PARSIPPANY, NJ -- 05/14/08 --
-- A cumulative forty-five percent (45%) of patients with stage 1
hypertension treated with a regimen of BENICAR® (olmesartan medoxomil)
and BENICAR HCT® (olmesartan medoxomil/hydrochlorothiazide) achieved
normotension ( < 120/80 mm Hg) (placebo: 1.4%).
-- Eight out of 10 (cumulative 81%) patients with stage 1 hypertension
were able to reach a goal blood pressure (BP) of < 140/90 mm Hg on BENICAR
and BENICAR HCT (placebo: 43.1%).
-- Six out of 10 (cumulative 60.3%) patients with stage 1 hypertension
were able to achieve a BP of < 130/80 mm Hg when treated with BENICAR and
BENICAR HCT (placebo: 6.9%).
Daiichi Sankyo, Inc. announced today that data presented at the American
Society of Hypertension's Twenty-Third Annual Scientific Meeting (ASH 2008)
in New Orleans demonstrates that a cumulative 45 percent of patients with
stage 1 hypertension treated with a regimen of BENICAR® (olmesartan
medoxomil) and BENICAR HCT® (olmesartan medoxomil/hydrochlorothiazide)
were able to safely and effectively achieve a normotensive blood pressure,
< 120/80 mm Hg (placebo: 1.4%). The Joint National Committee on Prevention,
Detection, Evaluation and Treatment of High Blood Pressure (JNC 7) defines
this level as normotension.
The 15-16 week, double-blind, randomized, placebo controlled titration
study conducted with 276 patients with Stage 1 and Stage 2 hypertension
further demonstrated in a sub analysis that eight out of ten (cumulative
81%) patients with stage 1 hypertension were able to reduce their blood
pressure to the < 140/90 mm Hg goal recommended by JNC 7 for patients
(placebo: 43.1%). The study also demonstrated that six out of 10
(cumulative 60.3%) patients with stage 1 hypertension were able to reach a
more aggressive BP target of < 130/80 mm Hg (placebo: 6.9%). In addition,
in another sub analysis, the study demonstrated that nearly seven out of
ten (cumulative 69%) with stage 2 hypertension were able to reach the <
140/90 mm Hg blood pressure goal recommended by the JNC 7 (placebo: 16.9%).
Stage 1 hypertension is defined by the JNC 7 as systolic blood pressure
(SBP) of 140-159 mm Hg or diastolic blood pressure (DBP) of 90-99 mm Hg;
Stage 2 hypertension is defined as 160/100 mm Hg or higher.(1)
"These results are very encouraging as we in the cardiovascular community
have been advocating to more aggressively fight hypertension," said Suzanne
Oparil M.D., Director, Vascular Biology & Hypertension Program, University
of Alabama at Birmingham, lead investigator of the study and President of
ASH. "The study showed the ability of a regimen of BENICAR and BENICAR HCT
to lower blood pressure beyond 140/90 mm Hg to the more aggressive
normotensive target."
In the overall study, both stage 1 and stage 2 patients receiving BENICAR
HCT 40/25 mg saw their seated systolic blood pressure (SeSBP) drop a mean
of 23 mm Hg from a mean SBP baseline of 158 mm Hg (placebo: -2.6 mm Hg).
In addition, more than one in four patients (27 percent) reached
normotension, defined as < 120/80 mm Hg (placebo: 1.5%).
Of this study patient population, those with stage 2 hypertension achieved
very good results with this regimen of BENICAR and BENICAR HCT. Of those
titrated up to the maximum dose of 40/25 mg, a cumulative 69 percent
achieved a BP of < 140/90 mm Hg (placebo: 17%) while a cumulative 15
percent achieved a BP of < 120/80 mm Hg (placebo: 1.5%). For those with
stage 2 hypertension, the average BP reduction for those patients on
BENICAR 40/25 mg was 25/14 mm Hg (placebo: 6.2/1.9 mm Hg).
Hypertension, also known as high blood pressure, affects approximately 73
million people in the United States and approximately one billion
worldwide. (2)(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 study was a double-blind, randomized,
placebo-controlled, parallel-group, multi-center titrate-to-goal study.
The primary endpoint was change from baseline in mean SBP at study end. The
secondary endpoints included change from baseline in mean DBP, and the
percent of patients achieving BP goals of < 140/90, < 130/85, < 130/80 and
< 120/80 mm Hg at each titration period and study end and a subgroup
analysis by baseline stage of hypertension (Stage 1 and Stage 2). Overall
mean baseline BP was 157/94 and 155/94 mm Hg for the active treatment and
placebo group, respectively.
The patient population of 465 initially entered a 3-4 week single-blind
placebo run-in period. Patients who met inclusion criteria (n=276) were
then randomized to receive olmesartan (OM) or placebo according to a
titration scheme consisting of a 12-week double-blind study period.
Patients randomized to olmesartan initially received 20 mg/day. If BP
remained greater than or equal to 120/80 mm Hg, patients were uptitrated
until BP was normalized. The titration schedule was as follows:
OM 40 mg/day (week 4-6), OM/HCTZ 40/12.5 mg/day (week 7-9), and OM/HCTZ
40/25 mg/day (week 10-12). Once BP was controlled to the target level,
patients stayed on the medication dosage that achieved this goal. If at any
point, patients BP exceeded 120/80, the titration schedule was resumed.
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 (e.g., 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.
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)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.
(2) http://www.americanheart.org/presenter.jhtml?identifier=4621 Site
accessed 4/18/2008
(3) Kearney, P. et al. “Global Burden of Hypertension: Analysis of
Worldwide Data.” Lancet 2005: 365: 217-23
(4) http://www.americanheart.org/presenter.jhtml?identifier=2114 Site
accessed 4/18/2008
(5) http://www.americanheart.org/presenter.jhtml?identifier=4621 Site
accessed 4/18/2008
For more information, please contact:
Kimberly Wix
Daiichi Sankyo, Inc.
Office: 973 695 8338
Cell: 908 656 5447
kwix@dsus.com
Rich Salem
Daiichi Sankyo, Inc.
Office: 973 695 8330
Cell: 973 563 1086
rsalem@dsus.com
