The pooled analysis looked at CV safety data from three previously published randomised, blinded clinical studies, which included people with type 2 diabetes randomised to receive sitagliptin 100mg/day (n = 1,226) or an SU (n = 1,225)as monotherapy, or as add on to metformin. There were no reports of major CV events (defined as ischaemic events or CV death) in the sitagliptin arm and 11 reports of patients experiencing at least one major CV event in the SU group.
In this pooled analysis, the incidence rate for reported major cardiovascular events (MACE) was 0 per 100 patient years in the sitagliptin group (0 events) and 0.9 per 100 patient years in the SU group (11 events, between-group difference, [95% CI] = -0.9 [-1.6, -0.5]). For CV-related death, the incidence rate was 0 per 100 patient-years (0 deaths) with sitagliptin, and 0.4 per 100 patient years (5 deaths) with SU [95% CI]=(-0.4 [-0.9, -0.1]).
Professor Anthony Barnett, Consultant Physician and Emeritus Professor of Medicine, Heart of England NHS Foundation Trust, Birmingham, commented: “Despite the limitations of a retrospective pooled analysis, these data add to the growing body of evidence which support the long-term tolerability and safety profile of sitagliptin and other DPP-4 inhibitors. People with type 2 diabetes are at greatly increased risk of cardiovascular events. This study is extremely welcome, therefore, supporting the view that this newer class of glucose lowering agents poses no additional cardiovascular risk and indeed provides preliminary information regarding possible cardiovascular protection. This latter point clearly needs testing in long-term cardiovascular outcome trials which are presently underway.”
MACE included collected adverse experience reports related to ischaemic events (heart attack and stroke) and CV deaths were assessed by pooling three double-blind studies.Two trials evaluated these agents when added to ongoing metformin therapy (30 weeks in duration [glimepride] and 104 weeks [glipizide]). The third study was a monotherapy trial 12 weeks in duration [glipizide] together with data on file at 104 weeks.At baseline, the 2,451 patients had a mean age of 56 years, HbA1c of 7.6 per cent, and a median duration of type 2 diabetes of 5 years. Baseline characteristics were similar between the two treatment groups.The cumulative patient exposure was 1,269 patient-years in the sitagliptin group and 1,274 patient-years in the SU group.
Dr Adrian Brady, Associate Professor and Consultant Cardiologist, Glasgow Royal Infirmary, added: “We know that people with diabetes have a 5-fold increased risk of developing cardiovascular disease compared to those who do not have the condition.If you have type 2 diabetes, you should be treated the same as if you have already had a heart attack and are at risk of having a repeat event. Cardiovascular disease is a primary concern when treating a person with type 2 diabetes and these encouraging data are an important consideration in how we manage our patients to minimise their risk.”
In the UK, type 2 diabetes is the most common form of the two main types of diabetes (type 1 and type 2) and accounts for between 85 per cent and 95 per cent of all people with diabetes.80 per cent of people with diabetes will die from CVD.People with diabetes account for 10 per cent of all hospital admissions and this includes about 30 per cent of coronary care admissions.A person’s risk of CVD can be reduced through intensive cholesterol management, smoking cessation, reduction of blood pressure, blood glucose and cholesterol.