Following pooled analyses of the safety and efficacy of Vildagliptin▼ in patients 75 years and over, a cautionary statement on its use in elderly patients with Type 2 diabetes has now been removed from the Summary of Product Characteristics (SmPC) of Vildagliptin, and Vildagliptin / Metformin. Vildagliptin is now the only DPP-4 inhibitor available in the UK that does not have a specific caution for use in the elderly, following the conclusions from the publication’s authors that Vildagliptin was effective and well-tolerated in Type 2 diabetic patients >75 years.
Professor Alan Sinclair, Professor of Medicine and Director, Institute of Diabetes for Older People (IDOP) commented: “Type 2 diabetes in older people is often a complex illness and the current range of glucose-lowering therapies can have restricted use because of the increased risk of adverse effects such as renal impairment and/or hypoglycaemia. The development of DPP-4 inhibitors has in general been well received by the diabetes professional community but the inclusion of a previous caution in the SmPC for DPP-4 inhibitor use in the very elderly was thought by some to restrict the benefits and availability of these drugs in this population of patients. The results of the study by Schweizer and colleagues provide evidence of Vildagliptin’s efficacy in this advanced age group. As always, longer term studies are required although these safety and tolerability data provide a platform for wider use of the drug in ageing populations with diabetes.”
The changes to the SmPC for Vildagliptin and Vildagliptin/Metformin are based on the pooled analyses of efficacy and safety data published in Diabetes, Obesity and Metabolism. Efficacy data from seven monotherapy (N.B. Vildagliptin is not licensed as a monotherapy) and three metformin add-on therapy, double-blind, randomised trials with Vildagliptin 50mg (twice daily) were included (n=87). Results showed that Vildagliptin, as add-on to metformin, demonstrated a change of -1.1% in HbA1c in patients of age 75 years and over from a baseline of 8.5% (p=0.0004) and achieved an HbA1c of ≤7% in 50% of elderly patients. There were no confirmed reports of hypoglycaemic events in
patients of age 75 years and over receiving Vildagliptin and no severe hypoglycaemic events1. Data also showed that there was no associated weight gain in these patients.
Due to an ageing population, Type 2 diabetes is an increasingly common health condition. In England, 15.7% of men and 10.4% of women between 65-74 years and 13.5% men and 10.6% of women over 75 years have diabetes. Type 2 diabetes is the more common type, affecting 90% of those with the condition. Increasing age puts the elderly at greater risk of complications associated with the condition.
Achieving tight glycaemic goals, while avoiding hypoglycaemia, is a major challenge in the management of elderly patients with diabetes as the risk of hypoglycaemia associated with the use of certain types of oral anti-diabetic medicine or insulin, increases markedly with age. Minimising the risk of hypoglycaemia in elderly patients is an important consideration when choosing an oral anti-diabetic therapy, as severe episodes may cause emotional distress and, in some cases, increase the risk of falls and fractures, as well as cardiovascular disease. A prospective study in patients over the age of 80 with well controlled Type 2 diabetes showed that 25% of hospital admissions associated with diabetes were due to severe hypoglycaemia.
The safety analysis of data pooled from 38 studies (n=12,326) evaluated adverse events (AEs) on Vildagliptin 50mg (twice daily) against a pool of comparators. Overall AEs were reported with a lower frequency in elderly patients receiving Vildagliptin than in elderly patients receiving comparators and the incidence of discontinuations due to AEs was similar across both groups. In elderly patients with mild renal impairment, AEs were less frequent in patients receiving Vildagliptin, than in those receiving a comparator.
In a general Type 2 diabetes population, treatment with Vildagliptin in combination with metformin, has been shown to be as efficacious as a sulphonylurea with a significantly lower incidence of associated hypoglycaemia, and as efficacious as a glitazone without the associated weight gain.