Article Impact Level: HIGH Data Quality: STRONG Summary of European Heart Journal, 43(21), 2023–2033. https://doi.org/10.1093/eurheartj/ehab919 Shahin Merat, Tehran University of Medical Sciences
Points
- There is an increased onset of cardiovascular mortality with high levels of hepatic enzymes or non-alcoholic steatohepatitis
- The randomized controlled trial divided the participants into intervention and control groups. Intervention group participants received polypill (atorvastatin, valsartan, hydrochlorothiazide, and aspirin)
- Polypill is safe and effective for the prevention of MCVE in individuals with and without elevated hepatic enzymes or non-alcoholic steatohepatitis
Summary
The onset of increased levels of liver enzymes or non-alcoholic steatohepatitis has a greater risk for cardiovascular mortality. However, the affected individuals are not included in the prevention trials. The goal of this open-label randomized controlled trial was to evaluate the outcomes of administration of fixed-dose polypill, comprising atorvastatin, valsartan, hydrochlorothiazide, and aspirin is associated with major cardiovascular events. The researchers also aimed to investigate the secondary outcomes in the polypill and control groups, which comprised all-cause mortality, changes in the levels of low-density lipoprotein (LDL), alterations in the systolic blood pressure, changes in liver stiffness, and changes in the levels of hepatic enzymes, aspartate aminotransferase (AST) and alanine aminotransferase (ALT).
1508 of the total selected 2400 participants above 50 years of age were randomized into two groups – the control group and the intervention (polypill) group. After obtaining consent, the intervention group participants were administered polypill, which contains atorvastatin, valsartan, hydrochlorothiazide, and aspirin. The total follow-up duration of the trial was 5 years or 60 months. Presumed non-alcoholic steatohepatitis, pre-existing cardiovascular disease, and presumed non-alcoholic fatty liver disease were attributed to 20%, 15%, and 40% of the study participants. The diagnosis of presumed non-alcoholic steatohepatitis was performed using higher levels of liver enzymes and ultrasonography. The primary outcome measured in the study participants in major cardiovascular events (MCVE).
8% of participants in the intervention group and 11.9% of the participants in the control group were subjected to MCVE such as sudden death, coronary artery revascularization procedures, fatal myocardial infarction, new-onset heart failure, stroke, and acute coronary event. In individuals with presumed non-alcoholic steatohepatitis who were administered polypill, there was a significant reduction in the levels of liver enzymes, particularly ALT, after the follow-up duration of 5 years. Moreover, all-cause mortality was significantly lower in the intervention group participants as compared to participants who did not receive polypill.
The study demonstrates polypill to be a safe and effective primary prevention approach for MCVE, even in individuals with elevated liver enzymes and presumed non-alcoholic steatohepatitis.
Link to the article: https://academic.oup.com/eurheartj/article-abstract/43/21/2023/6511856
References Merat, S., Jafari, E., Radmard, A. R., Khoshnia, M., Sharafkhah, M., Nateghi Baygi, A., Marshall, T., Shiravi Khuzani, A., Cheng, K. K., Poustchi, H., & Malekzadeh, R. (2022). Polypill for prevention of cardiovascular diseases with focus on non-alcoholic steatohepatitis: The PolyIran-Liver trial. European Heart Journal, 43(21), 2023–2033. https://doi.org/10.1093/eurheartj/ehab919
