The first presentation, titled BENICAR Efficacy in Systolic Hypertension Trial (BEST), demonstrated that a BENICAR based treatment algorithm significantly reduced mean systolic blood pressure in a stage 2 systolic hypertensive population. Results demonstrated that BENICAR HCT (BENICAR 40 mg/25mg HCTZ once daily) decreased the systolic blood pressure level by approximately 35 mm Hg on average, resulting in 70% of patients who had a mean baseline blood pressure of 171/95 mm Hg reaching the blood pressure goal of less than 140/90 mm Hg.
The second presentation, titled Treatment of Stage 1 and Stage 2 Hypertension Utilizing An Olmesartan Medoxomil-Based Treatment Algorithm was a secondary analysis of data based on an earlier study evaluating BENICAR. This analysis demonstrated that a BENICAR based treatment algorithm was effective in helping Stage 1 and Stage 2 patients reach their blood pressure goal. In Stage 1 patients, 89% of the eligible patient cohort taking BENICAR or BENICAR HCT reached the more aggressive blood pressure goal of less than or equal to 130/85 mm Hg. Of the total Stage 1 patients, 56% reached goal on BENICAR monotherapy alone. Of the total Stage 2 patients, more than half (54%) reached goal on BENICAR or BENICAR HCT.
"I believe that blood pressure reduction to goal or better should be the primary health concern for all patients, and that we as physicians need to be aware of the importance of achieving these goals outlined in JNC 7***," said Joseph Izzo Jr., M.D., Professor of Medicine and Pharmacology at State University of New York at Buffalo and member of the JNC 7 Executive Committee. "The results from these BENICAR studies demonstrate we have the tools to get patients to goal."
In 2003, the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure issued its seventh report (JNC 7) highlighting guidelines for hypertension prevention and management. The new guidelines stress the importance of getting the majority of patients to achieve the goal blood pressure of less than 140/90 mm Hg. For those Stage 2 patients that are difficult to treat, such as patients who have diabetes or chronic kidney disease, the blood pressure goal is more aggressive. Their goal should be less than 130/80 mm Hg. These goals are important because the risk of cardiovascular disease (CVD) doubles with each increment of 20/10 mm Hg beginning at 115/75 mm Hg.
Hypertension, also known as high blood pressure, affects approximately 65 million people in the United States and approximately one billion worldwide. 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.
BEST; Efficacy of Olmesartan Medoxomil and Olmesartan Medoxomil/Hydrochlorothiazide in Achieving Blood Pressure Control and Normalization in Stage 2 Systolic Hypertension
BEST was designed to investigate the systolic blood pressure lowering efficacy of a step-wise treatment regimen with BENICAR and BENICAR HCT, in patients with Stage 2 systolic hypertension. The primary endpoint of the study was mean change in baseline in systolic blood pressure after 12 weeks of treatment, with secondary endpoints including blood pressure changes from baseline at the end of each titration period and the proportion of patients achieving both blood pressure goal rates of less than 140/90 mm Hg and blood pressure normalization of less than 120/80 mm Hg.
The study was designed as a 16-week, prospective, open-label, multicenter, titration trial conducted in the United States. The study sample consisted of 176 patients with a mean age of 60 years and a mean blood pressure of 171/95 mm Hg. Following a 3-4 week placebo run-in period, the patients began treatment with BENICAR (20mg) once daily in the morning. Up-titration to olmesartan medoxomil 40 mg/day, olmesartan medoxomil/HCTZ 40/12.5 mg/day, and olmesartan medoxomil/HCTZ 40/25 mg/day occurred at 3-week intervals if blood pressure remained greater than or equal to 120/80 mm Hg.
Treatment of Stage 1 and Stage 2 Hypertension Utilizing An Olmesartan Medoxomil-Based Treatment Algorithm
The second study was a 24-week, multi-center, open label trial utilizing a BENICAR-based treatment algorithm to determine its efficacy in getting Stage 1 and Stage 2 patients to JNC 7 goals. The study sample consisted of 79 patients with Stage 1 hypertension and 100 patients with Stage 2; all were at least 18 years of age. The patients all had a seated diastolic blood pressure of 90-109 mm Hg and a seated systolic blood pressure of less than 200 mm Hg.
Patients followed a placebo run-in phase of up to 4 weeks and then started therapy with BENICAR (20 mg) once daily. If the blood pressure goal of less than or equal to 130/85 mm Hg was not reached, a step-wise therapy regimen was put into effect at 4-week intervals according to the algorithm, increasing BENICAR monotherapy from 20 to 40 mg and then adding the combination therapy such as BENICAR HCT 40/12.5 to 40/25 mg. If the patient did not achieve blood pressure goal following titration of BENICAR, amlodipine besylate 5-10 mg/d was added to the regimen.
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. 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.
No initial dosage adjustments are necessary 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. With BENICAR HCT, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.
In clinical trials, the withdrawal rates due to adverse events (AEs) were similar with BENICAR and BENICAR HCT to placebo: BENICAR (2.4% vs 2.7%); BENICAR HCT (2.0% vs 2.0%). The incidence of AEs with BENICAR and BENICAR HCT were similar to placebo. The only AE that occurred in >1% of patients treated with BENICAR and more frequently than placebo was dizziness (3% vs 1%). AEs reported in >2% of patients taking BENICAR HCT and more frequently than placebo included nausea (3%), hyperuricemia (4%), dizziness (9%), and upper respiratory tract infection (7%).
Please see prescribing information for BENICAR and BENICAR HCT.
Both products are co-promoted in the United States by Sankyo Pharma Inc. and Forest Laboratories, Inc.
About Sankyo Pharma
Sankyo Co., Ltd. of Tokyo, one of Japan's largest pharmaceutical companies, has a long history of discovering new classes of drugs, including the statin class of lipid-lowering drugs. Beginning with its discovery of the first statin, mevastatin, and the co-discovery of lovastatin, the first statin to be marketed, Sankyo has been a pioneer in the cardiovascular disease arena. Additionally, Sankyo discovered, developed, manufactures and markets pravastatin sodium and olmesartan medoximil, an angiotensin II receptor blocker (ARB). Sankyo also developed and launched the first glitazone, which revolutionized long-term control of type 2 diabetes, and has a number of other potentially promising compounds in the diabetes arena. Sankyo's early stage pipeline focuses on oral therapies to satisfy key unmet needs in six major fields -- cardiovascular disease, metabolic disease, respiratory and immune disease, bone and joint disease, infectious disease, and oncology. For further information about Sankyo and its products, log on to http://www.sankyo.co.jp/english/ .
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 HCl), 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 HCl 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
* mm Hg = millimeters of mercury – units of blood pressure measurement
** Stage 1 hypertension = systolic blood pressure levels between 140-159 mm Hg or diastolic blood pressure levels between 90-99 mm Hg; 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)
*** 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.
References:
Izzo, J., et al. "Efficacy of Olmesartan Medoxomil and Olmesartan Medoxomil/Hydrochlorothiazide in Achieving Blood Pressure Control and Normalization in Stage 2 Systolic Hypertension." Abstract presented at the 2005 American Society of Hypertension Meeting.
Neutel JM, et. al. "Use of an Olmesartan Medoxomil-Based Treatment Algorithm for Hypertension Control." Journal of Clinical Hypertension. 2004;6(4):168-174.
http://www.americanheart.org/presenter.jhtml?identifier=3008517. Site accessed on May 26, 2005.