PMID- 32372382
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200928
IS  - 1869-6953 (Print)
IS  - 1869-6961 (Electronic)
IS  - 1869-6961 (Linking)
VI  - 11
IP  - 6
DP  - 2020 Jun
TI  - Safety of Ertugliflozin in Patients with Type 2 Diabetes Mellitus: Pooled 
      Analysis of Seven Phase 3 Randomized Controlled Trials.
PG  - 1347-1367
LID - 10.1007/s13300-020-00803-3 [doi]
AB  - INTRODUCTION: The sodium-glucose cotransporter 2 (SGLT2) inhibitor ertugliflozin 
      is approved for the treatment of adults with type 2 diabetes mellitus (T2DM). 
      This analysis was conducted on safety data pooled from phase 3 studies using 
      ertugliflozin 5 mg or 15 mg versus placebo or an active comparator. METHODS: The 
      placebo pool (n = 1544) comprised data from three similarly designed 26-week 
      placebo-controlled studies. The broad pool (n = 4849) comprised these three 
      placebo-controlled studies plus four placebo- or active-controlled studies with 
      treatment durations of up to 104 weeks. RESULTS: In the placebo pool, there were 
      no notable differences across groups in the incidence of adverse events (AEs), 
      serious AEs, or AEs resulting in discontinuation from study medication, while 
      associations were observed with genital mycotic infection in both females (3.0%, 
      9.1%, and 12.2% in the placebo, ertugliflozin 5 mg, and ertugliflozin 15 mg 
      groups, respectively) and males (0.4%, 3.7%, 4.2%), thirst (0.2%, 1.3%, 1.0%), 
      and increased urination (1.0%, 2.7%, 2.4%). In the broad pool, volume depletion 
      was increased with ertugliflozin in patients with estimated glomerular filtration 
      rate < 60 ml/min/1.73 m(2), aged >/= 65 years, or who were taking diuretics. 
      Ertugliflozin was not associated with increased urinary tract infection, 
      fracture, hypoglycemia, pancreatitis, renal or hepatic injury, hypersensitivity, 
      malignancy, or venous thromboembolism. Small numbers of patients were reported 
      with lower limb amputation [0.1% (non-ertugliflozin group), 0.2% (ertugliflozin 
      5 mg), 0.5% (ertugliflozin 15 mg)]. There were three cases of ketoacidosis (all 
      ertugliflozin 15 mg) and no cases of Fournier's gangrene. CONCLUSION: This pooled 
      analysis showed that ertugliflozin was generally well tolerated in a large 
      population of patients with T2DM with and without moderate renal impairment who 
      were taking a range of background diabetes medications including insulin and 
      insulin secretagogs, with results that are generally consistent with those for 
      other SGLT2 inhibitors. TRIAL REGISTRATION: Clinicaltrials.gov indentifier, 
      NCT02033889, NCT01958671, NCT02036515, NCT01986855, NCT02099110, NCT02226003, 
      NCT01999218.
FAU - Patel, Shrita
AU  - Patel S
AD  - Merck & Co., Inc., Kenilworth, NJ, USA. shrita.patel@merck.com.
FAU - Hickman, Anne
AU  - Hickman A
AD  - Pfizer Inc., Groton, CT, USA.
FAU - Frederich, Robert
AU  - Frederich R
AD  - Pfizer Inc., Collegeville, PA, USA.
FAU - Johnson, Susan
AU  - Johnson S
AD  - Pfizer Inc., Collegeville, PA, USA.
FAU - Huyck, Susan
AU  - Huyck S
AD  - Merck & Co., Inc., Kenilworth, NJ, 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
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  - Journal Article
DEP - 20200505
PL  - United States
TA  - Diabetes Ther
JT  - Diabetes therapy : research, treatment and education of diabetes and related 
      disorders
JID - 101539025
PMC - PMC7261307
OTO - NOTNLM
OT  - Ertugliflozin
OT  - Genital mycotic infection
OT  - Sodium-glucose cotransporter 2 inhibitor
OT  - Type 2 diabetes mellitus
OT  - Urinary tract infection
OT  - Volume depletion
EDAT- 2020/05/07 06:00
MHDA- 2020/05/07 06:01
PMCR- 2020/05/05
CRDT- 2020/05/07 06:00
PHST- 2019/12/20 00:00 [received]
PHST- 2020/05/07 06:00 [pubmed]
PHST- 2020/05/07 06:01 [medline]
PHST- 2020/05/07 06:00 [entrez]
PHST- 2020/05/05 00:00 [pmc-release]
AID - 10.1007/s13300-020-00803-3 [pii]
AID - 803 [pii]
AID - 10.1007/s13300-020-00803-3 [doi]
PST - ppublish
SO  - Diabetes Ther. 2020 Jun;11(6):1347-1367. doi: 10.1007/s13300-020-00803-3. Epub 
      2020 May 5.