7/26/2011 

Media Contact:
Cheok Soh Hui
Pfizer Pte Ltd
(65) 6403 8798
(65) 9767 3945
sohhui.cheok@pfizer.com

New fixed dose combination therapy for high blood pressure approved in Singapore
  • Study shows fixed dose combination therapy is effective in the treatment of high blood pressure


Singapore, 26 July 2011 – The Health Sciences Authority (HSA) in Singapore has approved a new treatment, olmesartan medoxomil/amlodipine besylate, for high blood pressure. The fixed dose combination therapy, marketed in Singapore by pharmaceutical company Pfizer, has been clinically proven to be an effective treatment for hypertension, a common risk factor in cardiovascular diseases.

The new treatment is a convenient, once daily, single tablet combination of olmesartan medoxomil, an angiotensin II receptor blocker (ARB) and amlodipine besylate, a calcium channel blocker (CCB). It will not only enable physicians to achieve therapeutic blood pressure goals crucial for cardiovascular protection, but can also overcome the existing challenges faced by physicians in ensuring a 24-hour blood pressure control which may confer additional benefits to these patients.

Olmesartan medoxomil is an angiotensin II receptor blocker used to treat hypertensive patients. Olmesartan is a selective angiotensin II antagonist which blocks the binding of angiotensin II to specific receptor sites, thus reducing blood pressure.

Amlodipine besylate works primarily on the blood vessels. Its effect is to block the narrowing effect of calcium and relax the blood vessels so that they dilate and the blood pressure within them drops. Together, the two compounds relax the blood vessels, thus lowering blood pressure effectively.

This new combination treatment provides patients with a better tolerated side effect profile. The most common side effect of ankle edema (usually caused by calcium channel blockers) is reduced due to the complementary mechanism from these two classes of drugs.

“Hypertension increases one’s risk of cardiovascular disease as the increased pressure exerted by the blood flow aggravates the walls of the blood vessels,” said Dr Peter Yan, consultant cardiologist from Mount Elizabeth Medical Centre and Gleneagles Medical Centre.

“As more and more damage is done to the blood vessel walls, plaque tends to form, in turn increasing the likelihood of atherosclerosis and coronary heart disease. High blood pressure also affects major organs like the brain, the heart and the kidneys as uncontrolled hypertension will lead to stroke, heart failure and renal failure,” he added.

The latest 2010 National Health Survey has revealed that almost one in four Singaporeans suffer from hypertension. Worldwide, the number of people with high blood pressure is expected to reach about 1.6 billion by 2025.2

OSCAR Study

A recent OlmeSartan and calcium antagonists randomized (OSCAR) study compared the use of high dose ARB as a monotherapy and ARB in combination with CCB in elderly high-risk hypertensive patients. After 36 months, combination therapy reduced blood pressure to significantly lower levels than monotherapy (mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) were lower by 2.4 mmHg [p = 0.0315] and 1.7 mmHg [p =0.0240], respectively).3

The OSCAR study involved 1,164 patients and is the first large scale clinical trial comparing the efficacy of high-dose ARB monotherapy with that of ARB plus CCB combination therapy in elderly high-risk hypertensive patients.4

“The alarming hypertension rates in Singapore point to the need for more aggressive treatment to combat the risk of cardiovascular events,” Dr Yan said.

“The fixed dose combination therapy will give doctors a powerful alternative treatment option to treat and manage hypertensive patients. It will help to reduce their blood pressure to the required goal targets where olmesartan medoxomil or amlodipine besylate alone is not sufficient. In addition, the fixed dose combination therapy allows for better compliance with treatment,” he added.

– Ends –

About the OSCAR Study

The OSCAR trial was the first large scale clinical trial designed to compare the efficacy of Angiotensin II receptor blockers (ARB) as a monotherapy and ARB in combination with a calcium channel blocker (CCB) on elderly high-risk hypertensive patients. The trial was a multicenter, active-controlled, two-arm parallel group comparison which enrolled 1,164 patients with 578 patients assigned to the ARB monotherapy group and 586 patients being assigned to the combination therapy of ARB plus CCB. Baseline characteristics included, sex, age, Body-Mass Index (BMI), blood pressure, and smoking status.

For this study, elderly hypertensive patients were enrolled because there was much less evidence for the treatment of hypertension in elderly patients than in younger patients.

Pfizer (Singapore): Working together for a healthier world™

At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people. Our diversified global health care portfolio includes human biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world’s best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world’s leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care in Singapore. To learn more about our commitments, please visit us at www.pfizer.com.sg

 



  1. 26 November 2010. Diabetes rate in Singapore rises to a 12-year high. Singapore Government News. Retrieved 28.04.11
  2. Kearney PM, et al. Global burden of hypertension: analysis of worldwide data. Lancet 2005, 365:217-23
  3. 5 April 2011. Combination Therapy Produces Similar Outcomes Compared to ARB Alone for Elderly Hypertensive Patients, http://www.cardiosource.org/News-Media/Media-Center/News-Releases/2011/04/OSCAR.aspx, American College of Cardiology. Retrieved 20.07.11
  4. Ogawa H. et al. OlmeSartan and Calcium Antagonists Randomized (OSCAR) Study. Hypertension Research advance online publication, 15 May 2009 ; doi 10.1038
Text SizeAAA