PMID- 31456304
OWN - NLM
STAT- MEDLINE
DCOM- 20200727
LR  - 20210110
IS  - 1099-1557 (Electronic)
IS  - 1053-8569 (Print)
IS  - 1053-8569 (Linking)
VI  - 28
IP  - 12
DP  - 2019 Dec
TI  - Diabetic ketoacidosis in patients with type 2 diabetes treated with sodium 
      glucose co-transporter 2 inhibitors versus other antihyperglycemic agents: An 
      observational study of four US administrative claims databases.
PG  - 1620-1628
LID - 10.1002/pds.4887 [doi]
AB  - PURPOSE: To compare the incidence of diabetic ketoacidosis (DKA) among patients 
      with type 2 diabetes mellitus (T2DM) who were new users of sodium glucose 
      co-transporter 2 inhibitors (SGLT2i) versus other classes of antihyperglycemic 
      agents (AHAs). METHODS: Patients were identified from four large US claims 
      databases using broad (all T2DM patients) and narrow (intended to exclude 
      patients with type 1 diabetes or secondary diabetes misclassified as T2DM) 
      definitions of T2DM. New users of SGLT2i and seven groups of comparator AHAs were 
      matched (1:1) on exposure propensity scores to adjust for imbalances in baseline 
      covariates. Cox proportional hazards regression models, conditioned on propensity 
      score-matched pairs, were used to estimate hazard ratios (HRs) of DKA for new 
      users of SGLT2i versus other AHAs. When I(2) <40%, a combined HR across the four 
      databases was estimated. RESULTS: Using the broad definition of T2DM, new users 
      of SGLT2i had an increased risk of DKA versus sulfonylureas (HR [95% CI]: 1.53 
      [1.31-1.79]), DPP-4i (1.28 [1.11-1.47]), GLP-1 receptor agonists (1.34 
      [1.12-1.60]), metformin (1.31 [1.11-1.54]), and insulinotropic AHAs (1.38 
      [1.15-1.66]). Using the narrow definition of T2DM, new users of SGLT2i had an 
      increased risk of DKA versus sulfonylureas (1.43 [1.01-2.01]). New users of 
      SGLT2i had a lower risk of DKA versus insulin and a similar risk as 
      thiazolidinediones, regardless of T2DM definition. CONCLUSIONS: Increased risk of 
      DKA was observed for new users of SGLT2i versus several non-SGLT2i AHAs when T2DM 
      was defined broadly. When T2DM was defined narrowly to exclude possible 
      misclassified patients, an increased risk of DKA with SGLT2i was observed 
      compared with sulfonylureas.
CI  - (c) 2019 The Authors. Pharmacoepidemiology & Drug Safety Published by John Wiley & 
      Sons Ltd.
FAU - Wang, Lu
AU  - Wang L
AUID- ORCID: 0000-0001-7225-9407
AD  - Janssen Research & Development, LLC, Titusville, New Jersey.
FAU - Voss, Erica A
AU  - Voss EA
AD  - Janssen Research & Development, LLC, Raritan, New Jersey.
FAU - Weaver, James
AU  - Weaver J
AD  - Janssen Research & Development, LLC, Titusville, New Jersey.
FAU - Hester, Laura
AU  - Hester L
AD  - Janssen Research & Development, LLC, Titusville, New Jersey.
FAU - Yuan, Zhong
AU  - Yuan Z
AUID- ORCID: 0000-0002-5824-2040
AD  - Janssen Research & Development, LLC, Titusville, New Jersey.
FAU - DeFalco, Frank
AU  - DeFalco F
AD  - Janssen Research & Development, LLC, Raritan, New Jersey.
FAU - Schuemie, Martijn J
AU  - Schuemie MJ
AD  - Janssen Research & Development, LLC, Titusville, New Jersey.
FAU - Ryan, Patrick B
AU  - Ryan PB
AD  - Janssen Research & Development, LLC, Titusville, New Jersey.
FAU - Sun, Don
AU  - Sun D
AD  - Janssen Research & Development, LLC, Titusville, New Jersey.
FAU - Freedman, Amy
AU  - Freedman A
AD  - Janssen Research & Development, LLC, Titusville, New Jersey.
FAU - Alba, Maria
AU  - Alba M
AD  - Janssen Research & Development, LLC, Raritan, New Jersey.
FAU - Lind, Joan
AU  - Lind J
AD  - Janssen Research & Development, LLC, Raritan, New Jersey.
FAU - Meininger, Gary
AU  - Meininger G
AD  - Janssen Research & Development, LLC, Raritan, New Jersey.
FAU - Berlin, Jesse A
AU  - Berlin JA
AD  - Johnson & Johnson, Titusville, New Jersey.
FAU - Rosenthal, Norman
AU  - Rosenthal N
AD  - Janssen Research & Development, LLC, Raritan, New Jersey.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20190827
PL  - England
TA  - Pharmacoepidemiol Drug Saf
JT  - Pharmacoepidemiology and drug safety
JID - 9208369
RN  - 0 (Blood Glucose)
RN  - 0 (Glucagon-Like Peptide-1 Receptor)
RN  - 0 (Insulin)
RN  - 0 (Sodium-Glucose Transporter 2 Inhibitors)
RN  - 0 (Sulfonylurea Compounds)
RN  - 9100L32L2N (Metformin)
SB  - IM
MH  - Administrative Claims, Healthcare/statistics & numerical data
MH  - Aged
MH  - Blood Glucose
MH  - Databases, Factual/statistics & numerical data
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Diabetic Ketoacidosis/chemically induced/*epidemiology
MH  - Female
MH  - Glucagon-Like Peptide-1 Receptor/antagonists & inhibitors
MH  - Humans
MH  - Incidence
MH  - Insulin/adverse effects
MH  - Male
MH  - Metformin/adverse effects
MH  - Middle Aged
MH  - Risk Factors
MH  - Sodium-Glucose Transporter 2 Inhibitors/*adverse effects
MH  - Sulfonylurea Compounds/adverse effects
MH  - United States/epidemiology
PMC - PMC6916409
OTO - NOTNLM
OT  - SGLT2 inhibitor
OT  - diabetic ketoacidosis
OT  - type 2 diabetes
EDAT- 2019/08/29 06:00
MHDA- 2020/07/28 06:00
PMCR- 2019/12/17
CRDT- 2019/08/29 06:00
PHST- 2019/03/26 00:00 [received]
PHST- 2019/07/01 00:00 [revised]
PHST- 2019/07/25 00:00 [accepted]
PHST- 2019/08/29 06:00 [pubmed]
PHST- 2020/07/28 06:00 [medline]
PHST- 2019/08/29 06:00 [entrez]
PHST- 2019/12/17 00:00 [pmc-release]
AID - PDS4887 [pii]
AID - 10.1002/pds.4887 [doi]
PST - ppublish
SO  - Pharmacoepidemiol Drug Saf. 2019 Dec;28(12):1620-1628. doi: 10.1002/pds.4887. 
      Epub 2019 Aug 27.