Effectiveness of Dapagliflozin as Add-On to Metformin with or without Other Oral Antidiabetic Drugs in Type 2 Diabetes Mellitus: A Multicentre, Retrospective, Real-World Database Study.
Journal
Drugs - real world outcomes
ISSN: 2199-1154
Titre abrégé: Drugs Real World Outcomes
Pays: Switzerland
ID NLM: 101658456
Informations de publication
Date de publication:
28 Oct 2023
28 Oct 2023
Historique:
accepted:
05
10
2023
medline:
29
10
2023
pubmed:
29
10
2023
entrez:
29
10
2023
Statut:
aheadofprint
Résumé
Real-world Indian studies evaluating effectiveness of dapagliflozin as an add-on to other oral antidiabetic drugs (OAD) in patients with type 2 diabetes mellitus (DM) are scarce. An electronic medical record (EMR)-based, retrospective, multicentre study was conducted to evaluate the effectiveness of dapagliflozin as add-on therapy in adult patients with inadequately controlled DM on metformin with or without other OAD. Baseline characteristics (visit 1: metformin or metformin plus OAD treatment for at least 30 days) and treatment-related outcomes (visit 2: follow-up) considered between 60 and 140 days after adding/switching dapagliflozin [glycated haemoglobin (HbA1c), body mass index (BMI), systolic blood pressure (SBP) and diastolic blood pressure (DBP)] were analysed. A total of 3616 patients were screened from 478 centres. Most patients had received dapagliflozin (D) + metformin (M) + at least one other OAD [D + M + OAD, n = 2907 (80.4%), 408 followed-up with HbA1c reported], while 709 patients (19.6%, 138 followed-up with HbA1c reported) received dapagliflozin + metformin (D + M). Treatment with dapagliflozin as an add-on therapy resulted in significant change in HbA1c (-1.1 ± 1.44%; p < 0.05 for HbA1c subgroup ≥ 7.5%; -1.6 ± 1.41%; p < 0.05 for HbA1c subgroup ≥ 8%) at visit 2 compared with visit 1. Significant change in body weight (-1.4 ± 3.31 kg; p < 0.05 for HbA1c subgroup ≥ 7.5%; - 1.5 ± 3.22 kg; p < 0.05 for HbA1c subgroup ≥ 8%) was observed at visit 2. Similarly, a significant change in BMI was noted for the HbA1c subgroup ≥ 7.5% (-1.0 ± 8.38 kg/m Dapagliflozin showed significant improvement in glycemic parameter, BMI and BP when added to metformin, with or without other OADs in a real-world scenario.
Sections du résumé
BACKGROUND
BACKGROUND
Real-world Indian studies evaluating effectiveness of dapagliflozin as an add-on to other oral antidiabetic drugs (OAD) in patients with type 2 diabetes mellitus (DM) are scarce.
METHODS
METHODS
An electronic medical record (EMR)-based, retrospective, multicentre study was conducted to evaluate the effectiveness of dapagliflozin as add-on therapy in adult patients with inadequately controlled DM on metformin with or without other OAD. Baseline characteristics (visit 1: metformin or metformin plus OAD treatment for at least 30 days) and treatment-related outcomes (visit 2: follow-up) considered between 60 and 140 days after adding/switching dapagliflozin [glycated haemoglobin (HbA1c), body mass index (BMI), systolic blood pressure (SBP) and diastolic blood pressure (DBP)] were analysed.
RESULTS
RESULTS
A total of 3616 patients were screened from 478 centres. Most patients had received dapagliflozin (D) + metformin (M) + at least one other OAD [D + M + OAD, n = 2907 (80.4%), 408 followed-up with HbA1c reported], while 709 patients (19.6%, 138 followed-up with HbA1c reported) received dapagliflozin + metformin (D + M). Treatment with dapagliflozin as an add-on therapy resulted in significant change in HbA1c (-1.1 ± 1.44%; p < 0.05 for HbA1c subgroup ≥ 7.5%; -1.6 ± 1.41%; p < 0.05 for HbA1c subgroup ≥ 8%) at visit 2 compared with visit 1. Significant change in body weight (-1.4 ± 3.31 kg; p < 0.05 for HbA1c subgroup ≥ 7.5%; - 1.5 ± 3.22 kg; p < 0.05 for HbA1c subgroup ≥ 8%) was observed at visit 2. Similarly, a significant change in BMI was noted for the HbA1c subgroup ≥ 7.5% (-1.0 ± 8.38 kg/m
CONCLUSIONS
CONCLUSIONS
Dapagliflozin showed significant improvement in glycemic parameter, BMI and BP when added to metformin, with or without other OADs in a real-world scenario.
Identifiants
pubmed: 37898577
doi: 10.1007/s40801-023-00398-8
pii: 10.1007/s40801-023-00398-8
doi:
Types de publication
Journal Article
Langues
eng
Informations de copyright
© 2023. The Author(s).
Références
International Diabetes Federation. IDF Diabetes Atlas. 10th ed. International Diabetes Federation, Brussels. 2021. https://diabetesatlas.org/atlas/tenth-edition/ . Accessed 01 Feb 2023.
Anjana RM, Unnikrishnan R, Deepa M, et al. Metabolic non-communicable disease health report of India: the ICMR-INDIAB national cross-sectional study (ICMR-INDIAB-17). Lancet Diabetes Endocrinol. 2023. https://doi.org/10.1016/s2213-8587(23)00119-5 .
doi: 10.1016/s2213-8587(23)00119-5
pubmed: 37301218
Borgharkar SS, Das SS. Real-world evidence of glycemic control among patients with type 2 diabetes mellitus in India: the TIGHT study. BMJ Open Diabetes Res Care. 2019. https://doi.org/10.1136/bmjdrc-2019-000654 .
doi: 10.1136/bmjdrc-2019-000654
pubmed: 31413840
pmcid: 6673766
Zanella MT, Kohlmann O Jr, Ribeiro AB. Treatment of obesity hypertension and diabetes syndrome. Hypertension. 2001. https://doi.org/10.1161/01.hyp.38.3.705 .
doi: 10.1161/01.hyp.38.3.705
pubmed: 11566963
Gregg EW, Sattar N, Ali MK. The changing face of diabetes complications. Lancet Diabetes Endocrinol. 2016. https://doi.org/10.1016/s2213-8587(16)30010-9 .
doi: 10.1016/s2213-8587(16)30010-9
pubmed: 27595918
pmcid: 5094846
Pradeepa R, Mohan V. Prevalence of type 2 diabetes and its complications in India and economic costs to the nation. Eur J Clin Nutr. 2017. https://doi.org/10.1038/ejcn.2017.40 .
doi: 10.1038/ejcn.2017.40
pubmed: 28422124
Sathyanath S, Kundapur R, Deepthi R, et al. An economic evaluation of diabetes mellitus in India: a systematic review. Diabetes Metab Syndr. 2022. https://doi.org/10.1016/j.dsx.2022.102641 .
doi: 10.1016/j.dsx.2022.102641
pubmed: 36332443
American Diabetes Association. Standards of care in diabetes-2023 abridged for primary care providers. Clin Diabetes. 2022. https://doi.org/10.2337/cd23-as01 .
doi: 10.2337/cd23-as01
pmcid: 8865785
Garber AJ, Handelsman Y, Grunberger G, et al. Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm-2020 executive summary. Endocr Pract. 2020. https://doi.org/10.4158/cs-2019-0472 .
doi: 10.4158/cs-2019-0472
pubmed: 33471721
Prescribing Information of Dapagliflozin. 2021. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202293s024lbl.pdf . Accessed 08 September 2023.
Ferrannini E, Ramos SJ, Salsali A, Tang W, List JF. Dapagliflozin monotherapy in type 2 diabetic patients with inadequate glycemic control by diet and exercise: a randomized, double-blind, placebo controlled, phase 3 trial. Diabetes Care. 2010. https://doi.org/10.2337/dc10-0612 .
doi: 10.2337/dc10-0612
pubmed: 20566676
pmcid: 2945163
Bailey CJ, Gross JL, Pieters A, Bastien A, List JF. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomised, double-blind, placebo-controlled trial. Lancet. 2010. https://doi.org/10.1016/s0140-6736(10)60407-2 .
doi: 10.1016/s0140-6736(10)60407-2
pubmed: 20801398
Scheerer MF, Rist R, Proske O, Meng A, Kostev K. Changes in HbA1c, body weight, and systolic blood pressure in type 2 diabetes patients initiating dapagliflozin therapy: a primary care database study. Diabetes Metab Syndr Obes. 2016. https://doi.org/10.2147/dmso.s116243 .
doi: 10.2147/dmso.s116243
pubmed: 27822077
pmcid: 5096728
Heerspink HJL, Stefánsson BV, Correa-Rotter R, et al. Dapagliflozin in patients with chronic kidney disease. N Engl J Med. 2020. https://doi.org/10.1056/nejmoa2024816 .
doi: 10.1056/nejmoa2024816
pubmed: 32970396
Wiviott SD, Raz I, Bonaca MP, et al. Dapagliflozin and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2019. https://doi.org/10.1056/nejmoa1812389 .
doi: 10.1056/nejmoa1812389
pubmed: 31067395
Morales C, Merino-Torres JF, Moreno-Moreno P, et al. Effectiveness and safety of dapagliflozin in real-life patients: data from the DAPA-RWE Spanish multicentre study. Drugs Context. 2022. https://doi.org/10.7573/dic.2021-11-5 .
doi: 10.7573/dic.2021-11-5
pubmed: 36544626
pmcid: 9753601
Lazzaroni E, Lunati ME, Montefusco L, et al. Dapagliflozin acutely improves kidney function in type 2 diabetes mellitus. The PRECARE study. Pharmacol Res. 2022. https://doi.org/10.1016/j.phrs.2022.106374 .
doi: 10.1016/j.phrs.2022.106374
pubmed: 35908663
Lunati ME, Cimino V, Gandolfi A, et al. SGLT2-inhibitors are effective and safe in the elderly: the SOLD study. Pharmacol Res. 2022. https://doi.org/10.1016/j.phrs.2022.106396 .
doi: 10.1016/j.phrs.2022.106396
pubmed: 35970329
Komoroski B, Vachharajani N, Feng Y, Li L, Kornhauser D, Pfister M. Dapagliflozin, a novel, selective SGLT2 inhibitor, improved glycemic control over 2 weeks in patients with type 2 diabetes mellitus. Clin Pharmacol Ther. 2009. https://doi.org/10.1038/clpt.2008.250 .
doi: 10.1038/clpt.2008.250
pubmed: 19129749
McMurray JJV, Solomon SD, Inzucchi SE, et al. Dapagliflozin in patients with heart failure and reduced ejection fraction. N Engl J Med. 2019. https://doi.org/10.1056/nejmoa1911303 .
doi: 10.1056/nejmoa1911303
pubmed: 31535829
Parikh S, Wilding J, Jabbour S, Hardy E. Dapagliflozin in type 2 diabetes: effectiveness across the spectrum of disease and over time. Int J Clin Pract. 2015. https://doi.org/10.1111/ijcp.12531 .
doi: 10.1111/ijcp.12531
pubmed: 25438821
Xu X, Xu W, Zhuo Q, Yan Y. The efficacy and safety of dapagliflozin combined with oral hypoglycemic agents in patients with type 2 diabetes: a systematic review and meta-analysis. Ann Palliat Med. 2022. https://doi.org/10.21037/apm-22-121 .
doi: 10.21037/apm-22-121
pubmed: 36464966
Pinto LC, Rados DV, Remonti LR, Viana MV, Leitão CB, Gross JL. Dose-ranging effects of SGLT2 inhibitors in patients with type 2 diabetes: a systematic review and meta-analysis. Arch Endocrinol Metab. 2022. https://doi.org/10.20945/2359-3997000000440 .
doi: 10.20945/2359-3997000000440
pubmed: 35263050
pmcid: 9991024
Nauck MA, Del Prato S, Meier JJ, et al. Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin: a randomized, 52-week, double-blind, active-controlled noninferiority trial. Diabetes Care. 2011. https://doi.org/10.2337/dc11-0606 .
doi: 10.2337/dc11-0606
pubmed: 21816980
pmcid: 3161280
Rosenstock J, Vico M, Wei L, Salsali A, List JF. Effects of dapagliflozin, an SGLT2 inhibitor, on HbA (1c), body weight, and hypoglycemia risk in patients with type 2 diabetes inadequately controlled on pioglitazone monotherapy. Diabetes Care. 2012. https://doi.org/10.2337/dc11-1693 .
doi: 10.2337/dc11-1693
pubmed: 23193209
pmcid: 3476888
Wilding JP, Woo V, Soler NG, et al. Long-term efficacy of dapagliflozin in patients with type 2 diabetes mellitus receiving high doses of insulin: a randomized trial. Ann Intern Med. 2012. https://doi.org/10.7326/0003-4819-156-6-201203200-00003 .
doi: 10.7326/0003-4819-156-6-201203200-00003
pubmed: 22431673
Bolinder J, Ljunggren Ö, Kullberg J, et al. Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin. J Clin Endocrinol Metab. 2012. https://doi.org/10.1210/jc.2011-2260 .
doi: 10.1210/jc.2011-2260
pubmed: 22238392
Yildiz M, Esenboğa K, Oktay AA. Hypertension and diabetes mellitus: highlights of a complex relationship. Curr Opin Cardiol. 2020. https://doi.org/10.1097/HCO.0000000000000748 .
doi: 10.1097/HCO.0000000000000748
pubmed: 32371623
Ghosh A, Dutta K, Bhatt SP, et al. Dapagliflozin improves body fat patterning, and hepatic and pancreatic fat in patients with type 2 diabetes in North India. J Clin Endocrinol Metab. 2022. https://doi.org/10.1210/clinem/dgac138 .
doi: 10.1210/clinem/dgac138
pubmed: 35481572
Bhosle D, Indurkar S, Quadri U, Chandekar B. A comparative study of efficacy and safety of different sodium glucose co-transporter 2 (SGLT-2) inhibitors in the management of patients with type II diabetes mellitus. J Assoc Physicians India. 2022. https://doi.org/10.5005/japi-11001-0001 .
doi: 10.5005/japi-11001-0001
pubmed: 35702841
Lazzaroni E, Ben Nasr M, Loretelli C, et al. Anti-diabetic drugs and weight loss in patients with type 2 diabetes. Pharmacol Res. 2021. https://doi.org/10.1016/j.phrs.2021.105782 .
doi: 10.1016/j.phrs.2021.105782
pubmed: 34302978
Mamakou V, Eleftheriadou I, Katsiki N, Makrilakis K, Tsioufis K, Tentolouris N. Antidiabetic drugs as antihypertensives: new data on the horizon. Curr Vasc Pharmacol. 2017. https://doi.org/10.2174/1570161115666171010122332 .
doi: 10.2174/1570161115666171010122332
pubmed: 29032756
Bailey CJ, Gross JL, Hennicken D, Iqbal N, Mansfield TA, List JF. Dapagliflozin add-on to metformin in type 2 diabetes inadequately controlled with metformin: a randomized, double-blind, placebo-controlled 102-week trial. BMC Med. 2013. https://doi.org/10.1186/1741-7015-11-43 .
doi: 10.1186/1741-7015-11-43
pubmed: 23425012
pmcid: 3820155