التفاصيل البيبلوغرافية
| العنوان: |
Effect of saroglitazar 2 mg and 4 mg on glycemic control, lipid profile and cardiovascular disease risk in patients with type 2 diabetes mellitus: a 56-week, randomized, double blind, phase 3 study (PRESS XII study). |
| المؤلفون: |
Krishnappa, Manjunath, Patil, Kishor, Parmar, Krupi, Trivedi, Purav, Mody, Nirali, Shah, Chintan, Faldu, Khushboo, Maroo, Sanjay, for the PRESS XII study group, Desai, Piyush, Fatania, Kamlesh, Murthy, Satyanarayan, Balamurugan, R., Agarwal, Manish, Singh, K. P., Kalra, G. S., Khandelwal, Vipul, Singwala, Ashish, Thacker, Hemant, Tulle, Rahul |
| المصدر: |
Cardiovascular Diabetology; 6/19/2020, Vol. 19 Issue 1, p1-13, 13p, 2 Diagrams, 4 Charts, 1 Graph |
| مصطلحات موضوعية: |
TYPE 2 diabetes, GLYCEMIC control, GLYCOSYLATED hemoglobin, CARDIOVASCULAR diseases |
| مصطلحات جغرافية: |
INDIA |
| مستخلص: |
Background: The potential for PPAR agonists to positively affect risk of cardiovascular disease in patients with type 2 diabetes (T2DM) is of persistent attention. The PRESS XII study primarily aimed to evaluate the efficacy and safety of saroglitazar (2 mg and 4 mg) as compared to pioglitazone 30 mg on glycemic control in patients with type 2 diabetes mellitus. Methods: In this randomized double-blind study, patients with T2DM [glycosylated hemoglobin (HbA1c) ≥ 7.5%] were enrolled from 39 sites in India. Patients received once-daily doses of either saroglitazar or pioglitazone (1:1:1 allocation ratio) for a total of 24 weeks. Patients were continued in a double blind extension period for an additional 32 weeks. Efficacy evaluations of glycemic parameters [HbA1c (Primary endpoint at week 24), FPG and PPG] and other lipid parameters (TG, LDL-C, VLDL-C, HDL-C, TC, Non HDL-C, Apo A1 and Apo B) were conducted at week 12, 24 and 56 and compared to the baseline levels. The efficacy analyses were performed by using paired t-test and ANCOVA model. Results: A total of 1155 patients were enrolled in this study. The baseline characteristics were similar between the three treatment groups. The within group mean (± SD) change in HbA1c (%) from baseline of the saroglitazar (2 mg and 4 mg) and pioglitazone treatment groups at week 24 were: − 1.38 ± 1.99 for saroglitazar 2 mg; − 1.47 ± 1.92 for saroglitazar 4 mg and − 1.41 ± 1.86 for pioglitazone, respectively. Statistically significant reduction from baseline in HbA1c was observed in each treatment group at week 24 with p-value < 0.016. There was a significant reduction in TG, LDL-C, VLDL-C, TC and Non HDL-C with a significant increase in HDL-C from baseline levels (< 0.016). Most of the AE's were 'mild' to 'moderate' in severity and were resolved by the completion of the study. Conclusions: Saroglitazar effectively improved glycemic control and lipid parameters over 56 weeks in patients of T2DM receiving background metformin therapy and has a promising potential to reduce the cardiovascular risk in T2DM patients. Trial registration CTRI/2015/09/006203, dated 22/09/2015 [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
Complementary Index |
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