PMID- 31394044
OWN - NLM
STAT- MEDLINE
DCOM- 20191011
LR  - 20191011
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
VI  - 18
IP  - 10
DP  - 2019 Oct
TI  - Safety of bazedoxifene in Korean women with post-menopausal osteoporosis: a 
      post-marketing surveillance study (PMSS).
PG  - 1001-1008
LID - 10.1080/14740338.2019.1654454 [doi]
AB  - Objectives: Bazedoxifene was found to be effective and well tolerated for the 
      treatment and prevention of osteoporosis in postmenopausal women. This 
      post-marketing surveillance study (PMSS) examined the safety of bazedoxifene in 
      postmenopausal Korean women with osteoporosis, in a real-world setting. Methods: 
      This PMSS was conducted from 2013 to 2017. A total of 3,423 subjects from 68 
      centers were enrolled and monitored for about 3 months (+/- 2 weeks). Bazedoxifene 
      was prescribed at a dose of 20 mg/day. The safety of bazedoxifene was evaluated 
      based on the number and nature of adverse events (AEs), serious AEs (SAEs), 
      adverse drug reactions (ADRs) and serious ADRs (SADRs) in routine medical 
      practice. Results: The mean age of study subjects was 69.51 years. The incidence 
      of AEs and ADRs was 6.11% and 3.86%, respectively, and significantly decreased 
      with increasing age (p= 0.0007). AE and ADR rates with bazedoxifene treatment of 
      3 months or more were significantly lower than those of less than 3 months (AE, 
      3.64% vs 30.00%, p < 0.0001; ADR, 1.74% vs 24.38%, p < 0.0001). Conclusion: In 
      this study, bazedoxifene was well tolerated in the management of postmenopausal 
      osteoporosis in Korean women, including those aged 70 years or more.
FAU - Kim, Ji Wan
AU  - Kim JW
AD  - Department of Orthopaedic Surgery, Asan Medical Center, University of Ulsan, 
      College of Medicine , Seoul , South Korea.
FAU - Lee, Ji Young
AU  - Lee JY
AD  - Department of Obstetrics and Gynecology, Konkuk University School of Medicine , 
      Seoul , South Korea.
FAU - Park, Hyung-Eun
AU  - Park HE
AD  - Medical Affairs, Essential Health, Pfizer Pharmaceuticals Korea Ltd. , Seoul , 
      South Korea.
FAU - Kim, Sang-Hee
AU  - Kim SH
AD  - Medical Affairs, Essential Health, Pfizer Pharmaceuticals Korea Ltd. , Seoul , 
      South Korea.
FAU - Chung, Yoon-Sok
AU  - Chung YS
AD  - Department of Endocrinology and Metabolism, Ajou University School of Medicine , 
      Suwon , South Korea.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20190814
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
RN  - 0 (Bone Density Conservation Agents)
RN  - 0 (Indoles)
RN  - 0 (Selective Estrogen Receptor Modulators)
RN  - Q16TT9C5BK (bazedoxifene)
SB  - IM
MH  - Age Factors
MH  - Aged
MH  - Aged, 80 and over
MH  - Bone Density Conservation Agents/*administration & dosage/adverse effects
MH  - Female
MH  - Humans
MH  - Incidence
MH  - Indoles/*administration & dosage/adverse effects
MH  - Middle Aged
MH  - Osteoporosis, Postmenopausal/*drug therapy
MH  - Product Surveillance, Postmarketing
MH  - Republic of Korea
MH  - Selective Estrogen Receptor Modulators/*administration & dosage/adverse effects
MH  - Time Factors
OTO - NOTNLM
OT  - Post-marketing surveillance study
OT  - adverse drug reactions
OT  - adverse event
OT  - bazedoxifene
OT  - postmenopausal osteoporosis
OT  - safety
EDAT- 2019/08/09 06:00
MHDA- 2019/10/12 06:00
CRDT- 2019/08/09 06:00
PHST- 2019/08/09 06:00 [pubmed]
PHST- 2019/10/12 06:00 [medline]
PHST- 2019/08/09 06:00 [entrez]
AID - 10.1080/14740338.2019.1654454 [doi]
PST - ppublish
SO  - Expert Opin Drug Saf. 2019 Oct;18(10):1001-1008. doi: 
      10.1080/14740338.2019.1654454. Epub 2019 Aug 14.