Daiichi Sankyo, Inc. announced 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(R) (olmesartan medoxomil)
and BENICAR HCT(R) (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 40/25mg, 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.
Buy viagra pills 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
References
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
Daiichi Sankyo, Inc.
View drug information on Benicar.
Buy generic propecia | generic acomplia online buy | Buy generic levitra