PMID- 20535606
OWN - NLM
STAT- MEDLINE
DCOM- 20111121
LR  - 20211020
IS  - 1433-2965 (Electronic)
IS  - 0937-941X (Linking)
VI  - 22
IP  - 2
DP  - 2011 Feb
TI  - Safety and tolerability of bazedoxifene in postmenopausal women with 
      osteoporosis: results of a 5-year, randomized, placebo-controlled phase 3 trial.
PG  - 567-76
LID - 10.1007/s00198-010-1302-6 [doi]
AB  - Findings from this 5-year phase 3 study of postmenopausal women with osteoporosis 
      showed that bazedoxifene was associated with an overall favorable safety and 
      tolerability profile, with no evidence of endometrial or breast stimulation. 
      Overall, the results at 5 years were consistent with those seen at 3 years. 
      INTRODUCTION: We report safety and tolerability findings from a 5-year 
      randomized, double-blind, phase 3 study of bazedoxifene in postmenopausal women 
      with osteoporosis. METHODS: In the core study, healthy postmenopausal women with 
      osteoporosis (N=7,492; mean age, 66.4 years) were randomized to daily doses of 
      bazedoxifene 20 or 40 mg, raloxifene 60 mg, or placebo for 3 years. During the 
      2-year study extension, the raloxifene 60-mg treatment arm was discontinued after 
      the 3-year database was finalized, and subjects receiving bazedoxifene 40 mg were 
      transitioned in a blinded manner to bazedoxifene 20 mg (bazedoxifene 40-/20-mg 
      group) after 4 years. Safety and tolerability data are reported for subjects in 
      the bazedoxifene 20- and 40-/20-mg and placebo groups; efficacy findings are 
      reported elsewhere. RESULTS: A total of 3,146 subjects in the bazedoxifene 20- 
      and 40-mg and placebo groups were enrolled in the extension study (years 4 and 
      5). Overall, the 5-year incidence of adverse events (AEs), serious AEs, and 
      discontinuations due to AEs were similar among groups. The incidence of hot 
      flushes and leg cramps was higher with bazedoxifene compared with placebo. Venous 
      thromboembolic events, primarily deep vein thrombosis, were more frequently 
      reported in the bazedoxifene groups compared with the placebo group. Reports of 
      cardiac disorders and cerebrovascular events were few and evenly distributed 
      among groups. Bazedoxifene showed a neutral effect on the breast and endometrium. 
      CONCLUSION: Bazedoxifene was associated with an overall favorable safety and 
      tolerability profile in postmenopausal women with osteoporosis over 5 years of 
      therapy, consistent with findings at 3 years.
FAU - de Villiers, T J
AU  - de Villiers TJ
AD  - Panorama MediClinic and University of Stellenbosch, Room 118 Parow 7500, Cape 
      Town, South Africa. Tobie@iafrica.com
FAU - Chines, A A
AU  - Chines AA
FAU - Palacios, S
AU  - Palacios S
FAU - Lips, P
AU  - Lips P
FAU - Sawicki, A Z
AU  - Sawicki AZ
FAU - Levine, A B
AU  - Levine AB
FAU - Codreanu, C
AU  - Codreanu C
FAU - Kelepouris, N
AU  - Kelepouris N
FAU - Brown, J P
AU  - Brown JP
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20100610
PL  - England
TA  - Osteoporos Int
JT  - Osteoporosis international : a journal established as result of cooperation 
      between the European Foundation for Osteoporosis and the National Osteoporosis 
      Foundation of the USA
JID - 9100105
RN  - 0 (Indoles)
RN  - 0 (Selective Estrogen Receptor Modulators)
RN  - Q16TT9C5BK (bazedoxifene)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Double-Blind Method
MH  - Female
MH  - Hot Flashes/chemically induced
MH  - Humans
MH  - Indoles/*adverse effects/therapeutic use
MH  - Middle Aged
MH  - Muscle Cramp/chemically induced
MH  - Osteoporosis, Postmenopausal/*drug therapy
MH  - Selective Estrogen Receptor Modulators/*adverse effects/therapeutic use
MH  - Treatment Outcome
MH  - Venous Thrombosis/chemically induced
EDAT- 2010/06/11 06:00
MHDA- 2011/12/13 00:00
CRDT- 2010/06/11 06:00
PHST- 2009/12/31 00:00 [received]
PHST- 2010/04/07 00:00 [accepted]
PHST- 2010/06/11 06:00 [entrez]
PHST- 2010/06/11 06:00 [pubmed]
PHST- 2011/12/13 00:00 [medline]
AID - 10.1007/s00198-010-1302-6 [doi]
PST - ppublish
SO  - Osteoporos Int. 2011 Feb;22(2):567-76. doi: 10.1007/s00198-010-1302-6. Epub 2010 
      Jun 10.