BACKGROUND: The ultimate goal of antihypertensive therapy is cardiovascular risk (CVR) reduction. The aim of this study was to compare the efficacy and safety of once-daily fixed combination (ODFC) versus free-drug combination (FDC) of 3antihypertensive agents and statin. METHODS: The ALL-IN-ONE trial was a 12-week randomized, prospective, multicenter trial. A total of 305 hypertensive patients were randomized 1:1. The "fixed group" was given an ODFC of perindropil 10mg plus indapamide 2.5mg plus amlodipine 5 or 10mg plus atorvastatin 20mg. The "free group" was given a FDC of the 3antihypertensive agents plus atorvastatin 20mg. Primary end-points were the differences in clinic BP, cholesterol levels and CVR risk between the 2 groups after treatments. Secondary end-points included intragroup differences in clinic BP. Safety and compliance were also assessed. RESULTS: At 12-weeks, the fixed group had lower systolic BP and similar diastolic BP compared to the free group. BP targets at week 12 were more commonly reached with fixed than free combination (89% and 80% respectively, p=0.048). For cholesterol serum in both groups there was a significant reduction of values. Also CVR reduction was greater in those taking ODF. Safety was not significantly different between the 2 groups. Conversely, compliance was significantly greater in the fixed-group vs. the free-group. CONCLUSION: This randomized trial shows that ODF combination of perindropil, indapamide and amlodipine is as safe as free combination of the 3 drugs, but is associated with a greater efficacy in BP control, compliance and, associated with statin, in cholesterol reduction. A better cardiovascular risk control is achieved with ODF combination than with a free administration. ClinicalTrials.gov ID: NCT02710539.
RCT Entities:
BACKGROUND: The ultimate goal of antihypertensive therapy is cardiovascular risk (CVR) reduction. The aim of this study was to compare the efficacy and safety of once-daily fixed combination (ODFC) versus free-drug combination (FDC) of 3antihypertensive agents and statin. METHODS: The ALL-IN-ONE trial was a 12-week randomized, prospective, multicenter trial. A total of 305 hypertensivepatients were randomized 1:1. The "fixed group" was given an ODFC of perindropil 10mg plus indapamide 2.5mg plus amlodipine 5 or 10mg plus atorvastatin 20mg. The "free group" was given a FDC of the 3antihypertensive agents plus atorvastatin 20mg. Primary end-points were the differences in clinic BP, cholesterol levels and CVR risk between the 2 groups after treatments. Secondary end-points included intragroup differences in clinic BP. Safety and compliance were also assessed. RESULTS: At 12-weeks, the fixed group had lower systolic BP and similar diastolic BP compared to the free group. BP targets at week 12 were more commonly reached with fixed than free combination (89% and 80% respectively, p=0.048). For cholesterol serum in both groups there was a significant reduction of values. Also CVR reduction was greater in those taking ODF. Safety was not significantly different between the 2 groups. Conversely, compliance was significantly greater in the fixed-group vs. the free-group. CONCLUSION: This randomized trial shows that ODF combination of perindropil, indapamide and amlodipine is as safe as free combination of the 3 drugs, but is associated with a greater efficacy in BP control, compliance and, associated with statin, in cholesterol reduction. A better cardiovascular risk control is achieved with ODF combination than with a free administration. ClinicalTrials.gov ID: NCT02710539.
Authors: Ehete Bahiru; Angharad N de Cates; Matthew Rb Farr; Morag C Jarvis; Mohan Palla; Karen Rees; Shah Ebrahim; Mark D Huffman Journal: Cochrane Database Syst Rev Date: 2017-03-06