PMID- 28292480
OWN - NLM
STAT- MEDLINE
DCOM- 20170605
LR  - 20221207
IS  - 1524-4733 (Electronic)
IS  - 1098-3015 (Linking)
VI  - 20
IP  - 3
DP  - 2017 Mar
TI  - Multivariate Prediction Equations for HbA(1c) Lowering, Weight Change, and 
      Hypoglycemic Events Associated with Insulin Rescue Medication in Type 2 Diabetes 
      Mellitus: Informing Economic Modeling.
PG  - 357-371
LID - S1098-3015(16)34051-7 [pii]
LID - 10.1016/j.jval.2016.10.004 [doi]
AB  - BACKGROUND: Type 2 diabetes mellitus (T2DM) is chronic and progressive and the 
      cost-effectiveness of new treatment interventions must be established over long 
      time horizons. Given the limited durability of drugs, assumptions regarding 
      downstream rescue medication can drive results. Especially for insulin, for which 
      treatment effects and adverse events are known to depend on patient 
      characteristics, this can be problematic for health economic evaluation involving 
      modeling. OBJECTIVES: To estimate parsimonious multivariate equations of 
      treatment effects and hypoglycemic event risks for use in parameterizing insulin 
      rescue therapy in model-based cost-effectiveness analysis. METHODS: Clinical 
      evidence for insulin use in T2DM was identified in PubMed and from published 
      reviews and meta-analyses. Study and patient characteristics and treatment 
      effects and adverse event rates were extracted and the data used to estimate 
      parsimonious treatment effect and hypoglycemic event risk equations using 
      multivariate regression analysis. RESULTS: Data from 91 studies featuring 171 
      usable study arms were identified, mostly for premix and basal insulin types. 
      Multivariate prediction equations for glycated hemoglobin A(1c) lowering and 
      weight change were estimated separately for insulin-naive and insulin-experienced 
      patients. Goodness of fit (R(2)) for both outcomes were generally good, ranging 
      from 0.44 to 0.84. Multivariate prediction equations for symptomatic, nocturnal, 
      and severe hypoglycemic events were also estimated, though considerable 
      heterogeneity in definitions limits their usefulness. CONCLUSIONS: Parsimonious 
      and robust multivariate prediction equations were estimated for glycated 
      hemoglobin A(1c) and weight change, separately for insulin-naive and 
      insulin-experienced patients. Using these in economic simulation modeling in T2DM 
      can improve realism and flexibility in modeling insulin rescue medication.
CI  - Copyright (c) 2017 International Society for Pharmacoeconomics and Outcomes 
      Research (ISPOR). Published by Elsevier Inc. All rights reserved.
FAU - Willis, Michael
AU  - Willis M
AD  - The Swedish Institute for Health Economics, Lund, Sweden. Electronic address: 
      michael.willis@ihe.se.
FAU - Asseburg, Christian
AU  - Asseburg C
AD  - The Swedish Institute for Health Economics, Lund, Sweden.
FAU - Nilsson, Andreas
AU  - Nilsson A
AD  - The Swedish Institute for Health Economics, Lund, Sweden.
FAU - Johnsson, Kristina
AU  - Johnsson K
AD  - AstraZeneca, Gothenburg, Sweden.
FAU - Kartman, Bernt
AU  - Kartman B
AD  - AstraZeneca, Gothenburg, Sweden.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20161201
PL  - United States
TA  - Value Health
JT  - Value in health : the journal of the International Society for Pharmacoeconomics 
      and Outcomes Research
JID - 100883818
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Insulin)
RN  - 0 (hemoglobin A1c protein, human)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Body Mass Index
MH  - Body Weight
MH  - Computer Simulation
MH  - Cost-Benefit Analysis
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy/*economics
MH  - Female
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Hypoglycemia/blood/*drug therapy/*economics
MH  - Insulin/*economics/*therapeutic use
MH  - Male
MH  - Meta-Analysis as Topic
MH  - Middle Aged
MH  - Models, Econometric
MH  - Multivariate Analysis
MH  - Young Adult
OTO - NOTNLM
OT  - HbA(1c)
OT  - diabetes
OT  - insulin
OT  - weight
EDAT- 2017/03/16 06:00
MHDA- 2017/06/06 06:00
CRDT- 2017/03/16 06:00
PHST- 2016/05/12 00:00 [received]
PHST- 2016/09/28 00:00 [revised]
PHST- 2016/10/02 00:00 [accepted]
PHST- 2017/03/16 06:00 [entrez]
PHST- 2017/03/16 06:00 [pubmed]
PHST- 2017/06/06 06:00 [medline]
AID - S1098-3015(16)34051-7 [pii]
AID - 10.1016/j.jval.2016.10.004 [doi]
PST - ppublish
SO  - Value Health. 2017 Mar;20(3):357-371. doi: 10.1016/j.jval.2016.10.004. Epub 2016 
      Dec 1.