Healthcare Industry News:  Alzheimer's 

Biopharmaceuticals Cardiology

 News Release - May 21, 2007

BENICAR HCT(R) Reductions in Seated Systolic Blood Pressure for Stage 2 Patients Compared With Amlodipine + Benazepril

Comparison of BENICAR HCT 40/12.5 and 40/25 mg/day and Amlodipine + Benazepril 5/20 and 10/20 mg/day Presented at American Society of Hypertension Twenty-Second Annual Scientific Meeting

PARSIPPANY, N.J., May 21 (HSMN NewsFeed) -- New data presented today at the American Society of Hypertension's Twenty-Second Annual Scientific Meeting (ASH 2007) in Chicago demonstrated that the fixed-dose combination BENICAR HCT (olmesartan medoxomil/hydrochlorothiazide) was associated with a greater mean reduction in seated systolic blood pressure (SeSBP) at 12 weeks (primary endpoint) in patients with Stage 2 hypertension, compared with amlodipine + benazepril study doses(1). Systolic blood pressure is considered a better predictor of major cardiovascular adverse events than is diastolic blood pressure, particularly in older individuals. Blood pressure reductions with BENICAR HCT and amlodipine + benazepril were examined.

After 12 weeks of treatment, patients receiving BENICAR HCT 40 mg/12.5-25 mg saw their SeSBP drop a mean of 33* points from baseline (167/102 mm Hg vs. 133/84 mm Hg), compared with a mean of 27* points from baseline (167/101 mm Hg vs. 140/86 mm Hg) for patients receiving amlodipine + benazepril 5/20 mg and 10/20 mg, according to the study.

The purpose of this study was to compare the blood pressure (BP) lowering effect of fixed dose combinations of BENICAR HCT 40/12.5 mg and 40/25 mg and amlodipine + benazepril 5/20 mg and 10/20 mg. No comparisons were made with amlodipine + benazepril 10/40 mg, the current maximum dose of this combination, because it was not available at the time this study was designed and initiated.

"The efficacy data results show a benefit for patients receiving either therapy, while those receiving BENICAR HCT showed a greater reduction," said Henry Punzi, MD, of the Punzi Medical Center and Hypertension Research Institute, Carrollton, TX, one of the study investigators.

When these data were examined to determine the blood pressure goal endpoint, more patients treated with the BENICAR HCT study doses reached blood pressure goals recommended by JNC 7 (<140/90 mm Hg and <130/80 mm Hg) than those treated with the amlodipine + benazepril study doses(2). In patients receiving BENICAR HCT combination therapy (40/12.5-40/25 mg), 66 percent achieved a BP goal of <140/90 mm Hg and 33 percent achieved a BP goal of <130/80 mm Hg. In patients receiving amlodipine 5-10 mg + benazepril 20 mg, 45 percent achieved a BP goal of <140/90 mm Hg and 14 percent achieved a BP goal of <130/80 mm Hg.

In specifically examining the highest dose studied in both treatment arms, Dr. Punzi reported that 61 percent of the patients receiving BENICAR HCT 40/25 mg at week 12 reached a goal of BP<140/90 mm Hg, nearly 42 percent reached BP<130/85 mm Hg, and 30 percent reached BP<130/80 mm Hg, compared to 39 percent, 19 percent and 13 percent, respectively, of patients who were treated with amlodipine 10 mg + benazepril 20 mg.

Hypertension, also known as high blood pressure, affects approximately 72 million people in the United States and approximately one billion worldwide(3). Called the "silent killer" because it often has no specific symptoms, hypertension increases the risk of cardiovascular and related diseases such as stroke, heart attack, heart failure and kidney disease(4). Of those diagnosed with high blood pressure, 64.9 percent did not have the condition under control(5).

Study Design

The purpose of this study was to compare the blood pressure lowering effect of fixed dose combinations of BENICAR HCT with combinations of amlodipine + benazepril. Patients who failed to achieve the desired goal (<120/80 mm Hg) at any visit underwent dosage titration and were switched to combination therapy and titrated to the maximum available dose at the time of the study.

Patients were randomized to either 2 weeks of double-blind titration with olmesartan medoxomil 20 mg and then uptitrated to olmesartan medoxomil 40 mg for 2 weeks or 2 weeks of benazepril 10 mg uptitrated to 20 mg for 2 weeks. If BP remained greater than or equal to 120/80 mm Hg, then patients were uptitrated to the next treatment period; two 4-week periods with the combination of olmesartan 40 mg/HCTZ 12.5 and 25 mg or amlodipine + benazepril 5/20 mg to 10/20 mg. Patients exited the study at any visit if blood pressure <120/80 mm Hg was achieved.

About BENICAR and BENICAR HCT

Angiotensin II is a hormone that interacts with a receptor on arterial blood vessels, which results in constriction and increasing blood pressure. In addition, angiotensin II stimulates the release of another hormone that causes enhanced sodium and chloride (salt) retention, with a resultant increase in vascular water retention and blood volume that also contributes to an elevation in blood pressure. BENICAR is a member of the ARB class of antihypertensive medications that help lower blood pressure by blocking the angiotensin II receptor on the blood vessels and antagonizing the release of the hormone which causes salt retention and increased blood volume. BENICAR HCT combines BENICAR with the diuretic hydrochlorothiazide.

BENICAR and BENICAR HCT are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. BENICAR HCT is not indicated for initial therapy.

Important Safety Information

USE IN PREGNANCY

When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, BENICAR or BENICAR HCT should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity and Mortality in the prescribing information.

Hypotension in Volume -- or Salt-Depleted Patients

In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients (eg, those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with BENICAR. Treatment should start under close medical supervision. If hypotension does occur, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.

Impaired Renal Function

In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen (BUN) have been reported. There has been no long-term use of olmesartan medoxomil in patients with unilateral or bilateral renal artery stenosis, but similar results may be expected.

The prescribing information for BENICAR HCT also includes the following warnings regarding its hydrochlorothiazide component:

BENICAR HCT is not recommended in patients with severe renal impairment and is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.

Fetal/Neonatal Morbidity and Mortality

Thiazides cross the placental barrier and appear in cord blood. There is a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.

Hepatic Impairment

Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.

Hypersensitivity Reaction

Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history.

Systemic Lupus Erythematosus

Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.

Lithium Interaction
Lithium generally should not be given with thiazides.

Adverse Events

In clinical trials, the withdrawal rates due to adverse events (AEs) were similar with BENICAR and BENICAR HCT to placebo: BENICAR (2.4 percent vs 2.7 percent); BENICAR HCT (2.0 percent vs 2.0 percent). The incidence of AEs with BENICAR and BENICAR HCT were similar to placebo. The only AE that occurred in >1 percent of patients treated with BENICAR and more frequently than placebo was dizziness (3 percent vs 1 percent). AEs reported in >2 percent of patients taking BENICAR HCT and more frequently than placebo included nausea (3 percent vs 0 percent), hyperuricemia (4 percent vs 2 percent), dizziness (9 percent vs 2 percent), and upper respiratory tract infection (7 percent vs 0 percent).

No initial dosage adjustments are recommended with BENICAR in elderly, in moderate to marked renal impairment (creatinine clearance <40 mL/min), or in hepatic dysfunction. In patients with possible depletion of intravascular volume (e.g., patients on diuretics, particularly with impaired renal function), BENICAR should be initiated under close medical supervision and consideration given to use of a lower starting dose. For BENICAR HCT, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosage range.

Please see full prescribing information for BENICAR and BENICAR HCT.

Both products are co-promoted in the United States by Daiichi Sankyo, Inc. and Forest Laboratories, Inc.

About Daiichi Sankyo

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.

About Forest Laboratories and Its Products

Forest Laboratories' growing line of products includes: Lexapro® (escitalopram oxalate), an SSRI antidepressant indicated for the initial and maintenance treatment of major depressive disorder and for generalized anxiety disorder in adults; Namenda® (memantine HCI), an N-methyl-D-aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate to severe Alzheimer's disease; Benicar®** (olmesartan medoxomil), an angiotensin receptor blocker indicated for the treatment of hypertension; Benicar* HCT® (olmesartan medoxomil hydrochlorothiazide), an angiotensin receptor blocker and diuretic combination product is not indicated for initial therapy; Campral®** (acamprosate calcium), a glutamate receptor modulator, indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation in combination with psychosocial support; and Combunox(TM) (Oxycodone HCI and Ibuprofen), an opioid and NSAID combination indicated for the short-term management of acute, moderate to severe pain.

Except for historical information contained herein, this release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are subject to risks and uncertainties that affect our business, including risk factors listed from time to time in the Company's SEC reports, including the Company's Annual Report on Form 10-K for the fiscal year ended March 31, 2003, and Quarterly Reports on Form 10-Q for the periods ending June 30, 2003, September 30, 2003, and December 31, 2003. Actual results may differ materially from those projected.

Please see package insert for full prescribing information

Trademarks not owned by Daiichi Sankyo, Inc., are the property of their respective owners.

* Blood pressure reduction reported as least square means, last observation carried forward (LOCF)

** Benicar is a registered trademark of Sankyo Pharma, Inc., and Campral is a registered trademark of Merck Sante s.a.s, subsidiary of Merck KGaA, Darmstadt, Germany.

1. Stage 2 hypertension = systolic blood pressure greater than or equal to 160 mm Hg or a diastolic blood pressure greater than or equal to 100 mm Hg, as defined by The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC 7)

2. JNC 7 = The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC 7), which issued new guidelines in 2003 for hypertension prevention and management.

3. http://www.americanheart.org/presenter.jhtml?identifier=4621 Site accessed 5/11/2007

4. http://www.americanheart.org/presenter.jhtml?identifier=2114 Site accessed 5/17/2007

5. http://www.americanheart.org/presenter.jhtml?identifier=4621 Site accessed 5/11/2007


Source: Daiichi Sankyo

Issuer of this News Release is solely responsible for its content.
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