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Spanish Society of Hypertension

JEWEL Programme Results Show That a New Therapy, Caduet(R), can Optimise Treatment for Patients With Hypertension and Additional Cardiovascular (CV) Risk Factors

Madrid, Spain (ots/PRNewswire)

- Caduet, Single-Pill Amlodipine and Atorvastatin Combination,
Helps Patients Reduce Calculated Risk for a Fatal CV Event by 29 to
52  Percent
Results from the JEWEL programme show that single-pill
amlodipine/atorvastatin therapy, also known as Caduet, is an
effective treatment that simultaneously reduces two modifiable risk
factors, hypertension and cholesterol levels, which both contribute
to the overall likelihood of suffering a CV event, including heart
attack and stroke. In this 16 week programme, patients' calculated
risk of having a fatal CV event, as determined by the European
Society for Cardiology (ESC) SCORE Card[1], was reduced, compared to
baseline, by a range of 29 to 52 percent across participating
countries. The data also demonstrated that treatment targets - as
defined by European, Canadian and British guidelines[2] recommending
the routine use of statin therapy in hypertensive patients with
additional risk factors to reduce their total CV risk - can be
achieved effectively with Caduet single-pill therapy.
The results were presented during an oral plenary session today at
the annual meeting of the European Society of Hypertension (ESH) in
Madrid, Spain.
The JEWEL programme, (JEWEL I and JEWEL II) funded by Pfizer, was
comprised of two studies that were conducted in the UK and Canada
(JEWEL I) and 11 European countries (JEWEL II). The programme which
enrolled a total of 2,245 patients was designed to assess the
effectiveness and safety of single-pill amlodipine/atorvastatin
therapy for hypertensive patients with additional CV risk factors in
routine clinical practice.
"The Spanish Society of Hypertension recognises the importance of
the JEWEL programme as it is the first study in Europe evaluating the
effectiveness of this new fixed combination. The results may help
physicians optimise and simplify the management of total CV risk in
their patients," said Professor Luis Ruilope, President of the
Spanish Society of Hypertension, Chairman of the organising committee
for the ESH annual meeting and JEWEL Investigator. "The data showed
that by taking Caduet, patients can achieve and maintain blood
pressure (BP) and lipid goals. More importantly, the reduction in
calculated risk of suffering a fatal event as defined by the ESC
Score Card is significant (p<0.001, across the programme) and is
further evidence of the clinical utility of this regimen. This new
regimen provides an opportunity to potentially halve the calculated
risk of a fatal CV event in hypertensive patients with additional CV
risk factors."
The JEWEL programme shows that providing patients with two
effective treatments for the management of hypertension and
additional CV risk factors in a single pill continues to provide the
efficacy and safety of both amlodipine (Norvasc(R)), and atorvastatin
(Lipitor(R)), as the majority of patients (62.9 percent in JEWEL I
and 50.6 percent in JEWEL II) reached their country-specific targets
- for both blood pressure and cholesterol, a meaningful result given
that most hypertensive and dyslipidaemic patients are uncontrolled;
[3] only 9 percent of patients with both risk factors are
controlled[4]. The differences observed between the two studies may
be due to the differences in targets as defined by the
country-specific guidelines.
"We need to move away from treating risk factors for
cardiovascular disease individually and adopt a more holistic
approach, particularly in patients with hypertension who are likely
to have other risk factors, for example approximately 50 percent of
patients with hypertension also have dyslipidaemia,[5-7]" added
Professor Richard Hobbs, University of Birmingham, UK, who chaired
the steering committee for JEWEL I. "Many patients are sub-optimally
treated as a result of not maintaining treatment targets over long
periods of time."
Athanasios Manolis, from Tzanio Hospital, University of Piraeus,
Athens, Greece, co-chair of the steering committee for JEWEL II
concluded, "As physicians, we recognise the need to offer our
patients more effective and simpler ways to manage cardiovascular
risk factors. The results of the JEWEL programme provide a compelling
rationale for treating hypertensive patients with additional risk
factors with the single-pill combination Caduet. This is a
significant advance in the evolution of patient management."
About the JEWEL Programme
The JEWEL programme consisted of two 16-week, international,
open-label, multicentre, titration-to-goal studies in patients with
hypertension and dyslipidaemia. A total of 2,245 patients (JEWEL
I=1,138; JEWEL II=1,107) were enrolled in the programmes and received
treatment with single-pill amlodipine/atorvastatin. The primary
efficacy endpoint was the percentage of patients achieving both
country-specific BP and LDL-C targets.
Already after 16 weeks 62.9 percent of the subjects in JEWEL I and
50.6 percent of the patients in JEWEL II achieved both
country-specific BP and LDL-C goals. When the populations were
assessed using a common set of BP and LDL-C goals, a very similar
proportion of patients in JEWEL I (55.0 percent) versus JEWEL II
(56.0 percent) achieved both targets.
The treatment was well-tolerated across both studies; 166 patients
(7.4 percent) discontinued due to adverse events (AEs). The most
common AEs were peripheral oedema (11.0 percent), joint swelling (2.9
percent) and headache (2.9 percent). These adverse events are not
greater in frequency and intensity to those seen in the Norvasc and
Lipitor product information.
[1] Conroy, RM el al. Estimation of ten-year risk of fatal
cardiovascular disease in Europe: The SCORE project. European Heart
Journal (2003) 24, 987-1003
[2] Treatment guidelines from the European Society of Hypertension
(ESH) and the European Society of Cardiology (ESC): The
Canadian Hypertension Expert Panel (CHEP): and
[3] WHO/ISH Hypertension Guidelines:
[4] Wong ND, Lopez V, Franklin S, Tang S, Williams GR..
Prevalence, treatment status, and control of concomitant hypertension
and dyslipidemia in US adults in 2001-2002. Circulation. 2005;112
(17)(suppl 2):831 (abstract no. 3840).
[5] Thomas F, Bean K, Guize L, et al. Eur Heart J 2002;23:528-35.
[6] Tunstall-Pedoe H, Chen R, and Kramarz P. Pharmacoepidemiol
Drug Saf 2004;13 (Suppl 1):S307-8.
[7] Williams B, Wilson K, Lacey L, et al. Eur Heart J
2004;25(abstract suppl):528-9.


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