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Published online July 31, 2007
Diabetes Care 30:2773-2778, 2007
DOI: 10.2337/dc07-0717
© 2007 by the American Diabetes Association
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Clinical Care/Education/Nutrition/Psychosocial Research
Original Research

Pioglitazone Use and Heart Failure in Patients With Type 2 Diabetes and Preexisting Cardiovascular Disease

Data from the PROactive Study (PROactive 08)

Erland Erdmann, MD, FESC, FACC1, Bernard Charbonnel, MD2, Robert G. Wilcox, MD3, Allan M. Skene, PHD4, Massimo Massi-Benedetti, MD5, John Yates, MD6, Meng Tan, MD7, Robert Spanheimer, MD8, Eberhard Standl, MD9, John A. Dormandy, FRCS, DSC10 On behalf of the PROactive investigators

1 Medizinische Klinik III der Universität zu Köln, Köln, Germany
2 Clinique d'Endocrinologie, Hôtel Dieu, Nantes, France
3 Queen's Medical Centre, University Hospital, Nottingham, U.K
4 Nottingham Clinical Research Limited, Nottingham, U.K
5 Medicine and Metabolic Diseases, University of Perugia, Perugia, Italy
6 Medical Research and Development, Takeda Global Research and Development Center, Deerfield, Illinois
7 Lilly Research Laboratories, Eli Lilly, Indianapolis, Indiana
8 Medical and Scientific Affairs, Takeda Pharmaceuticals North America, Deerfield, Illinois
9 Munich Institute of Diabetes Research and Medical Department, Krankenhaus Munchen-Schwabing, Munich, Germany
10 St. George's Hospital, London, U.K

Address correspondence and reprint requests to Dr. Erland Erdmann, Medizinische Klinik III der Universität zu Köln Kerpener Str. 62, D-50937 Köln, Germany. E-mail: erland.erdmann{at}uni-koeln.de

OBJECTIVE— PROspective pioglitAzone Clinical Trial In macroVascular Events (PROactive) enrolled patients with type 2 diabetes and preexisting cardiovascular disease. These patients were at high risk for heart failure, so any therapeutic benefit could potentially be offset by risk of associated heart failure mortality. We analyzed the heart failure cases to assess the effects of treatment on morbidity and mortality after reports of serious heart failure.

RESEARCH DESIGN AND METHODS— PROactive was an outcome study in 5,238 patients randomized to pioglitazone or placebo. Patients with New York Heart Association Class II–IV heart failure at screening were excluded. A serious adverse event of heart failure was defined as heart failure that required hospitalization or prolonged a hospitalization stay, was fatal or life threatening, or resulted in persistent significant disability or incapacity. Heart failure risk was evaluated by multivariate regression.

RESULTS— More pioglitazone (5.7%) than placebo patients (4.1%) had a serious heart failure event during the study (P = 0.007). However, mortality due to heart failure was similar (25 of 2,605 [0.96%] for pioglitazone vs. 22 of 2,633 [0.84%] for placebo; P = 0.639). Among patients with a serious heart failure event, subsequent all-cause mortality was proportionately lower with pioglitazone (40 of 149 [26.8%] vs. 37 of 108 [34.3%] with placebo; P = 0.1338). Proportionately fewer pioglitazone patients with serious heart failure went on to have an event in the primary (47.7% with pioglitazone vs. 57.4% with placebo; P = 0.0593) or main secondary end point (34.9% with pioglitazone vs. 47.2% with placebo; P = 0.025).

CONCLUSIONS— Although the incidence of serious heart failure was increased with pioglitazone versus placebo in the total PROactive population of patients with type 2 diabetes and macrovascular disease, subsequent mortality or morbidity was not increased in patients with serious heart failure.

Abbreviations: MI, myocardial infarction • SAE, serious adverse event • TZD, thiazolidinedione


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