PMID- 29907581
OWN - NLM
STAT- MEDLINE
DCOM- 20180920
LR  - 20220408
IS  - 1935-5548 (Electronic)
IS  - 0149-5992 (Linking)
VI  - 41
IP  - 8
DP  - 2018 Aug
TI  - Analysis of Fractures in Patients With Type 2 Diabetes Treated With Empagliflozin 
      in Pooled Data From Placebo-Controlled Trials and a Head-to-Head Study Versus 
      Glimepiride.
PG  - 1809-1816
LID - 10.2337/dc17-1525 [doi]
AB  - OBJECTIVE: To assess the effect of empagliflozin on bone fractures and bone 
      mineral density in patients with type 2 diabetes in pooled placebo-controlled 
      trial data and a head-to-head study versus glimepiride. RESEARCH DESIGN AND 
      METHODS: Pooled data were analyzed from patients who were randomized 1:1:1 to 
      empagliflozin 10 mg, empagliflozin 25 mg, or placebo in phase I-III clinical 
      trials. Data were also analyzed from the EMPA-REG H2H-SU trial in which patients 
      received empagliflozin 25 mg or glimepiride as an add-on to metformin for 104 
      weeks with a 104-week extension. Bone fracture adverse events (AEs) were 
      evaluated through a search of investigator-reported (nonadjudicated) events. 
      RESULTS: In the pooled analysis, bone fracture AEs were reported in 119 of 4,221 
      (2.8%), 105 of 4,196 (2.5%), and 123 of 4,203 (2.9%) patients in the 
      empagliflozin 10 mg, empagliflozin 25 mg, and placebo groups, respectively (rates 
      of 1.55, 1.36, and 1.69/100 patient-years, respectively). In the EMPA-REG H2H-SU 
      trial, bone fracture AEs were reported in 31 of 765 (4.1%) patients receiving 
      empagliflozin 25 mg and in 33 of 780 (4.2%) patients receiving glimepiride (rates 
      of 1.28 and 1.40/100 patient-years, respectively). CONCLUSIONS: Empagliflozin did 
      not increase the risk of bone fracture compared with placebo in a pooled analysis 
      of >12,000 patients or compared with glimepiride in a 4-year head-to-head study.
CI  - (c) 2018 by the American Diabetes Association.
FAU - Kohler, Sven
AU  - Kohler S
AUID- ORCID: 0000-0002-6032-7588
AD  - Boehringer Ingelheim International GmbH, Ingelheim, Germany 
      sven.kohler@boehringer-ingelheim.com.
FAU - Kaspers, Stefan
AU  - Kaspers S
AD  - Boehringer Ingelheim International GmbH, Ingelheim, Germany.
FAU - Salsali, Afshin
AU  - Salsali A
AD  - Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT.
FAU - Zeller, Cordula
AU  - Zeller C
AD  - Boehringer Ingelheim Pharma GmbH, Biberach an der Riss, Germany.
FAU - Woerle, Hans J
AU  - Woerle HJ
AD  - Boehringer Ingelheim International GmbH, Ingelheim, Germany.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
DEP - 20180615
PL  - United States
TA  - Diabetes Care
JT  - Diabetes care
JID - 7805975
RN  - 0 (Benzhydryl Compounds)
RN  - 0 (Glucosides)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Placebos)
RN  - 0 (Sulfonylurea Compounds)
RN  - 6KY687524K (glimepiride)
RN  - 9100L32L2N (Metformin)
RN  - HDC1R2M35U (empagliflozin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Benzhydryl Compounds/adverse effects/*therapeutic use
MH  - Bone Density/drug effects
MH  - Clinical Trials, Phase I as Topic/statistics & numerical data
MH  - Clinical Trials, Phase II as Topic/statistics & numerical data
MH  - Clinical Trials, Phase III as Topic/statistics & numerical data
MH  - Diabetes Mellitus, Type 2/*drug therapy/*epidemiology
MH  - Female
MH  - Fractures, Bone/chemically induced/*epidemiology
MH  - Glucosides/adverse effects/*therapeutic use
MH  - Humans
MH  - Hypoglycemic Agents/therapeutic use
MH  - Male
MH  - Metformin/therapeutic use
MH  - Middle Aged
MH  - Placebos
MH  - Randomized Controlled Trials as Topic/statistics & numerical data
MH  - Sulfonylurea Compounds/adverse effects/*therapeutic use
EDAT- 2018/06/17 06:00
MHDA- 2018/09/21 06:00
CRDT- 2018/06/17 06:00
PHST- 2017/07/25 00:00 [received]
PHST- 2018/05/14 00:00 [accepted]
PHST- 2018/06/17 06:00 [pubmed]
PHST- 2018/09/21 06:00 [medline]
PHST- 2018/06/17 06:00 [entrez]
AID - dc17-1525 [pii]
AID - 10.2337/dc17-1525 [doi]
PST - ppublish
SO  - Diabetes Care. 2018 Aug;41(8):1809-1816. doi: 10.2337/dc17-1525. Epub 2018 Jun 
      15.