PMID- 20388226
OWN - NLM
STAT- MEDLINE
DCOM- 20100719
LR  - 20211028
IS  - 1471-2474 (Electronic)
IS  - 1471-2474 (Linking)
VI  - 11
DP  - 2010 Apr 14
TI  - Adverse events, bone mineral density and discontinuation associated with generic 
      alendronate among postmenopausal women previously tolerant of brand alendronate: 
      a retrospective cohort study.
PG  - 68
LID - 10.1186/1471-2474-11-68 [doi]
AB  - BACKGROUND: A rise in gastrointestinal (GI) adverse events (AEs) and a decline in 
      bone mineral density (BMD) was observed in patients previously tolerant to brand 
      alendronate shortly after generic versions were introduced in July 2005 to the 
      Canadian market. The objective of our study was to quantify changes in AE rates 
      and BMD scores, as well as associated alendronate discontinuation among patients 
      before and after switch from brand to generic alendronate. METHODS: A chart 
      review of postmenopausal women 50 years of age and older between 2003 and 2007 
      was conducted in two specialized tertiary care referral centers. Patients on 
      alendronate both before and after July 2005 were included. The change in the 
      number of AEs, changes in BMD and associated alendronate discontinuation was 
      compared before and after the switch from brand to generic alendronate. RESULTS: 
      301 women with an average age of 67.6 years (standard deviation (SD) = 9.5) had a 
      total of 47 AEs between July 2003 and December 2007 that resulted in 
      discontinuation of the medication. There was a significant increase in the rate 
      of AEs per patient-months-at-risk from 0.0001 before to 0.0044 after October 2005 
      (p < 0.001). The most common AEs were GI in nature (stomach pain, GI upset, 
      nausea, and reflux). In addition, 23 patients discontinued alendronate due to BMD 
      reduction after January 2006. In these patients, BMD scores were significantly 
      reduced from their prior BMD measures (change of -0.0534, p < 0.001 for spine BMD 
      and change of -0.0338, p = 0.01 for femur BMD). Among patients who discontinued 
      due to BMD reduction, BMD was stable in the period prior to January 2006 (change 
      of -0.0066, p = 0.5 for spine BMD and change of 0.0011, p = 0.9 for femur BMD); 
      however, testing for reduction after January 2006 in BMD measures (one-sided 
      T-test) revealed there was a significant reduction in BMD scores for both 
      anatomic sites (change of -0.0321, p = .005 for spine, change of -0.0205, p = 
      0.05 for femur). CONCLUSIONS: Patients who were previously stable on doses of 
      brand alendronate experienced an increase in AEs causing discontinuation after 
      introduction of automatic substitution to generic alendronate. In addition, 
      reductions in BMD were observed in some patients who had stable BMDs before 
      January 2006. Given the substantial increase in AEs, generic alendronate may not 
      be as well tolerated as brand alendronate.
FAU - Grima, Daniel T
AU  - Grima DT
AD  - Center for Osteoporosis and Arthritis Research and Education (COARE), 1185 
      Rushbrooke Dr, Oakville, ON, L6 M 1H8, Canada.
FAU - Papaioannou, Alexandra
AU  - Papaioannou A
FAU - Airia, Parisa
AU  - Airia P
FAU - Ioannidis, George
AU  - Ioannidis G
FAU - Adachi, Jonathan D
AU  - Adachi JD
LA  - eng
GR  - 88225-1/CAPMC/CIHR/Canada
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20100414
PL  - England
TA  - BMC Musculoskelet Disord
JT  - BMC musculoskeletal disorders
JID - 100968565
RN  - 0 (Bone Density Conservation Agents)
RN  - 0 (Drugs, Generic)
RN  - X1J18R4W8P (Alendronate)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Alendronate/*adverse effects/pharmacokinetics
MH  - Bone Density/*drug effects/physiology
MH  - Bone Density Conservation Agents/*adverse effects/pharmacokinetics
MH  - Bone and Bones/diagnostic imaging/*drug effects/physiopathology
MH  - Cohort Studies
MH  - Cost-Benefit Analysis
MH  - Drugs, Generic/*adverse effects
MH  - Female
MH  - Femur/diagnostic imaging/drug effects/physiopathology
MH  - Gastric Mucosa/drug effects/physiopathology
MH  - Gastrointestinal Diseases/chemically induced/physiopathology
MH  - Humans
MH  - Middle Aged
MH  - Osteoporosis, Postmenopausal/diagnostic imaging/*drug therapy/physiopathology
MH  - Patient Compliance/statistics & numerical data
MH  - Radiography
MH  - Retrospective Studies
MH  - Risk Factors
MH  - Spine/diagnostic imaging/drug effects/physiopathology
MH  - Therapeutic Equivalency
PMC - PMC2867835
EDAT- 2010/04/15 06:00
MHDA- 2010/07/20 06:00
PMCR- 2010/04/14
CRDT- 2010/04/15 06:00
PHST- 2009/07/06 00:00 [received]
PHST- 2010/04/14 00:00 [accepted]
PHST- 2010/04/15 06:00 [entrez]
PHST- 2010/04/15 06:00 [pubmed]
PHST- 2010/07/20 06:00 [medline]
PHST- 2010/04/14 00:00 [pmc-release]
AID - 1471-2474-11-68 [pii]
AID - 10.1186/1471-2474-11-68 [doi]
PST - epublish
SO  - BMC Musculoskelet Disord. 2010 Apr 14;11:68. doi: 10.1186/1471-2474-11-68.