PMID- 29764225
OWN - NLM
STAT- MEDLINE
DCOM- 20191004
LR  - 20221207
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 34
IP  - 9
DP  - 2018 Sep
TI  - Initial combination therapy with vildagliptin plus metformin in drug-naive 
      patients with T2DM: a 24-week real-life study from Asia.
PG  - 1605-1611
LID - 10.1080/03007995.2018.1476333 [doi]
AB  - AIMS: To assess the effectiveness and safety of vildagliptin/metformin initial 
      combination therapy in drug-naive patients with type 2 diabetes mellitus (T2DM). 
      METHODS: INITIAL was a 24-week prospective, observational study in T2DM patients 
      with glycated hemoglobin (HbA1c) >/= 7.5%, and prescribed vildagliptin/metformin as 
      initial combination therapy. The primary endpoint was change in HbA1c from 
      baseline to week 24. Key secondary endpoints were HbA1c change from baseline to 
      week 12, proportion of patients achieving HbA1c </=7.0%, change in body weight at 
      12 and 24 weeks, change in HbA1c by sub-groups (baseline HbA1c, age, body mass 
      index [BMI], dosage strength, co-morbidities) from baseline to week 24, and 
      safety. RESULTS: A total of 532 patients were enrolled. The mean age, HbA1c, and 
      BMI were 49.6 +/- 11.27 years, 9.3 +/- 1.57%, and 26.7 +/- 4.50 kg/m(2), respectively. 
      Cardiovascular risk factors present at baseline were dyslipidemia (30.1%), 
      hypertension (29.7%), and obesity (20.9%). The mean reductions in HbA1c from 
      baseline to week 12 (-1.6 +/- 1.59%) and 24 (-1.9 +/- 1.70%) were statistically 
      significant (p < .001). At 24 weeks, 39.6% of patients achieved HbA1c </= 7.0%, and 
      the mean body weight reduction was -1.1 +/- 2.62 kg. HbA1c reductions were 
      consistently seen from baseline to weeks 12 and 24 in the various sub-groups. 
      Overall, 48 (9.0%) patients reported adverse events, including one hypoglycemic 
      episode. There were no serious adverse events or deaths. CONCLUSIONS: Overall, in 
      a relatively young drug-naive T2DM Asian study population with high baseline 
      HbA1c and often associated with cardiovascular risk factors, 
      vildagliptin/metformin combination therapy was associated with significant and 
      clinically relevant HbA1c reduction from baseline. This effect was seen at week 
      12, was maintained over 24 weeks, and was accompanied by good tolerability.
FAU - Chawla, Manoj
AU  - Chawla M
AD  - a LINA Diabetes Care Center , Mumbai , India.
FAU - Kim, Tae Ho
AU  - Kim TH
AD  - b Seoul Medical Center , Seoul , Republic of Korea.
FAU - Mirasol, Roberto C
AU  - Mirasol RC
AD  - c St. Luke's Medical Center , Quezon City , Philippines.
FAU - Faruque, Pathan
AU  - Faruque P
AD  - d Bangladesh Institute of Research and Rehabilitation in Diabetes , Endocrine and 
      Metabolic Disorders (BIRDEM) , Dhaka , Bangladesh.
FAU - Cooke, Kathryn
AU  - Cooke K
AD  - e Novartis Pharma AG , Basel , Switzerland.
FAU - Hours-Zesiger, Peggy
AU  - Hours-Zesiger P
AD  - e Novartis Pharma AG , Basel , Switzerland.
FAU - Shete, Abhijit
AU  - Shete A
AD  - e Novartis Pharma AG , Basel , Switzerland.
LA  - eng
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20180612
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Drug Combinations)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 9100L32L2N (Metformin)
RN  - I6B4B2U96P (Vildagliptin)
SB  - IM
MH  - Adult
MH  - Asia/epidemiology
MH  - Body Mass Index
MH  - *Diabetes Mellitus, Type 2/diagnosis/drug therapy
MH  - Drug Combinations
MH  - Female
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - *Hypoglycemia/chemically induced/prevention & control
MH  - Hypoglycemic Agents/administration & dosage/adverse effects
MH  - Male
MH  - *Metformin/administration & dosage/adverse effects
MH  - Middle Aged
MH  - Risk Factors
MH  - Treatment Outcome
MH  - *Vildagliptin/administration & dosage/adverse effects
OTO - NOTNLM
OT  - Asia
OT  - Initial combination therapy
OT  - Metformin
OT  - Real-life
OT  - Type 2 diabetes mellitus
OT  - Vildagliptin
EDAT- 2018/05/17 06:00
MHDA- 2019/10/08 06:00
CRDT- 2018/05/17 06:00
PHST- 2018/05/17 06:00 [pubmed]
PHST- 2019/10/08 06:00 [medline]
PHST- 2018/05/17 06:00 [entrez]
AID - 10.1080/03007995.2018.1476333 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2018 Sep;34(9):1605-1611. doi: 10.1080/03007995.2018.1476333. 
      Epub 2018 Jun 12.