Effects of rosiglitazone and pioglitazone combined with metformin on the prothrombotic state of patients with type 2 diabetes mellitus and metabolic syndrome.

In this multicentre, randomized, double-blind, controlled, parallel-group trial, 103 patients with type 2 diabetes mellitus and metabolic syndrome were randomized to receive one of two thiazolidinediones--pioglitazone or rosiglitazone--in combination with 1500 mg/day of metformin, increasing up to 3000 mg/day, for 12 months. Anthropometric, metabolic, coagulation and fibrinolysis parameters were assessed at baseline and after 3, 6, 9 and 12 months. Significant decreases in glycosylated haemoglobin, fasting plasma glucose and post-prandial plasma glucose levels were seen after 9 and 12 months in both groups, and significant decreases in fasting plasma insulin and post-prandial plasma insulin levels were seen after 12 months in both groups. In both groups, improvement in the homeostasis model assessment index compared with baseline was obtained only after 12 months. Plasminogen activator inhibitor-1 levels were significantly lower in both groups after 12 months compared with baseline values. In patients with type 2 diabetes mellitus and metabolic syndrome, the combination of metformin plus thiazolidinediones improved glycaemic control and produced a slight but significant reduction in plasminogen activator inhibitor-1 levels.

Thrombotic events during oral anticoagulant treatment: results of the inception-cohort, prospective, collaborative ISCOAT study: ISCOAT study group (Italian Study on Complications of Oral Anticoagulant Therapy).

The paper reports on rate and type of thrombotic events occurring during the observational, prospective, inception-cohort, multicenter ISCOAT study. 2,745 unselected, daily practice patients, consecutively referring to 34 Italian anticoagulation clinics to monitor the oral anticoagulant treatment, were included in the study from beginning of their first anticoagulant course. During a total follow-up of 2,011 patient-years of treatment 70 thrombotic events (3.5 per 100 patient years) were recorded in 67 patients: 20 fatal (1%), 39 major (1.9%) and 11 minor (0.6%). 34/70 events occurred within the first 90 days of treatment (relative risk - at multivariate analysis - of < or =90 days vs. >90 = 20.6, C.I. 12.7-33.5; p <0.0001). The risk was higher in patients aged > or =70 y (1.62, C.I. 1.0-2.61; p <0.05), and when indication for anticoagulant treatment was peripheral/cerebral arterial disease (1.84, C.I. 1.01-3.36; p <0.05). The frequency of thrombotic events was 17.5% when international normalised ratio (INR) levels were < 1.5, decreasing to 2.3% for INRs within the 2-2.99 category (relative risk of INRs <2.0 vs. > or =2 = 1.88, C.I. 1.16-3.07; p <0.05). The recorded rate of thrombotic events was lower than that reported in the few available studies. A greater risk should be expected during the first 90 days of treatment, when anticoagulation levels are <2.0 INR, in patients > 70 years and in those with cerebrovascular/peripheral arterial disease.

Cigarette smoking is a risk factor for nephropathy and its progression in type 2 diabetes mellitus.

Cigarette smoking is a risk factor for diabetic nephropathy in Type 1 diabetes (T1DM); a few reports support this possibility in Type 2 diabetes (T2DM) as well. Since heterogeneity among populations could exist, we investigated the association of cigarette smoking and nephropathy, and progression of nephropathy in Italian T2DM patients. A retrospective study was conducted in 273 long-duration T2DM subjects with a 3-year follow-up in the out-patient clinic, and at least one access per year. Albumin excretion rate, serum creatinine, and a number of other parameters implicated in the development of diabetic renal disease were evaluated. Progression of nephropathy was defined as the passage from different stages of renal involvement (no renal derangement, microalbuminuria, proteinuric disease or severe nephropathy). At baseline, 13.2% of the subjects had microalbuminuria, and 3.7% proteinuric disease. Microalbuminuria and proteinuric disease were more frequent in actual smokers than in non- and former smokers (chi2=8.35; p=0.015). Progression of nephropathy was less common in non- and former smokers than in smokers (31 of 134, 23%, and 15 of 67, 22%, and 30 of 72, 42%, respectively; chi2=9.32;p=0.009). From logistic regression analysis, smoking (p=0.0012) emerged as the most important factor associated with progression of nephropathy, followed by packyears (p=0.011), HbA1c mean value at follow-up (p=0.024), and total cholesterol (p=0.038). In conclusion, cigarette smoking is a risk factor for progression of nephropathy also in Italian T2DM patients; reducing or quitting smoking should be part of the therapy or of the preventive measures in these patients and their relatives.