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Polypill protects MAFLD patients from cardiovascular events and mortality: a prospective trial
Alireza Ramandi1,2, Jacob George3, Shahin Merat1,2
1Liver and Pancreatobiliary Diseases Research Center, Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran.
Background:
Metabolic dysfunction-associated fatty liver disease (MAFLD) is a novel term that distinguishes patients at risk of adverse clinical outcomes with higher accuracy than those with non-alcoholic fatty liver disease (NAFLD). Cardiovascular mortality is the leading cause of death in MAFLD. The current literature lacks large-scale prospective studies that address preventive approaches for cardiovascular health in MAFLD. We investigated whether MAFLD patients benefit from a fixed-dose combination therapy (Aspirin, hydrochlorothiazide, atorvastatin, valsartan), known as a Polypill.
Methods:
Analysis was performed (stratified based on MAFLD status) of a clinical trial that included 1596 individuals randomly allocated to an intervention (polypill) or a control (usual care) group. Patients were followed up for five years for any adverse drug reaction, major cardiovascular events, and mortality. Univariable and multivariable survival analyses were performed, and the interaction level was assessed by R programming.
Results:
Patients who consumed the polypill had significantly lower hazard ratios of major cardiovascular events incidence (HR 0.56, 95% CI 0.41-0.78) and cardiovascular mortality (HR 0.41, 95% CI 0.2-0.86) compared to the control group. Polypill showed significantly better results in lowering cardiovascular events in MAFLD patients than in the general population. (p-value for interaction: 0.028). Moreover, comparing those patients who had high adherence to the Polypill, with the control group, further enhanced the results.
Conclusions:
Major cardiovascular events are prevented in MAFLD patients who consume the Polypill. MAFLD patients benefit from the Polypill more than the general population.
Insights
Metabolic dysfunction-associated fatty liver disease (MAFLD) patients taking a polypill significantly reduced cardiovascular events and mortality. This fixed-dose combination therapy offers greater benefits for MAFLD patients than the general population.
Area of Science:
- Cardiology
- Hepatology
- Pharmacology
Background:
- Metabolic dysfunction-associated fatty liver disease (MAFLD) is increasingly recognized for its association with adverse clinical outcomes.
- Cardiovascular mortality is the primary cause of death among individuals with MAFLD.
- There is a need for large-scale studies on preventive cardiovascular strategies in MAFLD.
Purpose of the Study:
- To investigate the efficacy of a fixed-dose combination therapy (Polypill) in preventing major cardiovascular events and mortality in MAFLD patients.
- To compare the benefits of the Polypill in MAFLD patients versus the general population.
Main Methods:
- A clinical trial involving 1596 individuals was analyzed, with participants randomized to either the Polypill intervention or usual care.
- Patients were followed for five years to monitor adverse drug reactions, major cardiovascular events, and mortality.
- Univariable and multivariable survival analyses were conducted, with interaction assessed using R programming.
Main Results:
- Polypill consumption was associated with significantly lower hazard ratios for major cardiovascular events (HR 0.56) and cardiovascular mortality (HR 0.41) compared to the control group.
- The Polypill demonstrated superior efficacy in reducing cardiovascular events in MAFLD patients compared to the general population (p-value for interaction: 0.028).
- High adherence to the Polypill further amplified these protective effects.
Conclusions:
- The Polypill is effective in preventing major cardiovascular events in patients with MAFLD.
- MAFLD patients derive a greater benefit from Polypill therapy than the general population, highlighting its targeted cardiovascular protective role.
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