PMID- 23511244 OWN - NLM STAT- MEDLINE DCOM- 20140519 LR - 20221207 IS - 1720-8386 (Electronic) IS - 0391-4097 (Linking) VI - 36 IP - 8 DP - 2013 Sep TI - Pioglitazone Randomised Italian Study on Metabolic Syndrome (PRISMA): effect of pioglitazone with metformin on HDL-C levels in Type 2 diabetic patients. PG - 606-16 LID - 10.3275/8895 [doi] AB - BACKGROUND: Previous evidence indicates that pioglitazone may improve dyslipidemia in patients with Type 2 diabetes mellitus (T2DM). AIM: The primary objective of this study was to evaluate the effect of either pioglitazone or placebo with metformin on levels of serum HDL cholesterol (HDL-C) in patients with T2DM. A secondary objective evaluated changes in metabolic syndrome (MS)-specific parameters. SUBJECTS AND METHODS: This multicenter, double-blind, randomized study was performed in patients with T2DM treated with metformin and hemoglobin A1c (HbA1c) levels between 6-8%, central obesity and reduced HDL-C. MS was evaluated from global changes in parameter values and expressed as a single factorial score following multivariate analysis of each parameter. 213 patients (110 in the pioglitazone group and 103 in the placebo group) were available for intention-to-treat analysis. RESULTS: Pioglitazone-treated patients showed a significant increase in HDL-C compared to placebo group (6.3 mg/dl vs 3.0 mg/dl; p<0.01) in addition to a greater reduction in the extent of MS (-13.2 vs -4.9; p=0.0055). Upon study completion, patients treated with pioglitazone had lower levels of HbA1c (6.41+/-0.65 vs 6.96+/-0.74%; p<0.001) and homeostasis model assessment-insulin resistance (HOMA-IR) (2.88+/-1.95 vs 4.68+/-3.63; p=0.013) and a reduction of the atherogenic LDL subfraction (pattern B) (-5.7%). CONCLUSIONS: The beneficial effects observed in pioglitazone-treated patients in the present study, (i.e. the increase in HDL-C and the reduction of insulin resistance and atherogenic LDL subfractions), support findings from the PROactive trial, where pioglitazone showed pleiotropic effects and reduced death, fatal myocardial infarction (MI) and non-fatal MI in T2DM patients with MS. Furthermore, medication used in this study showed good tolerability. FAU - Genovese, S AU - Genovese S AD - Diabetes and Metabolic Disease Unit, Cardiovascular and Metabolic Department, IRCCS Multimedica, Sesto San Giovanni, Milan. Italy. stefano.genovese@multimedica.it. FAU - Passaro, A AU - Passaro A FAU - Brunetti, P AU - Brunetti P FAU - Comaschi, M AU - Comaschi M FAU - Cucinotta, D AU - Cucinotta D CN - PRISMA study group FAU - Egan, C G AU - Egan CG FAU - Chinea, B AU - Chinea B FAU - Bravi, F AU - Bravi F FAU - Di Pietro, C AU - Di Pietro C LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20130319 PL - Italy TA - J Endocrinol Invest JT - Journal of endocrinological investigation JID - 7806594 RN - 0 (Cholesterol, HDL) RN - 0 (Drug Combinations) RN - 0 (Glycated Hemoglobin A) RN - 0 (Placebos) RN - 0 (Thiazolidinediones) RN - 9100L32L2N (Metformin) RN - X4OV71U42S (Pioglitazone) SB - IM MH - Adult MH - Aged MH - Cholesterol, HDL/*blood MH - Diabetes Mellitus, Type 2/blood/*drug therapy/metabolism MH - Double-Blind Method MH - Drug Combinations MH - Female MH - Glycated Hemoglobin/metabolism MH - Homeostasis MH - Humans MH - Insulin Resistance MH - Male MH - Metabolic Syndrome/*drug therapy/metabolism MH - Metformin/*administration & dosage MH - Middle Aged MH - Models, Biological MH - Pioglitazone MH - Placebos MH - Thiazolidinediones/*administration & dosage FIR - Aiello, Antimo IR - Aiello A FIR - Arcangeli, Adolfo IR - Arcangeli A FIR - Arsenio, Leone IR - Arsenio L FIR - Bertone, Vittorio IR - Bertone V FIR - Bevilacqua, Maurizio IR - Bevilacqua M FIR - Borzi, Vito IR - Borzi V FIR - Calatola, Pasqualino IR - Calatola P FIR - Di Bartolo, Paolo IR - Di Bartolo P FIR - Carulli, Nicola IR - Carulli N FIR - Ciavarella, Adolfo IR - Ciavarella A FIR - Cicioni, Giovanni IR - Cicioni G FIR - Cignarelli, Mauro IR - Cignarelli M FIR - Consoli, Agostino IR - Consoli A FIR - Corda, Angelo IR - Corda A FIR - Cordera, Renzo IR - Cordera R FIR - Corsi, Andrea IR - Corsi A FIR - Cucinotta, Domenico IR - Cucinotta D FIR - D'Avanzo, Antonio IR - D'Avanzo A FIR - De Feo, MariaEugenio IR - De Feo M FIR - De Riva, Carlo IR - De Riva C FIR - Diana, Antonio IR - Diana A FIR - Di Pietro, Sergio IR - Di Pietro S FIR - Fedele, Domenico IR - Fedele D FIR - Fellin, Renato IR - Fellin R FIR - Galluzzo, Aldo IR - Galluzzo A FIR - Genovese, Stefano IR - Genovese S FIR - Ghirlanda, Giovanni IR - Ghirlanda G FIR - Giugliano, Dario IR - Giugliano D FIR - Iannarelli, Rossella IR - Iannarelli R FIR - Lauro, Renato IR - Lauro R FIR - Leotta, Sergio IR - Leotta S FIR - Trabacca, Maria Stella IR - Trabacca MS FIR - Mainini, Edoardo IR - Mainini E FIR - Mannino, Domenico IR - Mannino D FIR - Mannucci, Edoardo IR - Mannucci E FIR - Maolo, Gabriele IR - Maolo G FIR - Marchesi, Mario IR - Marchesi M FIR - Marin, Narciso IR - Marin N FIR - Marini, Franco IR - Marini F FIR - Massi Benedetti, Massimo IR - Massi Benedetti M FIR - Muscogiuri, Antonio IR - Muscogiuri A FIR - Provenzano, Vincenzo IR - Provenzano V FIR - Rizzo, Mario IR - Rizzo M FIR - Rotella, CarloMaria IR - Rotella C FIR - Squatrito, Sebastiano IR - Squatrito S FIR - Testa, Ivano IR - Testa I FIR - Tizio, Biagio IR - Tizio B FIR - Tonolo, Giancarlo IR - Tonolo G FIR - Vincis, Luigi IR - Vincis L FIR - Bosi, Emanuele IR - Bosi E FIR - Muggeo, Michele IR - Muggeo M EDAT- 2013/03/21 06:00 MHDA- 2014/05/20 06:00 CRDT- 2013/03/21 06:00 PHST- 2013/03/21 06:00 [entrez] PHST- 2013/03/21 06:00 [pubmed] PHST- 2014/05/20 06:00 [medline] AID - 8895 [pii] AID - 10.3275/8895 [doi] PST - ppublish SO - J Endocrinol Invest. 2013 Sep;36(8):606-16. doi: 10.3275/8895. Epub 2013 Mar 19.