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 .
Single-pill amlodipine/atorvastatin helps patients of diverse ethnicity attain recommended goals for blood pressure and lipids (the Gemini-AALA study)
The Gemini-AALA ( Australia , Asia , Latin America , Africa/Middle East ) study evaluated the efficacy and safety of single-pill amlodipine/atorvastatin ( Caduet ) for the treatment of patients of diverse ethnicity with concomitant hypertension and dyslipidaemia . This was a 14-week , open-label study including patients from 27 countries across the Middle East , Asia-Pacific , Africa and Latin America . Eight dosage strengths of single-pill amlodipine/atorvastatin ( 5/10 , 10/10 , 5/20 , 10/20 , 5/40 , 10/40 , 5/80 and 10/80 mg ) were titrated to improve blood pressure and lipid control . Blood pressure and lipid goals were determined according to the Seventh Report of the Joint National Committee on Prevention , Detection , Evaluation , and Treatment of High Blood Pressure ( JNC 7 ) and National Cholesterol Education Program Expert Panel on Detection , Evaluation , and Treatment of High Blood Cholesterol in Adults ( NCEP ATP III ) guidelines , respectively ( blood pressure , < 140/90 or < 130/80 mm Hg ; low-density lipoprotein cholesterol ( LDL-C ) , < 4.1 to < 2.6 mmol l−1 ( < 160 to < 100 mgdl−1 ) ) . Overall , 1649 patients received study medication . Most patients ( 91.4 % ) had ⩾1 cardiovascular risk factor ( as defined by NCEP ATP III guidelines ) in addition to hypertension/dyslipidaemia , and 61.7 % had coronary heart disease/risk equivalent . At baseline , mean blood pressure was 146.6/88.3 mm Hg and LDL-C was 3.4 mmol l−1 ( 130.2 mgdl−1 ) . At week 14 , 55.2 % of patients reached both blood pressure and lipid goals , 61.3 % reached blood pressure goal and 87.1 % reached lipid goal ( 34.0 % were at lipid goal at baseline ) . Mean blood pressure reduction was 20.2/11.4 mm Hg . For patients who were lipid-lowering drug naive at baseline , mean reduction in LDL-C was 41.0 % . Treatment-related adverse events led to the discontinuation of 3.6 % of patients . Single-pill amlodipine/atorvastatin therapy was well tolerated and effective for the reduction of blood pressure and lipids to recommended goals in patients from diverse ethnic background
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 .