PMID- 18672190 OWN - NLM STAT- MEDLINE DCOM- 20090224 LR - 20220330 IS - 1532-8414 (Electronic) IS - 1071-9164 (Linking) VI - 14 IP - 6 DP - 2008 Aug TI - Pioglitazone and heart failure: results from a controlled study in patients with type 2 diabetes mellitus and systolic dysfunction. PG - 445-52 LID - 10.1016/j.cardfail.2008.02.007 [doi] AB - BACKGROUND: Thiazolidinediones are associated with fluid retention, often interpreted as worsening cardiac function, limiting their use in patients with heart failure (HF). We compared the effects of pioglitazone and glyburide on cardiac function in patients with type 2 diabetes, systolic dysfunction, and New York Heart Association (NYHA) functional Class II/III HF. METHODS AND RESULTS: Participants received pioglitazone or glyburide (+/-insulin) for 6 months in this double-blind, randomized, multicenter study. The primary end point was time to HF, a composite of cardiovascular mortality and hospitalization or emergency room (ER) visit for HF. Secondary endpoints included echocardiographic and functional classification assessments. An earlier time to onset and higher incidence of the primary endpoint was noted with pioglitazone (13%) versus glyburide (8%) (P = .024). Hospitalization or ER visit occurred in 30 pioglitazone and 15 glyburide participants, 19 and 12 of whom, respectively, continued treatment. Cardiac mortality (5 versus 6 participants, respectively) and cardiac function, as measured by change in ventricular mass index (P = .959), ejection fraction (P = .413), or fractional shortening (P = .280), were similar between treatments. CONCLUSIONS: Pioglitazone was associated with a higher incidence of hospitalization for HF without an increase in cardiovascular mortality or worsening cardiac function (by echocardiography). FAU - Giles, Thomas D AU - Giles TD AD - Tulane University School of Medicine, New Orleans, Louisiana, USA. FAU - Miller, Alan B AU - Miller AB FAU - Elkayam, Uri AU - Elkayam U FAU - Bhattacharya, Mondira AU - Bhattacharya M FAU - Perez, Alfonso AU - Perez A LA - eng SI - ClinicalTrials.gov/NCT00521820 PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20080527 PL - United States TA - J Card Fail JT - Journal of cardiac failure JID - 9442138 RN - 0 (Thiazolidinediones) RN - X4OV71U42S (Pioglitazone) SB - IM CIN - J Card Fail. 2008 Aug;14(6):453-5. PMID: 18672191 MH - Aged MH - Diabetes Mellitus, Type 2/*complications/*drug therapy/mortality MH - Double-Blind Method MH - Endpoint Determination/trends MH - Female MH - Heart Failure, Systolic/*chemically induced/*complications/mortality MH - Hospitalization/trends MH - Humans MH - Male MH - Middle Aged MH - Pioglitazone MH - Prospective Studies MH - Thiazolidinediones/*adverse effects EDAT- 2008/08/02 09:00 MHDA- 2009/02/25 09:00 CRDT- 2008/08/02 09:00 PHST- 2007/08/27 00:00 [received] PHST- 2008/01/22 00:00 [revised] PHST- 2008/02/05 00:00 [accepted] PHST- 2008/08/02 09:00 [pubmed] PHST- 2009/02/25 09:00 [medline] PHST- 2008/08/02 09:00 [entrez] AID - S1071-9164(08)00060-2 [pii] AID - 10.1016/j.cardfail.2008.02.007 [doi] PST - ppublish SO - J Card Fail. 2008 Aug;14(6):445-52. doi: 10.1016/j.cardfail.2008.02.007. Epub 2008 May 27.