HYVET
Trial question
What is the effect of indapamide treatment in patients ≥ 80 years of age with hypertension?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
60.0% female
40.0% male
N = 3845
3845 patients (2326 female, 1519 male).
Inclusion criteria: patients ≥ 80 years of age with a sustained SBP ≥ 160 mmHg.
Key exclusion criteria: a contraindication to use of the trial medications, accelerated hypertension, secondary hypertension, hemorrhagic stroke in the previous 6 months, HF requiring treatment with antihypertensive medication, gout, clinical dementia, and a requirement of nursing care.
Interventions
N=1933 active-treatment (diuretic indapamide, sustained releases 1.5 mg, if necessary perindopril 2 or 4 mg to achieve the target BP 150/80 mmHg).
N=1912 placebo (matching placebo of indapamide, if necessary matching placebo of perindopril).
Primary outcome
Incidence of stroke at 2 years
12.4
17.7
17.7/1000 py
13.3/1000 py
8.8/1000 py
4.4/1000 py
0.0/1000 py
Active-treatment
Placebo
No significant
difference ↔
No significant difference in the incidence of stroke at 2 years (12.4/1000 py vs. 17.7/1000 py; HR 0.7, 95% CI 0.49 to 1.01).
Secondary outcomes
Significant decrease in the incidence of death from stroke (6.5/1000 py vs. 10.7/1000 py; HR 0.61, 95% CI 0.38 to 0.99).
Significant decrease in the incidence of death from any cause (47.2/1000 py vs. 59.6/1000 py; HR 0.79, 95% CI 0.65 to 0.95).
Significant decrease in the incidence of HF (5.3/1000 py vs. 14.8/1000 py; HR 0.36, 95% CI 0.22 to 0.58).
Safety outcomes
Significant difference in serious adverse events (358 events vs. 448 events).
Conclusion
In patients ≥ 80 years of age with a sustained SBP ≥ 160 mmHg, active-treatment was not superior to placebo with respect to the incidence of stroke at 2 years.
Reference
Beckett NS, Peters R, Fletcher AE et al. Treatment of hypertension in patients 80 years of age or older. N Engl J Med. 2008 May 1;358(18):1887-98.
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