PMID- 33721213
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20210521
IS  - 1869-6953 (Print)
IS  - 1869-6961 (Electronic)
IS  - 1869-6961 (Linking)
VI  - 12
IP  - 5
DP  - 2021 May
TI  - Efficacy and Safety of Ertugliflozin in Patients with Type 2 Diabetes 
      Inadequately Controlled by Metformin and Sulfonylurea: A Sub-Study of VERTIS CV.
PG  - 1279-1297
LID - 10.1007/s13300-021-01033-x [doi]
AB  - INTRODUCTION: VERTIS CV is the cardiovascular outcome trial for the 
      sodium-glucose cotransporter 2 (SGLT2) inhibitor ertugliflozin. A sub-study was 
      conducted to assess the efficacy and safety of ertugliflozin in patients with 
      type 2 diabetes mellitus (T2DM) inadequately glycemic-controlled on metformin and 
      a sulfonylurea (SU). METHODS: Patients with T2DM, established atherosclerotic 
      cardiovascular disease (ASCVD), and an HbA1c of 7.0-10.5% on stable metformin 
      (>/= 1500 mg/day) and moderate to high SU doses were randomly assigned to 
      once-daily ertugliflozin (5 or 15 mg) or placebo. The primary sub-study 
      objectives were to assess the effect of ertugliflozin on HbA1c compared with 
      placebo and to evaluate safety following 18 weeks of treatment. Key secondary 
      endpoints included changes in fasting plasma glucose (FPG), body weight (BW), 
      blood pressure (BP), and the proportion of patients achieving HbA1c < 7%. 
      RESULTS: Of the 8246 patients enrolled in VERTIS CV, 330 were eligible for this 
      sub-study (ertugliflozin 5 mg, n = 100; ertugliflozin 15 mg, n = 113; placebo, 
      n = 117). This subgroup had a mean (SD) age of 63.2 (8.4) years and T2DM duration 
      of 11.4 (7.4) years. At week 18, ertugliflozin 5 mg and 15 mg were each 
      associated with significantly greater least squares (LS) mean reductions from 
      baseline in HbA1c relative to placebo (placebo-adjusted LS mean [95% CI] - 0.66% 
      [- 0.89, - 0.43] and - 0.75% [- 0.98, - 0.53], respectively, p < 0.001 for each 
      dose vs placebo). Ertugliflozin significantly reduced FPG and BW compared with 
      placebo (p < 0.001), but not systolic BP. Adverse events were reported in 48.0%, 
      54.9%, and 47.0% of patients in the ertugliflozin 5 mg and 15 mg, and placebo 
      groups. The incidences of symptomatic hypoglycemia were 11.0% (5 mg), 12.4% 
      (15 mg), and 7.7% (placebo), and of severe hypoglycemia 2.0% (5 mg), 1.8% 
      (15 mg), and 0.9% (placebo). CONCLUSIONS: In patients with T2DM and ASCVD, 
      ertugliflozin added to metformin and SU improved glycemic control, reduced BW, 
      and was generally well tolerated. TRIAL REGISTRATION: VERTIS CV 
      ClinicalTrials.gov identifier, NCT01986881.
FAU - Budoff, Matthew J
AU  - Budoff MJ
AD  - Lundquist Institute, Torrance, CA, USA. mbudoff@lundquist.org.
FAU - Davis, Timothy M E
AU  - Davis TME
AD  - Medical School, University of Western Australia, Crawley, Australia.
FAU - Palmer, Alexandra G
AU  - Palmer AG
AD  - Pfizer Inc., Groton, CT, USA.
FAU - Frederich, Robert
AU  - Frederich R
AD  - Pfizer Inc., Collegeville, PA, USA.
FAU - Lawrence, David E
AU  - Lawrence DE
AD  - Pfizer Inc., New York, NY, USA.
FAU - Liu, Jie
AU  - Liu J
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Gantz, Ira
AU  - Gantz I
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Derosa, Giuseppe
AU  - Derosa G
AD  - Fondazione IRCCS Policlinico San Matteo, University of Pavia, Pavia, Italy.
LA  - eng
SI  - ClinicalTrials.gov/NCT01986881
PT  - Journal Article
DEP - 20210315
PL  - United States
TA  - Diabetes Ther
JT  - Diabetes therapy : research, treatment and education of diabetes and related 
      disorders
JID - 101539025
PMC - PMC8099972
OTO - NOTNLM
OT  - Ertugliflozin
OT  - Glycemic control
OT  - HbA1c
OT  - Metformin
OT  - SGLT2 inhibitor
OT  - Sulfonylurea
OT  - Type 2 diabetes mellitus
EDAT- 2021/03/16 06:00
MHDA- 2021/03/16 06:01
PMCR- 2021/03/15
CRDT- 2021/03/15 17:37
PHST- 2020/12/21 00:00 [received]
PHST- 2021/02/13 00:00 [accepted]
PHST- 2021/03/16 06:00 [pubmed]
PHST- 2021/03/16 06:01 [medline]
PHST- 2021/03/15 17:37 [entrez]
PHST- 2021/03/15 00:00 [pmc-release]
AID - 10.1007/s13300-021-01033-x [pii]
AID - 1033 [pii]
AID - 10.1007/s13300-021-01033-x [doi]
PST - ppublish
SO  - Diabetes Ther. 2021 May;12(5):1279-1297. doi: 10.1007/s13300-021-01033-x. Epub 
      2021 Mar 15.