Table II.
Incremental Blood Pressure‐Lowering Effects of Amlodipine/Valsartan 5/160 mg and 10/160 mg in the Intent‐to‐Treat Population and According to the Severity of Hypertension at Baseline
| Week and Disease Severity | Amlodipine/Valsartan 5/160 mg MSSBP/MSDBP | Amlodipine/Valsartan 10/160 mg MSSBP/MSDBP | Amlodipine/Valsartan 5/160 vs 10/160 mg MSSBP/MSDBP | |||||
|---|---|---|---|---|---|---|---|---|
| No.a | Baseline, mg Hg | Change From Baseline, mg Hg (SEM) | No.a | Baseline, mg Hg | Change From Baseline, mg Hg (SEM) | Difference in Change (95% CI) | P Value | |
| Week 4 | ||||||||
| Intent‐to‐treatb | 440 | 149.8/90.8 | −13.9 (0.7)/−8.4 (0.4) | 449 | 150.4/90.6 | −16.1 (0.7)1−9.7 (0.4) | 2.2 (0.8–3.5)/1.3 (0.4–2.2) | .0016/.0038 |
| Less severec | 329 | 147.3/89.8 | −13.1/−8.2 | 341 | 147.1/89.3 | −15.0/−9.3 | ||
| More severed | 97 | 160.7/95.9 | −20.7/−10.9 | 101 | 162.7/95.5 | −23.6/−12.0 | ||
| Week 8 | ||||||||
| Intent‐to‐treatb | 423 | 149.6/90.9 | −18.0 (0.7)/−9.9 (0.5) | 410 | 150.8/90.9 | −20.8 (0.7)/−11.9 (0.5) | 2.8 (1.4–4.1)/2.0 (1.1–2.9) | <.0001/<.0001 |
| Less severec | 319 | 147.2/89.8 | −16.1/−93 | 310 | 147.4/89.7 | −18.5/−11.2 | ||
| More severed | 91 | 160.3/96.0 | −24.8/−13.2 | 93 | 163.4/95.7 | −29.7/−15.1 | ||
| End point week 8e | ||||||||
| Intent‐to‐treatb | 440 | 149.8/90.8 | −16.5 (0.7)/−9.3 (0.5) | 449 | 150.4/90.6 | −19.2 (0.7)/−11.3 (0.5) | 2.7 (1.3–4.1)/2.1 (1.2–3.0) | .0001/<.0001 |
| Less severec | 329 | 147.3/89.8 | −15.5/−9.0 | 341 | 147.1/89.3 | −17.5/−10.8 | ||
| More severed | 97 | 160.7/95.9 | −23.9/−12.5 | 101 | 162.7/95.5 | −28.8/−14.7 | ||
| Week 12 | ||||||||
| Intent‐to‐treatb | 410 | 149.9/91.0 | −19.2 (0.6)/−10.8 (0.4) | 388 | 150.7/91.0 | −21.8 (0.6)/−12.2 (0.4) | 2.6 (1.4–3.9)/1.4 (0.5–2.2) | <.0001/.0016 |
| Less severec | 309 | 147.3/89.8 | −17.5/−10.8 | 296 | 147.4/89.7 | −19.7/−12.1 | ||
| More severed | 91 | 160.3/96.0 | −25.9/−14.1 | 87 | 163.1/95.5 | −31.0/−15.4 | ||
| Week 16 | ||||||||
| Intent‐to‐treatb | 406 | 149.9/90.9 | −19.4 (0.7)/−11.3 (0.4) | 378 | 150.7/91.0 | −22.1 (0.7)/−12.4 (0.4) | 2.7 (1.4–4.0)/1.1 (0.2–1.9) | <.0001/.0121 |
| Less severec | 307 | 147.4/89.8 | −17.3/−10.9 | 289 | 147.3/89.7 | −19.9/−12.3 | ||
| More severed | 89 | 160.4/95.9 | −25.8/−14.6 | 85 | 163.1/95.9 | −30.6/−14.8 | ||
| Endpoint Week 16f | ||||||||
| Intent‐to‐treatb | 440 | 149.8/90.8 | −17.5 (0.7)/−10.4 (0.4) | 449 | 150.4/90.6 | −20.0 (0.7)/−11.6 (0.4) | 2.5 (1.1–3.8)/1.2 (0.4–2.1) | .0003/.0046 |
| Less severec | 329 | 147.3/89.8 | −16.3/−10.5 | 341 | 147.1/89.3 | −18.3/−11.7 | ||
| More severed | 97 | 160.7/95.9 | −24.7/−13.9 | 101 | 162.7/95.5 | −29.7/−14.5 | ||
| Abbreviations: CI, confidence interval; MSDBP, mean sitting diastolic blood pressure; MSSBP, mean sitting systolic blood pressure; SEM, standard error of the mean. aNumber of patients with nonmissing measurements at respective week. bThe least squares mean change from baseline is shown at each week for the intent‐to‐treat population. cPatients with MSSBP at baseline of ≥140 and <160 mm Hg or MSDBP of ≥90 and <100 mm Hg. dPatients with MSSBP at baseline of ≥160 and <180 mm Hg or MSDBP of ≥100 and <110 mm Hg. ePre‐hydrochlorothiazide end point (ie, week 8 or last observation carried forward [LOCF] value. fEnd point week 16 is the value at week 16 or LOCF value. The intent‐to‐treat population is based on a cutoff of 140/90 mm Hg; diabetic patients with a blood pressure value of 130–140 and 80–90 mm Hg were not included in the severity subgroup population. | ||||||||