Azor(TM) Reduces Blood Pressure In Difficult To Treat Special Populations
Sunday, July 6th, 2008
Daiichi Sankyo, Inc.,
announced that data presented at the American Society of
Hypertension’s Twenty- Third Annual Scientific Meeting (ASH 2008) in New
Orleans demonstrated that the powerful combination drug AZOR(TM)
(amlodipine and olmesartan medoxomil) safely and effectively helped
patients across several major subpopulations lower their blood pressure
(BP). An analysis of patient subgroups from the pivotal registrational
trial demonstrated the efficacy of AZOR in several key difficult to treat
patient groups including people of African and Hispanic/Latino decent,
people with high body mass index (BMI) and those with diabetes.
The subgroup analyses were based on data from a pivotal, randomized,
double-blind, placebo-controlled factorial design study conducted in 1,940
pts with mild to severe hypertension (SeDBP) 95-120 mm Hg) to determine
if amlodipine (AML) 5-10mg/day plus olmesartan (OM) 10-40 mg/day for eight
weeks is more efficacious in reducing BP versus monotherapy components. The
groups were chosen because each population generally have either poor
control rates (Blacks and Hispanic/Latinos),(1)(2) are difficult to control
(people with high BMI)(3) or require lower blood pressure to achieve
control (those with diabetes).(4)
"As we know, hypertension affects many people from all walks of life,"
said Suzanne Oparil, M.D., Director, Vascular Biology & Hypertension
Program, University of Alabama at Birmingham, an investigator in the study
and President of ASH. "No two patients are alike, nor do any two people
present in the exact same way. This study has demonstrated that AZOR is an
important tool for physicians to consider when treating hypertensive
patients of different ethnicities and health characteristics, as well as
the more difficult to treat populations, such as people with diabetes."
Hypertension, also known as high blood pressure, affects approximately
72 million people in the United States and approximately one billion
worldwide.(5)(6) 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.(7) Of those diagnosed with high blood pressure, 64.9 percent do
not have the condition under control.(8)
ABOUT THE ANALYSES
RACE/ETHNICITY:
Blood pressure control in patients with hypertension remains
unsatisfactorily low in the US, particularly in Black and Hispanic/Latino
populations, with fewer than 30% of patients in these minority groups
treated to goal BP.(9)(10) Guidelines acknowledge that combination therapy
will be required for the majority of patients to attain BP goals, and
recommend that combination therapy utilizing agents from complimentary drug
classes should be considered when BP is difficult to control or there is
high cardiovascular risk, such as in minority patient
populations.(11)(12)(13)
Of the 1,940 patients who entered the eight week pivotal study, 1,459
were non-Black and 481 were Black. Further, ethnicity was asked separately
from race: 245 patients were Hispanic/Latino. All subgroups were matched
for baseline BP of 164/102 mm Hg. AZOR 10/40 mg demonstrated a 29/16 mm Hg
mean reduction in the Black cohort vs. 31/20 mm Hg in non-blacks. Further,
in the Hispanic/Latino study patient population, AZOR 10/40 mg demonstrated
a mean reduction of 29/21 mm Hg compared to 30/19 mm Hg in
non-Hispanic/non-Latino.
BMI:
A higher body mass index (BMI) often makes it more difficult for
patients with hypertension to achieve target BP.(14) The analysis of data
from the pivotal study demonstrated the ability of AZOR to produce
substantial reductions in BP compared to the monotherapy components,
regardless of BMI levels. For those patients with BMI greater than or equal
to 30 kg/m(2), AZOR 10/40 mg demonstrated mean reductions of 30/18 mm Hg
from an average baseline BP of 163/102 in the total cohort. Patients with
BMI of less than 30 kg/m(2) saw BP reductions of 31/21 mm Hg when treated
with Buy generic amoxil AZOR 10/40 mg from an average baseline BP of 165/101 in total cohort.
DIABETES:
Patients with hypertension and diabetes are at greater risk of
cardiovascular and renal disease and consequently have a more stringent
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