Table 2.
Changes in BP and Laboratory Data During the Treatment Period (Intention‐to‐Treat Populations)
| Change | ALI/AML Group (n=47) | h‐dAML Group (n=51) | P Value |
|---|---|---|---|
| Clinic SBP, mm Hg | |||
| Baseline | 147.6±20.7 | 147.7±18.9 | .99 |
| End of study | 135.7±16.4 | 138.8±15.0 | .33 |
| Change after 16 weeks | −11.9±20.4a | −8.9±17.0b | .43 |
| Clinic DBP, mm Hg | |||
| Baseline | 73.9±10.3 | 76.2±10.9 | .30 |
| End of study | 70.5±9.1 | 70.3±8.8 | .92 |
| Change after 16 weeks | −3.4±7.3b | −5.8±7.5a | .11 |
| Clinic pulse rate, beats per min | |||
| Baseline | 68.8±12.0 | 69.9±11.9 | .65 |
| End of study | 71.5±12.0 | 71.5±10.5 | .98 |
| Change after 16 weeks | 2.7±10.8 | 1.6±10.5 | .63 |
| 24‐hour SBP, mm Hg | |||
| Baseline | 134.2±12.1 | 133.8±12.6 | .88 |
| End of study | 127.2±13.2 | 127.8±12.9 | .84 |
| Change after 16 weeks | −7.0±13.2b | −6.0±9.7a | .69 |
| 24‐hour DBP, mm Hg | |||
| Baseline | 74.5±7.5 | 74.4±8.1 | .97 |
| End of study | 69.9±7.5 | 70.7±7.5 | .62 |
| Change after 16 weeks | −4.6±6.8a | −3.7±5.4a | .51 |
| 24‐hour pulse rate, beats per min | |||
| Baseline | 64.7±8.9 | 64.4±8.0 | .91 |
| End of study | 65.0±9.2 | 65.0±7.5 | .99 |
| Change after 16 weeks | 0.3±5.4 | 0.5±3.9 | .85 |
| Daytime SBP, mm Hg | |||
| Baseline | 139.8±12.6 | 136.8±13.2 | .29 |
| End of study | 132.2±14.0 | 131.6±14.0 | .84 |
| Change after 16 weeks | −7.6±15.7b | −5.2±12.3b | .44 |
| Daytime DBP, mm Hg | |||
| Baseline | 77.5±7.8 | 76.6±8.6 | .60 |
| End of study | 73.1±7.8 | 73.2±7.8 | .96 |
| Change after 16 weeks | −4.4±9.1b | −3.4±6.4b | .54 |
| Daytime pulse rate, beats per min | |||
| Baseline | 68.1±8.7 | 68.6±8.7 | .81 |
| End of study | 68.7±9.4 | 69.7±7.7 | .60 |
| Change after 16 weeks | 0.6±6.8 | 1.1±5.7 | .71 |
| Nighttime SBP, mm Hg | |||
| Baseline | 124.2±15.7 | 127.6±13.8 | .29 |
| End of study | 119.6±16.6 | 121.2±14.3 | .62 |
| Change after 16 weeks | −4.6±13.6b | −6.3±9.6a | .49 |
| Nighttime DBP, mm Hg | |||
| Baseline | 69.0±9.4 | 70.0±8.5 | .62 |
| End of study | 65.4±9.4 | 66.6±8.4 | .53 |
| Change after 16 weeks | −3.7±7.0b | −3.4±7.4a | .88 |
| Nighttime pulse rate, beats per min | |||
| Baseline | 58.5±9.9 | 56.8±7.0 | .36 |
| End of study | 59.4±9.0 | 57.5±7.8 | .28 |
| Change after 16 weeks, beats per min | 0.9±5.3 | 0.7±4.2 | .79 |
| Early‐morning SBP, mm Hg | |||
| Baseline, mm Hg | 137.5±15.9 | 144.4±19.2 | .07 |
| End of study, mm Hg | 141.5±19.5 | 133.6±17.2 | .05 |
| Change after 16 weeks, mm Hg | 4.0±21.2 | −10.8±22.1b | .002 |
| Early‐morning DBP, mm Hg | |||
| Baseline, mm Hg | 77.1±11.5 | 77.0±10.0 | .96 |
| End of study, mm Hg | 75.6±11.2 | 75.3±12.3 | .93 |
| Change after 16 weeks, mm Hg | −1.6±11.5 | −1.7±13.5 | .97 |
| Early‐morning pulse rate, beats per min | |||
| Baseline, beats per min | 65.3±11.2 | 65.0±9.9 | .90 |
| End of the study, beats per min | 66.1±10.3 | 66.9±11.3 | .72 |
| Change after 16 weeks, beats per min | 0.8±9.8 | 1.9±9.8 | .59 |
| Lowest nighttime SBP, mm Hg | |||
| Baseline, beats per min | 109.9±15.2 | 113.9±13.2 | .19 |
| End of study, beats per min | 103.8±14.5 | 108.5±15.1 | .15 |
| Change after 16 weeks, beats per min | −6.0±10.8b | −5.4±10.2b | .79 |
| Morning BP surge, mm Hg | |||
| Baseline, mm Hg | 27.6±18.5 | 30.5±15.3 | .43 |
| End of study, mm Hg | 37.6±20.5 | 25.0±13.8 | .001 |
| Change after 16 weeks | 10.0±23.2b | −5.4±20.3 | .001 |
| SD of 24‐hour SBP, mm Hg | |||
| Baseline | 21.1±5.5 | 18.5±4.9 | .02 |
| End of study | 21.1±5.9 | 18.7±5.0 | .04 |
| Change after 16 weeks | 0.0±5.2 | 0.2±4.4 | .83 |
| SD of 24‐hour DBP, mm Hg | |||
| Baseline | 13.0±4.3 | 12.2±4.2 | .37 |
| End of study | 13.6±4.8 | 13.3±5.1 | .79 |
| Change after 16 weeks | 0.5±5.6 | 1.1±4.8 | .63 |
| SD of daytime SBP, mm Hg | |||
| Baseline | 21.0±5.9 | 19.3±5.9 | .20 |
| End of study | 21.7±6.1 | 19.2±5.8 | .05 |
| Change after 16 weeks | 0.7±6.4 | −0.2±6.2 | .51 |
| SD of daytime DBP, mm Hg | |||
| Baseline | 12.8±4.7 | 12.6±4.9 | .83 |
| End of study | 14.3±6.1 | 13.8±5.7 | .71 |
| Change after 16 weeks | 1.5±7.1 | 1.2±5.6 | .85 |
| SD of nighttime SBP, mm Hg | |||
| Baseline | 14.7±5.4 | 13.6±3.8 | .26 |
| End of study | 14.1±3.8 | 13.6±6.0 | .65 |
| Change after 16 weeks | −0.7±6.3 | 0.0±6.4 | .65 |
| SD of nighttime DBP, mm Hg | |||
| Baseline | 9.5±4.2 | 8.6±3.0 | .26 |
| End of study | 9.2±2.4 | 9.7±5.5 | .58 |
| Change after 16 weeks | −0.3±5.1 | 1.1±5.7 | .23 |
| Plasma renin activity, ng/mL/h | |||
| Baseline | 0.83 (0.66–1.04) | 0.74 (0.62–0.89) | .46 |
| End of study | 0.17 (0.13–0.22) | 1.27 (1.02–1.60) | <.001 |
| Change from baseline, % | −79.4 (−84.4 to −72.8)a | 71.3 (47.7–98.8)a | <.001 |
| Plasma aldosterone concentration, pg/mL | |||
| Baseline | 73.4 (62.2–86.7) | 84.1 (73.3–96.5) | .21 |
| End of study | 75.4 (63.7–89.3) | 109.4 (94.4–126.8) | .001 |
| Change from baseline, % | 2.7 (−13.6 to 22.1) | 30.1 (14.0–48.4)a | .03 |
Abbreviations: DBP diastolic blood pressure; SBP, systolic blood pressure. Data are expressed as mean±standard deviation (SD) or geometric mean (95% confidence interval). Clinic blood pressure (BP) was evaluated in 47 patients in the aliskiren/amlodipine (ALI/AML) group and in 51 patients in the high‐dose amlodipine (h‐dAML) group. Twenty‐four‐hour BP was evaluated in 40 patients in the ALI/AML group and in 46 patients in the h‐dAML group. Laboratory data were evaluated in 45 patients in the ALI/AML group and in 51 patients in the h‐dAML group. a P<.001 and b P<.05 vs baseline by paired t test.