PMID- 34234490
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220424
IS  - 1178-7007 (Print)
IS  - 1178-7007 (Electronic)
IS  - 1178-7007 (Linking)
VI  - 14
DP  - 2021
TI  - Efficacy of a Combination of Metformin and Vildagliptin in Comparison to 
      Metformin Alone in Type 2 Diabetes Mellitus: A Multicentre, Retrospective, 
      Real-World Evidence Study.
PG  - 2925-2933
LID - 10.2147/DMSO.S315227 [doi]
AB  - BACKGROUND: Early use of combination therapy in diabetes patients may lead to 
      sustained glycemic control and thereby reduce the progression of diabetic 
      complications. Given the limitation of the traditional stepwise intensification 
      strategy, early combination therapy can be an effective approach. Therefore, this 
      study aims to assess the real-world efficacy of a combination of metformin and 
      vildagliptin in comparison to metformin alone in type 2 diabetes mellitus (T2DM) 
      patients in India. METHODS: This was an observational, retrospective, 
      non-interventional study based on electronic medical records (EMRs) of 2740 T2DM 
      patients, retrieved from 2010 onwards from 22 diabetes centres across India. 
      Adult drug naive patients with a 5-year history of T2DM treated with either 
      metformin or a combination of metformin and vildagliptin for at least 3 months 
      were considered for this study. Efficacy assessment was done to evaluate the 
      post-treatment HbA1c levels and patients requiring additional oral antidiabetic 
      drugs (OADs) at the time of follow-up visit. Patients were also analyzed for the 
      occurrence of adverse events. RESULTS: Out of the total, 2452 patients were in 
      metformin only arm, and 288 patients were in metformin plus vildagliptin 
      treatment arm. A more significant reduction in HbA1c level was observed in 
      metformin plus vildagliptin arm than metformin only arm (median: -0.5% vs 0%, 
      respectively; p<0.001). Patients requiring additional OAD at follow-up were 
      significantly lesser in the metformin plus vildagliptin arm than the metformin 
      only arm (15.6% vs 35.2%, respectively; p<0.001). The adverse events were 
      comparable across the two arms, and commonly reported adverse events were 
      giddiness, fatigue and gastric discomfort. CONCLUSION: The findings of this 
      EMR-based real-world study emphasizes the need for early initiation of 
      combination therapy (metformin plus vildagliptin) over metformin monotherapy for 
      achieving better glycemic control.
CI  - (c) 2021 Mohan et al.
FAU - Mohan, Viswanathan
AU  - Mohan V
AUID- ORCID: 0000-0001-5038-6210
AD  - Department of Diabetes, Madras Diabetes Research Foundation & Dr Mohan's Diabetes 
      Specialities Centre, Chennai, Tamil Nadu, India.
FAU - Zargar, Abdul
AU  - Zargar A
AD  - Department of Diabetes and Endocrine Care, Centre for Diabetes and Endocrine 
      Care, Srinagar, Jammu and Kashmir, India.
FAU - Chawla, Manoj
AU  - Chawla M
AUID- ORCID: 0000-0003-0436-3266
AD  - Department of Diabetes, Lina Diabetes Care Mumbai Diabetes Research Centre, 
      Mumbai, India.
FAU - Joshi, Ameya
AU  - Joshi A
AUID- ORCID: 0000-0002-3671-2312
AD  - Department of Endocrinology, Bhaktivedanta Hospital and Research Institute, 
      Thane, India.
FAU - Ayyagari, Usha
AU  - Ayyagari U
AUID- ORCID: 0000-0002-5169-9208
AD  - Department of Endocrinology, Apollo Sugar Clinics, Apollo Speciality Hospital 
      OMR, Chennai, Tamil Nadu, India.
FAU - Sethi, Bipin
AU  - Sethi B
AD  - Department of Endocrinology, Care Hospitals, Hyderabad, Telangana, India.
FAU - Gaurav, Kumar
AU  - Gaurav K
AUID- ORCID: 0000-0003-1056-7855
AD  - Department of Medical Affairs, Dr Reddy's Laboratories Ltd, Hyderabad, Telangana, 
      India.
FAU - Patted, Usha Rani H
AU  - Patted URH
AUID- ORCID: 0000-0002-4815-3300
AD  - Department of Medical Affairs, Dr Reddy's Laboratories Ltd, Hyderabad, Telangana, 
      India.
FAU - Bhagat, Seema Vikas
AU  - Bhagat SV
AUID- ORCID: 0000-0003-0517-2664
AD  - Department of Medical Affairs, Dr Reddy's Laboratories Ltd, Hyderabad, Telangana, 
      India.
FAU - Mane, Amey Ishwara
AU  - Mane AI
AUID- ORCID: 0000-0002-2902-4693
AD  - Department of Medical Affairs, Dr Reddy's Laboratories Ltd, Hyderabad, Telangana, 
      India.
LA  - eng
PT  - Journal Article
DEP - 20210629
PL  - New Zealand
TA  - Diabetes Metab Syndr Obes
JT  - Diabetes, metabolic syndrome and obesity : targets and therapy
JID - 101515585
PMC - PMC8254563
OTO - NOTNLM
OT  - electronic medical records
OT  - metformin
OT  - real-world study
OT  - type-2 diabetes
OT  - vildagliptin
COIS- The authors, V Mohan, Abdul Zargar, Manoj Chawla, Ameya Joshi, Usha Ayyagari, 
      Bipin Sethi, declare that they serve as CME speakers and/or advisory board 
      members for Dr. Reddy's Laboratories Ltd, India. The authors, Kumar Gaurav, Seema 
      Vikas Bhagat, Amey Ishwara Mane, declare that they work in Medical Affairs 
      Department in Dr. Reddy's Laboratories Ltd, India. Usha Rani H Patted has been an 
      ex-employee at Dr.Reddy's Laboratories Ltd, and reports being employed at Dr 
      Reddy's Laboratories Ltd, during the conduct of the study. The authors reported 
      no other conflicts of interest for this work.
EDAT- 2021/07/09 06:00
MHDA- 2021/07/09 06:01
PMCR- 2021/06/29
CRDT- 2021/07/08 06:37
PHST- 2021/04/10 00:00 [received]
PHST- 2021/05/26 00:00 [accepted]
PHST- 2021/07/08 06:37 [entrez]
PHST- 2021/07/09 06:00 [pubmed]
PHST- 2021/07/09 06:01 [medline]
PHST- 2021/06/29 00:00 [pmc-release]
AID - 315227 [pii]
AID - 10.2147/DMSO.S315227 [doi]
PST - epublish
SO  - Diabetes Metab Syndr Obes. 2021 Jun 29;14:2925-2933. doi: 10.2147/DMSO.S315227. 
      eCollection 2021.