PMID- 32324082
OWN - NLM
STAT- MEDLINE
DCOM- 20210601
LR  - 20221207
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 36
IP  - 8
DP  - 2020 Aug
TI  - Efficacy and safety of ertugliflozin across racial groups in patients with type 2 
      diabetes mellitus.
PG  - 1277-1284
LID - 10.1080/03007995.2020.1760228 [doi]
AB  - Objective: To assess the efficacy and safety of the sodium-glucose cotransporter 
      2 inhibitor ertugliflozin across racial groups in patients with type 2 diabetes 
      mellitus (T2DM).Methods: Pooled analysis of data from randomized, double-blind 
      studies in the ertugliflozin phase III development program. Seven placebo- and 
      comparator-controlled studies were used to assess safety (N = 4859) and three 
      placebo-controlled studies were used to assess efficacy (N = 1544). Least-squares 
      (LS) mean change from baseline was calculated for glycated hemoglobin (HbA1c), 
      body weight and systolic blood pressure (SBP). Safety evaluation included overall 
      and prespecified adverse events (AEs).Results: At Week 26, ertugliflozin provided 
      a greater reduction in HbA1c, body weight and SBP versus placebo in all racial 
      subgroups. The placebo-adjusted LS mean change (95% confidence interval) from 
      baseline in HbA1c was -0.8% (-1.0, -0.7) and -1.0% (-1.1, -0.8) with 
      ertugliflozin 5 mg and 15 mg, respectively, in the White subgroup, -0.7% (-1.2, 
      -0.2) and -0.8% (-1.3, -0.3) in the Black subgroup, and -0.8% (-1.1, -0.5) and 
      -1.0% (-1.3, -0.8) in the Asian subgroup. The incidences of overall AEs, serious 
      AEs and AEs leading to discontinuation from study medication were similar between 
      the ertugliflozin 5 mg, 15 mg and non-ertugliflozin groups within each racial 
      subgroup. The incidence of female genital mycotic infection (GMI) was higher with 
      ertugliflozin than non-ertugliflozin across all racial subgroups. The incidence 
      of male GMI was higher with ertugliflozin than non-ertugliflozin in the White 
      sub-group; however, there were few male GMI events in the non-White 
      subgroups.Conclusions: In patients with T2DM, treatment with ertugliflozin 
      improved HbA1c, body weight and SBP across all racial subgroups. Ertugliflozin 
      had a generally similar safety profile across racial subgroups and was generally 
      well tolerated. Clinicaltrials.gov identifiers: NCT01986855, NCT01999218, 
      NCT01958671, NCT02099110, NCT02036515, NCT02033889, and NCT02226003.
FAU - Liu, Jie
AU  - Liu J
AD  - Merck & Co. Inc., Kenilworth, NJ, USA.
FAU - Tarasenko, Lisa
AU  - Tarasenko L
AD  - Pfizer Inc., New York, NY, USA.
FAU - Pong, Annpey
AU  - Pong A
AD  - Merck & Co. Inc., Kenilworth, NJ, USA.
FAU - Huyck, Susan
AU  - Huyck S
AD  - Merck & Co. Inc., Kenilworth, NJ, USA.
FAU - Wu, Larry
AU  - Wu L
AD  - Merck & Co. Inc., Kenilworth, NJ, USA.
FAU - Patel, Shrita
AU  - Patel S
AD  - Merck & Co. Inc., Kenilworth, NJ, USA.
FAU - Hickman, Anne
AU  - Hickman A
AD  - Pfizer Inc., Groton, CT, USA.
FAU - Mancuso, James P
AU  - Mancuso JP
AD  - Pfizer Inc., Groton, CT, USA.
FAU - Gantz, Ira
AU  - Gantz I
AD  - Merck & Co. Inc., Kenilworth, NJ, USA.
FAU - Terra, Steven G
AU  - Terra SG
AUID- ORCID: 0000-0002-5815-6193
AD  - Pfizer Inc., Andover, MA, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01986855
SI  - ClinicalTrials.gov/NCT02033889
SI  - ClinicalTrials.gov/NCT01999218
SI  - ClinicalTrials.gov/NCT02226003
SI  - ClinicalTrials.gov/NCT01958671
SI  - ClinicalTrials.gov/NCT02036515
SI  - ClinicalTrials.gov/NCT02099110
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20200513
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Bridged Bicyclo Compounds, Heterocyclic)
RN  - 0 (Sodium-Glucose Transporter 2 Inhibitors)
RN  - 6C282481IP (ertugliflozin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Black People
MH  - Bridged Bicyclo Compounds, Heterocyclic/adverse effects/*therapeutic use
MH  - Diabetes Mellitus, Type 2/*drug therapy/ethnology
MH  - Double-Blind Method
MH  - Female
MH  - Genital Diseases, Female/chemically induced
MH  - Genital Diseases, Male/chemically induced
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Mycoses/chemically induced
MH  - Sodium-Glucose Transporter 2 Inhibitors/*therapeutic use
MH  - White People
OTO - NOTNLM
OT  - HbA1c
OT  - SGLT2 inhibitor
OT  - ethnicity
OT  - race
OT  - type 2 diabetes
EDAT- 2020/04/24 06:00
MHDA- 2021/06/02 06:00
CRDT- 2020/04/24 06:00
PHST- 2020/04/24 06:00 [pubmed]
PHST- 2021/06/02 06:00 [medline]
PHST- 2020/04/24 06:00 [entrez]
AID - 10.1080/03007995.2020.1760228 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2020 Aug;36(8):1277-1284. doi: 10.1080/03007995.2020.1760228. 
      Epub 2020 May 13.