Abstract 14002: Randomized Comparison of Once-daily Fixed Combination versus Free-drug Combination of Three Antihypertensive Agents
Background: A 3 drug combination strategy is often needed to achieve blood pressure (BP) targets. However, the optimal strategy of drug administration remains unknown.
The aim of this study was to compare the efficacy and safety of once-daily fixed (ODF) combination versus free-drug combination of 3 antihypertensive agents.
Methods: The ONE&ONLY Trial was a randomized, prospective, multicenter trial. A total of 731 hypertensive patients (pts) treated with the combination of perindopril plus indapamide or amlodipine were screened initially. The 305 pts who did not meet the BP targets after 4 weeks were randomized to ODF combination of perindopril 10 mg + indapamide 2.5 mg + amlodipine 5 or 10 mg (N=154, fixed group) versus free-drug combination of the 3 antihypertensive agents (N=151, free group). Primary end-points were the differences in clinic BP between the 2 groups after 12 weeks. Secondary end-points included intragroup differences in clinic BP during the study period and achievement of BP targets at week 12. Safety and compliance were also assessed during the trial.
Results: Baseline characteristics were similar among the treatment groups. At 12-weeks, the fixed group had lower systolic BP (SBP) (125±12 vs 129±11 mm Hg, p=0.002) and similar diastolic BP (DBP) (82±9 vs 84±7 mm Hg, p=0.082) compared to the free group. With respect to baseline measures, changes in BP with fixed combination were statistically significant for systolic (-18.9± 11.2 mm Hg, p<0.01), and diastolic values (-6.3±5.7 mm Hg, p<0.01). On free combination, changes vs. baseline in SBP and DBP, conversely, were of borderline significance. BP targets at week 12 were more commonly reached with fixed than free combination (89% [137 of 154] and 80% [121 of 151], respectively, p=0.048). Safety was not significantly different between the 2 groups. Conversely, compliance was significantly greater in the fixed-group vs the free-group (94% [144 of 154] and 85% [129 of 151], respectively, p=0.034).
Conclusion: This randomized trial shows in a large population of hypertensive pts that ODF combination of perindopril, indapamide, and amlodipine is as effective and safe as free combination of the 3 drugs, although is associated with a significantly greater compliance. ClinicalTrials.gov ID: NCT02710539
Author Disclosures: G. Marazzi: None. F. Pelliccia: None. G. Campolongo: None. L. Cacciotti: None. S. Poggi: None. A. Tanzilli: None. M. Di Iorio: None. G. Rosano: None.
- © 2016 by American Heart Association, Inc.