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 .
Efficacy and tolerability of initial therapy with single-pill combination telmisartan/hydrochlorothiazide 80/25 mg in patients with grade 2 or 3 hypertension: a multinational, randomized, double-blind, active-controlled trial.
BACKGROUND Patients with grade 2 or 3 hypertension may require high-dose combination therapy to achieve blood pressure ( BP ) targets in a timely manner . OBJECTIVES This study compared the effectiveness and tolerability of a single-pill combination ( SPC ) of telmisartan/hydrochlorothiazide 80/25 mg ( T80/H25 ) with T80 monotherapy . METHODS In a Phase IV , multinational , r and omized , double-blind , double-dummy , active-controlled , parallel-group trial , 894 patients with mean seated trough cuff systolic BP [ SBP ] ≥160 mm Hg and diastolic BP [ DBP ] ≥100 mm Hg were r and omly assigned in a 2:1 ratio to receive T40/H12.5 SPC or telmisartan 40 mg monotherapy for 1 week before the dose was uptitrated to T80/H25 SPC or T80 , respectively , administered for 6 weeks . The primary efficacy measure was the change from baseline in mean seated cuff trough SBP . Adverse events ( AEs ) were recorded . RESULTS A total of 888 patients received treatment ( 294 and 594 patients in the T80/H25 and T80 groups , respectively ) ( mean age , 57.0 years ; age ≥65 years , 25.7 % ; male , 53.8 % ; white , 68.0 % ) ; 61 patients prematurely  discontinued . Mean baseline SBP/DBP values were 172.3/104.3 mm Hg ( T80/H25 ) and 173.3/104.5 mm Hg ( T80 ) . After 7 weeks , SBP was changed by -37.0 and -28.5 mm Hg in the T80/H25 and T80 groups ( P < 0.0001 ) ; DBP was changed by -18.6 and -15.4 mm Hg respectively ( P < 0.0001 ) . These differences were significant after 2 weeks at the higher dosage ( P < 0.0001 ) . BP target ( SBP/DBP < 140/<90 mm Hg ) was achieved in 55.5 % and 34.7 % of patients in the T80/H25 and T80 groups ( P < 0.0001 ) . T80/H25 SPC and T80 had a similar frequency of overall AEs ( 16.0 % vs 17.0 % ) . The prevalences of treatment-related AEs with T80/H25 SPC and T80 were low ( 4.6 % and 2.8 % ) , as were the rates of AEs that led to discontinuation ( 1.0 % and 2.8 % ) . CONCLUSIONS In these patients with grade 2 or 3 hypertension , initial therapy with T80/H25 was associated with a significantly greater reduction in mean seated cuff trough SBP compared with T80 alone , as well as with improved hypertension goal attainment rates . Both treatments appeared to be well tolerated
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 .