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Aim We aimed to perform a systematic review and meta-analysis of randomised controlled trials (RCTs) to determine the impact of a polypill-based strategy (PBS) on therapeutic adherence and cardiovascular outcomes compared with usual care for secondary prevention of cardiovascular diseases (CVD). Methods We systematically searched PubMed, Cochrane, and Scopus databases from inception to January 2023, including RCTs comparing PBS to usual care in patients with prior CVD. We assessed efficacy outcomes of therapeutic adherence, systolic blood pressure (SBP) and low-density lipoprotein-cholesterol (LDL-C), and safety outcomes of all-cause and cardiovascular mortality. Statistical analysis was performed with Review Manager 5.4.1 and R Version 4.2.1. Results A total of eight RCTs with a population of 6,541 individuals were included, of whom 3,318 (50.7%) were treated with PBS. Follow-up ranged from 6 to 60 months. PBS was associated with a significantly increased therapeutic adherence (risk ratio [RR] 1.22; 95% CI 1.10 to 1.34; p<0.001). Cardiovascular mortality (RR 0.61; 95% CI 0.44 to 0.85; p=0.004), SBP (mean difference [MD] -1.47 mmHg; 95% CI -2.86 to -0.09; p=0.04), and LDL-C (MD -3.83 mg/dL; 95% CI –6.99 to -0.67; p=0.02) were significantly lower in PBS group. The incidence of all-cause mortality was similar between groups (RR 0.83; 95% CI 0.54 to 1.29; p=0.41). Conclusions In patients with pre-existing CVD, a PBS is associated with lower cardiovascular mortality and improved therapeutic adherence, along with a modest decrease in SBP and LDL-C compared with usual care. Thus, PBS may be considered a preferred option for this patient population.