PMID- 32700421
OWN - NLM
STAT- MEDLINE
DCOM- 20210624
LR  - 20221207
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Linking)
VI  - 22
IP  - 12
DP  - 2020 Dec
TI  - Efficacy and safety of ertugliflozin in older patients with type 2 diabetes: A 
      pooled analysis of phase III studies.
PG  - 2276-2286
LID - 10.1111/dom.14150 [doi]
AB  - AIM: To assess the efficacy and safety of ertugliflozin in older patients with 
      type 2 diabetes (T2D). MATERIALS AND METHODS: This is a post hoc analysis of 
      patients with T2D aged less than 65 years and those aged 65 years or older who 
      participated in randomized, double-blind, phase III studies of ertugliflozin. 
      Efficacy was evaluated in a pooled analysis of three placebo-controlled studies 
      (ertugliflozin monotherapy and add-on therapy). Safety was evaluated in a pooled 
      analysis of seven placebo- and active-controlled studies (including those used 
      for efficacy). Least-squares mean change from baseline was calculated for HbA1c, 
      fasting plasma glucose (FPG), body weight (BW) and systolic blood pressure (SBP). 
      Safety evaluation included overall and prespecified adverse events (AEs). 
      RESULTS: In participants aged less than 65 years, the placebo-adjusted mean 
      changes from baseline in HbA1c, BW and SBP with ertugliflozin 5 and 15 mg at week 
      26 were -0.9% and -1.0%, -1.9 and -1.8 kg, and -3.7 and -3.6 mmHg, respectively; 
      in participants aged 65 years or older they were -0.6% and -0.8%, -1.9 and -2.2 
      kg, and -2.7 and -3.4 mmHg, respectively. The incidences of AEs, serious AEs, 
      discontinuations and deaths in participants aged less than 65 years and those 
      aged 65 years or older were generally similar across the treatment groups. In 
      patients aged 65 years or older the incidences of volume depletion AEs and 
      genital mycotic infection were higher with ertugliflozin than with 
      non-ertugliflozin. CONCLUSIONS: Ertugliflozin improved glycaemic control, BW and 
      SBP in younger and older individuals with T2D and was generally well tolerated in 
      both groups.
CI  - (c) 2020 John Wiley & Sons Ltd.
FAU - Pratley, Richard
AU  - Pratley R
AUID- ORCID: 0000-0002-2912-1389
AD  - AdventHealth Translational Research Institute for Metabolism and Diabetes, 
      Orlando, Florida, USA.
FAU - Dagogo-Jack, Samuel
AU  - Dagogo-Jack S
AD  - University of Tennessee Health Science Center, Memphis, Tennessee, USA.
FAU - Charbonnel, Bernard
AU  - Charbonnel B
AD  - University of Nantes, Nantes, France.
FAU - Patel, Shrita
AU  - Patel S
AD  - Merck & Co., Inc., Kenilworth, New Jersey, USA.
FAU - Hickman, Anne
AU  - Hickman A
AD  - Pfizer Inc., Groton, Connecticut, USA.
FAU - Liu, Jie
AU  - Liu J
AD  - Merck & Co., Inc., Kenilworth, New Jersey, USA.
FAU - Tarasenko, Lisa
AU  - Tarasenko L
AD  - Pfizer Inc., New York, New York, USA.
FAU - Pong, Annpey
AU  - Pong A
AD  - Merck & Co., Inc., Kenilworth, New Jersey, USA.
FAU - Ellison, Misoo C
AU  - Ellison MC
AD  - Merck & Co., Inc., Kenilworth, New Jersey, USA.
FAU - Huyck, Susan
AU  - Huyck S
AD  - Merck & Co., Inc., Kenilworth, New Jersey, USA.
FAU - Gantz, Ira
AU  - Gantz I
AD  - Merck & Co., Inc., Kenilworth, New Jersey, USA.
FAU - Terra, Steven G
AU  - Terra SG
AUID- ORCID: 0000-0002-5815-6193
AD  - Pfizer Inc., Andover, Massachusetts, USA.
LA  - eng
GR  - Funding for this research was provided by Merck Sharp & Dohme Corp., a 
      subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, in collaboration with 
      Pfizer Inc./
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
DEP - 20200831
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Blood Glucose)
RN  - 0 (Bridged Bicyclo Compounds, Heterocyclic)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Sodium-Glucose Transporter 2 Inhibitors)
RN  - 6C282481IP (ertugliflozin)
SB  - IM
MH  - Aged
MH  - Blood Glucose
MH  - Bridged Bicyclo Compounds, Heterocyclic/adverse effects
MH  - *Diabetes Mellitus, Type 2/drug therapy
MH  - Double-Blind Method
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Hypoglycemic Agents/adverse effects
MH  - Randomized Controlled Trials as Topic
MH  - *Sodium-Glucose Transporter 2 Inhibitors
MH  - Treatment Outcome
OTO - NOTNLM
OT  - SGLT2 inhibitor
OT  - antidiabetic drug
OT  - diabetes complications
OT  - glycaemic control
OT  - observational study
OT  - type 2 diabetes
EDAT- 2020/07/24 06:00
MHDA- 2021/06/25 06:00
CRDT- 2020/07/24 06:00
PHST- 2020/03/31 00:00 [received]
PHST- 2020/07/13 00:00 [revised]
PHST- 2020/07/21 00:00 [accepted]
PHST- 2020/07/24 06:00 [pubmed]
PHST- 2021/06/25 06:00 [medline]
PHST- 2020/07/24 06:00 [entrez]
AID - 10.1111/dom.14150 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2020 Dec;22(12):2276-2286. doi: 10.1111/dom.14150. Epub 2020 
      Aug 31.