PMID- 15745837
OWN - NLM
STAT- MEDLINE
DCOM- 20050630
LR  - 20220309
IS  - 1056-8727 (Print)
IS  - 1056-8727 (Linking)
VI  - 19
IP  - 2
DP  - 2005 Mar-Apr
TI  - Hyperglycemia and its effect after acute myocardial infarction on cardiovascular 
      outcomes in patients with Type 2 diabetes mellitus (HEART2D) Study design.
PG  - 80-7
AB  - OBJECTIVE: Cardiovascular (CV) disease is the major cause of death in patients 
      with diabetes. Up to 40% of patients with Type 2 diabetes mellitus (T2DM) who 
      survive an initial myocardial infarction (MI) suffer a recurrent event within 2 
      years, the majority of which are fatal. One independent risk factor for 
      cardiovascular disease (CVD) may be postprandial blood glucose (PPBG) excursions. 
      The HEART2D study seeks to determine the effect that PPBG control has on 
      cardiovascular outcomes in patients who suffered an MI within the 21 days before 
      study enrollment. RESEARCH DESIGN AND METHODS: Approximately 1355 patients with 
      T2DM with recent MI will be entered in this multicenter study of about 3.0-year 
      duration. Using infarct severity and peri-infarct treatment as randomization 
      factors, patients will be assigned to one of two insulin treatment strategies: 
      (1) postprandial strategy: premeal insulin lispro with basal insulin at bedtime 
      if needed (NPH insulin), targeting 2-h PPBG < or = 7.5 mmol/l or (2) basal 
      strategy: insulin (NPH insulin twice daily or insulin glargine once daily; or 
      premixed human insulin (70% NPH/30% regular; 30/70) twice daily), targeting 
      fasting and premeal blood glucose (BG; < or = 6.7 mmol/l). Both groups will aim 
      for a target hemoglobin AlC (AlC) of < 7%. ANTICIPATED RESULTS: The anticipated 
      difference in PPBG (approximately 2.0 to 2.5 mM) between strategies is expected 
      to demonstrate a 15% to 18.5% relative risk reduction in CV events for the 
      postprandial strategy. CONCLUSION: This study may provide practical insights into 
      the clinical management of patients with diabetes who have an increased risk of 
      recurrent CV events and death.
FAU - Milicevic, Zvonko
AU  - Milicevic Z
AD  - Eli Lilly and Company, Vienna, Austria. milicevic_zvonko@lilly.com
FAU - Raz, Itamar
AU  - Raz I
FAU - Strojek, Krzysztof
AU  - Strojek K
FAU - Skrha, Jan
AU  - Skrha J
FAU - Tan, Meng H
AU  - Tan MH
FAU - Wyatt, John W
AU  - Wyatt JW
FAU - Beattie, Scott D
AU  - Beattie SD
FAU - Robbins, David C
AU  - Robbins DC
CN  - HEART2D Study
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Diabetes Complications
JT  - Journal of diabetes and its complications
JID - 9204583
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin)
RN  - 0 (Insulin Lispro)
RN  - 0 (Insulin, Long-Acting)
RN  - 2ZM8CX04RZ (Insulin Glargine)
SB  - IM
MH  - Diabetes Mellitus, Type 2/*blood
MH  - Drug Administration Schedule
MH  - Fasting
MH  - Humans
MH  - Hyperglycemia/*physiopathology
MH  - Hypoglycemic Agents/*therapeutic use
MH  - Insulin/*analogs & derivatives/*therapeutic use
MH  - Insulin Glargine
MH  - Insulin Lispro
MH  - Insulin, Long-Acting
MH  - Myocardial Infarction/*blood
MH  - Postprandial Period
EDAT- 2005/03/05 09:00
MHDA- 2005/07/01 09:00
CRDT- 2005/03/05 09:00
PHST- 2004/02/05 00:00 [received]
PHST- 2004/05/17 00:00 [revised]
PHST- 2004/06/21 00:00 [accepted]
PHST- 2005/03/05 09:00 [pubmed]
PHST- 2005/07/01 09:00 [medline]
PHST- 2005/03/05 09:00 [entrez]
AID - S1056-8727(04)00075-3 [pii]
AID - 10.1016/j.jdiacomp.2004.06.003 [doi]
PST - ppublish
SO  - J Diabetes Complications. 2005 Mar-Apr;19(2):80-7. doi: 
      10.1016/j.jdiacomp.2004.06.003.