New Research Shows That Single Pill amlodipine besylate/atorvastatin calcium May Reduce 10-Year Risk for a Heart Attack or Stroke by More Than 50 Percent

Fukuoka, Japan (ots/PRNewswire) -

- Therapy May Benefit Hypertensive Patients With Additional Risk
Factors in Populations Across Asia and Latin America

Single-pill amlodipine besylate/atorvastatin calcium (Caduet(R))
may reduce the 10-year risk of having a cardiovascular (CV) event -
as determined by the Framingham 10-year Coronary Heart Disease (CHD)
Risk Score - by 54 percent in hypertensive patients with elevated
LDL-cholesterol (LDL-C, or "bad" cholesterol), according to new data
from the international GEMINI AALA trial. Further, patients across
participating countries who took Caduet achieved hypertension and
lipid treatment targets as recommended by JNC 7(i) and NCEP ATP
III(ii) guidelines. The results of the study were presented today at
the annual Scientific Meeting of the International Society of
Hypertension (ISH).

"This is the first large-scale clinical trial to evaluate the
real-world clinical effectiveness of amlodipine besylate/atorvastatin
calcium therapy in patients across both Asia and Latin America," said
Dr. Hung Fat Tse, GEMINI AALA Investigator, University of Hong Kong.
"The results show that by taking this new fixed combination treatment
with or without an existing antihypertensive regimen, these patients
may achieve and maintain blood pressure and lipid goals and, more
importantly, reduce their estimated 10-year risk of coronary heart
disease."

Cardiovascular disease (CVD) represents a growing burden in
populations across Asia(1-4). The Asia-Pacific region accounts for
nearly half of the global burden of CVD,(5) and in China and
Malaysia, the disease has become the leading cause of death(6). In
Latin America and the Caribbean, CVD accounted for more than 30
percent of all deaths in 2001, and this figure is expected to rise
to 38 percent by 2020(7).

"Hypertension and high cholesterol are modifiable risk factors
that, together, contribute to the overall likelihood of suffering a
CV event, including heart attack and stroke. As physicians, we must
recognize the need to move away from treating cardiovascular risk
factors in isolation and find more effective ways of treating total
CV risk," added Dr. Hilton Chaves, another GEMINI AALA Investigator,
Federal University of Pernambuco, Brazil. "The results of GEMINI AALA
provide a compelling rationale for treating patients with
hypertension and additional risk factors with amlodipine
besylate/atorvastatin calcium therapy. This may be an important
advance in the evolution of patient management."

About the study

The GEMINI AALA trial, funded by Pfizer, was a 14-week,
open-label, multicentre, titration-to-goal study involving 1,649
patients in 27 countries across the Middle East, Asia, Australia,
Africa, and Latin America. The study was designed to assess the
real-world clinical effectiveness and safety of single-pill
amlodipine besylate/atorvastatin calcium in hypertensive patients
from diverse ethnic backgrounds with additional high cholesterol
(dyslipidaemia). The primary efficacy endpoint was the percentage of
patients reaching both blood pressure (BP) and LDL-C targets as
defined by JNC 7 and NCEP ATP III guidelines. After 14 weeks of
treatment, 55.2 percent of patients reached both their blood pressure
(BP) and their LDL-C goals - significant because generally only 9
percent of patients with hypertension and high cholesterol are
controlled for both(8). Patients' mean BP was reduced by 20.2/11.4
mmHg (approximately 13 percent), and their mean LDL-C was reduced by
1.1 mmol/L (44.2 mg/dL) [29 percent]. Further, treatment was safe
and well-tolerated.

A post-hoc analysis also was conducted among a subgroup of
patients in Eastern Asian countries (excluding India and Pakistan).
Primary and secondary efficacy measures were compared between this
subgroup and a "non-Asian" subgroup of patients from all other
countries. In the Asian subgroup (n=694), 56 percent of patients
reached both their BP and their LDL-C therapeutic goals, and the mean
Framingham 10-year CHD risk score was reduced by 56 percent.

Treatment was well-tolerated in the study, with a total of 60
patients (3.6 percent) discontinuing due to adverse events (AEs). The
most common AEs were peripheral oedema (9.8 percent), respiratory
infection (5 percent), headache (3.3 percent), dizziness (3.1
percent), palpitations (1.5 percent) and myalgia (1.5 percent). These
events are consistent with those described in the amlodipine besylate
(Norvasc(R)) and atorvastatin calcium (Lipitor(R)) product
information.

References:

(i) Joint National Committee on Prevention, Detection, Evaluation,
and Treatment of High Blood Pressure

(ii) National Cholesterol Education Program (NCEP) Adult Treatment
Panel III (ATP III)

1 WHO. Integrated management of cardiovascular risk. Report of a
WHO meeting. Geneva: World Health Organization; 9-12 July 2002. From
Tse HF et al. Multiple-risk intervention with single-pill
amlodipine/atorvastatin therapy helps patients with diverse ethnicity
attain recommended therapeutic goals for blood pressure and lipids
(the GEMINI-AALA study). Core poster for ISH. Poster no. P3-79.

2 Thom T et al. Heart Disease and Stroke Statistics: 2006 Update.
A Report from the American Heart Association Statistics Committee and
Stroke Statistics Subcommittee. Circulation 2006.

3 Gaziano TA et al. Cardiovascular Disease: Disease Control
Priorities in Developing Countries. Second ed. New York: Oxford
University Press; 2006:645-662.

4 Murray CJL et al. Global Health Statistics: A Compendium of
Incidence, Prevalence and Mortality for Over 200 Conditions. Global
Burden of Disease: Harvard University Press; 1996.

5 Zhang X et al. Cholesterol, coronary heart disease, and stroke
in the Asia Pacific region. Asia Pacific Cohort Studies
Collaboration. International J of Epidemiology 2003;32:563-572.

6 Reynolds K et al. Geographic variations in the prevalence,
awareness, treatment and control of hypertension in China. J of
Hypertension 2003; 21:1273-1281.

7 Murray, C. J., and A. D. Lopez. 1994. Global Comparative
Assessments in the Health Sector: Disease Burden, Expenditures, and
Intervention Packages. Geneva: World Health Organization.

8 Wong ND, Lopez V, Franklin S, Tang S, Williams GR. Prevalence,
Treatment, and Control of Combined Hypertension and
Hypercholesterolemia in the United States. The American Journal of
Cardiology 2006;98 (2):204-208.

For more information, please contact Sameena Mirza,
+1-212-614-4016

ots Originaltext: GEMINI AALA Investigators
Im Internet recherchierbar: http://www.presseportal.de

Contact:
For more information, please contact Sameena Mirza, +1-212-614-4016