OBJECTIVE: To compare the incidence of hypoglycaemic events (HEs) in a real-world setting in Muslim patients with type 2 diabetes mellitus fasting during Ramadan. RESEARCH DESIGN AND METHODS: We performed a ≤16-week prospective, non-interventional, two-cohort study. Data were collected 1-6 weeks before and ≤6 weeks after fasting. Patients were enrolled who had been receiving vildagliptin (50 mg twice daily) or sulphonylurea (SU) as add-on to metformin at least 4 weeks prior to fasting. MAIN OUTCOME MEASURES: The primary efficacy endpoint was incidence of HEs during the Ramadan fast. Changes in glycated haemoglobin (HbA(1c)) and body weight, as well as adherence to treatment, were also assessed. RESULTS: Seventy-two patients were enrolled (vildagliptin, n = 30; SU, n = 41; no treatment, n = 1), of whom 23 (76.7%) and 36 (87.8%), respectively, completed the study. With vildagliptin, there were no HEs or severe HEs, compared with 34 HEs (15 patients, 41.7%) and one severe (grade 2) HE with SU. The mean between-group difference in the proportion who experienced at least one HE was -41.7% (95%CI -57.8%, -25.6%), p = 0.0002. Vildagliptin lowered mean HbA(1c) from 7.6% (SD 0.9%) at baseline to 7.2% (SD 0.7%) post-Ramadan, whereas SU had no effect (7.2% [SD 0.6%] vs 7.3% [SD 0.7%]; mean between-group difference -0.5% [95% CI -0.9%, -0.1%], p = 0.0262). The mean number of missed doses was markedly lower with vildagliptin (0.2 [SD 0.8] vs 7.6 [SD 14.9]; mean between-group difference -7.4 [95% CI -13.7, -1.20] doses; p = 0.0204). Body weight remained unchanged in both groups. CONCLUSION: Vildagliptin caused no hypoglycaemia, was well adhered to and improved HbA(1c), making it a suitable treatment option for managing fasting. Study limitations are the sample size and the lack of diet and exercise data. When extrapolated to the global Muslim population with a similar clinical background, these findings could have considerable public health and clinical implications.
OBJECTIVE: To compare the incidence of hypoglycaemic events (HEs) in a real-world setting in Muslim patients with type 2 diabetes mellitus fasting during Ramadan. RESEARCH DESIGN AND METHODS: We performed a ≤16-week prospective, non-interventional, two-cohort study. Data were collected 1-6 weeks before and ≤6 weeks after fasting. Patients were enrolled who had been receiving vildagliptin (50 mg twice daily) or sulphonylurea (SU) as add-on to metformin at least 4 weeks prior to fasting. MAIN OUTCOME MEASURES: The primary efficacy endpoint was incidence of HEs during the Ramadan fast. Changes in glycated haemoglobin (HbA(1c)) and body weight, as well as adherence to treatment, were also assessed. RESULTS: Seventy-two patients were enrolled (vildagliptin, n = 30; SU, n = 41; no treatment, n = 1), of whom 23 (76.7%) and 36 (87.8%), respectively, completed the study. With vildagliptin, there were no HEs or severe HEs, compared with 34 HEs (15 patients, 41.7%) and one severe (grade 2) HE with SU. The mean between-group difference in the proportion who experienced at least one HE was -41.7% (95%CI -57.8%, -25.6%), p = 0.0002. Vildagliptin lowered mean HbA(1c) from 7.6% (SD 0.9%) at baseline to 7.2% (SD 0.7%) post-Ramadan, whereas SU had no effect (7.2% [SD 0.6%] vs 7.3% [SD 0.7%]; mean between-group difference -0.5% [95% CI -0.9%, -0.1%], p = 0.0262). The mean number of missed doses was markedly lower with vildagliptin (0.2 [SD 0.8] vs 7.6 [SD 14.9]; mean between-group difference -7.4 [95% CI -13.7, -1.20] doses; p = 0.0204). Body weight remained unchanged in both groups. CONCLUSION:Vildagliptin caused no hypoglycaemia, was well adhered to and improved HbA(1c), making it a suitable treatment option for managing fasting. Study limitations are the sample size and the lack of diet and exercise data. When extrapolated to the global Muslim population with a similar clinical background, these findings could have considerable public health and clinical implications.
Authors: Syed H Ahmed; Tahseen A Chowdhury; Sufyan Hussain; Ateeq Syed; Ali Karamat; Ahmed Helmy; Salman Waqar; Samina Ali; Ammarah Dabhad; Susan T Seal; Anna Hodgkinson; Shazli Azmi; Nazim Ghouri Journal: Diabetes Ther Date: 2020-09-09 Impact factor: 2.945
Authors: S Al Sifri; A Basiounny; A Echtay; M Al Omari; I Harman-Boehm; G Kaddaha; K Al Tayeb; A S Mahfouz; A Al Elq; L Radican; C Ozesen; H L Katzeff; B J Musser; S Suryawanshi; C J Girman; M J Davies; S S Engel Journal: Int J Clin Pract Date: 2011-09-27 Impact factor: 2.503
Authors: J E Signorovitch; D Macaulay; M Diener; Y Yan; E Q Wu; J-B Gruenberger; B M Frier Journal: Diabetes Obes Metab Date: 2012-11-22 Impact factor: 6.577
Authors: Mir Iftikhar Bashir; Md Faruque Pathan; Syed Abbas Raza; Jamal Ahmad; A K Azad Khan; Osama Ishtiaq; Rakesh K Sahay; Aisha Sheikh; Abdul Hamid Zargar Journal: Indian J Endocrinol Metab Date: 2012-07