Olmetec(R) (olmesartan medoxomil) il primo antagonista dei recettori dell'angiotensina (ARB) che riduce l'aterosclerosi nell'uomo.

10 Dic, 2007, 07:00 GMT Da Daiichi-Sankyo

MONACO DI BAVIERA, Germania, December 10 /PRNewswire/ --

- Potential for MORE protection from CV disease in one treatment with ARB olmesartan

La malattia cardiovascolare, che comprende eventi cardiaci e ischemici, è la prima causa di morte in Europa(1). Olmesartan ha dimostrato di essere il primo farmaco, appartenente alla classe dei sartani, in grado di ridurre l'aterosclerosi - la causa maggiore di malattia cardiovascolare - e di ridurre la pressione arteriosa in un unica terapia, secondo un nuovo studio pubblicato oggi su Therapeutic Advances in Cardiovascular Disease.

I risultati dello studio MORE hanno dimostrato che olmesartan rispetto ad atenololo riduce significativamente il volume delle placche (PV) aterosclerotiche più grandi, in pazienti con ipertensione(2).

Entrambi i gruppi mostrano comparabili riduzioni della pressione arteriosa, tuttavia, soltanto i pazienti trattati con Olmetec hanno mostrato un effetto antiaterosclerotico sul volume della placca, effetto che sembra essere indipendente dall'effetto antipertensivo.

In una sottoanalisi di pazienti con volume della placca al basale al di sopra della media (valore di mediana 33.7 micro l), dopo due anni di trattamento con olmesartan si ha una riduzione del PV dell'8.9%, riduzione che risulta essere statisticamente significativa (p less than 0.05), paragonata all'aumento del 2.4% PV con atenololo.

Anche nelle placche più grandi (valore medio di almeno 50 micro l) il PV diminuisce del 12.8% nel gruppo Olmesartan, mentre aumenta del 2.1% nel gruppo atenololo (p equal to 0.017). Questi effetti di riduzione del volume della placca sono evidenti dalla 28 settimana(1).

"Questi risultati hanno evidenziato come è potenzialmente possibile ridurre due delle maggiori cause di malattia cardiovascolare- alta pressione arteriosa e aterosclerosi - con un solo farmaco", ha detto il prof. Enrico Agabiti Rosei, Dipartimento di Scienze Mediche e Chirurgiche, Università di Brescia, Italia. Inoltre ha aggiunto che questa è una buona notizia nel campo dell'aterosclerosi, la quale è la causa principale di malattia cardiovascolare, che uccide più di 4 milioni di europei ogni anno(1).

"Questo è il primo studio condotto con un ARB che dimostra la riduzione del volume della placca.

I risultati dello studio MORE si aggiungono alla crescente raccolta di studi di protezione vascolare di olmesartan, mostrando che nei pazienti con ipertensione arteriosa, in aggiunta all'efficace abbassamento dei valori pressori, Olmetec protegge contro il danno cardiovascolare e d'organo, "benefici che devono essere considerati seriamente quando si prescrive un agente antipertensivo in pazienti che possono avere una placca aterosclerotica"- ha detto il prof. Agabiti Rosei.

Notes to editors

About MORE(1)

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)

MORE and 3-D ultrasound innovation

MORE is the first study to measure atherosclerotic plaque volume using innovative three-dimensional (3-D) imaging. Traditional 2-D ultrasound imaging only tells part of the atherosclerosis story as it can only measures IMT (intima-media thickness), a surrogate marker of atherosclerosis, or shows a 2-D picture of an atherosclerotic plaque. 3-D ultrasound measures whole plaque formation (plaque volume calculated by measure of depth, width and length) so provides greater accuracy in determining the extent and severity of atherosclerosis

About Olmesartan

Olmesartan medoxomil, Olmetec(r), is an orally active, selective angiotensin II receptor (type AT1) 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,(3) in which 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. Clinical indications for Olmetec may vary from one country to another.

Olmesartan vascular protection studies in addition to MORE:

- Tsuda M, Iwai M et al. Inhibitory effects of AT1 receptor blocker, olmesartan, and estrogen on atherosclerosis via anti-oxidative stress.(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.(5)

- Min LJ, Mogi M et al. Aldosterone and angiotensin II synergistically induce mitogenic response in vascular smooth muscle cells.(6)

- Smith RD, Yokoyama H et al. The protective effects of angiotensin II blockade with olmesartan medoxomil on resistance vessel remodelling: rationale and baseline characteristics. Vascular Improvement with Olmesartan Medoxomil Study (VIOS).(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.(8)

- Fliser D, Buchholz K et al. Antiinflammatory effects of angiotensin II subtype 1 receptor blockade in hypertensive patients with microinflammation. EUropean Trial on Olmesartan and Pravastatin in Inflammation and Atherosclerosis (EUTOPIA).(9)

About Daiichi-Sankyo

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 by sales in Japan and as one of the 20 leading global pharmaceutical concerns.(10) On the way to become a "Global Pharma Innovator", the business strategy is to focus on the company's research activities to develop and commercialise innovative first and/or best in class products.

The current Daiichi-Sankyo product range is focused on the treatment of cardiovascular diseases and diabetes.

Daiichi-Sankyo facts

- Number one pharmaceutical company by sales in the Japanese market.

- First company to develop a statin for hyperlipidaemia.

- First company to develop a glitazone for type II diabetes.

- US$6.4 billion worldwide net sales. 17 % global net sales invested in R&D.

- One of the 20 leading global pharmaceutical companies.

- 15,400 employees around the world.

- 1,800 employees in Europe.

For further information please visit http://www.daiichi-sankyo.eu

References:

1. Petersen S, Peto V, Rayner M, et al (2005) European cardiovascular disease statistics. BHF: London http://www.heartstats.org/datapage.asp?id=1570 Accessed 15 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. Olmetec film-coated tablets SPC. Last updated 14 November 2006. Available at: http://emc.medicines.org.uk/emc/assets/c/html/DisplayDoc.asp?DocumentID=15152 Accessed August 2007

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. IMS Midas 2006

FONTE Daiichi-Sankyo