June 18, 2007 – Milan, Italy – A retrospective analysis of the VALUE trial found a higher risk of developing atrial fibrillation (AF) in the high-risk patients with hypertension, and the investigators propose that this development of AF may be the reason for the high risk of developing heart failure in this patient population. The data were presented by Prof. T. Aksnes, Ullevaal University Hospital, Oslo, Norway.

New-onset diabetes (NOD) was a prespecified endpoint in the VALUE trial,
Of the 9,995 patients in the VALUE trial without diabetes at baseline, 1,298 developed NOD during the course of the trial, as identified using the WHO criteria, initiation of anti-diabetic medication, or fasting glucose >/=7.0 mmol/L at study end. A total of 5,250 patients had diabetes at baseline, and all patients were followed for an average of 7.2 years. The patients were about 65 years old and 55-60% were men. BMI was higher in patients with diabetes, about 30 kg/m2, compared to 27 kg/m2 in persons without diabetes, and glucose was higher at 9.25 mmol/L in diabetics compared to 5.38 mmol/L in non-diabetics.

A 41% increased risk of new-onset AF was found in the NOD group compared to persons without diabetes and was previously reported. Heart failure, adjudicated by an expert panel, was defined as heart failure requiring hospitalization or heart failure-related death. An ECG was performed at baseline and at each yearly study visit. New-onset AF was identified ≥ 1 ECG recording of AF in patients without AF at baseline and persistent AF was defined as AF that developed during the trial and was maintained in all subsequent visits.

At baseline, significantly more persons with diabetes had AF (3%) compared to those who never had diabetes (2.4%), but there was no significant difference compared to the NOD group who developed AF.

A 49% increased risk of new-onset AF occurred in the NOD group and a 29% increased risk in the baseline diabetes group, compared to the nondiabetics (5.4%, 4.1%, and 3.8% of each group, respectively. An 87% increased risk of new persistent AF occurred in the NOD group and a 12% increased risk in the baseline diabetes group, compared to the nondiabetics (2.7%, 1.6%, and 1.5% of each group, respectively).

No absolute differences were seen in blood pressure levels at study end between the three groups (138/79 mmHg in NOD, 140/78 mmHg baseline diabetes, 138/79 mmHg nondiabetes group). Heart rate was also similar at 70-72 bpm at study end.

Heart failure developed more frequently in persons with NOD and baseline diabetes compared to the nondiabetics in VALUE (15.8%, 22.6%, and 11.3% of each group respectively). The patients with NOD and AF had a 4.2-fold higher risk of developing heart failure compared to the NOD patients who did not develop AF (p<0.0001). This high risk of developing AF in the high-risk hypertensive patient may explain the greater rate of hospitalization for heart failure in the new-onset diabetes population.