PMID- 31339784
OWN - NLM
STAT- MEDLINE
DCOM- 20200520
LR  - 20221207
IS  - 1557-8593 (Electronic)
IS  - 1520-9156 (Linking)
VI  - 21
IP  - 8
DP  - 2019 Aug
TI  - Use of Dapagliflozin in the Management of Type 2 Diabetes Mellitus: A Real-World 
      Evidence Study in Indian Patients (FOREFRONT).
PG  - 415-422
LID - 10.1089/dia.2019.0052 [doi]
AB  - Background: Dapagliflozin is approved in India based on a controlled clinical 
      study. This study included type 2 diabetes mellitus (T2DM) Indian patients to 
      determine effectiveness of dapagliflozin in the real-world setup. Methods: Data 
      were collected retrospectively and prospectively for 3 months. Primary endpoint 
      was mean change in glycated hemoglobin (HbA1c) from baseline to months 3 and 6. 
      Patients were stratified by baseline HbA1c and body mass index (BMI). Paired 
      t-test or Wilcoxon signed-rank test at 5% level of significance with two-sided 
      95% confidence intervals analyzed endpoints. Results: Total 98.1% (n = 1941/1978) 
      patients completed the study, majority of them were men (57.5%), <60 years 
      (77.8%). Mean (standard deviation [SD]) HbA1c decreased significantly from 
      baseline (9.11% [1.44]) to month 3 (8.11% [1.22]; Delta = 1.00% [1.01]) and month 6 
      (7.62% [1.04]; Delta = 1.49% [1.18]), P < 0.001. Per baseline HbA1c stratification, 
      the largest mean (SD) decrease in HbA1c was in patients with baseline HbA1c >10% 
      (1.86% [1.32] at month 3; 2.80% [1.22] at month 6). Decrease in mean body weight 
      was significant from baseline (78.15 kg [13.48]) to month 3 (77.01 kg [13.21]; 
      Delta = 1.14 kg [2.21]) and month 6 (76.16 kg [13.09]; Delta = 1.86 kg [3.04]), 
      P < 0.001, with maximum weight loss in patients with BMI >30 kg/m(2) (1.60 kg 
      [2.50] and 2.56 kg [3.50] at months 3 and 6, respectively). Systolic/diastolic 
      blood pressure also improved. Of the 58 (2.9%) patients having >/=1 adverse event 
      (AE), 9 (0.5%) had vulvovaginitis and 4 (0.2%) each had fungal infection and 
      urinary tract infection (UTI). One patient had a serious AE (SAE) of UTI. No 
      patients died or discontinued the study because of AEs or SAEs. Conclusion: 
      Dapagliflozin significantly decreased HbA1c and body weight in Indian T2DM 
      patients. Dapagliflozin was well tolerated and no new safety signals were 
      detected.
FAU - Viswanathan, Vijay
AU  - Viswanathan V
AD  - 1Head & Chief Diabetologist, MV Hospital Chennai, India.
FAU - Singh, K P
AU  - Singh KP
AD  - 2Endocrinologist, Fortis Med Centre, SCO-11, Chandigarh, India.
LA  - eng
PT  - Evaluation Study
PT  - Journal Article
PL  - United States
TA  - Diabetes Technol Ther
JT  - Diabetes technology & therapeutics
JID - 100889084
RN  - 0 (Benzhydryl Compounds)
RN  - 0 (Glucosides)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Sodium-Glucose Transporter 2 Inhibitors)
RN  - 1ULL0QJ8UC (dapagliflozin)
SB  - IM
EIN - Diabetes Technol Ther. 2019 Sep;21(9):531. PMID: 31437025
MH  - Adult
MH  - Benzhydryl Compounds/*therapeutic use
MH  - Body Weight/drug effects
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy
MH  - Female
MH  - Glucosides/*therapeutic use
MH  - Glycated Hemoglobin/drug effects
MH  - Humans
MH  - India
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Retrospective Studies
MH  - Sodium-Glucose Transporter 2 Inhibitors/*therapeutic use
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Dapagliflozin
OT  - India
OT  - Real-world evidence
OT  - T2DM
EDAT- 2019/07/25 06:00
MHDA- 2020/05/21 06:00
CRDT- 2019/07/25 06:00
PHST- 2019/07/25 06:00 [entrez]
PHST- 2019/07/25 06:00 [pubmed]
PHST- 2020/05/21 06:00 [medline]
AID - 10.1089/dia.2019.0052 [doi]
PST - ppublish
SO  - Diabetes Technol Ther. 2019 Aug;21(8):415-422. doi: 10.1089/dia.2019.0052.