Table 2. Changes in blood pressure and heart rate by randomisation group and type of analysis.
| Characteristic |
Type of analysis |
|||||||
|---|---|---|---|---|---|---|---|---|
|
All participants |
Cohort |
|||||||
| Old | New | Δ (CI) | P | Old | New | Δ (CI) | P | |
| Number | 89 | 94 | 57 | 67 | ||||
| Sitting position | ||||||||
| Last visit | ||||||||
| Systolic pressure, mm Hg | −21.2±1.5* | −26.4±1.5* | −5.2 (−9.3 to−1.1) | 0.013 | −22.6±1.8* | −28.0±1.7* | −5.4 (−10.3 to−0.4) | 0.035 |
| Diastolic pressure, mm Hg | −13.1±1.0* | −13.0±1.2* | −0.1 (−3.0 to 3.1) | 0.96 | −13.2±1.2* | −14.1±1.3* | −0.8 (−4.5 to 2.8) | 0.65 |
| Heart rate, beats per minute | −10.3±1.2* | −1.0±1.1 | 9.3 (6.0 to 12.6) | <0.0001 | −12.5±1.4* | −1.8±1.2 | 10.7 (7.1 to 14.3) | <0.0001 |
| All visits | ||||||||
| Systolic pressure, mm Hg | −19.5±1.2* | −24.8±1.2* | −5.2 (−7.7 to−2.9) | <0.0001 | −21.6±1.4* | −25.7±1.3* | −5.5 (−8.1 to−2.9) | <0.0001 |
| Diastolic pressure, mm Hg | −12.0±0.8* | −13.2±0.9* | −1.3 (−3.0 to 0.3) | 0.12 | −12.9±0.9* | −13.9±1.0* | −1.8 (−3.7 to 0.1) | 0.073 |
| Heart rate, beats per minute | −9.7±1.0* | 0.2±0.9 | 9.6 (7.7 to 11.5) | <0.0001 | −11.3±1.1* | −0.2±1.0 | 9.8 (7.7 to 11.9) | <0.0001 |
| Standing position | ||||||||
| Last visit | ||||||||
| Systolic pressure, mm Hg | −21.9±1.7* | −25.8±1.7* | −3.9 (−8.6 to 0.8) | 0.11 | −25.2±2.0* | −26.8±2.0* | −1.6 (−7.3 to 4.1) | 0.58 |
| Diastolic pressure, mm Hg | −12.9±1.0* | −14.3±1.1* | −1.5 (−4.4 to 1.4) | 0.30 | −13.4±1.2* | −14.7± 1.3* | 1.3 (−2.2 to 4.8) | 0.46 |
| Heart rate, beats per minute | −11.7±1.3* | −0.5±1.2 | 11.2 (7.6 to 14.8) | <0.0001 | −13.5±1.7* | −1.9±1.4 | 11.6 (7.4 to 15.8) | <0.0001 |
| All visits | ||||||||
| Systolic pressure, mm Hg | −18.9±1.4* | −23.8±1.3* | −4.6 (−7.1 to−2.1) | 0.004 | −21.3±1.8* | −24.1±1.5* | −4.6 (−7.2 to−2.0) | 0.0008 |
| Diastolic pressure, mm Hg | −12.0±0.8* | −14.1±0.8* | −1.3 (−2.8 to 0.20) | 0.092 | −12.7±1.0* | −14.4±0.9* | −1.6 (−3.3 to 0.1) | 0.072 |
| Heart rate, beats per minute | −11.4±1.2* | 0.7±0.9 | 11.3 (9.2 to 13.3) | <0.0001 | −12.9±1.5* | −0.5±0.9 | 11.3 (9.0 to 13.6) | <0.0001 |
Abbreviation: CI, confidence interval.
The analysis of all participants and of the cohort encompasses patients with at least one follow-up visit after randomisation and patients who attended all scheduled visits, respectively. Old and new refer to single-pill combinations of hydrochlorothiazide plus bisoprolol and valsartan plus amlodipine. Within-group decreases (follow-up minus baseline) are mean±s.e. Δ (CI) refers to the baseline-adjusted differences (95% confidence interval) of the treatment effects (new minus old). A negative value of Δ (CI) indicates lower values on treatment with new drugs. P-values for the between-group differences were computed from t-tests for the data at the last visit and from mixed models for all visits combined. An asterisk indicates significance (P<0.001) for the within-group change in blood pressure or heart rate.