{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,4]],"date-time":"2026-07-04T02:42:03Z","timestamp":1783132923312,"version":"3.54.6"},"reference-count":20,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2022,11,28]],"date-time":"2022-11-28T00:00:00Z","timestamp":1669593600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,11,28]],"date-time":"2022-11-28T00:00:00Z","timestamp":1669593600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Endocr Disord"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Sodium-Glucose-Co-Transporter 2 (SGLT2) inhibitor (Empagliflozin) is an effective drug in controlling blood glucose through predominantly glycosuria. Glycosuria increases the risk of genitourinary infections in diabetes. This study was aimed to establish the safety and efficacy of Empagliflozin (Group-A) versus standard care (Group-B) in Pakistani Muslim individuals with type 2 diabetes.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>A multicenter, randomized clinical trial was conducted in five cities across Pakistan from July 2019 to August 2020. Patients of both genders aged 18\u201375\u2009years, body mass index (BMI)\u2009\u2264\u200945\u2009kg\/m<jats:sup>2<\/jats:sup>, glycosylated hemoglobin (HbA1c) 7\u201310% (53\u2009mmol\/mol to 86\u2009mmol\/mol) and treatment-naive to Empagliflozin were included. Treatment was given for 24\u2009weeks, and allocation was done through randomization.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Out of 745 screened patients, 333 met the eligibility criteria, and a total of 244 (73.3%) patients were enrolled. More hypoglycemic events were reported in the standard care group, whereas positive urine culture, fungal infection, dehydration, and hypotension occurrence were comparable between the two groups. The 6\u2009months mean HbA1c reduction was significant in both groups; (Group-A: 0.91\u2009\u00b1\u20090.15; <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001 vs. Group-B2: 0.79\u2009\u00b1\u20090.14; <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001). Efficacy comparison at 6\u2009months revealed a significant reduction in weight and systolic blood pressure (SBP) in Group A only (Group-A: 1.4\u2009\u00b1\u20090.4\u2009kg; <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.002 vs. Group-B: 0.01\u2009\u00b1\u20090.5\u2009kg; <jats:italic>p<\/jats:italic>\u2009&lt;\u20091.00), (Group-A: 5.1\u2009\u00b1\u20091.7\u2009mmHg; <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.012 vs. Group-B: 2.3\u2009\u00b1\u20091.7\u2009mmHg; <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.526).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>Empagliflozin was a safe drug compared to standard care in Pakistani Muslim patients with diabetes. It was as effective as standard care in the clinical setting but achieved glycemic control by reducing weight and SBP in type 2 diabetes patients.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>This study was registered in the NIH US National Library of Medicine clinical trials registry at Clinicaltrials.gov with the registration number: NCT04665284 on 11\/12\/2020.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12902-022-01213-1","type":"journal-article","created":{"date-parts":[[2022,11,28]],"date-time":"2022-11-28T09:07:34Z","timestamp":1669626454000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Safety and efficacy of Empagliflozin in Pakistani Muslim patients with type 2 diabetes (SAFE-PAK); a randomized clinical trial"],"prefix":"10.1186","volume":"22","author":[{"given":"Azizul Hasan","family":"Aamir","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Umar Yousaf","family":"Raja","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Faisal Masood","family":"Qureshi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ali","family":"Asghar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Saeed Ahmed","family":"Mahar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ibrar","family":"Ahmed","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tahir","family":"Ghaffar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jamal","family":"Zafar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohammad Imtiaz","family":"Hasan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amna","family":"Riaz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Syed Abbas","family":"Raza","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irshad Ahmed","family":"Khosa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jahanzeb","family":"Khan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jaffer Bin","family":"Baqar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2022,11,28]]},"reference":[{"key":"1213_CR1","unstructured":"Federation ID. IDF Diabetes Atlas 2019 [Cited 2019]. Available from: http:\/\/www.diabetesatlas.org."},{"key":"1213_CR2","doi-asserted-by":"publisher","unstructured":"Kaiser AB, Zhang N, Van Der Pluijm W. Global prevalence of type 2 diabetes over the next ten years (2018-2028). Am Diabetes Assoc. 2018. https:\/\/doi.org\/10.2337\/db18-202-LB.","DOI":"10.2337\/db18-202-LB"},{"issue":"2","key":"1213_CR3","doi-asserted-by":"publisher","first-page":"e025300","DOI":"10.1136\/bmjopen-2018-025300","volume":"9","author":"AH Aamir","year":"2019","unstructured":"Aamir AH, Ul-Haq Z, Mahar SA, Qureshi FM, Ahmad I, Jawa A, et al. Diabetes prevalence survey of Pakistan (DPS-PAK): prevalence of type 2 diabetes mellitus and prediabetes using HbA1c: a population-based survey from Pakistan. BMJ Open. 2019;9(2):e025300.","journal-title":"BMJ Open"},{"issue":"3","key":"1213_CR4","doi-asserted-by":"publisher","first-page":"393","DOI":"10.1517\/14740338.2016.1135900","volume":"15","author":"IJ Neeland","year":"2016","unstructured":"Neeland IJ, Salahuddin U, McGuire DK. A safety evaluation of empagliflozin for the treatment of type 2 diabetes. Expert Opin Drug Saf. 2016;15(3):393\u2013402.","journal-title":"Expert Opin Drug Saf"},{"issue":"1","key":"1213_CR5","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1186\/s12879-021-06106-7","volume":"21","author":"AH Aamir","year":"2021","unstructured":"Aamir AH, Raja UY, Asghar A, Mahar SA, Ghaffar T, Ahmed I, et al. Asymptomatic urinary tract infections and associated risk factors in Pakistani Muslim type 2 diabetic patients. BMC Infect Dis. 2021;21(1):1\u20136.","journal-title":"BMC Infect Dis"},{"issue":"1","key":"1213_CR6","doi-asserted-by":"publisher","first-page":"210","DOI":"10.4103\/2230-8210.196029","volume":"21","author":"S Kalra","year":"2017","unstructured":"Kalra S, Ghosh S, Aamir A, Ahmed MT, Amin MF, Bajaj S, et al. Safe and pragmatic use of sodium\u2013glucose co-transporter 2 inhibitors in type 2 diabetes mellitus: south Asian Federation of Endocrine Societies consensus statement. Indian J Endocrinol Metab. 2017;21(1):210.","journal-title":"Indian J Endocrinol Metab"},{"key":"1213_CR7","doi-asserted-by":"publisher","unstructured":"Professional practice committee: standards of medical Care in Diabetes\u20142021. Diabetes Care. 2021;44(Supplement_1):S3. https:\/\/doi.org\/10.2337\/dc21-Sppc.","DOI":"10.2337\/dc21-Sppc"},{"key":"1213_CR8","unstructured":"Jan A, Weir CB. BMI Classification Percentile and Cut Off Points. Treasure Island: StatPearls; 2021."},{"issue":"4","key":"1213_CR9","doi-asserted-by":"publisher","first-page":"262","DOI":"10.7326\/0003-4819-159-4-201308200-00007","volume":"159","author":"D Vasilakou","year":"2013","unstructured":"Vasilakou D, Karagiannis T, Athanasiadou E, Mainou M, Liakos A, Bekiari E, et al. Sodium\u2013glucose cotransporter 2 inhibitors for type 2 diabetes: a systematic review and meta-analysis. Ann Intern Med. 2013;159(4):262\u201374.","journal-title":"Ann Intern Med"},{"issue":"1","key":"1213_CR10","doi-asserted-by":"publisher","first-page":"41","DOI":"10.2337\/diaspect.17.1.41","volume":"17","author":"TE Burroughs","year":"2004","unstructured":"Burroughs TE, Desikan R, Waterman BM, Gilin D, McGill J. Development and validation of the diabetes quality of life brief clinical inventory. Diabetes Spectr. 2004;17(1):41\u20139.","journal-title":"Diabetes Spectr"},{"issue":"3","key":"1213_CR11","doi-asserted-by":"publisher","first-page":"382","DOI":"10.1080\/00325481.2017.1259544","volume":"129","author":"R Devi","year":"2017","unstructured":"Devi R, Mali G, Chakraborty I, Unnikrishnan MK, Abdulsalim S. Efficacy and safety of empagliflozin in type 2 diabetes mellitus: a meta-analysis of randomized controlled trials. Postgrad Med. 2017;129(3):382\u201392.","journal-title":"Postgrad Med"},{"issue":"2","key":"1213_CR12","doi-asserted-by":"publisher","first-page":"246","DOI":"10.1590\/1806-9282.65.2.246","volume":"65","author":"IR Figueiredo","year":"2019","unstructured":"Figueiredo IR, Rose SCP, Freire NB, Patroc\u00ednio MS, Pierdon\u00e1 N, Bittencourt RJ. Use of sodium-glucose cotransporter-2 inhibitors and urinary tract infections in type 2 diabetes patients: a systematic review. AMB Rev Assoc Med Bras. 2019;65(2):246\u201352.","journal-title":"AMB Rev Assoc Med Bras"},{"issue":"22","key":"1213_CR13","doi-asserted-by":"publisher","first-page":"2117","DOI":"10.1056\/NEJMoa1504720","volume":"373","author":"B Zinman","year":"2015","unstructured":"Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2015;373(22):2117\u201328.","journal-title":"N Engl J Med"},{"issue":"11","key":"1213_CR14","doi-asserted-by":"publisher","first-page":"1094","DOI":"10.1056\/NEJMc1600827","volume":"374","author":"B Zinman","year":"2016","unstructured":"Zinman B, Lachin JM, Inzucchi SE. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2016;374(11):1094. https:\/\/doi.org\/10.1056\/NEJMc1600827.","journal-title":"N Engl J Med"},{"issue":"1","key":"1213_CR15","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1186\/s12933-015-0314-0","volume":"14","author":"M Roden","year":"2015","unstructured":"Roden M, Merker L, Christiansen AV, Roux F, Salsali A, Kim G, et al. Safety, tolerability and effects on cardiometabolic risk factors of empagliflozin monotherapy in drug-na\u00efve patients with type 2 diabetes: a double-blind extension of a phase III randomized controlled trial. Cardiovasc Diabetol. 2015;14(1):1\u201311.","journal-title":"Cardiovasc Diabetol"},{"issue":"11","key":"1213_CR16","doi-asserted-by":"publisher","first-page":"1184","DOI":"10.1139\/cjpp-2018-0359","volume":"96","author":"N Kumar","year":"2018","unstructured":"Kumar N, Garg A, Bhatt DL, Sabongui S, Gupta N, Chaudhry S, et al. Empagliflozin improves cardiorespiratory fitness in type 2 diabetes: translational implications. Can J Physiol Pharmacol. 2018;96(11):1184\u20137.","journal-title":"Can J Physiol Pharmacol"},{"issue":"18","key":"1213_CR17","doi-asserted-by":"publisher","first-page":"2098","DOI":"10.1161\/CIRCULATIONAHA.118.036568","volume":"139","author":"KC Ferdinand","year":"2019","unstructured":"Ferdinand KC, Izzo JL, Lee J, Meng L, George J, Salsali A, et al. Antihyperglycemic and blood pressure effects of empagliflozin in black patients with type 2 diabetes mellitus and hypertension. Circulation. 2019;139(18):2098\u2013109.","journal-title":"Circulation"},{"issue":"3","key":"1213_CR18","doi-asserted-by":"publisher","first-page":"629","DOI":"10.3390\/ijms20030629","volume":"20","author":"TM Ansary","year":"2019","unstructured":"Ansary TM, Nakano D, Nishiyama A. Diuretic effects of sodium glucose cotransporter 2 inhibitors and their influence on the renin-angiotensin system. Int J Mol Sci. 2019;20(3):629.","journal-title":"Int J Mol Sci"},{"issue":"1","key":"1213_CR19","first-page":"87","volume":"37","author":"E Sohail","year":"2021","unstructured":"Sohail E, Ahsan T, Ghaus S, Aijaz W. SGLT 2 inhibitors; glycemic control, weight loss and safety profile in patients with type 2 diabetes, at Medicell institute (MIDEM). Pak J Med Sci. 2021;37(1):87\u201392.","journal-title":"Pak J Med Sci"},{"issue":"43","key":"1213_CR20","doi-asserted-by":"publisher","first-page":"e12843","DOI":"10.1097\/MD.0000000000012843","volume":"97","author":"Y-J Zhang","year":"2018","unstructured":"Zhang Y-J, Han S-L, Sun X-F, Wang S-X, Wang H-Y, Liu X, et al. Efficacy and safety of empagliflozin for type 2 diabetes mellitus: meta-analysis of randomized controlled trials. Medicine. 2018;97(43):e12843. https:\/\/doi.org\/10.1097\/MD.0000000000012843.","journal-title":"Medicine"}],"container-title":["BMC Endocrine Disorders"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12902-022-01213-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s12902-022-01213-1\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12902-022-01213-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,11,30]],"date-time":"2022-11-30T06:45:11Z","timestamp":1669790711000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmcendocrdisord.biomedcentral.com\/articles\/10.1186\/s12902-022-01213-1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,11,28]]},"references-count":20,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2022,12]]}},"alternative-id":["1213"],"URL":"https:\/\/doi.org\/10.1186\/s12902-022-01213-1","relation":{},"ISSN":["1472-6823"],"issn-type":[{"value":"1472-6823","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,11,28]]},"assertion":[{"value":"27 June 2022","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"14 November 2022","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"28 November 2022","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The study was approved by the institutional review boards from Postgraduate Medical Institute Hayatabad Medical Complex Peshawar (ERC No. 5579\/Dy.Reg.\/PGMI) and the National Institute of Cardiovascular Diseases (ERC-56\/2019), Karachi. Informed consent was obtained from all participants at the time of enrolment after a thorough explanation of the study. This study was performed in accordance with all relevant and applicable guidelines and regulations.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"N\/A.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"All the authors approved the final manuscript, and they have no conflict of interest to declare.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"295"}}