Polypill for prevention of cardiovascular diseases with focus on non-alcoholic steatohepatitis: the PolyIran-Liver Trial

Shahin Merat, Elham Jafari, Amir-Reza Radmard, Masoud Khoshnia, Maryam Sharafkhah, Alireza Nateghi Baygi, Tom Marshall, Abolfazl Shiravi Khuzani, KK Cheng, Hossein Poustchi, Reza Malekzadeh

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Background: Individuals with nonalcoholic steatohepatitis or elevated liver enzymes have increased cardiovascular mortality but are often excluded from prevention trials. We investigated the effectiveness of fixed-dose combination therapy for the prevention of major cardiovascular events (MCVE) among individuals with and without presumed non-alcoholic steatohepatitis (pNASH).
Methods: 2400 Participants over 50 were randomized into intervention and control groups. Consent was obtained post-randomization. Consenting participants in the intervention group were given a pill containing aspirin, atorvastatin, hydrochlorothiazide, and valsartan (polypill). Participants were followed for 5 years. pNASH was diagnosed by ultrasonography and elevated liver enzymes. The primary outcome was MCVE. ClinicalTrials.gov: NCT01245608.
Results: Among the originally randomized population, 138/1249 in the intervention group (11.0%) and 137/1017 controls (13.5%) had MCVE during the 5-year follow-up (unadjusted risk ratio [RR] 0.83, 95% confidence interval [CI] 0.66-1.03). Of the 1508 participants who consented to additional measurements and treatment, 63/787 (8.0%) intervention group participants and 86/721 (11.9%) controls had MCVE (adjusted RR 0.61, 95% CI 0.44-0.83). Although the adjusted relative risk of MCVE in participants with pNASH (0.35, 95% CI 0.17-0.74) was under half that for participants without pNASH (0.73, 95% CI 0.49-1.00), the difference did not reach statistical significance. There was no change in liver enzymes in participants taking polypill but among those with pNASH, there was a significant decrease after 60 months of follow-up (intragroup -12.0 IU/L, 95% CI -14.2 to -9.6).
Conclusion: Among patients consenting to receive fixed-dose combination therapy, polypill is safe and effective for prevention of MCVE, even among participants with fatty liver and increased liver enzymes.

Original languageEnglish
Article numberehab919
JournalEuropean Heart Journal
Early online date20 Jan 2022
Publication statusE-pub ahead of print - 20 Jan 2022


  • cardiovascular diseases
  • primary prevention
  • secondary prevention
  • polypill


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