Rasilez HCT (aliskiren and hydrochlorothiazide), a single-pill combination of two high blood pressure medicines - first-in-class direct renin inhibitor Rasilez (aliskiren) and the diuretic hydrochlorothiazide (HCT) - has been approved by Swissmedic as a new treatment for high blood pressure.
High blood pressure is estimated to affect nearly one in four adults worldwide. While it is easy to measure and can be successfully managed, nearly 65 per cent of patients with high blood pressure do not have the condition under control, underscoring the critical need for more effective treatment regimens. Most patients require two or more medicines to reach their target blood pressure. Single-pill combinations are likely to improve patient adherence and may provide a practical solution to managing high blood pressure.
Rasilez HCT is twice as effective at reducing blood pressure compared to HCT alone. The first new type of blood pressure medicine in over a decade Rasilez, known as Tekturna in the US, provides effective blood pressure lowering that lasts beyond 24 hours. HCT, sometimes called a "water pill", is one of the most commonly used diuretics in the treatment of high blood pressure.
"Up to 70 per cent of patients may need multiple medications to help them reach blood pressure goals. Because of complex treatment regimens, patients may have a hard time adhering to their treatment plan, which can contribute to uncontrolled blood pressure," said Professor Michel Burnier, University of Lausanne, Faculty of Biology and Medicine, Head of Nephrology and Hypertension CHUV, Lausanne. "By combining two therapies into a single-pill combination, Rasilez HCT effectively lowers high blood pressure and provides patients with the convenience of only having to take one pill."
The Swiss approval of Rasilez HCT for patients not controlled by either medicine alone follows the US approval of Tekturna HCT earlier this year. The submission was based on clinical trials involving more than 2,700 patients.
"Having received the US approval of Tekturna HCT earlier this year, we are pleased to now have regulatory approval of Rasilez HCT in Switzerland. This regulatory decision also supports expanded regulatory submissions in 100 countries worldwide," said Trevor Mundel, MD, Head of Global Development Functions at Novartis Pharma AG. "We are expecting a regulatory decision from the European health authorities for Rasilez HCT in the first quarter of 2009."
The heart and kidney protection potential of Rasilez/Tekturna, independent of its blood pressure lowering ability, is currently being further studied in the landmark ASPIRE HIGHER programme, the largest ongoing cardio-renal outcomes program worldwide involving more than 35,000 patients in 14 trials.
Rasilez/Tekturna is approved in 57 countries. Tekturna was approved in the US in March 2007, and in the European Union in August 2007 under the trade name Rasilez. Tekturna HCT, the first single-pill combination involving Tekturna, was approved in the US in January 2008.
Novartis is focused on improving the lives of the hundreds of millions of people with cardiovascular and metabolic diseases. As a global leader in cardiovascular and metabolic health for nearly 50 years, Novartis provides innovative therapies and support programmes to treat high blood pressure and diabetes - both major public health issues. The portfolio includes the world's most-prescribed angiotensin receptor blocker, the first and only approved direct renin inhibitor, a single pill combining two leading high blood pressure medicines, and a novel DPP-4 inhibitor.