PMID- 32228183
OWN - NLM
STAT- MEDLINE
DCOM- 20210121
LR  - 20221207
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
VI  - 19
IP  - 5
DP  - 2020 May
TI  - Cardiovascular safety and effectiveness of vildagliptin in patients with type 2 
      diabetes mellitus: a 3-year, large-scale post-marketing surveillance in Japan.
PG  - 625-631
LID - 10.1080/14740338.2020.1740679 [doi]
AB  - Objectives: The dipeptidyl peptidase-4 (DPP-4) inhibitor vildagliptin is 
      indicated for type 2 diabetes mellitus (T2DM). However, the long-term safety, 
      effectiveness, and clinical relationship with cardiovascular events of 
      vildagliptin have not been evaluated in Japan.Methods: The authors conducted 
      post-marketing surveillance (PMS) to evaluate the safety and effectiveness of 
      vildagliptin in more than 3000 Japanese T2DM patients for up to 3 years. Main 
      assessments included demographics, major adverse cardiovascular events (MACE), 
      adverse events (AEs), adverse drug reactions (ADRs), and glycated hemoglobin 
      (HbA1c).Results: In this PMS, 3831 patients (775 sites) were registered in April 
      2010 - April 2012. The safety analysis population comprised 3769 patients; 2085 
      patients were aged >/=65 years, and 240, 411, and 114 had renal impairment, hepatic 
      impairment, and heart failure, respectively. The median treatment duration was 
      2.7 years. The incidence of MACE was 6.04 cases/1000 person-years, mostly 
      attributable to cerebrovascular events (4.27 cases/1000 person-years). The AE and 
      ADR incidences were 26.0% and 5.3%, respectively. The incidence of hypoglycemia 
      was 0.6%. No significant changes in body weight occurred and mean change in HbA1c 
      from baseline at final assessment was -0.74 +/- 1.41% (p < 0.0001).Conclusions: In 
      real-world clinical settings, vildagliptin was well tolerated, with similar 
      profiles as previously reported.
FAU - Ishida, Yosuke
AU  - Ishida Y
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  - Japan Development, Novartis Pharma K.K., Tokyo, Japan.
FAU - Sasajima, Takayoshi
AU  - Sasajima T
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 - 20200331
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
RN  - 0 (Dipeptidyl-Peptidase IV Inhibitors)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - I6B4B2U96P (Vildagliptin)
SB  - IM
MH  - Aged
MH  - Cardiovascular Diseases/chemically induced/epidemiology
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Dipeptidyl-Peptidase IV Inhibitors/*administration & dosage/adverse effects
MH  - Female
MH  - Glycated Hemoglobin/metabolism
MH  - Humans
MH  - Hypoglycemia/chemically induced/epidemiology
MH  - Hypoglycemic Agents/*administration & dosage/adverse effects
MH  - Japan
MH  - Male
MH  - Middle Aged
MH  - Product Surveillance, Postmarketing
MH  - Vildagliptin/*administration & dosage/adverse effects
OTO - NOTNLM
OT  - Cardiovascular events
OT  - DPP-4 inhibitor
OT  - Japanese
OT  - post-marketing surveillance
OT  - type 2 diabetes mellitus
OT  - vildagliptin
EDAT- 2020/04/02 06:00
MHDA- 2021/01/22 06:00
CRDT- 2020/04/02 06:00
PHST- 2020/04/02 06:00 [pubmed]
PHST- 2021/01/22 06:00 [medline]
PHST- 2020/04/02 06:00 [entrez]
AID - 10.1080/14740338.2020.1740679 [doi]
PST - ppublish
SO  - Expert Opin Drug Saf. 2020 May;19(5):625-631. doi: 10.1080/14740338.2020.1740679. 
      Epub 2020 Mar 31.