TY - JOUR
T1 - Fixed-Dose Combination (Polypill) for Cardiovascular Disease Prevention
T2 - A Meta-Analysis
AU - Abushouk, Abdelrahman I.
AU - Sayed, Ahmed
AU - Munir, Malak
AU - Ghanem, Esraa
AU - Abdelfattah, Omar
AU - Michos, Erin D.
AU - Mentias, Amgad
AU - Kapadia, Samir
AU - Nissen, Steven E.
N1 - Funding Information:
AIA and AS contributed equally to this work. SK and SN contributed equally to this work. All authors declare no conflicts of interest, relevant to the current work. Outside of this work, EDM reports advisory board relationships with Esperion, Amarin, Novartis, and Astra Zeneca. SN has conducted clinical trials with Novartis, Eli Lilly, Abbvie, MyoKardia, Astra Zeneca, Pfizer, Novo Nordisk, Medtronic, Amgen, and Takeda. SN does not accept honoraria, consulting fees, or any other reimbursement for these activities. No other financial disclosures were reported. Abdelrahman I. Abushouk: Conceptualization, Formal analysis, Methodology, Project administration; Software, Writing - original draft. Ahmed Sayed: Data curation, Formal analysis, Software, Visualization, Writing - original draft. Malak Munir: Data curation, Verification. Esraa Ghanem: Data curation, Resources. Omar Abdelfattah: Writing - original draft. Erin D. Michos: Writing - review and editing. Amgad Mentias: Writing - review and editing. Samir Kapadia: Supervision, Writing - review and editing. Steven Nissen: Project administration, Supervision Writing – review and editing.
Publisher Copyright:
© 2022 American Journal of Preventive Medicine
PY - 2022/9
Y1 - 2022/9
N2 - Introduction: This meta-analysis was performed to assess the efficacy of fixed-dose combination (polypill) in reducing the risk of mortality and cardiovascular events. Methods: Medline, Scopus, Web of Science, and Cochrane Central were searched during May 2021. All randomized trials investigating the efficacy of antihypertensive and lipid-lowering ± antiplatelet drug combinations in patients at cardiovascular risk were included. Outcomes were presented as risk ratios or standardized mean differences with 95% CIs. Results: A total of 16 trials (N = 26,567 participants) were included. The risk reduction for all-cause mortality (risk ratio = 0.90; 95% CI = 0.79, 1.01; I2 = 0%; moderate certainty) and major adverse cardiac events (risk ratio=0.84; 95% CI=0.68, 1.04; I2=51%; very low certainty) did not reach statistical significance in comparison with those of the control group. Subgroup analysis of studies that used an active control yielded similar results. However, significant reductions in major adverse cardiac event risk were observed in studies that exclusively targeted primary prevention, followed patients for ≥4 years, and had a low risk of bias. The polypill group had significantly higher adherence (risk ratio=1.18; 95% CI=1.06, 1.32; I2=96%; very low certainty) and comprable rates of adverse side effects (risk ratio=1.10; 95% CI=0.98, 1.23; I2=58%; moderate certainty) with those of the control group. Patients randomized to the polypill had significant reductions in systolic and diastolic blood pressure as well as in total and low-density lipoprotein cholesterol. Discussion: Despite reductions in cardiovascular risk factors, the observed mortality benefit for the polypill did not reach statistical significance. Further studies are needed to validate its clinical benefits and determine the patient populations likely to achieve such benefits.
AB - Introduction: This meta-analysis was performed to assess the efficacy of fixed-dose combination (polypill) in reducing the risk of mortality and cardiovascular events. Methods: Medline, Scopus, Web of Science, and Cochrane Central were searched during May 2021. All randomized trials investigating the efficacy of antihypertensive and lipid-lowering ± antiplatelet drug combinations in patients at cardiovascular risk were included. Outcomes were presented as risk ratios or standardized mean differences with 95% CIs. Results: A total of 16 trials (N = 26,567 participants) were included. The risk reduction for all-cause mortality (risk ratio = 0.90; 95% CI = 0.79, 1.01; I2 = 0%; moderate certainty) and major adverse cardiac events (risk ratio=0.84; 95% CI=0.68, 1.04; I2=51%; very low certainty) did not reach statistical significance in comparison with those of the control group. Subgroup analysis of studies that used an active control yielded similar results. However, significant reductions in major adverse cardiac event risk were observed in studies that exclusively targeted primary prevention, followed patients for ≥4 years, and had a low risk of bias. The polypill group had significantly higher adherence (risk ratio=1.18; 95% CI=1.06, 1.32; I2=96%; very low certainty) and comprable rates of adverse side effects (risk ratio=1.10; 95% CI=0.98, 1.23; I2=58%; moderate certainty) with those of the control group. Patients randomized to the polypill had significant reductions in systolic and diastolic blood pressure as well as in total and low-density lipoprotein cholesterol. Discussion: Despite reductions in cardiovascular risk factors, the observed mortality benefit for the polypill did not reach statistical significance. Further studies are needed to validate its clinical benefits and determine the patient populations likely to achieve such benefits.
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U2 - 10.1016/j.amepre.2022.03.027
DO - 10.1016/j.amepre.2022.03.027
M3 - Review article
C2 - 35613977
AN - SCOPUS:85130428492
SN - 0749-3797
VL - 63
SP - 440
EP - 449
JO - American journal of preventive medicine
JF - American journal of preventive medicine
IS - 3
ER -