Allergan plc, 2525 Dupont Drive; T1-1B, Irvine, CA, 92623-9534, USA.
Allergan plc, Bridgewater, NJ, USA.
CNS Drugs. 2020 Apr;34(4):433-445. doi: 10.1007/s40263-020-00709-5.
OnabotulinumtoxinA is approved as a treatment across multiple indications. For the treatment of spasticity, onabotulinumtoxinA is injected directly into affected muscles. Intramuscular injections may result in local bleeding and related complications, especially in patients receiving anticoagulant therapy. Despite anticoagulants being commonly used, there is limited information in the medical literature regarding the safety of intramuscular medications in patients receiving oral anticoagulants. This retrospective analysis included pooled safety data from Allergan-sponsored studies evaluating onabotulinumtoxinA for the treatment of patients with muscle spasticity.
The objective of this study was to determine the risk of bleeding complications in patients with post-stroke spasticity receiving antithrombotic therapy and intramuscular onabotulinumtoxinA.
We conducted a retrospective analysis of pooled safety data from 16 randomized, double-blind, placebo-controlled Allergan-sponsored studies of onabotulinumtoxinA for the treatment of post-stroke upper or lower limb muscle spasticity, including adult patients with at least moderate upper or lower limb spasticity and receiving at least one dose of the study drug. Bleeding-related adverse events starting within 4 weeks of study treatment were assessed. The incidence rates of bleeding complications were compared for patients receiving classes of antithrombotic therapy vs those not receiving antithrombotic therapy and for those receiving onabotulinumtoxinA vs placebo (with or without antithrombotic therapy).
Of 1877 patients, 1182 received antithrombotic therapy. The overall incidence of bleeding complications was < 2%. In those receiving any antithrombotic therapy, the incidence of bleeding was 1.0% vs 1.4% (no antithrombotic therapy); after onabotulinumtoxinA, it was 0.9% for those receiving antithrombotic therapy vs 1.4% (no antithrombotic therapy), and for placebo 1.2% vs 1.4%, respectively. Subgroup results were similar.
No apparent increased risk of bleeding complications was observed following administration of onabotulinumtoxinA to patients receiving antithrombotic therapy. Nonetheless, patient education and careful observation of the injection site in patients receiving antithrombotic therapy remains warranted.
肉毒毒素 A 已被批准用于多种适应证的治疗。对于痉挛的治疗，肉毒毒素 A 直接注射到受影响的肌肉中。肌肉内注射可能导致局部出血和相关并发症，尤其是在接受抗凝治疗的患者中。尽管抗凝剂被广泛使用，但在接受口服抗凝剂的患者中，关于肌肉内药物安全性的医学文献信息有限。这项回顾性分析包括评估肉毒毒素 A 治疗肌肉痉挛患者的 Allergan 赞助研究的汇总安全性数据。
本研究的目的是确定接受抗血栓治疗和肌肉内肉毒毒素 A 的脑卒中后痉挛患者发生出血并发症的风险。
我们对 16 项评估肉毒毒素 A 治疗脑卒中上肢或下肢肌肉痉挛的随机、双盲、安慰剂对照 Allergan 赞助研究的汇总安全性数据进行了回顾性分析，包括至少有中度上肢或下肢痉挛且至少接受一次研究药物治疗的成年患者。评估了治疗开始后 4 周内与出血相关的不良事件。比较了接受抗血栓治疗的患者与未接受抗血栓治疗的患者以及接受肉毒毒素 A 与安慰剂（无论是否接受抗血栓治疗）的患者发生出血并发症的发生率。
在 1877 例患者中，有 1182 例接受了抗血栓治疗。出血并发症的总发生率<2%。在接受任何抗血栓治疗的患者中，出血发生率为 1.0%比 1.4%（未接受抗血栓治疗）；接受肉毒毒素 A 治疗后，接受抗血栓治疗的患者为 0.9%比 1.4%（未接受抗血栓治疗），而安慰剂组分别为 1.2%和 1.4%。亚组结果相似。
未观察到接受抗血栓治疗的患者接受肉毒毒素 A 治疗后出血并发症的风险明显增加。然而，仍需要对接受抗血栓治疗的患者进行患者教育并仔细观察注射部位。
