Original investigation

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

Walter Zidek¹ , Joachim Schrader² , Stephan Lüders² , Stephan Matthaei³ , Christoph Hasslacher⁴ , Joachim Hoyer⁵ , Peter Bramlage⁶ , Claus-Dieter Sturm² and W Dieter Paar⁷

¹  Medical Department IV, University Hospital Charité, Campus Benjamin-Franklin, Berlin, Germany

²  St. Joseph's Hospital and INFO GmbH Institute for Hypertension and Cardiovascular Research, Cloppenburg, Germany

³  Diabetes Center, Quakenbrück, Germany

⁴  Department for Internal Medicine, St. Joseph's Hospital, Heidelberg, Germany

⁵  Clinic for Internal Medicine, Nephrology, Marburg, Germany

⁶  Institute for Clinical Pharmacology, Medical Faculty Carl Gustav Carus, TU Dresden, Germany

⁷  Medical Department, Sanofi-Aventis Germany, Berlin, Germany

author email corresponding author email

Cardiovascular Diabetology 2008, 7:22doi:10.1186/1475-2840-7-22

Published:	24 July 2008

Abstract

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.

Conclusion

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.