Pilot Study of Endothelin Receptor Blockade in Heart Failure with Diastolic Dysfunction and Pulmonary Hypertension (BADDHY-Trial).

BACKGROUND: In this multi-centre, randomised, placebo-controlled pilot trial, we investigated the clinical and haemodynamic effects of the endothelin-receptor blocker Bosentan in patients with heart failure, preserved ejection fraction and pulmonary hypertension (PH-HFpEF). MATERIALS AND METHODS: Eligible patients received either 12 weeks of Bosentan therapy, or a placebo drug. Patients were thereafter followed for a further period of 12 weeks without the study medication. At three points during the study (study Commencement, Week 12 and Week 24), a six-minute walk test (6MWT), echocardiographic and laboratory assessments were performed, as well as a quality of life survey. Right heart catheterisation (RHC) was undertaken at commencement only. The study was aborted early, after an interim analysis favoured the placebo. RESULTS: Six-minute walk distance (6MWD) did not change in the Bosentan group (309.7±96.3m (Commencement), 317.0±126.1m (Week 12), 307.0±84.4m (Week 24); p=0.86), but almost reached statistical significance in the placebo group from 328.8±79.6m, to 361.6±98.2m and 384.0±74.9m (Week 24); p=0.075. In the placebo group, estimated systolic pulmonary artery pressure (measured via echocardiography) significantly decreased (from 62.3±16.7mmHg [Commencement], 45.3±13.9mmHg [Week 12], to 44.6±14.5mmHg [Week 24]; p=0.014) as did right atrial pressure (13.1±5.3 [Commencement], 10.0±3.8 [Week 12], to 9.4±3.2 [Week 24]; p=0.046). CONCLUSION: Despite this study's limited sample size and premature cessation, it nevertheless suggests that endothelin receptor blockade in patients with PH-HFpEF may have no beneficial effects and could even be detrimental in comparison to a placebo.

[Blood glucose self-monitoring in intensified insulin therapy: acceptance of frequent measurements and effect on quality of diabetic control]. / Blutzucker-Selbstkontrolle unter intensivierter Insulintherapie: Akzeptanz häufiger Kontrollen und Auswirkung auf die Qualität der Diabeteseinstellung.

In intensive insulin therapy frequent measurements of blood glucose are necessary for daily insulin adjustments. The aim of our study was to determine acceptance of frequent blood glucose measurements and its relation to quality of glycemic control over a period of 5 years. We report on 57 unselected patients with type 1 diabetes mellitus, who were at least half a year under intensive insulin therapy when entering the study. Mean age was 34 +/- 9, diabetes duration 18 +/- 8 years. The number of daily blood glucose measurements, HbA1c, body mass index, daily insulin dose, routine laboratory values, number of severe hypoglycemic reactions and frequency of retinopathy, nephropathy and neuropathy were determined for year 1 and 5. We found an increase in daily blood glucose measurements from 2.5 to 4.5 per day (year 1 resp. year 5). The frequency of blood glucose measurements at the begin of our study respectively after 5 years was: < or = 2.0/day in 51% vs. 12%, > 2.0 but < 4.0/day in 20% vs. 21% and > or = 4.0/day in 29% vs. 67% of patients. HbA1c decreased from 7.3 +/- 1.2 to 6.4 +/- 1.1% after 5 years (p < 0.001). A comparison of subgroups of patients showed that frequency of blood glucose measurement is not the only cause for this improvement, but adequate education of diabetic patients seems to be most important. Retinopathy and neuropathy increased despite better diabetic control, 2 patients developed microalbuminuria, all other data determined at study entry remained unchanged after 5 years. We conclude that frequent daily blood glucose measurements were accepted by the majority of our patients over a long period of time. Mean blood glucose determined by HbA1c improved under intensive insulin therapy. In our study group with low HbA1c values at baseline this effect was only partly related to the frequency of daily blood glucose measurements.

[The status of managing the type I diabetic patient in Austria. Organization]. / Stand der Betreuung der Typ-I-Diabetiker in Osterreich*. Organisation.

During the Annual Meeting of the Austrian Diabetes Association various diabetic centres presented their success and failure rates with respect to metabolic control and prevention of late complications in diabetic patients on a country-wide basis. The analysis revealed that only 30% of all type I diabetic patients are adequately controlled. Intensive education in diabetes self-management, capable of leading to optimal metabolic control in up to 50% of the instructed patients, is however available only to a small minority of the diabetic patients to date. Despite the enormous improvement which has been achieved in the management of pregnant diabetic women, intensive specialized care is often commenced far too late. In rural areas, in particular, even conventional therapy is not fully implemented and late complications are, thus, inevitable.