# Efficacy and safety of tafolecimab a new PCSK9 inhibitor in patients with hyperlipidemia: a systematic review and meta-analysis of randomized controlled trials

## TL;DR

This study evaluates tafolecimab, a new PCSK9 inhibitor, for treating hyperlipidemia, finding it effective at lowering LDL cholesterol but with increased injection site reactions.

## Contribution

The study provides a meta-analysis of tafolecimab's efficacy and safety in hyperlipidemia, including novel lipid indices and adverse event data.

## Key findings

- Tafolecimab significantly reduced LDL percent change, LDL-C reduction, and other lipid markers.
- It increased injection site reactions but did not raise overall adverse events or serious adverse events.
- The drug showed consistent improvements across multiple lipid indices in randomized controlled trials.

## Abstract

Hyperlipidemia is a common condition as nearly over 50% of adult Americans have high low-density lipoprotein (LDL) levels. Hyperlipidemia increases the risk of strokes, myocardial infarction, and other vascular events. PCSK9 monoclonal antibodies are one of the available options for the treatment of hyperlipidemia. Our study is a systematic review and meta-analysis that assesses the efficacy and safety of a new PCSK9 antibody, tafolecimab, in hyperlipidemia.

Searching PubMed, EMBASE, Scopus, Web of Science (WOS), and Cochrane, we performed a PRISMA-based systematic review and meta-analysis to study effects of tafolecimab compared with placebo on different lipid indices that included LDL percent change, number of patients achieving ≥ 50% low-density lipoprotein cholesterol (LDL-C) reduction, LDL change from baseline, LDL change from baseline (CFB), apolipoprotein B CFB, and non-high-density lipoprotein cholesterol (non-HDL-C) CFB.

Four randomized controlled trials (RCTs) with 1093 patients were included in our study; 709 (64.87%) of them were males. Tafolecimab reduced LDL percent change [mean difference (MD) = − 62.28, 95% confidence interval (CI) (− 65.21, -59.35), P < 0.00001], the number of patients achieving ≥ 50% LDL-C reduction [MD = 46.92, 95% CI (21.91, 103.9), P < 0.0001], LDL CFB [MD = − 73.58, 95% CI (− 83.13, -64.03), P < 0.001], non-HDL-C CFB [MD = − 82.21, 95% CI (− 86.65, − 77.77), P < 0.001], apolipoprotein B CFB [MD = − 52.01, 95% CI (− 54.86, − 49.17, P < 0.001]. No difference was detected in overall adverse events (AEs) [risk ratio (RR) = 0.94, 95% CI (0.88, 1.01), P = 0.1128], serous AEs [RR = 0.93, 95% CI (0.57, 1.52), P = 0.7799], and AEs leading to treatment discontinuation [RR = 2.58, 95% CI (0.76, 8.77), but yielded more injection site reactions [RR = 2.53, 95% CI (1.14, 5.63), P = 0.0222].

Tafolecimab is a valuable treatment option for hyperlipidemia, which showed improvement in several lipid indices (LDL, LDL-C, LDL CFB, non-HDL-C CFB, and apolipoprotein B CFB). However, it increased the rates of injection site reactions.

The online version contains supplementary material available at 10.1186/s43044-025-00653-z.