SSaSS (stroke or hypertension)
Trial question
Is salt substitution superior to regular salt in patients with a history of stroke or those aged ≥ 60 years with hypertension?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
50.0% female
50.0% male
N = 20995
20995 patients (10393 female, 10602 male).
Inclusion criteria: patients with a history of stroke or patients aged ≥ 60 years with hypertension.
Key exclusion criteria: patient or family member with a potential contraindication to salt substitute, unlikely to live > 6 months, eats most meals outside home.
Interventions
N=10504 salt substitute (75% sodium chloride and 25% potassium chloride by mass).
N=10491 regular salt (100% sodium chloride).
Primary outcome
Incidence of stroke
29.14 /1K py
33.65 /1K py
33.6/1K py
25.2/1K py
16.8/1K py
8.4/1K py
0.0/1K py
Salt
substitute
Regular
salt
Significant
decrease ▼
Significant decrease in the incidence of stroke (29.14 events /1000 py vs. 33.65 events /1000 py; RR 0.86, 95% CI 0.77 to 0.96).
Secondary outcomes
Significant decrease in the incidence of major adverse CV events (49.09 events /1000 py vs. 56.29 events /1000 py; RR 0.87, 95% CI 0.8 to 0.94).
Significant decrease in the incidence of death from vascular causes (22.9 events /1000 py vs. 26.3 events /1000 py; RR 0.87, 95% CI 0.79 to 0.96).
Safety outcomes
No significant difference in clinical hyperkalemia.
Conclusion
In patients with a history of stroke or patients aged ≥ 60 years with hypertension, salt substitute was superior to regular salt with respect to the incidence of stroke.
Reference
Bruce Neal, Yangfeng Wu, Xiangxian Feng et al. Effect of Salt Substitution on Cardiovascular Events and Death. N Engl J Med. 2021 Sep 16;385(12):1067-1077.
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