PMID- 31016153
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220408
IS  - 2230-8210 (Print)
IS  - 2230-9500 (Electronic)
IS  - 2230-9500 (Linking)
VI  - 23
IP  - 1
DP  - 2019 Jan-Feb
TI  - Adverse Effect Profile and Effectiveness of Sodium Glucose Co-transporter 2 
      Inhibitors (SGLT2i) - A Prospective Real-world Setting Study.
PG  - 50-55
LID - 10.4103/ijem.IJEM_566_18 [doi]
AB  - BACKGROUND: Clinical trials have shown promising results in terms of glycemic 
      control and weight reduction with the use of sodium glucose co-transporter 2 
      inhibitors (SGLT2i) in type 2 diabetes mellitus (T2DM). However, real-world 
      evidence from standard clinical practice especially from Asia is still limited. 
      The aim of this study was to evaluate the safety and effectiveness of SGLT2i in 
      patients with T2DM in real-world setting. METHODS: This was a prospective 
      observational longitudinal study involving consecutive patients with T2DM, 
      initiated on SGLT2i from 1 April 2015 to 31 March 2016. The adverse effects and 
      metabolic parameters were evaluated at 3 monthly intervals up to 1 year. RESULTS: 
      Total 486 patients were initiated on SGLT2i. At baseline, mean age, glycosylated 
      haemoglobin (HbA1c), and weight was 51.03 +/- 9.82 years, 8.76 +/- 1.59%, and 89.32 +/- 
      16.04 kg, respectively. Data of 388 patients were available at 6 months of 
      follow-up for analysis of adverse effects profile. About 38.6% patients 
      experienced adverse effects. Genitourinary tract infection was the most common 
      adverse effect (20.6%) followed by generalized weakness (10.5%). Significant 
      reduction in mean weight and HbA1c reduction seen at 6 months (n = 202): 3.2 kg 
      and 1.26%, respectively, and at 12 months (n = 104): 3.9 kg and 1.27%, 
      respectively. CONCLUSION: In this real-world study of patients with T2DM living 
      in hot climate, use of SGLT2i was associated with adverse effects in higher 
      proportion of patients than those reported in clinical trials, but effectiveness 
      was comparable. Patient guidance regarding adequate hydration and hygiene can 
      maximize the benefits of this promising class of drugs.
FAU - Gill, Harmandeep Kaur
AU  - Gill HK
AD  - Division of Endocrinology and Diabetes, Medanta The Medicity, Gurugram, Haryana, 
      India.
FAU - Kaur, Parjeet
AU  - Kaur P
AD  - Division of Endocrinology and Diabetes, Medanta The Medicity, Gurugram, Haryana, 
      India.
FAU - Mahendru, Shama
AU  - Mahendru S
AD  - Division of Endocrinology and Diabetes, Medanta The Medicity, Gurugram, Haryana, 
      India.
FAU - Mithal, Ambrish
AU  - Mithal A
AD  - Division of Endocrinology and Diabetes, Medanta The Medicity, Gurugram, Haryana, 
      India.
LA  - eng
PT  - Journal Article
PL  - India
TA  - Indian J Endocrinol Metab
JT  - Indian journal of endocrinology and metabolism
JID - 101555690
PMC - PMC6446693
OTO - NOTNLM
OT  - Effectiveness
OT  - SGLT2i
OT  - real world
OT  - safety
OT  - type 2 diabetes
COIS- There are no conflicts of interest.
EDAT- 2019/04/25 06:00
MHDA- 2019/04/25 06:01
PMCR- 2019/01/01
CRDT- 2019/04/25 06:00
PHST- 2019/04/25 06:00 [entrez]
PHST- 2019/04/25 06:00 [pubmed]
PHST- 2019/04/25 06:01 [medline]
PHST- 2019/01/01 00:00 [pmc-release]
AID - IJEM-23-50 [pii]
AID - 10.4103/ijem.IJEM_566_18 [doi]
PST - ppublish
SO  - Indian J Endocrinol Metab. 2019 Jan-Feb;23(1):50-55. doi: 
      10.4103/ijem.IJEM_566_18.