Brief Article
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World J Diabetes. Dec 15, 2013; 4(6): 358-364
Published online Dec 15, 2013. doi: 10.4239/wjd.v4.i6.358
Vildagliptin vs sulfonylurea in Indian Muslim diabetes patients fasting during Ramadan
Abhijit Shete, Aheson Shaikh, K Javeed Nayeem, Lily Rodrigues, Mohamed Sheikamunadeen Sadiq Ali, Parag Shah, Rajiv Khanna, Sarfaraj Majid, Sabeer A Rasheed, Shehla Shaikh, Tawfiqur Rahman
Abhijit Shete, Medical Department, Novartis Pharma AG, CH-4002 Basel, Switzerland
Aheson Shaikh, Diabetes Care Centre, Dil Shad Villa, Aurangabad 431003, India
K Javeed Nayeem, Bibi Ayesha Mili Hospital, Mysore 570007, India
Lily Rodrigues, Suraksha Multi Speciality Hospital, Hyderabad 500072, India
Mohamed Sheikamunadeen Sadiq Ali, Irfan Cardiac and Diabetic Clinic, Ramanathapuram 623503, India
Parag Shah, Gujarat Endocrine Centre, Ahmedabad 380006, India
Rajiv Khanna, Khanna Clinic, Gole Darwaza, Radhey lal, Chowk, Lucknow 226003, India
Sarfaraj Majid, B P Poddar Hospital, Kolkata 700023, India
Sabeer A Rasheed, Dr. Rasheed’s Diabetes Speciality Centre, Trivandrum 695011, India
Shehla Shaikh, KGN Diabetes & Endocrinology Center, Mumbai 400027, India
Tawfiqur Rahman, G D Diabetic Institute, Kolkata 700017, India
Author contributions: Shete A, Nayeem KJ, Rodrigues L, Ali MSS, Shah P, Khanna R, Majid S, Rasheed SA, Shaikh S and Rahman T served as the investigators for this study; all authors participated in the development and writing of the paper and approved the final manuscript for publication.
Supported by Novartis Healthcare Private Limited, India
Correspondence to: Dr. Abhijit Shete, MD, Medical Department, Novartis Pharma AG, Core Technology Area, CH-4002, Basel, Switzerland. abhijit.shete@novartis.com
Telephone: +41-616-963648 Fax: +41-613-243571
Received: June 20, 2013
Revised: September 20, 2013
Accepted: October 17, 2013
Published online: December 15, 2013
Processing time: 197 Days and 0.3 Hours
Abstract

AIM: To compare the use of vildagliptin and sulfonylurea with or without metformin in Indian Muslim patients with type 2 diabetes mellitus, fasting during Ramadan.

METHODS: This was a 4-wk, multicenter, non-interventional, open-label, observational study. Incidence of hypoglycemic events (HEs), adverse events, and changes in glycosylated hemoglobin A1c (HbA1c), fasting plasma glucose, postprandial plasma glucose and body weight were measured pre- and post-Ramadan.

RESULTS: Totally, 97 patients were recruited and all completed the study (vildagliptin group, n = 55; sulfonylurea group, n = 42). HEs were reported in low frequencies in both the vildagliptin and the sulfonylurea groups [0 vs 2 (4.8%) patients, respectively]. Interestingly, HbA1c reduced by -0.43% (-4.71 mmol/mol) in the vildagliptin group [8.75% (72.10 mmol/mol) to 8.32% (67.38 mmol/mol), P = 0.009] while in the sulfonylurea group there was a small increase by 0.01% [0.08 mmol/mol; 8.64% (70.92 mmol/mol) to 8.65% (71.00 mmol/mol), P = 0.958]. Higher percentage of vildagliptin-treated patients achieved HbA1c < 7.0% (< 53 mmol/mol) compared with sulfonylurea (16.4% vs 4.8%). Mean decrease in the body weight was 1.2 kg and 0.03 kg, respectively (P < 0.001). Both treatment groups were well tolerated during Ramadan.

CONCLUSION: Vildagliptin is an attractive treatment option for Indian patients with type 2 diabetes mellitus who are fasting during Ramadan.

Keywords: Dipeptidyl-peptidase 4 inhibitors; Fasting hypoglycemia; Sulfonylurea; Type 2 diabetes mellitus; Vildagliptin

Core tip: Management of glycemic control in diabetes patients fasting during Ramadan has been recognized as a critically important health challenge worldwide. India has the world’s second largest diabetes population and caters large Muslim community; however, there is limited data available exploring the effect of treatments in these fasting diabetes patients. This non-interventional, multicenter, double-arm study compared the effect of vildagliptin with sulfonylureas on hypoglycemic events, HbA1c, blood glucose levels, and response rate in 97 fasting diabetic patients during Ramadan in real-world setting. Vildagliptin appears to be an attractive treatment option for diabetes patients fasting during Ramadan.