PMID- 32306246
OWN - NLM
STAT- MEDLINE
DCOM- 20201210
LR  - 20221207
IS  - 1865-8652 (Electronic)
IS  - 0741-238X (Print)
IS  - 0741-238X (Linking)
VI  - 37
IP  - 5
DP  - 2020 May
TI  - Long-Term Safety and Efficacy of Sitagliptin for Type 2 Diabetes Mellitus in 
      Japan: Results of a Multicentre, Open-Label, Observational Post-Marketing 
      Surveillance Study.
PG  - 2442-2459
LID - 10.1007/s12325-020-01293-2 [doi]
AB  - INTRODUCTION: A post-marketing surveillance (PMS) study was conducted to confirm 
      the long-term risk-benefit profile of sitagliptin administered to Japanese 
      patients with type 2 diabetes mellitus (T2DM) under real-world conditions. 
      METHODS: This prospective, multicentre, open-label PMS collected data from 3326 
      patients receiving sitagliptin according to the approved indication during the 
      case registration period (July 2010-June 2012; observation period, 3 years). 
      Safety was assessed via collection of data on adverse drug reactions (ADRs), 
      estimated glomerular filtration rate (eGFR) and cardiovascular events whereas 
      efficacy was assessed via changes in glycated hemoglobin (HbA1c). RESULTS: In 
      3265 patients evaluated for safety, 270 ADRs occurred in 207 (6.3%) patients 
      overall. Metabolism and nutrition disorders were the most common class of ADRs, 
      occurring in 58 patients overall (53 non-serious, 5 serious) with hypoglycaemia 
      (17 patients, 0.52%) the most common ADR. In patients with 
      eGFR > 90 mL/min/1.73 m(2) at baseline (mean +/- SD, 
      106.42 +/- 18.11 mL/min/1.73 m(2), n = 584), eGFR declined by 
      11.83 +/- 17.53 mL/min/1.73 m(2) (P < 0.0001; n = 360) over the observation period 
      whereas eGFR appeared to be relatively maintained in patients with lower baseline 
      eGFR levels. Cardiovascular events were infrequent [occurring in 4 of 84 (4.76%) 
      patients at high cardiovascular risk] with no distinct features in this Japanese 
      population and the cumulative incidence [8.42% (3.12-21.70) at 36 months; n = 32] 
      was similar to that noted in previous studies involving sitagliptin. In patients 
      evaluated for efficacy, the overall change in HbA1c from baseline to final 
      evaluation was mean +/- SD - 0.68 +/- 1.34% (P < 0.0001, n = 2070). Reductions in 
      HbA1c tended to be greater in younger patients and patients with higher body mass 
      index (BMI) and HbA1c values at the start of administration. CONCLUSION: 
      Long-term sitagliptin administration in the routine clinical practice setting is 
      associated with good efficacy, including as monotherapy, with no additional 
      safety concerns.
FAU - Yoshikawa, Ken
AU  - Yoshikawa K
AD  - Pharmacovigilance Division, Ono Pharmaceutical Co., Ltd., Osaka, Japan. 
      k.yoshikawa@ono.co.jp.
FAU - Tsuchiya, Akira
AU  - Tsuchiya A
AD  - Pharmacovigilance Division, Ono Pharmaceutical Co., Ltd., Osaka, Japan.
FAU - Kido, Tomoyuki
AU  - Kido T
AD  - Pharmacovigilance Division, Ono Pharmaceutical Co., Ltd., Osaka, Japan.
FAU - Ota, Tomohiro
AU  - Ota T
AD  - Japan Pharmacovigilance, MSD K.K., Tokyo, Japan. tomohiro.ota@merck.com.
FAU - Ikeda, Keiko
AU  - Ikeda K
AD  - Japan Pharmacovigilance, MSD K.K., Tokyo, Japan.
FAU - Iwakura, Mika
AU  - Iwakura M
AD  - Japan Pharmacovigilance, MSD K.K., Tokyo, Japan.
FAU - Maeda, Yoshikazu
AU  - Maeda Y
AD  - Japan Pharmacovigilance, MSD K.K., Tokyo, Japan.
FAU - Maekawa, Shinichiroh
AU  - Maekawa S
AD  - Japan Pharmacovigilance, MSD K.K., Tokyo, Japan.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20200418
PL  - United States
TA  - Adv Ther
JT  - Advances in therapy
JID - 8611864
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - TS63EW8X6F (Sitagliptin Phosphate)
MH  - Aged
MH  - Aged, 80 and over
MH  - Cardiovascular Diseases/epidemiology
MH  - Diabetes Mellitus, Type 2/*drug therapy/epidemiology
MH  - Female
MH  - Glomerular Filtration Rate
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Hypoglycemia/chemically induced
MH  - Hypoglycemic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Japan/epidemiology
MH  - Male
MH  - Middle Aged
MH  - Product Surveillance, Postmarketing
MH  - Prospective Studies
MH  - Sitagliptin Phosphate/administration & dosage/adverse effects/*therapeutic use
PMC - PMC7467485
OTO - NOTNLM
OT  - Efficacy
OT  - Observational study
OT  - Post-marketing surveillance
OT  - Safety
OT  - Sitagliptin
OT  - Type 2 diabetes mellitus
EDAT- 2020/04/20 06:00
MHDA- 2020/12/15 06:00
PMCR- 2020/04/18
CRDT- 2020/04/20 06:00
PHST- 2020/01/27 00:00 [received]
PHST- 2020/04/20 06:00 [pubmed]
PHST- 2020/12/15 06:00 [medline]
PHST- 2020/04/20 06:00 [entrez]
PHST- 2020/04/18 00:00 [pmc-release]
AID - 10.1007/s12325-020-01293-2 [pii]
AID - 1293 [pii]
AID - 10.1007/s12325-020-01293-2 [doi]
PST - ppublish
SO  - Adv Ther. 2020 May;37(5):2442-2459. doi: 10.1007/s12325-020-01293-2. Epub 2020 
      Apr 18.