BACKGROUNDSalt substitutes with reduced sodium levels and increased potassium levels have been shown to lower blood pressure, but their effects on cardiovascular and safety outcomes are uncertain. METHODSWe conducted an open-label, cluster-randomized trial involving persons from 600 villages in rural China. The participants had a history of stroke or were 60 years of age or older and had high blood pressure. The villages were randomly assigned in a 1:1 ratio to the intervention group, in which the participants used a salt substitute (75% sodium chloride and 25% potassium chloride by mass), or to the control group, in which the participants continued to use regular salt (100% sodium chloride). The primary outcome was stroke, the secondary outcomes were major adverse cardiovascular events and death from any cause, and the safety outcome was clinical hyperkalemia. RESULTSA total of 20,995 persons were enrolled in the trial. The mean age of the participants was 65.4 years, and 49.5% were female, 72.6% had a history of stroke, and 88.4% a history of hypertension. The mean duration of follow-up was 4.74 years. The rate of stroke was lower with the salt substitute than with regular salt (29.14 events vs. 33.65 events per 1000 person-years; rate ratio, 0.86; 95% confidence interval [CI], 0.77 to 0.96; P = 0.006), as were the rates of major cardiovascular events (49.09 events vs. 56.29 events per 1000 person-years; rate ratio, 0.87; 95% CI, 0.80 to 0.94; P<0.001) and death (39.28 events vs. 44.61 events per 1000 person-years; rate ratio, 0.88; 95% CI, 0.82 to 0.95; P<0.001). The rate of serious adverse events attributed to hyperkalemia was not significantly higher with the salt substitute than with regular salt (3.35 events vs. 3.30 events per 1000 person-years; rate ratio, 1.04; 95% CI, 0.80 to 1.37; P = 0.76). CONCLUSIONSAmong persons who had a history of stroke or were 60 years of age or older and had high blood pressure, the rates of stroke, major cardiovascular events, and death from any cause were lower with the salt substitute than with regular salt.

Background: : The Salt Substitute and Stroke Study (SSaSS) ─ a five-year cluster randomized controlled trial, demonstrated that replacing regular salt with a reduced-sodium added-potassium salt substitute reduced the risks of stroke, major adverse cardiovascular events and premature death among individuals with prior stroke or uncontrolled high blood pressure living in rural China. This study assessed the cost-effectiveness profile of the intervention. Methods: A within-trial economic evaluation of SSaSS was conducted from the perspective of the healthcare system and consumers. The primary health outcome assessed was stroke and we also quantified effects on quality-adjusted life years (QALYs). Healthcare costs were identified from participant health insurance records and the literature. All costs (Chinese Yuan - CNY ¥) and QALYs were discounted at 5% per annum. Incremental costs, stroke events averted, and QALYs gained were estimated using bivariate multilevel models. Results: Mean follow-up of the 20,995 participants was 4.7 years. Over this period, replacing regular salt with salt substitute reduced the risk of stroke by 14% (rate ratio 0.86, 95% confidence interval 0.77 to 0.96; p=0.006) and the salt substitute group had on average 0.054 more QALYs per person. The average costs (CNY ¥1,538 for the intervention group and CNY ¥1,649 for the control group) were lower in the salt substitute group (CNY ¥110 less). The intervention was dominant (better outcomes at lower cost) for prevention of stroke as well as for QALYs gained. Sensitivity analyses showed that these conclusions were robust, except when the price of salt substitute was increased to the median and highest market prices identified in China. The salt substitute intervention had a 95.0% probability of being cost-saving, and a greater than 99.9% probability of being cost-effective. Conclusions: Replacing regular salt with salt substitute was a cost-saving intervention for the prevention of stroke and improvement of quality of life amongst the SSaSS participants.

Excess consumption of dietary sodium is a major cause of high blood pressure, leading to increased risk of cardiovascular disease (CVD) and mortality. Globally, 1.7 million annual deaths from cardiovascular causes are attributed to excess sodium intake. 1 Dietary sodium reduction has been identified as an effective public health strategy for reducing the risk of major CVDs. 2,3 Despite World