GERRARDS CROSS, England, December 10 /PRNewswire/ --

- MORE Study Shows Potential for Vascular Benefits in Addition to BP Lowering with olmesartan

Olmetec(R) (olmesartan medoxomil), licensed in the UK for essential hypertension, is the first ARB to suggest a regression of atherosclerosis (plaque volume (PV)) , a major risk factor for cardiovascular disease (CVD), according to a new study published today in the inaugural issue of Therapeutic Advances in Cardiovascular Disease. Regression of PV is a compelling clinical goal, with potential to prevent cardiovascular and cerebrovascular events. In the Multicentre Olmesartan Atherosclerosis Regression Evaluation (MORE) study the primary end point, common carotid - intima media thickness (CC-IMT), a surrogate risk factor for CVD, decreased after 2 years treatment with olmesartan. A post hoc analysis in patients with larger plaques demonstrated a significant reduction in PV compared to atenolol the active comparator, although change in PV for the whole study population only showed trend towards significance for olmesartan. This is a promising finding which provides a focus for further evaluation in future clinical studies.

In the MORE study, olmesartan did not significantly reduce plaque volume (PV) compared with the beta-blocker atenolol in the overall population. However a post hoc analysis of patients with above average plaques (more than or equal to 33microl) at baseline (those at greater risk of cardiovascular events) olmesartan showed a significant reduction in PV by -8.9%, compared with a 2.4% increase with atenolol. In very large plaques the beneficial effect of olmesartan was even greater - PV declined by -12.8% and increased by 2.1% respectively in the olmesartan and atenolol groups. Both olmesartan and atenolol patients showed a similar reduction in blood pressure(2). The observed decrease in plaque volume may thus occur independently of blood pressure lowering and offers a further potential benefit of olmesartan.

The MORE findings add to Olmesartan's growing portfolio of vascular protective studies.(3-8) "The MORE study is a landmark because it is the first study to show an anti-atherosclerotic effect using an ARB. This suggests that in patients with hypertension, in addition to effective blood pressure lowering, olmesartan may potentially protect against cardiovascular and organ damage, benefits that should be considered seriously when prescribing an anti-hypertensive agent in patients who already have atherosclerotic disease" said Dr Lina Izzat, Associate Specialist in Cardiology, Prince Phillip Hospital, Llanelli.

Notes for Editors

About MORE(2)

Aim: To use carotid 2-dimensional (2D) and 3-dimensional (3D) ultrasound to compare the effects of 2 years' treatment with olmesartan medoxomil with the beta-blocker atenolol on intima-media thickness (IMT) and atherosclerotic plaque volume (PV) of the common carotid (CC) artery in patients with hypertension and cardiovascular risk.

Methods: A total of 165 patients (with systolic/diastolic blood pressure 140-180/90-105 mmHg) were randomized to receive either olmesartan (20-40mg/day) or atenolol (50-100mg/day). Ultrasound (US) was performed at baseline and 28, 52 and 104 weeks. The primary efficacy outcome was the change from baseline in CC-IMT assessed by 2D US. Secondary outcomes included PV assessment by 3D US and blood pressure (BP)

Results: Olmesartan significantly reduced the plaque volume (PV) of larger atherosclerotic plaques compared with atenolol (p equal to 0.023). In a subanalysis of patients with above average plaques at baseline (median value 33.7 microl), two years treatment with olmesartan reduced PV by 8.9% compared with a 2.4% PV increase with atenolol (p less than 0.05). In even larger plaques (mean value with at least 50 microl) PV declined by 12.8% and increased by 2.1% respectively in the olmesartan and atenolol groups (p equal to 0.017). Olmesartan's regressive effects on PV on large plaques were evident from 28 weeks.(2)

About Atherosclerosis

Atherosclerosis is a disease of the inner wall of the artery, causing narrowing and impaired blood flow. It involves the build up of fatty deposits called plaques (atheromas). Atherosclerosis can start to develop in the early 20s and the number and thickness of plaques increases with age, building up over many years. The plaque also encourages blood clots (thrombus) to form; these can block blood flow and may also travel to other parts of the body and block smaller vessels.

Atherosclerosis can affect the arteries of the heart, brain, kidneys, other vital organs, and the arms and legs. Symptoms will depend on where the plaques develop and narrowing occurs. The initial symptom may be pain or cramps when the body requires more oxygen, for example, during exercise a person may suffer from angina (chest pain). If blood clots form in the arteries in the brain this may result in a stroke. In the heart, it may result in heart failure or a heart attack. In the kidneys it can lead to high blood pressure and renal failure.

Cardiovascular disease (CVD), including heart attacks and strokes, is the number one cause of death in the UK.(1)

About Olmesartan

Olmesartan medoxomil, Olmetec(r), is an orally active, selective angiotensin II receptor (type AT(1)) antagonist, which is one of a class of agents known more commonly as angiotensin-receptor blockers (ARBs). Olmetec is indicated for the treatment of essential (primary) hypertension(9) (where clinicians cannot identify an underlying physical cause for the raised blood pressure). In clinical trials, the pattern and frequency of adverse events seen in patients taking Olmetec was similar to that in the placebo arm.


Through the merger of two major pharmaceutical companies with Japanese origin, completed in April 2007, DAIICHI SANKYO has strengthened its position as the number one pharmaceutical company in Japan and the 19th largest pharmaceutical company in the world. As a global pharma innovator, the business strategy is to focus on the company's research activities to develop and commercialise innovative medicines.

DAIICHI SANKYO UK moved to a brand new office in Gerrards Cross, Buckinghamshire during June 2006 to provide much-needed space and facilities to continue building the UK business in the future. The current UK product range is focused on the treatment of cardiovascular diseases and diabetes.

In addition, DAIICHI SANKYO has located their European Research & Development Division in the same office building. This demonstrates the importance of the UK in the company's global clinical development programme.


- Largest pharmaceutical company in the Japanese market

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(1). Office for National Statistics: London. Mortality Statistics: cause. England and Wales 2005. Accessed 23rd November 2007

(2). Stumpe K O, Agabiti-Rosei E, Zielinski T et al. Carotid intima-media thickness and plaque volume changes following 2-year angiotensin II-receptor blockade. The Multicentre Olmesartan atherosclerosis Regression Evaluation (MORE) study. Therapeutic Advances in Cardiovascular Disease (2007) 1(1) 1-6

(3). Tsuda M, Iwai M et al. Inhibitory effects of AT1 receptor blocker, olmesartan, and estrogen on atherosclerosis via anti-oxidative stress. Hypertension. 2005;45(4):545-51. Epub 2005 Feb 21

(4). Takai S, Kim S et al. Mechanisms of angiotensin II type 1 receptor blocker for anti-atherosclerotic effect in monkeys fed a high-cholesterol diet. J Hypertens. 2003;21(2):361-9

(5). Min LJ, Mogi M et al. Aldosterone and angiotensin II synergistically induce mitogenic response in vascular smooth muscle cells. Circ Res. 2005;97(5):434-42.Epub 2005 Aug 4

(6). Smith RD, Yokoyama H et al. The protective effects of angiotensin II blockade with olmesartan medoxomil on resistance vessel remodelling (VIOS study): rationale and baseline characteristics. Am J Cardiovasc Drugs. 2006;6(5):335-42

(7). Kato M, Sada T et al. Severity of hyperlipidemia does not affect antiatherosclerotic effect of an angiotensin II receptor antagonist in apolipoprotein E-deficient mice. J Cardiovasc Pharmacol. 2006;47(6):764-9

(8). Fliser D, Buchholz K et al. Antiinflammatory effects of angiotensin II subtype 1 receptor blockade in hypertensive patients with microinflammation. Circulation 2004;110(9):1103-7.Epub 2004 Aug 16

(9). Olmetec film-coated tablets SPC. Last updated 14th November 2006. Available at: Accessed August 2007

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