Tratamiento diabetes y enfermedad cardiovascular

By John Schieszer

DUBAI, United Arab Emirates -- December 8, 2011 -- Patients with type 2 diabetes may experience a lower incidence of cardiovascular events if they are treated with sitagliptin versus sulphonylureas, researchers said here December 5 at the International Diabetes Federation (IDF) 2011 World Diabetes Congress.

In recent years, there has been heightened concern about the potential cardiovascular risk associated with antihyperglycaemic agents used to treat type 2 diabetes. In a previously published pooled analysis of 19 clinical trials, researchers found that treatment of type 2 diabetes with sitagliptin 100 mg/day was not associated with an increased risk of cardiovascular events compared with patients not exposed to sitagliptin (0.6 vs 0.9 incident events per 100 patient-years, respectively).

Barry J. Goldstein, Merck, Sharp & Dohme Corporation, Whitehouse Station, New Jersey, and colleagues reported that sulphonylureas have potentially deleterious cellular effects in the cardiovascular system and have been shown in some clinical studies to increase the risk of cardiovascular events.

The investigators assessed cardiovascular safety by pooling 3 double-blind studies, which randomised patients at baseline to sitagliptin 100 mg/day (n = 1,226) or sulphonylureas (n = 1,225).

The trials analysed these agents when added to ongoing metformin therapy (30 weeks in duration with glimepiride) and 104 weeks (with glipizide), and the other was a monotherapy trial (104 weeks with glyburide).

In this current investigation, the researchers performed a post hoc safety analysis using custom major adverse cardiovascular events (MACE) that incorporated ischaemic events and CV deaths, without adjudication of these events.

Mean haemoglobin A1C (Hb A1C) was 7.6% and the median duration of diabetes was 5 years at baseline. Baseline characteristics were similar between groups. The cumulative patient exposure was 1,269 patient-years in the sitagliptin group and 1,274 patient-years in the sulphonylurea group.

They found that none of the patients in the sitagliptin group reported a MACE-related event, but 11 patients in the sulphonylureas group had at least 1 reported event. The incidence rate was 0 per 100 patient-years in the sitagliptin group compared with 0.9 per 100 patient-years in the sulphonylurea group.

For CV-related death, the incidence rate was 0 per 100 patient-years (0 deaths) with sitagliptin compared with 0.4 per 100 patient-years (5 deaths) with sulphonylureas.

The investigators concluded that the incidence of CV events was lower in patients treated with sitagliptin compared with sulphonylureas. They cautioned that more research is warranted and they noted the effect of sitagliptin on CV outcomes currently is being evaluated prospectively in a randomised, placebo-controlled trial.

[Presentation title: Cardiovascular Safety of Sitagliptin Versus a Sulphonylurea in Patients With Type 2 Diabetes Mellitus: A Pooled Analysis. Abstract P-1133a]