Bayer Schering Kicks Off Antihypertensive Study in Asia

Bayer Schering Pharma has held two investigators meetings in Beijing, China and Seoul, Korea to announce the start of ADVISE, the Asia Pacific trial - nifeDipine in combination with Valsartan to achIeve blood preSsure targEts, a major phase IV study that is taking place in Asia Pacific (AP).

ADVISE will evaluate the efficacy of combination treatment with Bayer Schering Pharma's calcium channel blocker (CCB) Adalat GITS/OROS and the angiotensin receptor blocker (ARB), valsartan, for lowering blood pressure (BP) compared with up-titrated valsartan monotherapy.

In patients with hypertension, the primary goal of treatment is to control BP in order to reduce long-term risk of cardiovascular disease (CVD). European guidelines recognize this and recommend the use of combination therapy to achieve BP goals. The combination of a CCB with a renin-angiotensin-aldosterone system (RAAS) blocker, such as an ARB, is recommended by the European guidelines as a rational and effective approach.

In the AP region, where the prevalence of hypertension is comparable with that of Western/developed countries, there are currently no consensus guidelines for hypertension management. However, those issued by the Chinese Hypertension Society and the Japanese Society of Hypertension are similar to those in Europe and the US.

The combination of Adalat GITS/OROS and an ARB has also been explored in another study: A Multicentre STudy EvALuating the Efficacy of Nifedipine GITS - Telmisartan Combination in Blood Pressure Control and Beyond: comparison of two strategies (TALENT) the results of which are due to be announced in 2010.

ADVISE will build on this data, examining the benefits of an Adalat-based combination in hypertensive patients from the AP region. It will recruit approximately 356 patients at 17 centres in the AP region - 256 patients at 10 centres in China, and 100 patients at seven centres in Korea. The study will consider if the combination of Adalat GITS/OROS 30mg plus valsartan 80mg is:
- at least as effective as a high dose valsartan 160mg alone
- safe and well tolerated.

The primary endpoint of the study is to assess the change in mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) on office BP at 12 weeks of treatment compared to baseline. Results from the study are expected in 2011.