Advertisement





Click here for more guidelines.
CME Topic Collections Past Issues Search Current Issue Home
     

J Am Coll Cardiol, 2007; 49:1696-1704, doi:10.1016/j.jacc.2006.10.077 (Published online 3 April 2007).
© 2007 by the American College of Cardiology Foundation
This Article
Right arrow Figures Only
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow All Versions of this Article:
j.jacc.2006.10.077v1
49/16/1696    most recent
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in ISI Web of Science
Right arrow Alert me to new issues of the journal
Right arrow Download to citation manager
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via ISI Web of Science (42)
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Dargie, H. J.
Right arrow Articles by Wilding, J. P.H.
Right arrow Search for Related Content
PubMed
Right arrow Articles by Dargie, H. J.
Right arrow Articles by Wilding, J. P.H.
Related Collections
Right arrowRelated Article

CLINICAL RESEARCH: HEART FAILURE

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

Henry J. Dargie, MBChB*,*, Per R. Hildebrandt, MD{dagger}, Günter A.J. Riegger, MD{ddagger}, John J.V. McMurray, MD*, Stephen O. McMorn, PhD§, Jeremy N. Roberts, MSc||, Andrew Zambanini, MRCP§ and John P.H. Wilding, DM

* Department of Cardiology, Western Infirmary, Glasgow, Scotland
{dagger} Department of Cardiology, Frederiksberg Hospital, Fredriksberg, Denmark
{ddagger} Department of Cardiology, University of Regensberg, Regensberg, Germany
§ Cardiovascular and Metabolic Medicines Development Centre, GlaxoSmithKline, Harlow, England
|| Biomedical Data Sciences, GlaxoSmithKline, Oakville, Canada
Clinical Sciences Centre, University Hospital Aintree, Liverpool, England.

Manuscript received November 11, 2005; revised manuscript received September 6, 2006, accepted October 12, 2006.

* Reprint requests and correspondence: Dr. Henry J. Dargie, Western Infirmary, CRI Department, Level 4, Glasgow, G11 6NT United Kingdom. (Email: H.Dargie{at}bio.gla.ac.uk).

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 ≤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.

Abbreviations and Acronyms
  BNP = brain natriuretic peptide
  CHF = chronic heart failure
  ECHO = echocardiogram/echocardiography
  EE = efficacy evaluable
  ITT = intent-to-treat with last observation carried forward
  LVEDVI = left ventricular end-diastolic volume index
  LVEF = left ventricular ejection fraction
  LVESVI = left ventricular end-systolic volume index
  LVMI = left ventricular mass index
  NYHA = New York Heart Association
  PLB = placebo
  RSG = rosiglitazone
  T2DM = type 2 diabetes mellitus


Related Article

Fluid Retention With Thiazolidinediones: Does the Mechanism Influence the Outcome?
JoAnn Lindenfeld and Frederick A. Masoudi
J. Am. Coll. Cardiol. 2007 49: 1705-1707. [Full Text] [PDF]



This article has been cited by other articles:


Home page
HeartHome page
H Kaneda, T Shiono, Y Miyashita, S Takahashi, Y Taketani, H Domae, J Matsumi, S Mizuno, Y Minami, K Sugitatsu, et al.
Efficacy and safety of pioglitazone in patients with ST elevation myocardial infarction treated with primary stent implantation
Heart, July 1, 2009; 95(13): 1079 - 1084.
[Abstract] [Full Text] [PDF]


Home page
HeartHome page
K M Goode, J John, A S Rigby, E S Kilpatrick, S L Atkin, T Bragadeesh, A L Clark, and J G F Cleland
Elevated glycated haemoglobin is a strong predictor of mortality in patients with left ventricular systolic dysfunction who are not receiving treatment for diabetes mellitus
Heart, June 1, 2009; 95(11): 917 - 923.
[Abstract] [Full Text] [PDF]


Home page
Diabetes and Vascular Disease ResearchHome page
D. K Mcguire, R. See, S. M Abdullah, P. G Snell, J. M Mcgavock, C. R Ayers, and L. S Szczepaniak
The effect of rosiglitazone on integrated cardiovascular performance, cardiac structure, function and myocardial triglyceride: trial design and rationale
Diabetes and Vascular Disease Research, January 1, 2009; 6(1): 43 - 50.
[Abstract] [PDF]


Home page
Diabetes and Vascular Disease ResearchHome page
H. Von Bibra, M. Diamant, P. G Scheffer, T. Siegmund, and P.-M. Schumm-Draeger
Rosiglitazone, but not glimepiride, improves myocardial diastolic function in association with reduction in oxidative stress in type 2 diabetic patients without overt heart disease
Diabetes and Vascular Disease Research, November 1, 2008; 5(4): 310 - 318.
[Abstract] [PDF]


Home page
HeartHome page
A. H Wu
Cardiotoxic drugs: clinical monitoring and decision making
Heart, November 1, 2008; 94(11): 1503 - 1509.
[Full Text] [PDF]


Home page
Am J Health Syst PharmHome page
J. Odom, B. Williamson, and L. Carter
Rosiglitazone and pioglitazone in the treatment of diabetes mellitus
Am. J. Health Syst. Pharm., October 1, 2008; 65(19): 1846 - 1850.
[Full Text] [PDF]


Home page
The Annals of PharmacotherapyHome page
U. Khanderia, R. Pop-Busui, and K. A Eagle
Thiazolidinediones in Type 2 Diabetes: A Cardiology Perspective
Ann. Pharmacother., October 1, 2008; 42(10): 1466 - 1474.
[Abstract] [Full Text] [PDF]


Home page
Eur Heart JHome page
M. R. MacDonald, M. C. Petrie, N. M. Hawkins, J. R. Petrie, M. Fisher, R. McKelvie, D. Aguilar, H. Krum, and J. J.V. McMurray
Diabetes, left ventricular systolic dysfunction, and chronic heart failure
Eur. Heart J., May 2, 2008; 29(10): 1224 - 1240.
[Abstract] [Full Text] [PDF]


Home page
Diabetes CareHome page
The DREAM Trial Investigators
Effects of Ramipril and Rosiglitazone on Cardiovascular and Renal Outcomes in People With Impaired Glucose Tolerance or Impaired Fasting Glucose: Results of the Diabetes REduction Assessment with ramipril and rosiglitazone Medication (DREAM) trial
Diabetes Care, May 1, 2008; 31(5): 1007 - 1014.
[Abstract] [Full Text] [PDF]


Home page
Evid. Based Med.Home page
V. Lingegowda
Review: evidence for major benefits and harms of antidiabetic agents for diabetes with heart failure is limited
Evid. Based Med., February 1, 2008; 13(1): 9 - 9.
[Full Text] [PDF]


Home page
J Am Coll CardiolHome page
A. N. DeMaria, J. J. Bax, O. Ben-Yehuda, P. Clopton, G. K. Feld, G. S. Ginsburg, B. H. Greenberg, J. D. Knoke, W. Y.W. Lew, J. A.C. Lima, et al.
Highlights of the year in JACC 2007.
J. Am. Coll. Cardiol., January 29, 2008; 51(4): 490 - 512.
[Full Text] [PDF]


Home page
CirculationHome page
D. K. McGuire and S. E. Inzucchi
New Drugs for the Treatment of Diabetes Mellitus: Part I: Thiazolidinediones and Their Evolving Cardiovascular Implications
Circulation, January 22, 2008; 117(3): 440 - 449.
[Full Text] [PDF]


Home page
Eur Heart JHome page
E. Erdmann and R. G. Wilcox
Weighing up the cardiovascular benefits of thiazolidinedione therapy: the impact of increased risk of heart failure
Eur. Heart J., January 1, 2008; 29(1): 12 - 20.
[Abstract] [Full Text] [PDF]


Home page
Am J Health Syst PharmHome page
J. S. Stroup
Thiazolidinedione-induced edema in patients with heart failure
Am. J. Health Syst. Pharm., December 1, 2007; 64(23): 2426 - 2430.
[Full Text] [PDF]


Home page
J Am Coll CardiolHome page
R. Lewanczuk and P. W. Armstrong
Physiologic Straws in the Wind: In Which Direction Do They Bend?
J. Am. Coll. Cardiol., November 20, 2007; 50(21): 2059 - 2060.
[Full Text] [PDF]


Home page
CJASNHome page
R. E. Gilbert
Rosiglitazone: Opening Pandora's Black Box?
Clin. J. Am. Soc. Nephrol., November 1, 2007; 2(6): 1329 - 1331.
[Full Text] [PDF]


Home page
JAMAHome page
S. Singh, Y. K. Loke, and C. D. Furberg
Long-term Risk of Cardiovascular Events With Rosiglitazone: A Meta-analysis
JAMA, September 12, 2007; 298(10): 1189 - 1195.
[Abstract] [Full Text] [PDF]


Home page
CirculationHome page
H. Ashrafian, M. P. Frenneaux, and L. H. Opie
Metabolic Mechanisms in Heart Failure
Circulation, July 24, 2007; 116(4): 434 - 448.
[Abstract] [Full Text] [PDF]


Home page
J Am Coll CardiolHome page
J. Lindenfeld and F. A. Masoudi
Fluid Retention With Thiazolidinediones: Does the Mechanism Influence the Outcome?
J. Am. Coll. Cardiol., April 24, 2007; 49(16): 1705 - 1707.
[Full Text] [PDF]



 
  CME Topic Collections Past Issues Search Current Issue Home

Advertisement