Document Detail


International open-label studies to assess the efficacy and safety of single-pill amlodipine/atorvastatin in attaining blood pressure and lipid targets recommended by country-specific guidelines: the JEWEL programme.
MedLine Citation:
PMID:  19407658     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Single-pill amlodipine/atorvastatin targets the two most common modifiable cardiovascular risk factors, hypertension and dyslipidaemia. We evaluated the clinical utility of this single pill to help patients across Europe and Canada achieve country-specific targets for blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C). DESIGN: Two 16-week, open-label studies conducted in 122 study centres across the United Kingdom and Canada (JEWEL 1) and 113 centres across 11 European countries (JEWEL 2). METHODS: Patients with uncontrolled BP and controlled/uncontrolled LDL-C qualifying for treatment according to local governing guidelines were administered single-pill amlodipine/atorvastatin with appropriate lifestyle modification. Eight dosages of amlodipine/atorvastatin (5/10-10/80 mg) were titrated to achieve country-specific BP and LDL-C targets. The primary outcome was the percentage of patients reaching country-specific BP and LDL-C targets in 16 weeks. RESULTS: Among 2245 patients enrolled in the studies (JEWEL 1, n = 1138; JEWEL 2, n = 1107), 62.9% in JEWEL 1 and 50.6% in JEWEL 2 achieved both country-specific BP and LDL-C goals. BP was reduced by 20.4/10.7 and 21.8/12.6 mmHg in JEWEL 1 and JEWEL 2, respectively, and reductions in LDL-C were 0.90 mmol/l (34.8 mg/dl) and 1.09 mmol/l (42.2 mg/dl), respectively. The most common adverse events were peripheral oedema (11.0%), joint swelling (2.9%) and headache (2.9%), of which, only oedema was linked to study treatment. CONCLUSION: Single-pill amlodipine/atorvastatin is an effective and well-tolerated treatment, which in a real-world setting helped more than half of the patients achieve both BP and LDL-C targets as recommended by local guidelines. Although fewer patients met their goals in JEWEL 2 than JEWEL 1, reductions in BP and LDL-C were slightly greater in JEWEL 2, suggesting that the observed differences are likely because of more stringent targets in Europe than in the UK/Canada.
Authors:
Frederick D Richard Hobbs; Gianfranco Gensini; Giovanni B John Mancini; Athanasios J Manolis; Beverly Bauer; Jacques Genest; Ross D Feldman; Peter Harvey; Trond G Jenssen; Pedro Marques da Silva;
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  European journal of cardiovascular prevention and rehabilitation : official journal of the European Society of Cardiology, Working Groups on Epidemiology & Prevention and Cardiac Rehabilitation and Exercise Physiology     Volume:  16     ISSN:  1741-8275     ISO Abbreviation:  Eur J Cardiovasc Prev Rehabil     Publication Date:  2009 Aug 
Date Detail:
Created Date:  2009-07-30     Completed Date:  2009-10-29     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101192000     Medline TA:  Eur J Cardiovasc Prev Rehabil     Country:  England    
Other Details:
Languages:  eng     Pagination:  472-80     Citation Subset:  IM    
Affiliation:
University of Birmingham, Edgbaston, Birmingham, UK. f.d.r.hobbs@bham.ac.uk
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00174304;  NCT00330785
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Aged
Aged, 80 and over
Amlodipine / administration & dosage*
Anticholesteremic Agents / administration & dosage*
Antihypertensive Agents / administration & dosage*
Blood Pressure / drug effects
Canada
Cardiovascular Diseases / prevention & control*
Drug Combinations
Dyslipidemias / drug therapy*
Europe
Female
Heptanoic Acids / administration & dosage*
Humans
Hypertension / drug therapy*
Lipid Metabolism / drug effects
Male
Middle Aged
Practice Guidelines as Topic
Pyrroles / administration & dosage*
Tablets
Treatment Outcome
Chemical
Reg. No./Substance:
0/Anticholesteremic Agents; 0/Antihypertensive Agents; 0/Drug Combinations; 0/Heptanoic Acids; 0/Pyrroles; 0/Tablets; 110862-48-1/atorvastatin; 88150-42-9/Amlodipine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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