OLMETEC® opens narrowed arteries in patients with hypertension
Berlin, Germany 15th June 2008 – New research clearly demonstrates that Olmetec® (olmesartan), a potent angiotensin receptor blocker (ARB), reverses narrowing of the arteries in patients with essential hypertension.1,2 The findings were presented during a satellite symposium at Hypertension 2008, a scientific conference co-hosted by the European and the International Societies of Hypertension.
“This study is a significant step forward in reducing the cardiovascular disease risks associated with hypertension by demonstrating olmesartan’s reversal of narrowed arteries resulting in normal artery architecture. Importantly this observation was in addition to olmesartan’s control of hypertension,” said investigator Professor Carlos Ferrario, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
In the Vascular Improvement with Olmesartan Study (VIOS*), olmesartan achieved the primary endpoint by alleviating small artery constriction caused by hypertrophy of the blood vessel’s wall (as measured by arterial wall to lumen ratio, W/L). The W/L ratio returned to near normal levels after one year of treatment with olmesartan. This protective effect was not seen with the comparator agent in the study, the beta-blocker atenolol.1,2 VIOS, olmesartan’s beneficial action on arterial structure was independent of its efficacy in lowering blood pressure.1 Olmesartan’s effectiveness in lowering blood pressure has already been established in previous studies involving some 3,000 patients.3,4,5,6,7,8
The cardiovascular continuum
Links between elevated blood pressure and organ damage are well-known.9,10,11 Current clinical thinking now regards cardiovascular disease (CVD) as a continuum driven by risk factors such as hypertension, with early signs like vascular inflammation and changes in arterial structure, later progressing through multiple pathophysiological routes to end in heart disease, stroke, and kidney damage.9,10,11
The VIOS data add to growing evidence for olmesartan’s potentially beneficial role in regressing or reversing vascular damage at many stages during this disease process. In other recent studies of hypertensive patients, treatment with olmesartan showed the potential to reduce the size of atherosclerotic plaques (the MORE study**)12 and significantly lowered plasma levels of vascular inflammatory markers (the EUTOPIA study***).13
Strong BP reduction in clinical trials
Olmesartan is the latest ARB (a class of drugs recommended in European hypertension guidelines).11 Olmesartan has demonstrated effective blood pressure control throughout a comprehensive clinical trial programme involving some 3,000 patients.3,4,5,6,7,8
In head-to-head trials with other ARBs, olmesartan has demonstrated a significantly greater efficacy in lowering blood pressure compared to losartan, valsartan, candesartan and irbesartan.3,4,5,14
Olmesartan has been well tolerated in these studies with an incidence of side effects similar to placebo.6,7,8 It is also taken as a once-daily dose,15 a regimen that guidelines acknowledge as an aid to better compliance.11
* Vascular Improvement with Olmesartan medoxomil Study (VIOS)
** Multicentre Olmesartan atherosclerosis Regression Evaluation study (MORE)
*** European Trial on Olmesartan and Pravastatin in Inflammation and Atherosclerosis (EUTOPIA)
Notes to editors
For more information or to request an interview at the conference with one of the VIOS investigators, please contact the press representative on site:
Caron Kennedy
Account Director
Huntsworth Health,
Morris Place, Liston Road,
Marlow, Bucks SL7 1DF
+44 (0)1628 480402
+44 (0)7850 465978
CaronKennedy@hhealth.com
Frank Chwallek, MD
Vice Director Medical & Scientific Affairs Olmetec
DAIICHI SANKYO EUROPE GmbH
Zielstattstrasse 48, 81379 Munich, Germany
Phone: +49 - (0)89 7808 434
Mobile: +49 - (0)172 8 33 35 02
Fax: +49 - (0)89 7808 595
E-Mail: frank.chwallek@daiichi-sankyo.eu
VIOS study design
Details of the study design have been published in the literature.1,2 In this open-label study 100 non-diabetic patients, mean age 53 years, with established Stage 1 hypertension were randomized to either olmesartan medoxomil 40 mg/day or atenolol 100mg/day following a 4 week wash-out period. Additional interventions were allowed if target blood pressure was not met with agents known not to influence vascular properties. The study period was one year. The primary endpoint was change in the morphological characteristics of arteries as determined by differences in the wall / lumen (W/L) ratio. This parameter was measured using a pressure myograph procedure on arteriole biopsy samples obtained from patients who consented to undergo the biopsy procedure: this formed a sub-group of 49 patients who had a repeat biopsy and received treatment. Samples from 11 normotensive subjects were also tested.
VIOS study results
The results reported here were recently published.1 The arteriolar dimensions in the olmesartan and atenolol groups were similar prior to drug treatment (14.9% and 16% respectively) whereas arteries from the normotensive subjects had significantly smaller W/L ratios (11%). At the end of the study the W/L ratio in the olmesartan group was significantly reduced (to a mean of 11.1%, P<0.01) while vessel dimensions in the atenolol group were unchanged. Blood pressure reductions from baseline occurred within 12 weeks for both treatments and were statistically significant (P<0.05). The mean reduction of systolic BP for the weeks 12, 24, and 52 was similar and not significantly different over the 40 weeks of stabilized treatment (olmesartan, 124 ± 3 mmHg vs. atenolol, 127 ± 2 mmHg, P=0.08). Likewise, the mean diastolic BP for olmesartan-treated patients compared with those treated with atenolol was 78 ± 1 mmHg vs 78 ± 1 mmHg, respectively (P=0.35).
__________________________________________________________________
References
1 Smith RD, Yokoyama H, Averill DB et al. Reversal of vascular hypertrophy in hypertensive patients through blockade of angiotensin II receptors. In press. Journal of the American Society of Hypertension 2008;2(3):165–172.
2 Smith RD, Yokoyama H, Averill DB 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):335-342.
3 Brunner HR, Arakawa K. Antihypertensive efficacy of olmesartan medoxomil and candesartan cilexetil in achieving 24-hour blood pressure reductions and ambulatory blood pressure goals. Clinical Drug Investigation 2006;26(4):185-193.
4 Oparil S, Silfani TN, Walker JF. Role of angiotensin receptor blockers as monotherapy in reaching blood pressure goals. Am J Hypertens. 2005 Feb;18(2 Pt 1):287-294.
5 Smith DHG, Dubiel R; Jones M et al. Use of 24-Hour ambulatory blood pressure monitoring to assess antihypertensive efficacy: A comparison of olmesartan medoxomil, losartan potassium, valsartan, and irbesartan. Am J Cardiovasc Drugs 2005;5(1):41-50.
6 Brunner HR, Laeis P. Clinical efficacy of olmesartan medoxomil. J Hypertens 2003;21(Suppl 2):S43-S46.
7 Püchler K, Laeis P, Stumpe KO. Blood pressure response, but not adverse event incidence, correlates with dose of angiotensin II antagonist. J Hypertens 2001;19(S1):S41-S48.
8 Neutel JM. Clinical studies of CS-866, the newest angiotensin II receptor antagonist. Am J Cardiol 2001;87(Suppl):37C-43C.
9 Dzau VJ, Antman E, Black H et al. The cardiovascular disease continuum validated: Clinical evidence of improved patient outcomes. Part I: Pathophysiology and clinical trial evidence (risk factors through stable coronary artery disease). Circulation 2006;114:2850-2870.
10 Zanchetti J. Evidence-based medicine in hypertension: what type of evidence? Hypertens 2005; 23:1113-1120.
11 Mancia G, de Backer G, Dominiczak A et al for the Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). Guidelines for the management of arterial hypertension: J Hypertens 2007;25:1105-1187.
12 Stumpe KO, 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. Ther Adv Cardiovasc Diseases 2007;1(2):97-106.
13 Fliser D, Buchholz K, Haller H et al. Antiinflammatory effects of angiotensin II subtype 1 receptor blockade in hypertensive patients with microinflammation. Circulation 2004;110:1103-1107.
14 Fabia MJ, Abdilla N, Oltra R et al. Antihypertensive activity of angiotensin II AT1 receptor antagonists: a systematic review of studies with 24 h ambulatory blood pressure monitoring. J Hypertens 2007;25:1327-1336.
15 Olmesartan summary of product characteristics, April 2008, EU
Forward-looking statements
This press release contains forward-looking statements and information about future developments in the sector, and the legal and business conditions of DAIICHI SANKYO EUROPE GmbH. Such forward-looking statements are uncertain and are subject at all times to the risks of change, particularly to the usual risks faced by a global pharmaceutical company, including the impact of the prices for products and raw materials, medication safety, changes in exchange rates, government regulations, employee relations, taxes, political instability and terrorism as well as the results of independent demands and governmental inquiries that affect the affairs of the company. All forward-looking statements contained in this release hold true as of the date of publication. They do not represent any guarantee of future performance. Actual events and developments could differ materially from the forward-looking statements that are explicitly expressed or implied in these statements. DAIICHI SANKYO EUROPE GmbH assumes no responsibility for the updating of such forward-looking statements about future developments of the sector, legal and business conditions and the company.
