HypertensionRandomised controlled trial
Lowering systolic blood pressure to less than 120 mm Hg versus less than 140 mm Hg in patients with high cardiovascular risk with and without diabetes or previous stroke: an open-label, blinded-outcome, randomised trial
- Randomised controlled trial
- open-label
- blinded-outcome
- minimised randomisation
- 116 hospitals or communities in China
Authors' conclusion
For hypertensive patients at high cardiovascular risk, regardless of the status of diabetes or history of stroke, the treatment strategy of targeting systolic blood pressure of less than 120 mm Hg, as compared with that of less than 140 mm Hg, prevents major vascular events, with minor excess risk.
Study context
- Population
- Patients with high CV risk, with and without DM or previous stroke, China4,359 with DM, 3022 with previous stroke
- Participants
- 11,255 patients
- Comparison
- Intensive SBP target <120 mm Hg vs standard target <140 mm Hg
- Intensive treatmentn = 5,624
- Standard treatmentn = 5,631reference
- Primary endpoint
- Composite of:
- MI
- Revascularisation
- Hospitalisation for HF
- Stroke
- CV death
- Follow-up
- Median 3.4 years
Primary result
As reported in the abstract
Hazard ratio
0.88
95% CI 0.78–0.99
P = 0.028
Events by treatment group
Intensive treatment vs Standard treatment
HR 0.88 (95% CI 0.78–0.99); P = 0.028
Further findings
Mean SBP during follow-up (except first 3 months of titration)
Primary outcome by DM status, DM duration or history of stroke (subgroups)
- No heterogeneity of effects by DM status, duration of DM, or history of stroke
Safety
| Outcome | Intensive treatment | Standard treatment | HR (95% CI) | |
|---|---|---|---|---|
| Serious adverse events of syncope | 0.4% | 0.1% | 3.00 (1.35–6.68) | |
| 0.10.31310Hazard ratio (log scale) |
Serious adverse events of hypotension, electrolyte abnormality, injurious fall or AKI
- No significant between-group difference
Original publication
Lowering systolic blood pressure to less than 120 mm Hg versus less than 140 mm Hg in patients with high cardiovascular risk with and without diabetes or previous stroke: an open-label, blinded-outcome, randomised trial. Lancet. Published 27 June 2024. doi:10.1016/s0140-6736(24)01028-6
Summarised from the published abstract; every number is checked against it