First-line antihypertensive treatment in patients with pre-diabetes: rationale, design and baseline results of the ADaPT investigation.
BACKGROUND
Recent 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.


METHODS
The 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.


RESULTS
Until 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.


CONCLUSIONS
Comparing 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.
Zidek
Walter
W
Medical Department IV, University Hospital Charité, Campus Benjamin-Franklin, Berlin, Germany. walter.zidek@charite.de
Schrader
Joachim
J
Lüders
Stephan
S
Matthaei
Stephan
S
Hasslacher
Christoph
C
Hoyer
Joachim
J
Bramlage
Peter
P
Sturm
Claus-Dieter
CD
Paar
W Dieter
WD
D000319:Adrenergic beta-Antagonists / Q000627:therapeutic use*; D000368:Aged; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D003627:Data Interpretation, Statistical; D003924:Diabetes Mellitus, Type 2 / Q000517:prevention & control*; D018450:Disease Progression; D004232:Diuretics / Q000627:therapeutic use*; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D011236:Prediabetic State / Q000188:drug therapy*; D011446:Prospective Studies; D017257:Ramipril / Q000627:therapeutic use*; D018401:Sample Size
D000319:Adrenergic beta-Antagonists; D000806:Angiotensin-Converting Enzyme Inhibitors; D000959:Antihypertensive Agents; D004232:Diuretics; D017257:Ramipril