[Презентация] Эффективность Asundexian в профилактике повторного инсульта

Asundexian продемонстрировал снижение риска повторного ишемического инсульта у пациентов с некардиоэмболическим инсультом или высоким риском транзиторной ишемической атаки (ТИА), без увеличения частоты серьезных кровотечений. Добавление препарата к стандартной антиагрегантной терапии безопасно и эффективно.

We conducted a phase 3, double-blind, event-driven, randomized, placebo-controlled trial at 702 centers in 37 countries. Relevant health authorities and independent ethics committees approved the trial. Written informed consent was obtained from all participants or their legally authorized representatives. An independent data and safety monitoring board supervised the trial. It was conducted according to the principles of the Declaration of Helsinki and international ethical guidelines. Bayer sponsored the trial, and amendments to the protocol are described in the protocol and in Table S1. The steering committee, including Population Health Research Institute investigators and external experts, oversaw the trial's conduct. Data were entered into an electronic case-record form and maintained by the sponsor. Confidentiality agreements ensured the authors' independence in analyzing, interpreting, and reporting the results. All data analyses were performed at the Population Health Research Institute. The authors guaranteed the completeness and accuracy of the data and the fidelity of the trial to the protocol.

Снижение риска смерти от сердечно-сосудистых заболеваний в группе аспунде́ксиана (Фиг. 1А, Табл. 2). Аспунде́ксиан снижает риск инсульта Серьезные неблагоприятные события схожи в группах

Secondary efficacy outcomes evaluated included various endpoints such as any stroke, death from cardiovascular causes, myocardial infarction, or stroke, death from any cause, ischemic stroke within 90 days, disabling or fatal stroke, and transient ischemic attack (TIA). Secondary safety outcomes assessed ISTH major or clinically relevant nonmajor bleeding, symptomatic intracranial hemorrhage, hemorrhagic stroke, fatal bleeding, and minor bleeding. Adverse events occurred in 69.3% of the asundexian group and 70.1% of the placebo group. Serious adverse events were reported in 19.2% of patients receiving asundexian and 19.5% of those receiving placebo. The study findings indicate a lower risk of ischemic stroke with asundexian compared to placebo, without an increased risk of major bleeding.

Безопасность терапии без увеличения кровотечений Широкая применимость и преимущества лечения Снижение риска ишемического инсульта Эффективность при различных типах инсультов