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AbbVie : Phase 2 Trial Of AGN-151607 In POAF In Cardiac Surgery Patients Fails To Meet Main Goal

AbbVie (ABBV) announced results from its exploratory NOVA phase 2 dose-ranging study evaluating the efficacy and safety of AGN-151607, a novel investigational neurotoxin for the prevention of postoperative atrial fibrillation in cardiac surgery patients.
The primary endpoint of evaluating the occurrence of continuous atrial fibrillation greater than or equal to 30 seconds was not met for the modified intent-to-treat population; however, the data showed relative risk reduction in specific study populations, such as coronary artery bypass graft patients and patients aged 65 years and older.

Postoperative atrial fibrillation is the most common complication following cardiac surgery, leading to increased morbidity, mortality, increased length of hospital stay, healthcare utilization, and cost.

In the Study, relative risk reduction was seen in certain subgroups; specifically, pre-specified coronary artery bypass graft patients treated with 125 units of AGN-151607 received the greatest benefit with 29 percent relative risk reduction compared to placebo, the company said.

In a post hoc analysis of coronary artery bypass graft patients aged 65 years and older treated with 125 units of AGN-151607, the study found a greater risk reduction at 51 percent compared to placebo.

Regarding rehospitalization within 30 days following discharge, patients treated with 125 units had lower rates of all-cause rehospitalization within 30 days compared to placebo. In addition, at the time of this analysis, more patients on 125 units (62.9%) were atrial fibrillation-free and anticoagulation-free versus placebo (45.1%).

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