Results of the ACCOMPLISH* study were published December 4, 2008 in the New England Journal of Medicine. This study which is the first to compare Renin-Angiotensin-System (RAS) Inhibitor- based single-pill combinations in reducing cardiovascular complications showed exceptional blood pressure control and substantial further risk reduction for the benazepril/amlodipine vs benazepril/diuretic combination.

"This study could definitely change current treatment guidelines for hypertension", says associate professor Björn Dahlöf, Sahlgrenska University Hospital, Göteborg, member of the Executive Committee of the ACCOMPLISH trial.

11,506 patients in Denmark, Finland, Norway, Sweden and the U.S. with hypertension and who were at high risk for cardiovascular events were randomized at 548 study centers. When the trial was terminated early due to the large benefit in one of the treatment-arms, after a mean follow-up of 36 months the blood pressure control was better than in previous hypertension studies, even though a majority of the patients were diabetic. The risk of reaching the primary composite endpoint however was significantly lower in the benazepril/amlodipine group with an absolute risk reduction of 2.2% and relative risk reduction of 19,6% (hazard ratio, 0.80; P<0.001).

Drawing from the previous experience of large clinical trials A+Science generated high-quality data collected from a total of 154 clinical investigators participating in Denmark, Finland, Norway and Sweden.

"Through careful selection, monitoring and follow-up of the randomized patients it was possible to maximize quality and to limit the amount of lost data to a minimum", says Ola Jeppsson, Senior CRM and Large Clinical Trials Manager at A+Science. No patients were lost to follow-up among the 3,354 patients randomized in the Nordic countries.

We would like to take this opportunity to acknowledge all the hard work from participating investigators and to thank all patients for their contribution leading to these important results.

A+ Science with head-quarters in Sweden, was responsible for the coordination of the ACCOMPLISH trial in the Nordic countries. A+ Science is a full-service CRO with more than 10 years experience of conducting large cardiovascular outcomes studies (e.g. the ASCOT trial).  In ACCOMPLISH, A+ Science coordinated selection of the 154 clinical study sites , monitored all the Nordic patients, coordinated endpoint handling for the region and in. collaboration with the ECG core laboratory at Sahlgrenska University Hospital in Göteborg, also coordinated the collection and analysis of more than 30,000 ECGs from the all the  study centers including US centers.

Gothenburg December 11, 2008
A+ Science

For further information, please contact:

Ola Jeppsson, Senior CRM and Large Clinical Trials Manager, +46 706 24 09 09

Facts

*The Avoiding Cardiovascular Events through Combination Therapy in Patients Living with Systolic Hypertension (ACCOMPLISH) trial
The New England Journal of Medicine
N ENGL J MED 2008; 359:2417-2428 December 4, 2008

Former publications

Rationale and Design of the Avoiding Cardiovascular events through COMbination therapy in Patients LIving with Systolic Hypertension (ACCOMPLISH) Trial
American Journal of Hypertension, Ltd, 2004; 17:793-801

Exceptional early blood Pressure control rates: The ACCOMPLISH trial
Blood Pressure. 2007; 16: 80-86

Baseline characteristics in the Avoiding Cardiovascular events through Combination
Therapy in Patients Living with Systolic Hypertension (ACCOMPLISH) trial: A hypertensive population at high cardiovascular Risk
Blood Pressure. 2007; 16: 13-19

Predictors of blood pressure response to intensified and fixed combination treatment of hypertension: The Accomplish Study
Blood Pressure. 2008; 17: 7-17