PMID- 31689132
OWN - NLM
STAT- MEDLINE
DCOM- 20200203
LR  - 20221207
IS  - 1744-7666 (Electronic)
IS  - 1465-6566 (Linking)
VI  - 21
IP  - 1
DP  - 2020 Jan
TI  - Safety and efficacy of vildagliptin: 52-week post-marketing surveillance of 
      Japanese patients with type 2 diabetes in combination with other oral 
      antidiabetics and insulin.
PG  - 121-130
LID - 10.1080/14656566.2019.1685500 [doi]
AB  - Background: Vildagliptin is a dipeptidyl peptidase-4 inhibitor that reduces 
      glycemia in patients with type 2 diabetes mellitus (T2DM). When approved in 2013, 
      data on vildagliptin combined with >750 mg/day metformin in Japanese patients 
      were limited. There is a need to confirm the safety and efficacy of vildagliptin 
      in combination with oral antidiabetic drugs (OADs).Research design and methods: 
      This 52-week post-marketing surveillance (PMS) observational study in Japanese 
      T2DM patients evaluated the safety and efficacy of vildagliptin in combination 
      with OADs including high-dose metformin or insulin but excluding combination with 
      sulfonylureas alone.Results: During this survey of 3006 Japanese T2DM patients, 
      13.61% of patients experienced adverse events (AEs) and 2.20% reported a serious 
      AE (SAE). The frequency of AEs/SAEs was similar when in combination with 
      biguanides (12.93%/1.46%), metformin >/=1000 mg/day (12.92%/1.22%), metformin <1000 
      mg/day (12.62%/1.54%), thiazolidine derivatives (16.71%/2.86%), alpha-glucosidase 
      inhibitors (13.18%/1.90%), rapid-acting insulin secretagogues  (glinides) 
      (20.41%/5.71%), or insulin (15.87%/2.47%). The mean +/- SD changes from baseline at 
      endpoint in glycated hemoglobin and fasting blood glucose were -0.76 +/- 1.27% and 
      -23.3 +/- 57.3 mg/dL, respectively, and these changes were consistent, regardless 
      of concomitant OAD.Conclusions: Long-term vildagliptin combination therapy is 
      safe and effective in Japanese T2DM patients in real-world settings.
FAU - Hayashi, Tomoko
AU  - Hayashi T
AD  - Medical Division, Novartis Pharma K.K., Tokyo, Japan.
FAU - Murayama, Hiroki
AU  - Murayama H
AD  - Medical Division, Novartis Pharma K.K., Tokyo, Japan.
FAU - Shinfuku, Yohei
AU  - Shinfuku Y
AD  - Regulatory Office Japan, Novartis Pharma K.K., Tokyo, Japan.
FAU - Taniguchi, Tomoko
AU  - Taniguchi T
AD  - Regulatory Office Japan, Novartis Pharma K.K., Tokyo, Japan.
FAU - Tsumiyama, Isao
AU  - Tsumiyama I
AD  - Japan Development, Novartis Pharma K.K., Tokyo, Japan.
FAU - Oyama, Naotsugu
AU  - Oyama N
AD  - Medical Division, Novartis Pharma K.K., Tokyo, Japan.
LA  - eng
PT  - Journal Article
PT  - Observational Study
DEP - 20191105
PL  - England
TA  - Expert Opin Pharmacother
JT  - Expert opinion on pharmacotherapy
JID - 100897346
RN  - 0 (Blood Glucose)
RN  - 0 (Dipeptidyl-Peptidase IV Inhibitors)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Glycoside Hydrolase Inhibitors)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin)
RN  - 0 (Sulfonylurea Compounds)
RN  - 9100L32L2N (Metformin)
RN  - I6B4B2U96P (Vildagliptin)
SB  - IM
MH  - Aged
MH  - Blood Glucose/drug effects
MH  - Cohort Studies
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Dipeptidyl-Peptidase IV Inhibitors/*administration & dosage/therapeutic use
MH  - Drug Therapy, Combination
MH  - Female
MH  - Glycated Hemoglobin/analysis
MH  - Glycoside Hydrolase Inhibitors/therapeutic use
MH  - Humans
MH  - Hypoglycemic Agents/*administration & dosage/therapeutic use
MH  - Insulin/administration & dosage/therapeutic use
MH  - Japan
MH  - Male
MH  - Metformin/administration & dosage/therapeutic use
MH  - Middle Aged
MH  - Product Surveillance, Postmarketing
MH  - Sulfonylurea Compounds/therapeutic use
MH  - Vildagliptin/*administration & dosage/adverse effects
OTO - NOTNLM
OT  - DPP-4 inhibitor
OT  - Japan
OT  - Vildagliptin
OT  - post-marketing surveillance
OT  - type 2 diabetes
EDAT- 2019/11/07 06:00
MHDA- 2020/02/06 06:00
CRDT- 2019/11/06 06:00
PHST- 2019/11/07 06:00 [pubmed]
PHST- 2020/02/06 06:00 [medline]
PHST- 2019/11/06 06:00 [entrez]
AID - 10.1080/14656566.2019.1685500 [doi]
PST - ppublish
SO  - Expert Opin Pharmacother. 2020 Jan;21(1):121-130. doi: 
      10.1080/14656566.2019.1685500. Epub 2019 Nov 5.