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 .
Comparison of Risk Factor Reduction and Tolerability of a Full-Dose Polypill (With Potassium) Versus Low-Dose Polypill (Polycap) in Individuals at High Risk of Cardiovascular Diseases: The Second Indian Polycap Study (TIPS-2) Investigators
Background — A daily single capsule ( polycap ) of 3 blood pressure ( BP ) lowering drugs ( hydrochlorthiazide , 12.5 mg ; atenolol , 50 mg ; ramipril , 5 mg ) at low doses , simvastatin ( 20 mg ) , and aspirin ( 100 mg ) has been demonstrated to be well tolerated and to reduce BP and low-density lipoprotein cholesterol . We examined the incremental effects of 2 ( full dose ) plus K+ supplementation versus single polycap ( low dose ) on risk factors and tolerability . Methods and Results — After a run-in period , 518 individuals with previous vascular disease or diabetes mellitus from 27 centers in India were r and omly assigned to a single-dose polycap or to 2 capsules of the polycap plus K+ supplementation for 8 weeks . The effects on BP , heart rate ( HR ) , serum lipids , serum and urinary K+ , and tolerability were assessed using an intention-to-treat analysis . The full-dose polycap ( plus K+ supplementation )  reduced BP by a further 2.8 mm Hg systolic and 1.7 mm Hg diastolic , compared with that observed with the low-dose polycap ( P=0.003 ; P=0.001 ) , but there were no differences in HR ( 0.1 bpm ) . The differences in total and low-density lipoprotein cholesterol between the full-dose and low-dose polycap was 7.2 mg/dL ( P=0.014 ) and 6.6 mg/dL ( P=0.006 ) , respectively , but there were no differences in high-density lipoprotein cholesterol or triglycerides . The rates of discontinuation of the study drug after r and omization were similar in the 2 groups ( 6.9 % low dose versus 7.8 % full dose ) . Conclusions — The full-dose polycap ( plus K+ supplementation ) reduces BP and low-density lipoprotein cholesterol to a greater extent compared with the low dose , with similar tolerability . Therefore , the full-dose polycap should potentially lead to larger benefits . Clinical Trial Registration — URL : http://www.ctri.nic.in . Unique identifier : CTRI/2010/091/000054
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 .