PMID- 21527115
OWN - NLM
STAT- MEDLINE
DCOM- 20111129
LR  - 20211020
IS  - 1932-2968 (Electronic)
IS  - 1932-2968 (Linking)
VI  - 5
IP  - 2
DP  - 2011 Mar 1
TI  - The fixed combination of pioglitazone and metformin improves biomarkers of 
      platelet function and chronic inflammation in type 2 diabetes patients: results 
      from the PIOfix study.
PG  - 426-32
AB  - BACKGROUND: Type 2 diabetes mellitus (T2DM) is characterized by a proinflammatory 
      and procoagulant condition. This study investigates the impact of a pioglitazone 
      plus metformin therapy on biomarkers of inflammation and platelet activation in 
      comparison to a treatment with glimepiride plus metformin. METHODS: The study was 
      designed as a multicenter, randomized, double-blinded two-arm trial. Patients 
      with T2DM and dyslipidemia under metformin monotherapy with hemoglobin A1c value 
      between 6.5% and 9.0% were eligible for trial participation. Blood was drawn at 
      baseline and after 24 weeks of treatment from patients of five centers. Markers 
      of inflammation and thrombocyte function (soluble CD40 ligand, thromboxane, 
      vWillebrand factor, adhesion molecules, clotting reaction) were evaluated 
      subsequently in a central laboratory. RESULTS: A total of 46 patients were 
      included in the final analyses. Mean (+/- standard deviation) age was 58.5 +/- 9.0 
      years (13 women, 33 men; disease duration 6.3 +/- 5.0 years; body mass index 32.0 +/- 
      4.8 kg/m(2)). A total of 25 patients were treated with pioglitazone plus 
      metformin, and 21 patients were in the glimepiride arm. There was a significant 
      decline of E-selectin (-3.7 +/- 4.8 ng/ml, p < .001 versus baseline), vWillebrand 
      factor (-19.5 +/- 32.0%, p < .05), and high-sensitivity C-reactive protein 
      concentrations (-1.08 +/- 0.91 mg/liter, p < .05) in the metformin + pioglitazone 
      arm only (metformin + glimepiride, -0.5 +/- 3.4 ng/ml, +1.4 +/- 33.2%, + 0.08 +/- 0.72 
      mg/liter, respectively, all not significant). Also, all other surrogate markers 
      for platelet function and inflammation showed slight improvements in the 
      metformin + pioglitazone arm but not in the metformin + glimepiride arm. 
      CONCLUSIONS: The fixed metformin + pioglitazone combination treatment showed an 
      overall improvement of laboratory surrogate markers, indicating improvement of 
      platelet function and of chronic systemic inflammation, which was not seen with 
      metformin + glimepiride.
CI  - (c) 2011 Diabetes Technology Society.
FAU - Schondorf, Thomas
AU  - Schondorf T
AD  - Institute for Clinical Research and Development, Mainz, Germany.
FAU - Musholt, Petra B
AU  - Musholt PB
FAU - Hohberg, Cloth
AU  - Hohberg C
FAU - Forst, Thomas
AU  - Forst T
FAU - Lehmann, Ute
AU  - Lehmann U
FAU - Fuchs, Winfried
AU  - Fuchs W
FAU - Lobig, Mirjam
AU  - Lobig M
FAU - Muller, Jurgen
AU  - Muller J
FAU - Pfutzner, Andreas
AU  - Pfutzner A
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20110301
PL  - United States
TA  - J Diabetes Sci Technol
JT  - Journal of diabetes science and technology
JID - 101306166
RN  - 0 (Biomarkers)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Ligands)
RN  - 0 (Sulfonylurea Compounds)
RN  - 0 (Thiazolidinediones)
RN  - 0 (Thromboxanes)
RN  - 0 (von Willebrand Factor)
RN  - 6KY687524K (glimepiride)
RN  - 9100L32L2N (Metformin)
RN  - X4OV71U42S (Pioglitazone)
SB  - IM
MH  - Aged
MH  - Biomarkers/metabolism
MH  - Blood Coagulation
MH  - Blood Platelets/*metabolism
MH  - Body Mass Index
MH  - Diabetes Mellitus, Type 2/*blood
MH  - Female
MH  - Humans
MH  - Hypoglycemic Agents/therapeutic use
MH  - Inflammation/*blood
MH  - Ligands
MH  - Male
MH  - Metformin/*therapeutic use
MH  - Middle Aged
MH  - Pioglitazone
MH  - Platelet Function Tests
MH  - Sulfonylurea Compounds/pharmacology
MH  - Thiazolidinediones/*therapeutic use
MH  - Thromboxanes/metabolism
MH  - von Willebrand Factor/metabolism
PMC - PMC3125938
EDAT- 2011/04/30 06:00
MHDA- 2011/12/13 00:00
PMCR- 2012/03/01
CRDT- 2011/04/30 06:00
PHST- 2011/04/30 06:00 [entrez]
PHST- 2011/04/30 06:00 [pubmed]
PHST- 2011/12/13 00:00 [medline]
PHST- 2012/03/01 00:00 [pmc-release]
AID - dst.5.2.0426 [pii]
AID - 10.1177/193229681100500233 [doi]
PST - epublish
SO  - J Diabetes Sci Technol. 2011 Mar 1;5(2):426-32. doi: 10.1177/193229681100500233.