Press Release

• With 15,000 patients, the 3A Registry is Europe’s largest registry of high blood pressure patients, including high-risk patients often excluded from clinical trials

• Results provide insight into the effect of Rasilez on a large real-life patient population outside the traditional clinical trial setting

• After one year of treatment, Rasilez – the only approved direct renin inhibitor (DRI) – provided better systolic blood pressure control than other treatment regimens1

Basel, June 19, 2010 – Results from the 3A Registry, Europe’s largest real-life registry of high blood pressure patients, showed that in a real-life setting, Rasilez® (aliskiren), the only approved direct renin inhibitor, showed greater systolic blood pressure reductions after one year of treatment, compared with either an ACE inhibitor (ACEI), angiotensin-receptor blocker (ARB) or non-RAAS blockade treatment1.

The 3A Registry was initiated in August 2008 by the Institute for Heart Attack Research in Ludwigshafen, Germany and was funded by Novartis Pharma GmbH. 14,996 patients with high blood pressure were recruited by 923 practices throughout Germany. Of these, 68% of patients were treated with a Rasilez-based regimen, 18% of patients were treated with an ACEI/ARB-based regimen and 14% were treated with non-RAAS blockade therapy.

Data from the 3A Registry, presented at the 20th Scientific Meeting of the European Society of Hypertension (ESH), showed that after one year of treatment, systolic blood pressure (SBP) measurements were reduced by 11.7% in patients treated with Rasilez compared to a reduction of 9.7% in the ACEI/ARB-treated group and 9.9% in patients treated with a non-RAAS blockade treatment (p<0.001)1.

“For the first time in Europe, we have information on the effect of aliskiren on a large real-life population of blood pressure patients outside the clinical trial setting”, said Professor Zeymer, lead investigator of the 3A Registry study. “This data highlights the impressive efficacy of aliskiren, in a population that includes high-risk patients, with a more significant systolic blood pressure reduction compared to other treatment regimens”.

The aliskiren-treated group showed greater systolic blood pressure reductions compared to the other treatment arms. The aliskiren group had higher baseline blood pressure, more cardiovascular co-morbidities, a higher prevalence of diabetes and renal disease, and were treated with more high blood pressure drugs at baseline1.

“The 3A Registry provides an important insight into the management of high blood pressure in a real-life setting. We are pleased to see that this data reflects the clinical results we have already demonstrated for Rasilez.” said Trevor Mundel, MD, Global Head of Development at Novartis Pharma AG. “We look forward to seeing further analyses from the 3A Registry that may provide new insights into the effectiveness of Rasilez.”

Rasilez, known as Tekturna® in the US, is a first-in-class, innovative high blood pressure treatment that works at the point of activation of the renin angiotensin aldosterone system (RAAS), directly inhibiting the activity of renin, an enzyme that triggers a process that may lead to high blood pressure2.

Rasilez/Tekturna is approved in over 80 countries. Tekturna was approved in the US in March 2007 and in the European Union in August 2007 under the trade name Rasilez. Rasilez also received approval in Japan in 2009. Tekturna HCT®, a single-pill combination of aliskiren and hydrochlorothiazide, was approved in the US in January 2008 for second-line treatment of high blood pressure, and in July 2009 for first-line treatment of high blood pressure. The single-pill combination Rasilez HCT® was approved in the European Union in January 2009. In September 2009, Valturna®, a single-pill combination of aliskiren and valsartan (Diovan®), was approved in the US. Other single-pill combinations with aliskiren are currently in development including a single-pill combination with amlodipine.

Novartis has a strong cardiovascular and metabolic portfolio, focusing on innovative treatments for high blood pressure and diabetes. These include Diovan® (valsartan), the number one selling blood pressure medication worldwide3, Exforge® (valsartan/ amlodipine), a single-pill combining two leading medicines for high blood pressure; Exforge HCT® (amlodipine/valsartan/HCT); and Rasilez® (aliskiren), the first and only approved direct renin inhibitor, and two single-pill combinations of Rasilez®, Rasilez HCT® (aliskiren/HCT) and Valturna® (aliskiren/valsartan). For the treatment of type 2 diabetes, these include Galvus® (vildagliptin, a DPP-4 inhibitor) and Eucreas® (vildagliptin and metformin).
 

For more information:
http://www.novartis.com.

Last updated on: 27/08/2010 11:40:18