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Diabetes Care. 2007 Nov;30(11):2773-8. Epub 2007 Jul 31.

Pioglitazone use and heart failure in patients with type 2 diabetes and preexisting cardiovascular disease: data from the PROactive study (PROactive 08).

Collaborators (366)

Erdmann E, Charbonnel B, Dormandy JA, Massi-Benedetti M, Miyazaki M, Skene AM, Spanheimer R, Tan MH, Wilcox R, Lefèbvre PJ, Murray GD, Standl E, Wilcox RG, Wilhelmsen L, Brunetti P, Brousser M-, Norgren L, Thomas D, Dormandy JA, Betteridge J, Birkeland K, Charbonnel B, Eckland DJ, Erdmann E, Golay A, Korányi L, Heine RJ, Koranyi L, Laakso M, Massi-Benedetti M, Mokan M, Moules IK, Norkus A, Pirags V, Podar T, Rungby J, Scheen AJ, Scherbaum W, Schernthaner G, Schmitz O, Skene AM, Skrha J, Smith U, Sulcaite R, Tan MH, Taton J, Thorsby P, Biesenbach G, Bratusch-Marrain P, Drexel H, Egger T-, Hoppichler F, Kaczerovsky G, Ludvik B, Patsch P, Possnig K, Prager R, Schernthaner G, Wascher T, Daubresse J-, Ducobu J, Fery F, Herbaut C, Nobels F, Penninckx H, Scheen AJ, Van Gaal L, Klimovicova A, Kvapil M, Loykova V, Olsovsky J, Patek F, Skrha J, Smahelova A, Vlasakova Z, Baumbach L, Christensen C, Clemmensen K, Faber J, Lervang HH, Madsbad S, Prange A, Schmitz O, Thorsteinsson B, Laks T, Podar T, Airas J, Antikainen RL, Ebeling P, Eriksson J, Haapamaki H, Hakamaki T, Himanen P, Huttunen M, Junnila S, Kuusisto P, Laakso M, Latva-Nevala A, Laukkanen S, Levanen H, Salmela P, Sodervik H-, Strandberg A, Tuomilehto J, Vanhala M, Attali J-, Berthezene F, Blickle J-, Brun JM, Brunnetierer C, Charbonnel B, Charpentier G, Courreges J-, Estour B, Hanaire Broutin H, Kerlan V, Laoufi A, Le Devehat C, Ritz P, Rodier M, Roger P, Slama G, Vannereau D, Ziegler O, Algenstaedt P, Allolio B, Ansel J, Barakat A, Bauschert AP, Blume J, Bohm G, Etzrodt H, Even K, Eversmann T, Freudenberg M, Gruneklee D, Hanefeld M, Hasche H, Herold-Beifuss R, Heun K, Hirschhauser B, Ilge H, Kellner A, Klausmann G, Klenner E, Kuppers A, Maass U, Mayer P, Nauck M, Orda U, Priebe P, Sauter J, Schaller J, Scherbaum WA, Schlauch W, Schmeck J, Schmidt W, Woywood G, Zender T, Baranyi M, Bardos J, Bolcsvolgyi T, Bruncsak A, Domotor E, Dudas M, Faludi P, Foldesi I, Fovenyi J, Gero L, Hidvegi T, Janoskuti L, Jermendy G, Juhasz E, Kassay-Farkas S, Kautzky L, Kerenyi Z, Kovacs A, Neuwirth G, Patkay J, Peterfai E, Pogatsa G, Poor F, Rumi G, Ruzsa C, Sasvary E, Simon K, Somogyi A, Takacs J, Tamas G, Tarko M, Tarnok F, Valenta B, Vandorfi G, Voros P, Aiello A, Anichini R, Cavallo Perin P, Cicioni G, Crepaldi G, Folli F, Fossati C, Manunta R, Marino C, Massi Benedetti M, Seghieri G, Sivieri R, Squatrito S, Bogdanova A, Jegere B, Lagzdina I, Leitane I, Lejnieks A, Pirags V, Rezgale I, Sokolova J, Valtere A, Baubiniene A, Danilevicius JS, Jurgeviciene N, Kazanavicius G, Norkus A, Pliuskys A, Urbanavicius V, Varanauskiene E, Zalinkevicius R, Blonk MC, Jonker JJ, Storms GE, Swart J, van de Wiel A, Birkeland K, Claudi T, Dyrbekk D, Fossum C, Halse J, Istad H, Langberg H, Skeie S, Thordarsson H, Vaaler S, Wessel-Aas T, Adamiec R, Bandurska-Stankiewicz E, Bochenek A, Ceremuzyn'ski L, Chmielnicka-Pruszczynska M, Fuchs H, Gasior Z, Grzywa M, Junik R, Jusiak K, Kinalska I, Klysiak A, Kozina M, Loba J, Majcher-Witczak G, Markiewicz K, Nowakowski A, Pacyk G, Petryka R, Pinis G, Polaszewska-Muszynska M, Roman'czuk P, Romanowski L, Semetkowska-Jurkiewicz E, Stankiewicz A, Stepien Z, Strugala C, Swatko A, Szybin'ski Z, Taton J, Wierusz-Wysocka B, Wilejto-Cierpisz E, Wojciechowska M, Zytkiewicz-Jaruga D, Krahulec B, Martinka E, Mokan M, Pontuch P, Porubska M, Raslova K, Tkac I, Uliciansky V, Vozar J, Adamsson U, Andersson P-, Brandstrom H, Hanni A, Hellke P, Hillorn V, Hulthen L, Jonsson A, Lager I, Larsson L-, Lofsjogard-Nilsson E, Norrby A, Nystrom T, Oden A, Polhem B, Rose G, Ruter G, Smith U, Ursing D, Gaillard RC, Gerber P, Golay A, Graf H-, Nuzi-Constam E, Abourawi F, Akintewe T, Andrews J, Atkin SL, Beer S, Bhatnager D, Bodansky J, Bodmer C, Borthwick LJ, Boulton AJ, Clark J, Collier A, Darko D, Davies M, Dean J, Dormandy JA, Fiad T, Fox CJ, Frier BM, Gilbey S, Gregory R, Hardisty C, Hurel S, Jackson A, Jennings PE, Johnson A, Johnston C, Jones SC, Kerr D, Kesson CM, Krentz AJ, Leese G, Levy DM, Macleod A, MacLeod KM, Matthews D, Matthews DM, McIntyre M, Millward B, Nagi DK, Ochoa JG, O'Malley B, Page MD, Page SR, Petrie J, Reckless J, Robertson DA, Roland J, Sampson M, Scobie I, Sharp P, Shaw K, Small M, Vaughan N, Vora JP, Weaver J, Wilding J, Williams TD.

Author information

1
Medizinische Klinik III der Universität zu Köln Kerpener Str. 62, D-50937 Köln, Germany. erland.erdmann@uni-koeln.de

Abstract

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.

PMID:
17666462
DOI:
10.2337/dc07-0717
[Indexed for MEDLINE]

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