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 .
Long-Term Tolerability and Efficacy of Single-Pill Combinations of Telmisartan 40-80 mg Plus Amlodipine 5 or 10 mg in Patients Whose Blood Pressure Was Not Initially Controlled by Amlodipine 5-10 mg: Open-Label, Long-Term Follow-Ups of the TEAMSTA-5 and TEAMSTA-10 Studies.
BACKGROUND Two 8-week , r and omized , double-blind , controlled studies previously evaluated the efficacy and tolerability of single-pill combinations of telmisartan 40 - 80 mg/amlodipine 5 - 10 mg ( T40 - 80/A5 - 10 ) in patients with hypertension not at diastolic blood pressure ( DBP ) goal ( DBP < 90 mm Hg ) after 6 weeks of amlodipine 5 mg monotherapy ( A5 ) ( TEAMSTA-5 ) or amlodipine 10 mg monotherapy ( A10 ) ( TEAMSTA-10 ) . The long-term ( ≥6 months ) tolerability and efficacy of single-pill combinations of T40-T80/A5-A10 have now been evaluated in 2 open-label studies in patients who had successfully completed either TEAMSTA-5 or TEAMSTA-10 ( TEAMSTA-5 and TEAMSTA-10 Follow-Ups ) . METHODS In the TEAMSTA-5 Follow-Up , 976 patients whose blood pressure was not initially controlled by taking A5 received T40/A5 for 4 or 8 weeks , with consecutive uptitration to T80/A5 if DBP was ≥90 mm Hg . In TEAMSTA-10 Follow-Up , 838 patients not initially achieving blood pressure control using A10 received T40/A10 for 4 weeks before r and omization to T40/A10 or T80/A10 ; after 4 weeks , patients r and omized to T40/A10 with DBP ≥90 mm Hg were uptitrated to T80/A10 . In both studies , add-on antihypertensive medication was allowed if DBP was not at goal . RESULTS Treatment compliance in both follow-up studies was ≥98.4 % . Single-pill combinations of T40-T80/A5-A10 result ed in additional clinical ly relevant blood pressure reductions and 67 % to 93 % of patients achieved DBP goal ( < 90 mm Hg ) ; only 1 % to 19 % of patients received additional medication for hypertension , of whom 29 % to 76 % achieved DBP goal . Long-term treatment with T40-T80/A5-A10 was well tolerated , with comparable adverse event profiles for all telmisartan/amlodipine combinations . The most common drug-related adverse events were peripheral edema ( 1.9%-3.9 % ) and dizziness ( 1.5 % in the T80/A5 group only ) ; these were consistent with the known tolerability profiles of telmisartan/amlodipine combinations . Overall treatment discontinuation rates due to adverse events were low ( 0.7%-1.5 % ) . CONCLUSIONS In patients not achieving DBP goal with either A5 or A10 monotherapy , the vast majority achieved DBP goal with single-pill combinations of T40-T80/A5-A10 . Long-term treatment was well tolerated with high compliance , promoting treatment adherence regardless of telmisartan/amlodipine dose . Clinical Trials.gov identifiers : NCT00614380 ( TEAMSTA-5 Follow-up ) and NCT00624052 ( TEAMSTA-10 Follow-up )
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 .