PMID- 30575426
OWN - NLM
STAT- MEDLINE
DCOM- 20190617
LR  - 20190617
IS  - 1941-837X (Electronic)
IS  - 1369-6998 (Linking)
VI  - 22
IP  - 3
DP  - 2019 Mar
TI  - Economic modelling of costs associated with outcomes reported for type 2 diabetes 
      mellitus (T2DM) patients in the CANVAS and EMPA-REG cardiovascular outcomes 
      trials.
PG  - 280-287
LID - 10.1080/13696998.2018.1562817 [doi]
AB  - AIMS: To model direct medical costs associated with reductions in cardiovascular 
      disease (CVD) events in T2DM patients reported in the CANVAS and EMPA-REG trials, 
      which assessed the cardiovascular safety of canagliflozin and empagliflozin, 
      respectively. MATERIALS AND METHODS: Costs were modeled from a US managed care 
      organization (MCO) perspective for the CVD outcomes included in both trials: 
      three-point major adverse cardiovascular event (MACE) and its components 
      (cardiovascular-related death, nonfatal myocardial infarction, nonfatal stroke), 
      as well as heart failure requiring hospitalization. The rate of CVD events 
      averted (difference between study drug and placebo) was projected to the portion 
      of an MCO T2DM population matching the respective trial's inclusion criteria. A 
      targeted literature search for paid amounts directly associated with each CVD 
      event provided the unit costs, which were applied to the projected number of 
      events averted, to calculate costs avoided per member per year (PMPY). One-way 
      sensitivity analyses were performed on events averted, unit costs, and 
      percentages of trial-applicable patients. RESULTS: Based on three-point MACE 
      events averted, costs avoided PMPY of $6.17 (range: $1.27-$10.94) for CANVAS and 
      $2.75 ($0.19-$4.83) for EMPA-REG were estimated. Costs avoided for individual 
      components of MACE ranged from $0.77 to $3.84 PMPY for CANVAS and from -$0.97 
      (additional costs) to $1.54 for EMPA-REG. PMPY costs avoided for heart failure 
      were $2.72 for CANVAS and $1.32 for EMPA-REG. LIMITATIONS AND CONCLUSIONS: Models 
      assumed independent, non-recurrent outcomes and were restricted to medical costs 
      directly associated with the trial-reported events. The reductions in CVD events 
      in T2DM patients reported for both CANVAS and EMPA-REG project to a positive cost 
      avoidance for these events in an MCO population. The analysis did not include an 
      assessment of the impact on total cost, as the costs associated with adverse 
      events, drug utilization or other clinical outcomes were not examined.
FAU - Kamstra, Rhiannon
AU  - Kamstra R
AD  - a Analysis Group Inc. , Montreal , Quebec , Canada.
FAU - Durkin, Mike
AU  - Durkin M
AD  - b Janssen Scientific Affairs, LLC , Titusville , NJ , USA.
FAU - Cai, Jennifer
AU  - Cai J
AD  - b Janssen Scientific Affairs, LLC , Titusville , NJ , USA.
FAU - Bookhart, Brahim
AU  - Bookhart B
AD  - b Janssen Scientific Affairs, LLC , Titusville , NJ , USA.
FAU - Lafeuille, Marie-Helene
AU  - Lafeuille MH
AD  - a Analysis Group Inc. , Montreal , Quebec , Canada.
FAU - Pilon, Dominic
AU  - Pilon D
AD  - a Analysis Group Inc. , Montreal , Quebec , Canada.
FAU - Tiggelaar, Sean
AU  - Tiggelaar S
AD  - a Analysis Group Inc. , Montreal , Quebec , Canada.
FAU - Manceur, Ameur M
AU  - Manceur AM
AD  - a Analysis Group Inc. , Montreal , Quebec , Canada.
FAU - Lefebvre, Patrick
AU  - Lefebvre P
AD  - a Analysis Group Inc. , Montreal , Quebec , Canada.
LA  - eng
PT  - Journal Article
DEP - 20190111
PL  - England
TA  - J Med Econ
JT  - Journal of medical economics
JID - 9892255
RN  - 0 (Benzhydryl Compounds)
RN  - 0 (Glucosides)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Sodium-Glucose Transporter 2 Inhibitors)
RN  - 0SAC974Z85 (Canagliflozin)
RN  - HDC1R2M35U (empagliflozin)
SB  - IM
MH  - Benzhydryl Compounds/*therapeutic use
MH  - Canagliflozin/*therapeutic use
MH  - Cardiovascular Diseases/economics/*epidemiology
MH  - Diabetes Mellitus, Type 2/*complications/*drug therapy
MH  - Glucosides/*therapeutic use
MH  - Health Expenditures
MH  - Humans
MH  - Hypoglycemic Agents/*therapeutic use
MH  - Models, Economic
MH  - Sodium-Glucose Transporter 2 Inhibitors/therapeutic use
OTO - NOTNLM
OT  - CVD-related cost avoidance
OT  - I11
OT  - I19
OT  - Type 2 diabetes mellitus
OT  - canagliflozin
OT  - cardiovascular outcomes
OT  - empagliflozin
OT  - sodium-glucose co-transporter 2 inhibitors
EDAT- 2018/12/24 06:00
MHDA- 2019/06/18 06:00
CRDT- 2018/12/22 06:00
PHST- 2018/12/24 06:00 [pubmed]
PHST- 2019/06/18 06:00 [medline]
PHST- 2018/12/22 06:00 [entrez]
AID - 10.1080/13696998.2018.1562817 [doi]
PST - ppublish
SO  - J Med Econ. 2019 Mar;22(3):280-287. doi: 10.1080/13696998.2018.1562817. Epub 2019 
      Jan 11.