Some types of medicines, like effervescent, dispersible, and soluble formulations, contain a substance called 'salt,' which helps these medicines work better and be more convenient to use. However, taking such medicines can add to the amount of salt we consume daily, possibly leading to unintentional and harmful effects on our health. Studies have already shown that reducing salt intake can be beneficial for people with high blood pressure, as it lowers their risk of heart diseases.
Now, we want to find out if stopping these salt-containing medicines can also have similar benefits for people who have developed high blood pressure after using these drugs. To do this, we will be looking at data from the Clinical Practice and Research Datalink. By comparing the risks of heart-related problems when people stop taking these salt-containing medicines versus those who continue to take them, we hope to learn whether stopping these medicines can help prevent heart diseases.
The information from this study will be essential for doctors and public health experts to make better decisions about the use of these medicines and develop strategies to reduce the potential harmful effects of excessive salt intake.
This study aims to assess the association between discontinuation of sodium-containing drugs after developing hypertension and cardiovascular events by applying a cohort study design with sequential trials emulation approach. The study population includes individuals aged ≥60 years who have been newly diagnosed with hypertension and receive regular treatments with sodium-containing drugs before initial hypertension diagnosis during 2004-2022. Regular treatment with sodium-containing medications is defined as having ≥2 prescriptions of same class within 180 days prior to the hypertension diagnosis. Treatment strategies in this study are (1) discontinuation and (2) continuation of sodium-containing drug use after the initial hypertension diagnosis. The primary outcomes are major adverse cardiovascular events (composite of nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death) and hospitalisation for heart failure. Secondary outcomes include individual components of major adverse cardiovascular events and all-cause death. We will use prescription records from primary care data to ascertain patients’ compatible treatment strategy, and primary care, HES and ONS data for outcome ascertainment. We will estimate risks of outcomes in people who discontinue the sodium-containing drug after hypertension diagnosis comparing people who continuously use. We will emulate a sequence of target trials during each three months from initial hypertensive diagnosis through up to five years (each with a 3-month enrolment period). For each sequential trial, we will identify eligible patients who continued sodium-containing drug until the previous period and assigned them to sodium-containing drug discontinuation or not at that period. Pooled logistic regression model will be used as the outcome model to pool the data from all sequential trials into a single model. We will then several subgroup and analyses and sensitivity analyses to assess the robustness of the results. This proposed research can generate important evidence to guide deprescribing of sodium-containing medications that could reduce cardiovascular disease burdens.
The outcome of interest will be 3-point major adverse cardiovascular events (3P-MACE; including myocardial infarction, stroke, and cardiovascular death), and hospitalisation for heart failure. The secondary study outcomes will be individual outcome of 3P-MACE and all-cause death.
Li Wei - Chief Investigator - University College London ( UCL )
Sohee Park - Corresponding Applicant - University College London ( UCL )
Chengsheng Ju - Collaborator - University College London ( UCL )
Kenneth Man - Collaborator - University College London ( UCL )
Wallis Lau - Collaborator - University College London ( UCL )
Chengsheng Ju - Collaborator - University College London ( UCL )
HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation