20 06:00 PHST- 2019/11/12 00:00 [received] PHST- 2019/12/25 00:00 [revised] PHST- 2020/01/05 00:00 [accepted] PHST- 2020/05/20 06:00 [entrez] PHST- 2020/05/20 06:00 [pubmed] PHST- 2021/01/21 06:00 [medline] PHST- 2021/01/01 00:00 [pmc-release] AID - S0019-4832(20)30001-8 [pii] AID - 10.1016/j.ihj.2020.01.001 [doi] PST - ppublish SO - Indian Heart J. 2020 Jan-Feb;72(1):7-13. doi: 10.1016/j.ihj.2020.01.001. Epub 2020 Jan 13.