PMID- 36192565
OWN - NLM
STAT- MEDLINE
DCOM- 20221005
LR  - 20221201
IS  - 2045-2322 (Electronic)
IS  - 2045-2322 (Linking)
VI  - 12
IP  - 1
DP  - 2022 Oct 3
TI  - Safety and effectiveness of 4-week therapy with aceclofenac controlled release 
      once a day.
PG  - 16519
LID - 10.1038/s41598-022-20633-6 [doi]
LID - 16519
AB  - 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.
CI  - (c) 2022. The Author(s).
FAU - Jeong, Ju-Cheol
AU  - Jeong JC
AD  - Department of Pharmacology, College of Medicine, Chung-Ang University, Seoul, 
      06974, Republic of Korea.
AD  - Clinical Research Team, Korea United Pharm Inc., Seoul, Republic of Korea.
FAU - Chung, Yoon Hee
AU  - Chung YH
AD  - Department of Anatomy, College of Medicine, Chung-Ang University, Seoul, Republic 
      of Korea.
FAU - Park, Taejun
AU  - Park T
AD  - Department of Pharmacology, College of Medicine, Chung-Ang University, Seoul, 
      06974, Republic of Korea.
FAU - Park, Seung Yeon
AU  - Park SY
AD  - Department of Pharmacology, College of Medicine, Chung-Ang University, Seoul, 
      06974, Republic of Korea.
AD  - Department of Global Innovative Drug, The Graduate School of Chung-Ang 
      University, Seoul, Republic of Korea.
FAU - Jung, Tae Woo
AU  - Jung TW
AD  - Department of Pharmacology, College of Medicine, Chung-Ang University, Seoul, 
      06974, Republic of Korea.
FAU - Abd El-Aty, A M
AU  - Abd El-Aty AM
AD  - Department of Pharmacology, Faculty of Veterinary Medicine, Cairo University, 
      Giza 12211, Egypt.
AD  - Department of Medical Pharmacology, Medical Faculty, Ataturk University, Erzurum 
      25240, Turkey.
FAU - Bang, Joon Seok
AU  - Bang JS
AD  - College of Pharmacy, Sookmyung Women's University, Seoul, Republic of Korea. 
      jsbang@sookmyung.ac.kr.
FAU - Jeong, Ji Hoon
AU  - Jeong JH
AD  - Department of Pharmacology, College of Medicine, Chung-Ang University, Seoul, 
      06974, Republic of Korea. jhjeong3@cau.ac.kr.
AD  - Department of Global Innovative Drug, The Graduate School of Chung-Ang 
      University, Seoul, Republic of Korea. jhjeong3@cau.ac.kr.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20221003
PL  - England
TA  - Sci Rep
JT  - Scientific reports
JID - 101563288
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Tablets)
RN  - 144O8QL0L1 (Diclofenac)
RN  - RPK779R03H (aceclofenac)
SB  - IM
MH  - *Anti-Inflammatory Agents, Non-Steroidal/adverse effects
MH  - Delayed-Action Preparations
MH  - Diclofenac/adverse effects/analogs & derivatives
MH  - Double-Blind Method
MH  - *Drug-Related Side Effects and Adverse Reactions/epidemiology
MH  - Female
MH  - Humans
MH  - Tablets
MH  - Treatment Outcome
PMC - PMC9530112
COIS- J.-C.J. works for Korea United Pharm. Inc., a sponsor of this research. T. P. 
      worked for this company from 2018 to 2019. Other authors declare that they have 
      no competing interests.
EDAT- 2022/10/04 06:00
MHDA- 2022/10/06 06:00
PMCR- 2022/10/03
CRDT- 2022/10/03 23:30
PHST- 2021/11/15 00:00 [received]
PHST- 2022/09/15 00:00 [accepted]
PHST- 2022/10/03 23:30 [entrez]
PHST- 2022/10/04 06:00 [pubmed]
PHST- 2022/10/06 06:00 [medline]
PHST- 2022/10/03 00:00 [pmc-release]
AID - 10.1038/s41598-022-20633-6 [pii]
AID - 20633 [pii]
AID - 10.1038/s41598-022-20633-6 [doi]
PST - epublish
SO  - Sci Rep. 2022 Oct 3;12(1):16519. doi: 10.1038/s41598-022-20633-6.