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: ular_diseases/guidelines/hypertension/en/ [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. ots Originaltext: Spanish Society of Hypertension Im Internet recherchierbar: Contact: MEDIA CONTACTS: Spanish media: Nieves Barousse, E-mail:, Mobile: +(34)-627-28-58-65. International media: Stig Albinus, E-mail:, Mobile: +(1)-646-894-9046

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