Department of Pharmacology, College of Medicine, Chung-Ang University, Seoul, 06974, Republic of Korea.
Clinical Research Team, Korea United Pharm Inc., Seoul, Republic of Korea.
Sci Rep. 2022 Oct 3;12(1):16519. doi: 10.1038/s41598-022-20633-6.
Aceclofenac controlled-release (CR) is a once-a-day tablet with 200 mg of aceclofenac, and is bioequivalent to conventional aceclofenac. However, its safety in humans has not been well studied in Korea. Therefore, we aimed to evaluate the overall incidence and patterns of adverse events (AEs), the effectiveness of aceclofenac CR, and the differences in incidence rates of the AEs based on each patient's baseline charateristics. This study was conducted on patients receiving aceclofenac CR in clinical practice at each investigational institution to treat musculoskeletal pain and inflammation. The subjects were administered one tablet of aceclofenac CR (200 mg once-a-day) and were observed for 4 weeks post-administration. Factors affecting the occurrence of AEs were evaluated, and the Visual Analogue Scale (VAS) was used to measure the pain intensity. Among 14,543 subjects, the incidence rate of AEs was 0.86%, and that of adverse drug reactions was 0.74%. No serious AEs and unexpected adverse drug reactions were monitored. The incidence rates of AEs were significantly higher in females, inpatient treatment, individuals with concurrent disorders, and those receiving concomitant medications, respectively (all P < 0.05). Four weeks post-using aceclofenac CR, the mean changes in VAS was significantly decreased compared to prior administration. The overall clinical efficacy rate was 91.63%. This study confirmed that no severe adverse reactions were observed for aceclofenac CR exceeding those previously reported for safety results of conventional formulation of this drug in routine clinical practice settings. The use of aceclofenac CR might not violate the previously reported information on the safety and effectiveness of aceclofenac.
双氯芬酸控释片（CR）是一种每日一次的片剂，含有 200 毫克双氯芬酸，与普通双氯芬酸具有生物等效性。然而，其在韩国人群中的安全性尚未得到充分研究。因此，我们旨在评估双氯芬酸 CR 的总体不良反应（AE）发生率和模式、有效性，以及根据每位患者的基线特征，AE 发生率的差异。本研究在各研究机构的临床实践中，对接受双氯芬酸 CR 治疗肌肉骨骼疼痛和炎症的患者进行。受试者服用一片双氯芬酸 CR（每日一次 200 毫克），并在给药后 4 周进行观察。评估了影响 AE 发生的因素，并使用视觉模拟量表（VAS）测量疼痛强度。在 14543 名受试者中，AE 的发生率为 0.86%，药物不良反应的发生率为 0.74%。未监测到严重 AE 和意外药物不良反应。AE 的发生率在女性、住院治疗、合并症患者和同时使用合并药物的患者中分别显著更高（均 P < 0.05）。与给药前相比，使用双氯芬酸 CR 4 周后，VAS 的平均变化显著降低。总体临床疗效率为 91.63%。本研究证实，在常规临床实践环境中，与该药物常规制剂的安全性结果相比，双氯芬酸 CR 未观察到严重不良反应。使用双氯芬酸 CR 可能不会违反先前报告的关于双氯芬酸安全性和有效性的信息。
