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First Product in a New Class of Medicine to Treat High Blood Pressure in Over 10 Years Now Available in the UK(1,2)
VIENNA, Austria, September 3 /PRNewswire/ -- Data presented yesterday at a symposium at the European Society of Cardiology Congress (ESC) shows that Rasilez(R) (aliskiren) produces a significant additional reduction in blood pressure (typically between 30% - 50%) when added to commonly prescribed hypertension medication classes, and is as effective as these agents when used alone(3-7). Available as of today on the NHS, aliskiren offers a promising option for the five million people with diagnosed high blood pressure in the UK who do not reach the target of lesser than or equal to 140/90mmHg, set by leading experts at the British Hypertension Society (BHS) and by the National Institute of Clinical Excellence (NICE)(8,9). Aliskiren is the first in a new class of medicine to treat high blood pressure to be made available to UK patients in over a decade(1,2). It works by inhibiting renin (an enzyme secreted by the kidney) at the 'source' of the Renin System, the effects of which are cascaded down the pathway. The Renin System is a key regulator of blood pressure and excess levels of renin can lead to hypertension(1,2). Other commonly prescribed antihypertensives, such as angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), work further along this pathway rather than acting at its source(1,2). Professor Peter Sever, Imperial College, London, comments "Blocking the Renin-Angiotensin System by direct inhibition of renin has been a long standing goal for scientists involved in developing antihypertensive therapy. The renin system in one of the most important systems in the body involved in regulating blood pressure. I believe Rasilez is a drug that could help many people whose blood pressure is not currently at target levels." Reductions in blood pressure are important as each increase of 20/10 mmHg in blood pressure doubles the risk of cardiovascular events such as stroke, heart attack and heart failure(10). Even a 2mmHg reduction in systolic blood pressure at a population level can lower stroke mortality by 10% and lower mortality from ischemic heart disease and other vascular conditions in middle age by 7%(11). The data presented at ESC demonstrate that aliskiren provides consistent blood pressure lowering effects which are sustained over 24 hours(12). When aliskiren was added to a high dose ARB or the ACE inhibitor ramipril, an additional 4mmHg to 5mmHg reduction in systolic blood pressure was seen(4,6). When aliskiren was added to a diuretic HCTZ there was an additional 7mmHg reduction in systolic blood pressure(3). When added to a calcium channel blocker (CCB), aliskiren doubled the reduction in systolic blood pressure (-6mmhg)(7). In trials of more than 7,800 patients, aliskiren was shown to have an overall incidence of adverse events in clinical trials similar to placebo(13). The most commonly reported effects in the trials were diarrhoea and rash which were generally mild and transient(13). The British Hypertension Society and Joint British Society Guidelines recommend that for some patients combinations of drugs are invariably required to reach optimal target blood pressure levels(14) - and aliskiren has no known clinically significant relevant interactions with medical products commonly used to treat hypertension or diabetes such as CCBs, ACE inhibitors, ARBs, beta blockers (BBs) and thiazide diuretics(13). Aliskiren has an extensive ongoing clinical trial programme to explore potential cardiovascular benefits, both in the short term and through long term trials. High blood pressure, and its consequences, is the leading cause of death in the UK, including an estimated 62,000 unnecessary deaths every year from stroke and ischaemic heart disease(15). Notes to Editors - Rasliez(R) (aliskiren) has been evaluated for safety in more than 7,800 patients, including over 2,300 treated for over six months, and more than 1,200 for over one year(12) - Novartis has a long-standing heritage in cardiovascular disease and is proud to now offer a treatment option for each major stage of the BHS treatment pathway - Mean change from baseline in SBP for aliskiren /ARB (valsartan) combination: -17mmHg compared to ARB monotherapy: -13mmHg(6) - Mean change from baseline in SBP for aliskiren /ACE (ramipril) combination: -17mmHg compared to ramipril monotherapy: -12mmHg(4) - Mean change from baseline in SBP for aliskiren/HCTZ combination: -21mmHg compared to HCTZ monotherapy: -14mmHg(3) - Mean change from baseline in SBP for aliskiren/amlodipine combination: -11mmHg compared to CCB monotherapy: -5mmHg(7) - Further info about hypertension, direct renin inhibitors and aliskiren is available on request About Novartis Novartis AG (NYSE: NVS) is a world leader in offering medicines to protect health, cure disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. Novartis is the only company with leadership positions in these areas. In 2006, the Group's businesses achieved net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com/ References (1) Azizi M, Menard J, Bissery A et al. Pharmacologic demonstration of the synergistic effects of a combination of the renin inhibitor aliskiren and the AT1 receptor antagonist valsartan on the angiotensin II-renin feedback interruption. J Am Soc Nephrol 2004;15(12):3126-33 (2) Wood JM, Maibaum J, Rahuel J et al. Structure-based design of aliskiren, a novel orally effective renin inhibitor. Biochem Biophys Res Commun 2003;308(4):698-705 (3) Villamil A, Chrysant SG, Calhoun D, Schober B, Hsu H, Matrisciano-Dimichino L, Zhang J. Renin inhibition with aliskiren provides additive antihypertensive efficacy when used in combination with hydrochlorothiazide. J Hypertens 2007;25:217-226 (4) Data on file: Clinical Study Report 2307. Novartis Pharmaceuticals Corp. (5) Gradman AH, Schmieder RE, Lins RL et al. Aliskiren, a novel orally effective renin inhibitor, provides dose-dependent antihypertensive efficacy and placebo-like tolerability in hypertensive patients. Circulation 2005;111(8):1012-8 (6) Oparil S et al. Efficacy and safety of combined use of aliskiren and valsartan in patients with hypertension: a randomised, double-blind trial. The Lancet 2007; 370:221-229 (7) Munger MA, Drummond W, Essop MR et al. Aliskiren as add-on to amlodipine provides significant additional blood pressure lowering without increased oedema associated with doubling the amlodipine dose. Eur Heart J 2006;27(Suppl 1): (abstract P784) (8) Product Thales, Company Cegadin Strategic Data, 2005 (9) National Collaborating Centre for Chronic Conditions. Hypertension: management in adults in primary care: pharmacological update. London: Royal College of Physicians, 2006 (10) Chobanian AV, Bakris GL, Black HR et al. Seventh report of the Joint National Committee on prevention, detection, evaluation, and treatment of high blood pressure. Hypertension 2003; 42: 1206-1251 (11). Protective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. The Lancet 2002:360 1903-13 (12). Oh BH, Mitchell J, Herron JR et al. Aliskiren, an oral renin inhibitor, provides dose-dependent efficacy and sustained 24-hour blood pressure control in patients with hypertension. J Am Coll Cardiol 2007;49:1157-63 (13) Rasilez(R) (aliskiren) Summary of Product Characteristics, Novartis Pharmaceuticals UK Ltd (14) British Cardiac Society, British Hypertension Society, Diabetes UK, HEART UK, Primary Care Cardiovascular Society, The Stroke Association. 2005 JBS 2: Joint British Societies' guidelines on prevention of cardiovascular disease in clinical practice. Heart 2005;91(suppl-5):1-52 (15) He FJ and MacGregor GA. Cost of poor blood pressure control in the UK: 62,000 unnecessary deaths per year. J Hum Hypertension 2003; 17: 455-457
