Abstract
Background: Randomized controlled trials (RCTs) of sodium-glucose transporter-2 inhibitors (SGLT-2is) have proven to be effective in decreasing major adverse cardiovascular events (MACE) in patients with heart failure. A recently published meta-analysis showed that the use of SGLT-2i among women with diabetes resulted in less reduction in MACE vs. men. This study aims to determine sex differences in MACE in patients with chronic heart failure. Methods: We systematically searched the medical database until April 30, 2022, and retrieved all the RCTs using SGLT-2is with specified CV outcomes. We used PRISMA, Preferred Reporting Items for a Review and Meta-analysis. We pooled the hazard ratio (HR) of MACE in both sexes, did a meta-analysis, and analyzed the odds ratio (OR) of MACE based on sex. Statistical analysis was completed with the use of Cochrane Review Manager (RevMan) version 5.4. Results of the pooled hazard ratio (HR) and the 95% confidence interval (CI) were made based on intention-to-treat analysis. Results: Figure 1 shows the results of the meta-analysis of 4 RCTs conducted with SGLT-2is (n=20725) vs. placebo. MACE was significantly lower in males and females taking SGLT-2is (men - HR 0.76; 95% CI 0.69 to 0.83; p=0.00001; women - HR 0.72; 95% CI 0.63 to 0.83; p=0.00001). Pooled data from three of the RCTs (n=7233) revealed a greater reduction in MACE in females vs. males (OR 1.32; 95% CI 1.14 to 1.53; p=0.0002). Conclusion: SGLT-2is reduce the risk of MACE in patients with heart failure, regardless of sex. However, the benefits were more pronounced in females, contrary to the meta-analysis of SGLT-2is in patients with diabetes. This finding may reflect an actual sex difference due to physiologic or behavioral factors or can be due to inadequate statistical power. More sex-based RCTs may help establish these sex differences in cardiovascular outcomes.
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