Abstract
BackgroundRecent clinical trials reported conflicting results on the reduction of new-onset diabetes using RAS blocking agents. Therefore the role of these agents in preventing diabetes is still not well defined. Ramipril is an ACE inhibitor (ACEi), that has been shown to reduce cardiovascular events in high risk patients and post-hoc analyses of the HOPE trial have provided evidence for its beneficial action in the prevention of diabetes.MethodsThe ADaPT investigation ("ACE inhibitor-based versus diuretic-based antihypertensive primary treatment in patients with pre-diabetes") is a 4-year open, prospective, parallel group phase IV study. It compares an antihypertensive treatment regimen based on ramipril versus a treatment based on diuretics or betablockers. The primary evaluation criterion is the first manifestation of type 2 diabetes. The study is conducted in primary care to allow the broadest possible application of its results. The present article provides an outline of the rationale, the design and baseline characteristics of AdaPT and compares these to previous studies including ASCOT-BLPA, VALUE and DREAM.ResultsUntil March 2006 a total of 2,015 patients in 150 general practices (general physicians and internists) throughout Germany were enrolled. The average age of patients enrolled was 67.1 ± 10.3 years, with 47% being male and a BMI of 29.9 ± 5.0 kg/m2. Dyslipidemia was present in 56.5%. 37.8% reported a family history of diabetes, 57.8% were previously diagnosed with hypertension (usually long standing). The HbA1c value at baseline was 5.6 %. Compared to the DREAM study patients were older, had more frequently hypertension and patients with cardiovascular disease were not excluded.ConclusionComparing the ADaPT design and baseline data to previous randomized controlled trial it can be acknowledged that AdaPT included patients with a high risk for diabetes development. Results are expected to be available in 2010. Data will be highly valuable for clinical practice due to the observational study design.
Highlights
Recent clinical trials reported conflicting results on the reduction of new-onset diabetes using RAS blocking agents
Hypertensive patients with diabetes, and hypertensive patients without diabetes tend to be resistant to insulin stimulated glucose uptake and are hyperinsulinaemic compared with normotensive controls [5]
Patient population Inclusion criteria Patients eligible for this study were at high risk for the development of type 2 diabetes according to the modified PreDiSc Score [22]: They had to be ≥ 45 year old, have hypertension, impaired fasting glucose (IFG) defined as glucose level 110–125 mg/dl in venous plasma or 100–109 mg/dl in capillary whole blood, and a glycosylated haemoglobin A1c (HbA1c) of 6–6.5% determined within the last six months
Summary
Recent clinical trials reported conflicting results on the reduction of new-onset diabetes using RAS blocking agents. Ramipril is an ACE inhibitor (ACEi), that has been shown to reduce cardiovascular events in high risk patients and post-hoc analyses of the HOPE trial have provided evidence for its beneficial action in the prevention of diabetes. About 20% of patients with hypertension will develop type 2 diabetes in a three year period [6] and new onset diabetes in treated hypertensive patients is not trivial as recent studies suggest [7,8]. The adjusted relative risk of events was about 3-times higher in both previous and new onset diabetes compared to patients with hypertension but without diabetes [9]
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