PMID- 17448371
OWN - NLM
STAT- MEDLINE
DCOM- 20070509
LR  - 20220330
IS  - 1558-3597 (Electronic)
IS  - 0735-1097 (Linking)
VI  - 49
IP  - 16
DP  - 2007 Apr 24
TI  - A randomized, placebo-controlled trial assessing the effects of rosiglitazone on 
      echocardiographic function and cardiac status in type 2 diabetic patients with 
      New York Heart Association Functional Class I or II Heart Failure.
PG  - 1696-704
AB  - OBJECTIVES: This study investigated the effects of rosiglitazone (RSG) on left 
      ventricular ejection fraction (LVEF) in subjects with type 2 diabetes (T2DM) and 
      pre-existing chronic heart failure (CHF) (New York Heart Association [NYHA] 
      functional class I to II). BACKGROUND: Fluid retention is an important 
      consideration in the use of thiazolidinediones in T2DM patients because it could 
      exacerbate symptoms or precipitate decompensation in those with previously stable 
      CHF. METHODS: A total of 224 patients with T2DM and NYHA functional class I to II 
      CHF with LVEF < or =45% were randomized to a 52-week treatment with RSG (4 to 8 
      mg daily, n = 110) or placebo (PLB) (n = 114) in addition to background 
      antidiabetes therapy. Treatment was uptitrated to achieve target fasting plasma 
      glucose <126 mg/dl; CHF medications were adjusted as appropriate. RESULTS: The 
      LVEF was similar in both groups at baseline (RSG 35.3 +/- 6.2%, PLB 35.7 +/- 
      7.8%) and after 52 weeks of treatment (mean difference 1.49%, p = 0.1). Glycemic 
      control was significantly better in the RSG group (mean difference in hemoglobin 
      A1c -0.65%, p < 0.0001). There were significantly more adjudicated events in the 
      RSG group of new or worsening edema (RSG n = 28 [25.5%]; PLB n = 10 [8.8%]; p = 
      0.005) and increased CHF medication (RSG n = 36 [32.7%], PLB n = 20 [17.5%]; p = 
      0.037), but no significant difference between groups for other adjudicated end 
      points. A similar proportion of patients withdrew from each treatment group 
      because of adverse events. CONCLUSIONS: After 52 weeks of treatment, RSG improved 
      glycemic control but did not adversely affect LVEF in patients with T2DM and NYHA 
      functional class I to II CHF. More fluid-related events occurred with RSG, 
      although these generally did not lead to withdrawal from the study.
FAU - Dargie, Henry J
AU  - Dargie HJ
AD  - Department of Cardiology, Western Infirmary, Glasgow, Scotland. 
      H.Dargie@bio.gla.ac.uk
FAU - Hildebrandt, Per R
AU  - Hildebrandt PR
FAU - Riegger, Gunter A J
AU  - Riegger GA
FAU - McMurray, John J V
AU  - McMurray JJ
FAU - McMorn, Stephen O
AU  - McMorn SO
FAU - Roberts, Jeremy N
AU  - Roberts JN
FAU - Zambanini, Andrew
AU  - Zambanini A
FAU - Wilding, John P H
AU  - Wilding JP
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20070406
PL  - United States
TA  - J Am Coll Cardiol
JT  - Journal of the American College of Cardiology
JID - 8301365
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Thiazolidinediones)
RN  - 05V02F2KDG (Rosiglitazone)
SB  - IM
CIN - J Am Coll Cardiol. 2007 Apr 24;49(16):1705-7. PMID: 17448372
MH  - Aged
MH  - Cardiac Output, Low/*drug therapy
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Double-Blind Method
MH  - Echocardiography/drug effects
MH  - Female
MH  - Humans
MH  - Hypoglycemic Agents/adverse effects/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Rosiglitazone
MH  - Thiazolidinediones/adverse effects/*therapeutic use
MH  - Ventricular Function, Left/*drug effects
MH  - Water-Electrolyte Balance/drug effects
EDAT- 2007/04/24 09:00
MHDA- 2007/05/10 09:00
CRDT- 2007/04/24 09:00
PHST- 2005/11/11 00:00 [received]
PHST- 2006/09/06 00:00 [revised]
PHST- 2006/10/12 00:00 [accepted]
PHST- 2007/04/24 09:00 [pubmed]
PHST- 2007/05/10 09:00 [medline]
PHST- 2007/04/24 09:00 [entrez]
AID - S0735-1097(07)00558-X [pii]
AID - 10.1016/j.jacc.2006.10.077 [doi]
PST - ppublish
SO  - J Am Coll Cardiol. 2007 Apr 24;49(16):1696-704. doi: 10.1016/j.jacc.2006.10.077. 
      Epub 2007 Apr 6.