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Volume 366, Issue 9493, 8 October 2005-14 October 2005, Pages 1279-1289

Volume 366, Issue 9493, 8 October 2005-14 October 2005, Pages 1279-1289. Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trial

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Volume 366, Issue 9493, 8 October 2005-14 October 2005, Pages 1279-1289

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  1. Volume 366, Issue 9493, 8 October 2005-14 October 2005, Pages 1279-1289 Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trial ProfJohn A Dormandy DSca, , , ProfBernard Charbonnel MDb, David JA Eckland MRCPc, ProfErland Erdmann MDd, ProfMassimo Massi-Benedetti MDe, Ian K Moules BScf, Allan M Skene PhDg, ProfMeng H Tan MDh, ProfPierre J Lefèbvre MDi, ProfGordon D Murray PhDj, ProfEberhard Standl MDk, ProfRobert G Wilcox DMl, ProfLars Wilhelmsen MDm, ProfJohn Betteridge MDn, ProfKåre Birkeland MDo, ProfAlain Golay MDp, ProfRobert J Heine MDq, ProfLászló Korányi DScr, ProfMarkku Laakso MDs, ProfMarián Mokáň MDt, ProfAntanas Norkus PhDu, ProfValdis Pirags MDv, ProfToomas Podar MDw, ProfAndré Scheen MDx, ProfWerner Scherbaum MDy, ProfGuntram Schernthaner MDz, ProfOle Schmitz MDaa, ProfJan Škrha MDab, ProfUlf Smith MDac, ProfJan Tatoň MDad and on behalf of the PROactive investigators‡

  2. Tausta • Hyvä sokeritasapaino vähentää diabeteksen mikrovaskulaarisia kompilkaatioita, mutta merkitys kuolleisuuten ja makrovaskulaarisiin komplikaatioihin pienempi • UKPDS-study: metformiini vähentää kardiovaskulaarisia sairauksia ja kuolleisuutta

  3. Materiaali ja metodit • 35-75 -vuotiaat DMII-potilaat, joilla GHbA1C >6.5, verisuonisairaus (AMI, tai aivoinfarkti, ohitusleikkaus, akuutti koronaarisdr, MCC tai ASO-tauti) • poissulkukriteerit: DMI, vain insuliinihoito, NYHA luokka >II, hemodialyysi, ALAT > 2.5 x viitearvon yläraja

  4. Materiaali ja metodit • Potilaat saivat joko placeboa tai pioglitatsonia aloitusannoksella 15mg/vrk, lopullinen annostavoite 45 mg/vrk • tavoite: GHbA1C < 6.5

  5. Materiaali ja metodit • Seuranta 3 v • Primaariset päätetapahtumat: - kuolema - AMI - aivoinfarkti - akuutti koronaarisdr - sepelvaltimoiden tai alaraajojen valtimoiden operatiivinen hoito - alaraaja-amputaatio

  6. Tulokset

  7. Primaariset päätetapahtumat eri ryhmissä

  8. Muutokset potilaiden lääkityksissä tutkimuksen aikana

  9. Pysyvä insuliinihoito eri ryhmissä

  10. Muutokset laboratorioarvoissa tutkimuksen aikana

  11. Haittatapahtumat

  12. Haittavaikutukset pioglitatsoni placebo * ei-sydänperäinen turvotus 562341 *hypoglykemia 726 (28%) 528 (20%) * muutos painossa + 3.6 kg -0.4 kg

  13. Comment • The PROactive study: some answers, many questions • Hannele Yki-Järvinena,

  14. Pros, cons, and unknowns of pioglitazoneGood newsPioglitazone reduces composite of all-cause mortality, non-fatal myocardial infarction, and stroke in patients with type 2 diabetes with pre-existing cardiovascular disease by about 16%Bad newsIncidence of oedema not attributable to heart failure is four times greater, and that of heart failure two times greater, than reduction in incidence of cardiovascular events by pioglitazoneBody weight increases more than with other antihyperglycaemic therapies, including insulinUnknownsWhat is prognosis of heart failure?Who is at greatest risk of developing oedema not attributable to heart failure and who is at risk of developing heart failure?Is it safe to use insulin with pioglitazone?Why does pioglitazone reduce cardiovascular events?

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