Navigation Links
Amlodipine and Olmesartan Study Results Released;Late Breaker,Presented at American Society of Hypertension Twenty-Second Annual,Scientific Meeting (ASH 2007)

First Release of Data for New Combination

PARSIPPANY, NJ (May 21, 2007) -- Combining the calcium channel blocker amlodipine besylate with the angiotensin receptor blocker olmesartan medoxomil, produced significant mean reductions in seated systolic and diastolic blood pressure in patients with hypertension, according to data presented at the American Society of Hypertension’s Twenty-Second Annual Scientific Meeting and Exposition (ASH 2007). The Phase III registration trial data was presented for the first time at today’s “late breaker” session at the ASH meeting in Chicago. Daiichi Sankyo, Inc. filed a New Drug Application (NDA) in November 2006 for a fixed-dose combination of the two antihypertensives. This investigational agent of amlodipine besylate/olmesartan medoxomil (AZOR™) is under regulatory review in the United States, including trade name review.

“All combinations of amlodipine and olmesartan produced significantly greater mean reductions in both diastolic and systolic blood pressure than either medication alone,” said Steven G. Chrysant, MD, of the Oklahoma Cardiovascular and Hypertension Center and the University of Oklahoma School of Medicine, and lead investigator on the study. “All combinations with amlodipine 10 mg demonstrated a lower incidence of edema versus amlodipine 10 mg monotherapy,” he added.

Amlodipine 10 mg/day plus olmesartan 40 mg/day reduced systolic blood pressure an average of 30.1 mm Hg and the diastolic reading an average of 19.0 mm Hg. These results were in comparison w ith mean reductions of 19.7 mm Hg systolic/12.7 mm Hg diastolic for amlodipine 10 mg alone (placebo= 4.8/3.1 mm Hg). When compared to amlodipine 10 mg alone, amlodipine 10 mg/day plus olmesartan 40 mg/day resulted in a 53 percent greater reduction in systolic blood pressure. Amlodipine combined with olmesartan provides two complimentary mechanisms of action to lower blood pressure: calcium channel blockade with amlodipine and angiotensin receptor blockade with olmesartan.

The AE profile for each of the combinations was similar in nature to the monotherapy components. Most reported treatment-emergent adverse events across all treatment groups were considered mild in severity.

Hypertension, also known as high blood pressure, affects approximately 72 million people in the United States and approximately one billion worldwide. It is often difficult to control, and of those diagnosed with high blood pressure, 64.9 percent do not have the condition under control.1

Study Design

The study was a Phase III, 8-week, randomized, double-blind, placebo-controlled, parallel-group, factorial study in 1,940 patients with mild to severe hypertension defined as seated diastolic BP between ? 95 mm Hg and ? 120 mm Hg. The purpose of the study was to determine if co-administration of amlodipine 5-10 mg/day and olmesartan 10-20-40 mg/day had a significant benefit vs. its respective monotherapy components. Primary and one of the secondary endpoints were mean change from baseline in seated diastolic and seated systolic blood pressure at week 8, respectively.

About Daiichi Sankyo, Inc.

Daiichi Sankyo, Inc., headquartered in Parsippany, New Jersey, is the U.S. subsidiary of Daiichi Sankyo Co., Ltd., Japan’s second largest pharmaceutical company and a global leader in pharmaceutical innovation since 1899. The company is dedicated to the discovery, development and commercialization of innovative medicines that improve the lives of patients throughout the world.

The primary focus of Daiichi Sankyo’s research and development is cardiovascular disease, including therapies for dyslipidemia, hypertension, diabetes, and acute coronary syndrome. The company is also pursuing the discovery of new medicines in the areas of glucose metabolic disorders, infectious diseases, cancer, bone and joint diseases, and immune disorders.

For more information, please visit www.dsus.com.

# # #

1. http://www.americanheart.org/presenter.jhtml?identifier=4621 Site accessed 5/10/2007

Bill Heineke Jason Ford

(708) 366-9985 Daiichi Sankyo, Inc.

(708) 308-0572 (cell) (973) 359-2634

billheineke@comcast.net (908) 868 4554 (cell)

jaford@dsus.com

Patty Bifulco

Hill & Knowlton

(212) 885-0494

(917) 626-2780 (cell)

patty.bifulco@hillandknowlton.com


'"/>




Related medicine technology :

1. Benicar HCT Reductions in Seated Systolic Blood Pressure for Stage 2 Patients Compared With Amlodipine + Benazepril
2. Amlodipine and Olmesartan Study Results Released; Late Breaker Presented at American Society of Hypertension Twenty-Second Annual Scientific Meeting (ASH 2007)
3. Data Available From Erbitux Phase III Study in First-Line Treatment of Advanced Lung Cancer
4. Clinical Study Shows Regenecare Relieves Pain and Itching of Skin Rashes Caused by Widely Used Cancer Drugs
5. Cell Therapeutics, Inc. Management to Discuss Todays Announcement of Interim Pixantrone Study Results
6. Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy of BF-200 ALA In Actinic Keratosis
7. Reaction to Avandia Warnings Stronger Among Internists Than Endocrinologists, According to Study by GfK Market Measures
8. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
9. Actemra (tocilizumab) Third Phase III Study Results Show Significant Improvement in Symptoms of Patients with Rheumatoid Arthritis
10. Protox Announces Positive Clinical Data from Prostate Cancer Study
11. International ENDORSE Study Shows That the Majority of Hospitalized Patients Surveyed are at Risk for VTE and Many do not Receive Recommended VTE prophylaxis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/19/2017)... , Jan. 19, 2017 The U.S. Food and ... Chronic Idiopathic Constipation (CIC) in adult patients. ... gastrointestinal disorders," said Julie Beitz , M.D., director of ... for Drug Evaluation and Research. "With the availability of new ... treatment for their condition." ...
(Date:1/19/2017)... YORK , Jan. 19, 2017 This ... the current and future scenario of the global market. ... rising opioid consumption. Severe chronic constipation is a major ... to traditional laxatives. Hence, novel targeted therapy has been ... OIC sufferers, launch of targeted medicines, and growing awareness ...
(Date:1/19/2017)... , January 19, 2017 Incretin Mimetics/GLP-1 Agonists, ... Others The global anti-obesity drugs market is ... half of the forecast period and CAGR of 38.7% in the ... grow at a CAGR of 32.8% from 2016 to 2027. The ... 2021, and $24,063 million in 2027. ...
Breaking Medicine Technology:
(Date:1/20/2017)... ... 2017 , ... Doctor C LLC, a company based out of Arizona that ... continue the marketing and distribution of its product, The Right C. , The Right ... absorption than traditional vitamin C supplements. At the trade show, Doctor C had the ...
(Date:1/20/2017)... ... , ... International Protein, a company based out of Australia that focuses on ... ECRM trade show in Hilton Head, SC. , International Protein was founded by ... line of products that would elevate her fitness regime. At this ECRM trade show, ...
(Date:1/20/2017)... , ... January 20, 2017 , ... “Mary Magdalene: Grace ... mysterious life of the woman who witnessed Jesus Christ firsthand. “Mary Magdalene: Grace is ... who spent her career as an educator interacting with countless women who had little ...
(Date:1/20/2017)... (PRWEB) , ... January 20, 2017 , ... ... vPEP ® Oscillating Positive Expiratory Pressure (OPEP) device, was featured in a study ... Doug Pursley, MEd, RRT-ACCS, FAARC, “Analysis of Three Oscillating Positive Expiratory Pressure ...
(Date:1/20/2017)... (PRWEB) , ... January 20, 2017 , ... “The Land ... brings attention to the issue of world hunger, and shares the simple and achievable ... Brubaker, devoted husband and member of the Fairview Missionary Church in Angola, Indiana where ...
Breaking Medicine News(10 mins):