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J Am Coll Cardiol. 2007 May 1;49(17):1772-80. Epub 2007 Apr 16.

The effect of pioglitazone on recurrent myocardial infarction in 2,445 patients with type 2 diabetes and previous myocardial infarction: results from the PROactive (PROactive 05) Study.

Collaborators (364)

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, Charbonel B, Eckland DJ, Erdmann E, Golay A, Korányi L, Heine RJ, 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 J, 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, Brunetiere 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, Woywod 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, Pogasta 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, Varanuskiene E, Zalinkevisicus 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-Muszynaska M, Roman'czuk P, Romanowski L, Smetkowska-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, 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-, Nutzi-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, Köln, Germany. erland.erdmann@uni-koeln.de

Abstract

OBJECTIVES:

This analysis from the PROactive (PROspective pioglitAzone Clinical Trial In macroVascular Events) study assesses the effects of pioglitazone on mortality and macrovascular morbidity in patients with type 2 diabetes and a previous myocardial infarction (MI).

BACKGROUND:

People with type 2 diabetes have an increased incidence of MI compared with the general population. Those with diabetes and MI have a worse prognosis than nondiabetic patients with cardiovascular disease.

METHODS:

The PROactive study was a prospective, multicenter, double-blind, placebo-controlled trial of 5,238 patients with type 2 diabetes and macrovascular disease. Patients were randomized to either pioglitazone or placebo in addition to their other glucose-lowering and cardiovascular medication. Treatment of diabetes, dyslipidemia, and hypertension was encouraged according to the International Diabetes Federation guidelines. Patients were followed for a mean of 2.85 years. The primary end point was the time to first occurrence of macrovascular events or death. Of the total cohort, the subgroup of patients who had a previous MI (n = 2,445 [46.7%]; n = 1,230 in the pioglitazone group and n = 1,215 in the placebo group) was evaluated using prespecified and post-hoc analyses.

RESULTS:

Pioglitazone had a statistically significant beneficial effect on the prespecified end point of fatal and nonfatal MI (28% risk reduction [RR]; p = 0.045) and acute coronary syndrome (ACS) (37% RR; p = 0.035). There was a 19% RR in the cardiac composite end point of nonfatal MI (excluding silent MI), coronary revascularization, ACS, and cardiac death (p = 0.033). The difference in the primary end point defined in the main PROactive study did not reach significance in the MI population (12% RR; p = 0.135). The rates of heart failure requiring hospitalization were 7.5% (92 of 1,230) with pioglitazone and 5.2% (63 of 1,215) with placebo. Fatal heart failure rates were similar (1.4% [17 of the 92] with pioglitazone versus 0.9% [11 of the 63] with placebo).

CONCLUSIONS:

In high-risk patients with type 2 diabetes and previous MI, pioglitazone significantly reduced the occurrence of fatal and nonfatal MI and ACS. (PROspective pioglitAzone Clinical Trial In macroVascular Events; http://www.clinicaltrials.gov/ct/show/NCT00174993?order = 1; ISRCTN NCT00174993).

PMID:
17466227
DOI:
10.1016/j.jacc.2006.12.048
[Indexed for MEDLINE]
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