RESUMO
BACKGROUND: SSaSS (Salt Substitute and Stroke Study), a 5-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 previous 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 health care system and consumers. The primary health outcome assessed was stroke. We also quantified the effect on quality-adjusted life-years (QALYs). Health care costs were identified from participant health insurance records and the literature. All costs (in Chinese yuan [¥]) 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% CI, 0.77-0.96]; P=0.006), and the salt substitute group had on average 0.054 more QALYs per person. The average costs (¥1538 for the intervention group and ¥1649 for the control group) were lower in the salt substitute group (¥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 >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 among SSaSS participants.
Assuntos
Hipertensão , Acidente Vascular Cerebral , Análise Custo-Benefício , Humanos , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Cloreto de Sódio na Dieta/efeitos adversos , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/prevenção & controleRESUMO
INTRODUCTION: Cardiovascular diseases (CVDs) are the leading causes of death and disability worldwide. Reducing dietary salt consumption is a potentially cost-effective way to reduce blood pressure and the burden of CVD. To date, economic evidence has focused on sodium reduction in food industry or processed food with blood pressure as the primary outcome. This study protocol describes the planned within-trial economic evaluation of a low-sodium salt substitute intervention designed to reduce the risk of stroke in China. METHODS AND ANALYSES: The economic evaluation will be conducted alongside the Salt Substitute and Stroke Study: a 5-year large scale, cluster randomised controlled trial. The outcomes of interest are quality of life measured using the EuroQol-5-Dimensions and major adverse cardiovascular events. Costs will be estimated from a healthcare system perspective and will be sought from the routinely collected data available within the New Rural Cooperative Medical Scheme. Cost-effectiveness and cost-utility analyses will be conducted, resulting in the incremental cost-effectiveness ratio expressed as cost per cardiovascular event averted and cost per quality-adjusted life year gained, respectively. ETHICS AND DISSEMINATION: The trial received ethics approval from the University of Sydney Ethics Committee (2013/888) and Peking University Institutional Review Board (IRB00001052-13069). Informed consent was obtained from each study participant. Findings of the economic evaluation will be published in a peer-reviewed journal and presented at international conferences. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT02092090).
Assuntos
Qualidade de Vida , Acidente Vascular Cerebral , China , Análise Custo-Benefício , Humanos , Anos de Vida Ajustados por Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Acidente Vascular Cerebral/prevenção & controleRESUMO
BACKGROUND: Regular salt is about 100% sodium chloride. Low-sodium salts have reduced sodium chloride content, most commonly through substitution with potassium chloride. Low-sodium salts have a potential role in reducing the population's sodium intake levels and blood pressure, but their availability in the global market is unknown. OBJECTIVE: The aim of this study is to assess the availability, formulation, labeling, and price of low-sodium salts currently available to consumers worldwide. METHODS: Low-sodium salts were identified through a systematic literature review, Google search, online shopping site searches, and inquiry of key informants. The keywords "salt substitute," "low-sodium salt," "potassium salt," "mineral salt," and "sodium reduced salt" in six official languages of the United Nations were used for the search. Information about the brand, formula, labeling, and price was extracted and analyzed. RESULTS: A total of 87 low-sodium salts were available in 47 out of 195 (24%) countries worldwide, including 28 high-income countries, 13 upper-middle-income countries, and 6 lower-middle-income countries. The proportion of sodium chloride varied from 0% (sodium-free) to 88% (as percent of weight; regular salt is 100% sodium chloride). Potassium chloride was the most frequent component with levels ranging from 0% to 100% (potassium chloride salt). A total of 43 (49%) low-sodium salts had labels with the potential health risks, and 33 (38%) had labels with the potential health benefits. The median price of low-sodium salts in high-income, upper-middle-income, and lower-middle-income countries was US $15.00/kg (IQR 6.4-22.5), US $2.70/kg (IQR 1.7-5.5), and US $2.90/kg (IQR 0.50-22.2), respectively. The price of low-sodium salts was between 1.1 and 14.6 times that of regular salts. CONCLUSIONS: Low-sodium salts are not widely available and are commonly more expensive than regular salts. Policies that promote the availability, affordability, and labeling of low-sodium salts should increase uptake, helping populations reduce blood pressure and prevent cardiovascular diseases. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1111/jch.14054.