The DOI matches its Crossref record; 19 of the 19 references it cites were found in a registry or an index.
Effects of Dapagliflozin, an SGLT2 Inhibitor, on HbA1c, Body Weight, and Hypoglycemia Risk in Patients With Type 2 Diabetes Inadequately Controlled on Pioglitazone Monotherapy
Open accessAbstract
OBJECTIVE: To examine the safety and efficacy of dapagliflozin, a sodium-glucose cotransporter-2 inhibitor, added on to pioglitazone in type 2 diabetes inadequately controlled on pioglitazone. RESEARCH DESIGN AND METHODS: Treatment-naive patients or those receiving metformin, sulfonylurea, or thiazolidinedione entered a 10-week pioglitazone dose-optimization period with only pioglitazone. They were then randomized, along with patients previously receiving pioglitazone ≥30 mg, to 48 weeks of double-blind dapagliflozin 5 (n = 141) or 10 mg (n = 140) or placebo (n = 139) every day plus open-label pioglitazone. The primary objective compared HbA1c change from baseline with dapagliflozin plus pioglitazone versus placebo plus pioglitazone at week 24. Primary analysis was based on ANCOVA model using last observation carried forward; all remaining analyses used repeated-measures analysis. RESULTS: At week 24, the mean reduction from baseline in HbA1c was −0.42% for placebo versus −0.82 and −0.97% for dapagliflozin 5 and 10 mg groups, respectively (P = 0.0007 and P < 0.0001 versus placebo). Patients receiving pioglitazone alone had greater weight gain (3 kg) than those receiving dapagliflozin plus pioglitazone (0.7–1.4 kg) at week 48. Through 48 weeks: hypoglycemia was rare; more events suggestive of genital infection were reported with dapagliflozin (8.6–9.2%) than placebo (2.9%); events suggestive of urinary tract infection showed no clear drug effect (5.0–8.5% for dapagliflozin and 7.9% for placebo); dapagliflozin plus pioglitazone groups had less edema (2.1–4.3%) compared with placebo plus pioglitazone (6.5%); and congestive heart failure and fractures were rare. CONCLUSIONS: In patients with type 2 diabetes inadequately controlled on pioglitazone, the addition of dapagliflozin further reduced HbA1c levels and mitigated the pioglitazone-related weight gain without increasing hypoglycemia risk.
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Nathan, D. M., Buse, J. B., Davidson, M. B., Ferrannini, E., Holman, R. R., Sherwin, R., & Zinman, B. (2009) · Diabetes Care · doi:10.2337/dc08-9025 · Cited by 3,834
Bailey, C. J., Gross, J. L., Pieters, A., Bastien, A., & List, J. F. (2010) · The Lancet · doi:10.1016/s0140-6736(10)60407-2 · Cited by 860
Self-citationFerrannini, E., Ramos, S. J., Salsali, A., Tang, W., & List, J. F. (2010) · Diabetes Care · doi:10.2337/dc10-0612 · Cited by 716
Self-citationSodium-Glucose Cotransport Inhibition With Dapagliflozin in Type 2 Diabetes
List, J. F., Woo, V., Morales, E., Tang, W., & Fiedorek, F. T. (2009) · Diabetes Care · doi:10.2337/dc08-1863 · Cited by 698
Self-citationMeng, W., Ellsworth, B. A., Nirschl, A. A., McCann, P. J., Patel, M., Girotra, R. N., Wu, G., Sher, P. M., Morrison, E. P., Biller, S. A., et al. (2008) · Journal of Medicinal Chemistry · doi:10.1021/jm701272q · Cited by 634
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Risk of Bladder Cancer Among Diabetic Patients Treated With Pioglitazone
Lewis, J. D., Ferrara, A., Peng, T., Hedderson, M., Bilker, W. B., Quesenberry, C. P., Vaughn, D. J., Nessel, L., Selby, J., & Strom, B. L. (2011) · Diabetes Care · doi:10.2337/dc10-1068 · Cited by 625
Strojek, K., Yoon, K. H., Hruba, V., Elze, M., Langkilde, A. M., & Parikh, S. (2011) · Diabetes, Obesity and Metabolism · doi:10.1111/j.1463-1326.2011.01434.x · Cited by 406
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Wilding, J. P. H., Norwood, P., T'joen, C., Bastien, A., List, J. F., & Fiedorek, F. T. (2009) · Diabetes Care · doi:10.2337/dc09-0517 · Cited by 363
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Sodium–Glucose Cotransporter 2 Inhibitors for Type 2 Diabetes: A Systematic Review and Meta-analysis
Vasilakou, D., Karagiannis, T., Athanasiadou, E., Mainou, M., Liakos, A., Bekiari, E., Sarigianni, M., Matthews, D. R., & Tsapas, A. (2013) · Annals of Internal Medicine · doi:10.7326/0003-4819-159-4-201308200-00007 · Cited by 911
Kohan, D. E., Fioretto, P., Tang, W., & List, J. F. (2014) · Kidney International · doi:10.1038/ki.2013.356 · Cited by 652
Self-citationUpdate on the treatment of type 2 diabetes mellitus
Marín-Peñalver, J. J., Martín-Timón, I., Sevillano-Collantes, C., & Cañizo-Gómez, F. J. D. (2016) · World Journal of Diabetes · doi:10.4239/wjd.v7.i17.354 · Cited by 647
Scheen, A. J. (2015) · Drugs · doi:10.1007/s40265-014-0337-y · Cited by 554
Zaccardi, F., Webb, D. R., Htike, Z. Z., Youssef, D., Khunti, K., & Davies, M. J. (2016) · Diabetes, Obesity and Metabolism · doi:10.1111/dom.12670 · Cited by 489
Metadata
- Authors
- Rosenstock, J., Vico, M., Wei, L., Salsali, A., & List, J. F.
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2012-06-12
- Volume
- 35
- Issue
- 7
- Pages
- 1473-1478
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- OpenAlex
- W2123984464
- Cited by
- 408
- References
- 19
- FWCI
- 35.67
- Type
- journal article
- Language
- en
- Open access
- hybrid
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- Rosenstock, J., Vico, M., Wei, L., Salsali, A., & List, J. F. (2012). Effects of Dapagliflozin, an SGLT2 Inhibitor, on HbA1c, Body Weight, and Hypoglycemia Risk in Patients With Type 2 Diabetes Inadequately Controlled on Pioglitazone Monotherapy. Diabetes Care. https://doi.org/10.2337/dc11-1693
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