Table II.
Efficacy and Safety Results of Analyzed Studies
| Efficacy | Safety | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Office | ABPM (24 Hour) | ||||||||
| No. | SBP | DBP | Control Ratea | No. | SBP | DBP | No. | Any AE (%) | |
| BP‐CRUSH study 21 | |||||||||
| A/O/H 10/40/0 | 776 | −20.3 | −11.3 | 65.7 | 229 | −14.8 | −9.4 | 795 | 23.6 |
| A/O/H 10/40/12.5 | 671 | −23.8 | −13.3 | 74.2 | NR | 699 | 25.8 | ||
| A/O/H 10/40/25 | 484 | −25.1 | −13.7 | 76.0 | 199 | −21.0 | −13.3 | 496 | 20.0 |
| Calhoun and colleagues 16 , 22 , 23 | |||||||||
| A/V/H 0/320/25 | 553 | −32.0 | −19.7 | 48.3 | 69 | −23.9 | −15.5 | 559 | 45.3 |
| A/V/H 10/320/0 | 558 | −33.5 | −21.5 | 54.1 | 71 | −24.1 | −14.9 | 566 | 44.9 |
| A/V/H 10/0/25 | 554 | −31.5 | −19.5 | 44.8 | 76 | −18.8 | −11.7 | 561 | 48.3 |
| A/V/H 10/320/25 | 571 | −39.7 | −24.7 | 70.8 | 67 | −30.3 | −19.7 | 582 | 45.2 |
| EXALT study 24 , 25 | |||||||||
| A/V/H 5/160/0 | 241 | −24.0 | −9.8 | NR | NR | NR | |||
| A/V/H 5/160/25 | 229 | −31.8 | −13.7 | 56.8 | 36 | −22.0 | −13.3 | NR | |
| EX‐EFFECTS study26 26 , 27 | |||||||||
| A/V/H 10/0/12.5 | 206 | −24.3 | −8.3 | 15.4b | NR | 208 | 33.2 | ||
| A/V/H 10/160/12.5 | 133 | −30.5 | −13.8 | 37.7b | NR | 136 | 33.8 | ||
| EX‐FAST study 28 , 29 | |||||||||
| A/V/H 5/160/0 | 59 | −11.7 | −4.6 | NR | NR | NR | |||
| A/V/H 5/160/12.5 | 59 | −18.9 | −10.7 | NR | NR | NR | |||
| A/V/H 5/160/0 | 51 | −6.8 | −5.7 | NR | NR | NR | |||
| A/V/H 5/160/25 | 51 | −15.7 | −10.4 | NR | NR | NR | |||
| A/V/H 10/160/0 | 57 | −17.8 | −10.1 | NR | NR | NR | |||
| A/V/H 10/160/12.5 | 57 | −22.7 | −13.8 | NR | NR | NR | |||
| A/V/H 10/160/0 | 29 | −9.1 | −7.6 | NR | NR | NR | |||
| A/V/H 10/160/25 | 29 | −16.3 | −10.1 | NR | NR | NR | |||
| EX‐STAND study 30 | |||||||||
| A/V/H 10/0/12.5 | 251 | −30.0 | −12.8 | 35.9 | NR | NR | |||
| A/V/H 10/320/12.5 | 250 | −37.0 | −16.1 | 57.2 | NR | NR | |||
| EXTRA study 31 , 32 , 33 | |||||||||
| A/V/H 5/160/0 | 357 | −19.2 | −8.7 | 31.3 | NR | 170 | 22.4 | ||
| A/V/H 5/160/12.5 | 357 | −23.2 | −11.5 | 46.2 | NR | 170 | 28.8 | ||
| A/V/H 5/160/25 | 170 | −25.3 | −12.3 | 50.7 | 36 | −16.3 | −10.2 | 170 | 37.6 |
| A/V/H 10/320/0 | 366 | −23.0 | −10.4 | 43.7 | NR | 127 | 23.6 | ||
| A/V/H 10/320/12.5 | 366 | −27.9 | −14.3 | 61.7 | NR | 127 | 33.1 | ||
| A/V/H 10/320/25 | 127 | −29.0 | −14.8 | 59.8 | 44 | −21.5 | −13.7 | 127 | 40.2 |
| Fogari and colleagues 34 | |||||||||
| A/O/H 5/0/12.5 | 75 | −24.5 | −14.3 | NR | 74 | −21.1 | −14.1 | NR | |
| A/O/H 5/20/12.5 | 75 | −36.7 | −24.0 | NR | 74 | −28.5 | −23.0 | 75 | 8.0 |
| A/V/H 5/0/12.5 | 74 | −24.4 | −14.4 | NR | 75 | −20.9 | −13.9 | NR | |
| A/V/H 5/160/12.5 | 74 | −40.8 | −26.1 | NR | 75 | −31.5 | −25.4 | 74 | 9.0 |
| Ram and colleagues 35 | |||||||||
| A/O/H 10/40/0 | 163 | −22.6 | −10.4 | 71.0 | 165 | −19.9 | −11.2 | 167 | 19.8 |
| A/O/H 10/40/12.5 | 144 | −27.6 | −14.0 | 78.0 | NR | 146 | 17.8 | ||
| A/O/H 10/40/25 | 100 | −28.0 | −13.7 | 83.0 | NR | 101 | 11.9 | ||
| TRINITY study 17 , 36 | |||||||||
| A/O/H 10/40/0 | 624 | −30.0 | −18.0 | 52.9 | 112 | −23.5 | −13.9 | 596 | 51.7 |
| A/O/H 0/40/25 | 627 | −29.7 | −16.9 | 53.4 | 116 | −23.9 | −14.5 | 580 | 55.0 |
| A/O/H 10/0/25 | 593 | −27.5 | −15.1 | 41.1 | 95 | −18.5 | −10.7 | 552 | 58.9 |
| A/O/H 10/40/25 | 614 | −37.1 | −21.8 | 69.9 | 117 | −30.3 | −18.0 | 574 | 58.4 |
| Val‐DICTATE study 37 | |||||||||
| A/V/H 0/320/25 | NR | 36.0 | NR | NR | |||||
| A/V/H 5/320/25 | NR | 43.0 | NR | NR | |||||
| A/V/H 10/320/25 | NR | 58.0 | NR | NR | |||||
Abbreviations: A, amlodipine; AE, adverse event; ABPM, ambulatory blood pressure measurement; H, hydrochlorothiazide; NR, not reported in evaluable format; O, olmesartan; SBP/DBP, systolic/diastolic blood pressure; V, valsartan. aRatio of patients achieving blood pressure target <140/90 mm Hg. bAdditional blood pressure control rate after hydrochlorothiazide was added.