Experience with Vildagliptin in Type 2 Diabetic Patients Fasting During Ramadan in France: Insights from the VERDI Study

Abstract

AimTo assess in real life the rate of hypoglycemia during Ramadan in patients with type 2 diabetes (T2DM) in France, according to their ongoing dual therapy of metformin-vildagliptin or metformin-sulfonylurea/glinide (IS).MethodsProspective, non-interventional study with 2 visits (within 8 weeks before and 6 weeks after the end of Ramadan 2012). Study diaries were not used to collect events or record values of glucose monitoring. One hundred and ninety-eight patients on stable oral dual therapy for ≥2 months and with glycosylated hemoglobin (HbA1c) ≤8.0% were recruited by 62 centers: 83 in the IS cohort and 115 in the vildagliptin cohort.ResultsApproximately 90% of patients were from Maghreb. The two cohorts were well balanced: 60% men, mean age 59 years, BMI 28 kg/m2, metformin dose ~2,000 mg/day, and HbA1c 7.2%. Distinct therapeutic management was planned in view of Ramadan with drug-adaptation intended in 61.4% of IS and 18.3% of vildagliptin patients. Hypoglycemia was reported in 37% of IS and 34% of vildagliptin patients; episodes declared as confirmed in 30.8% and 23.5%, respectively, and episodes documented as adverse event (AE) in 17.9% (22 episodes) and 7.5% (13 episodes), respectively (P = 0.025). Severe episodes were reported in 3.9% of IS and 1.7% of vildagliptin patients. 10.4% of IS and 2.6% of vildagliptin patients reported severe episodes and/or unscheduled medical visits due to hypoglycemia (P = 0.029). Glycemic control remained stable in both cohorts. Compliance with fasting was high, as well as adherence to drug with ≥5 missed-dose for 15.4% of IS and 8.5% of vildagliptin patients.ConclusionAlthough the overall frequency of malaise suggestive of hypoglycemia was high, which would be expected with prolonged fasting in a well-controlled T2DM population during hot summer days, the incidence of more severe and better-documented episodes (AE, severe event, event leading to unscheduled medical visit) were much lower, with consistently less events with vildagliptin therapy.

Diabetes and Ramadan: Practical guidelines

“…A number of observational studies have examined the efficacy and safety of DPP-4 inhibitor treatment during Ramadan [32,[43][44][45][46]. In the VECTOR study, no self-reported hypoglycaemic events were reported in the vildagliptin group compared with 35 events in 15 patients (41.7%) in the gliclazide arm (including one severe event).…”

“…In addition, the change in glycated haemoglobin (HbA1c) from baseline to postRamadan was significantly greater in the vildagliptin group compared with the gliclazide group (p = 0.026) [45]. The VERDI study compared the incidence of hypoglycaemic events during Ramadan in patients who received vildagliptin or SU/glinide and found no significant difference in the number of patients experiencing at least one hypoglycaemic event [44]. However, the proportion of patients experiencing a severe…”

“…Reduce evening dose by 25-50% and take at suhoor • TID -Omit aŌernoon dose. Adjust iŌar and suhoor doses Dose ƟtraƟon should be performed every three days and dose adjustments made according to BG levels hypoglycaemic event and/or an unscheduled medical visit due to hypoglycaemia was significantly lower in the vildagliptin group (p = 0.029) [44]. The VIRTUE study, conducted in the Middle East and Asia, is the largest of the observational studies to date and enrolled >1300 patients with T2DM.…”

Comparative studies of dipeptidyl peptidase 4 inhibitor vs sulphonylurea among Muslim Type 2 diabetes patients who fast in the month of Ramadan: A systematic review and meta-analysis

“…Nine papers, with a total of 4276 patients, were included in this meta-analysis [13][14][15][16][17][18][19][20][21]. Sample size ranged between 52 and 1333.…”

“…All of the included patients were type 2 diabetes mellitus 18 years or older. Seven studies used Vildagliptin as the DPP4 inhibitor of choice [13,15,[17][18][19][20][21] whereas the other two studies used Sitagliptin [14,16]. All of the studies had a control group using sulphonylurea (glipizide, glibenclamide, glimepiride, gliclazide slow release or gliclazide standard formulation) or the other insulin secretagogue -meglitinides.…”