Treatment adherence with vildagliptin compared to sulphonylurea as add-on to metformin in Muslim patients with type 2 diabetes mellitus fasting during Ramadan

Abstract

Objective:

To assess treatment adherence to dipeptidyl peptidase-4 inhibitor vildagliptin compared with sulphonylureas (SU) in Muslim patients with type 2 diabetes mellitus who were fasting during Ramadan in the UK.

Research design and methods:

This prospective, observational cohort study was conducted in four UK centres. Patients already taking vildagliptin (50 mg twice a day) or an SU as add-on therapy to metformin were followed up for ≤16 weeks. They were asked to record all missed doses of anti-diabetes medications.

Results:

Of the 72 patients enrolled (vildagliptin, n = 30; SU, n = 41; not allocated to treatment, n = 1), 59 (81.9%) completed the study (vildagliptin, n = 23; SU, n = 36), including one patient in the SU arm who completed but failed to provide information on missed doses; all patients in the SU arm were taking gliclazide. In the vildagliptin arm one patient (4.3%) missed a total of four doses while in the SU arm 10 patients (27.8%) missed a total of 266 doses (mean [SD] number of doses missed per patient: 26.6 [16.5]). The mean (SD) proportions of doses missed during fasting were 0.2% (0.9) and 10.4% (21.7) in the vildagliptin and SU arms, respectively, with a significant mean between-group difference of −10.2% (95% CI: −19.3%, −1.1%; p = 0.0292). There were no patients in the vildagliptin arm who missed more than 20% of OAD doses compared with 19.4% in the SU arm (p = 0.0358). Of the patients receiving an SU, 15 (42%) collectively reported 34 hypoglycaemic events (HEs) and one grade 2 HE; of these, fewer were non-adherent (n = 6, 40%) than adherent (n = 9, 60%). No patients reported HEs in the vildagliptin arm.

Conclusion:

During Ramadan fasting, treatment with vildagliptin resulted in better treatment adherence compared with SU in Muslim patients with type 2 diabetes mellitus. Study limitations are the sample size and the lack of diet and exercise data.

Keywords::

• Fasting
• Hypoglycaemic events
• Muslim patients
• Ramadan
• Treatment adherence
• Type 2 diabetes mellitus

Transparency

Declaration of funding

This study was funded by Novartis Pharmaceuticals UK Ltd, who helped in the study design and in the collection, analysis and interpretation of data. The co-authors from Novartis were also involved in writing the manuscript and in the decisions during submission for publication.

Declaration of financial/other relationships

A.H.B. has received honoraria for lectures and advisory work from Novartis Pharmaceuticals Corporation, Merck Sharp & Dohme Limited, Bristol-Myers Squibb Company, AstraZeneca LP, Boehringer Ingelheim, Takeda, Eli Lilly and Company, Novo Nordisk A/S, and Sanofi-Aventis. W.H. has received research grants and honoraria from and acted as a consultant for Novartis Pharmaceuticals Corporation, Novo-Nordisk and Merck Sharp and Dohme. W.M. has received educational grant sponsorship to attend scientific meetings and honoraria for lectures from Novartis Pharmaceuticals Corporation, Novo Nordisk A/S, Eli Lilly and Company, AstraZeneca LP and Merck Sharp & Dohme Limited. M.H. has no conflict of interests with the study sponsors, but has received honoraria for lectures and Advisory Boards with Eli Lilly, and honoraria for lectures with Takeda, Novo Nordisk, Merck Sharp & Dohme Limited, Boehringer Ingelheim and Sanofi-Aventis. A.K. and M.A. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article. P.G. and C.A. are employees of Novartis Pharmaceuticals UK Ltd, Frimley, UK, and C.A. owns shares in Novartis.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgements

The authors gratefully acknowledge the work and contributions of the clinical project manager Jocelyn Cannon, as well as Sue Hunt, for carrying out the data management for the study and Sailesh Sankar for assistance with recruitment. We gratefully acknowledge research nurse Helen Jenner from Heart of England NHS Foundation Trust for her support with this study. The authors would like to acknowledge Dr Sandip Ghosh from University Hospital Birmingham for his help with recruitment for this study. Writing and editorial support to the authors was provided by Lakshmi Deepa from Novartis Healthcare Private Limited.

Previous presentation: Presented at the World Diabetes Congress, 4–8 December 2011, Dubai. Presented at the 47th European Association for the Study of Diabetes, 12–16 September 2011, Lisbon, Portugal.