Reductions in blood pressure and lipid parameters are generally lower than those previously projected , though substantial heterogeneity of results exists .
Fixed-dose combination therapy is associated with modest increases in adverse events compared with placebo , single drug active component , or usual care but may be associated with improved adherence to a multidrug regimen .
BACKGROUND Cardiovascular disease ( CVD ) is the leading cause of death and disability worldwide , yet CVD risk factor control and secondary prevention rates remain low .
A fixed-dose combination of blood pressure and cholesterol lowering and antiplatelet treatments into a single pill , or polypill , has been proposed as one strategy to reduce the global burden of CVD by up to 80 % given its potential for better adherence and lower costs .
OBJECTIVES To determine the effectiveness of fixed-dose combination therapy on reducing fatal and non-fatal CVD events and on improving blood pressure and lipid CVD risk factors for both primary and secondary prevention of CVD .
We also aim ed to determine discontinuation rates , adverse events , health-related quality of life , and costs of fixed-dose combination therapy .
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
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
Reductions in blood pressure and lipid parameters are generally lower than those previously projected , though substantial heterogeneity of results exists .
Fixed-dose combination therapy is associated with modest increases in adverse events compared with placebo , single drug active component , or usual care but may be associated with improved adherence to a multidrug regimen .
BACKGROUND Cardiovascular disease ( CVD ) is the leading cause of death and disability worldwide , yet CVD risk factor control and secondary prevention rates remain low .
A fixed-dose combination of blood pressure and cholesterol lowering and antiplatelet treatments into a single pill , or polypill , has been proposed as one strategy to reduce the global burden of CVD by up to 80 % given its potential for better adherence and lower costs .
OBJECTIVES To determine the effectiveness of fixed-dose combination therapy on reducing fatal and non-fatal CVD events and on improving blood pressure and lipid CVD risk factors for both primary and secondary prevention of CVD .
We also aim ed to determine discontinuation rates , adverse events , health-related quality of life , and costs of fixed-dose combination therapy .