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Udgivelsesdato: 2009-Jun-20 BACKGROUND: Rosiglitazone is an insulin sensitiser used in combination with metformin, a sulfonylurea, or both, for lowering blood glucose in people with type 2 diabetes. We assessed cardiovascular outcomes after addition of rosiglitazone to either metformin or sulfonylurea compared with the combination of the two over 5-7 years of follow-up. We also assessed comparative safety. METHODS: In a multicentre, open-label trial, 4447 patients with type 2 diabetes on metformin or sulfonylurea monotherapy with mean haemoglobin A(1c) (HbA(1c)) of 7.9% were randomly assigned to addition of rosiglitazone (n=2220) or to a combination of metformin and sulfonylurea (active control group, n=2227). The primary endpoint was cardiovascular hospitalisation or cardiovascular death, with a hazard ratio (HR) non-inferiority margin of 1.20. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00379769. FINDINGS: 321 people in the rosiglitazone group and 323 in the active control group experienced the primary outcome during a mean 5.5-year follow-up, meeting the criterion of non-inferiority (HR 0.99, 95% CI 0.85-1.16). HR was 0.84 (0.59-1.18) for cardiovascular death, 1.14 (0.80-1.63) for myocardial infarction, and 0.72 (0.49-1.06) for stroke. Heart failure causing admission to hospital or death occurred in 61 people in the rosiglitazone group and 29 in the active control group (HR 2.10, 1.35-3.27, risk difference per 1000 person-years 2.6, 1.1-4.1). Upper and distal lower limb fracture rates were increased mainly in women randomly assigned to rosiglitazone. Mean HbA(1c) was lower in the rosiglitazone group than in the control group at 5 years. INTERPRETATION: Addition of rosiglitazone to glucose-lowering therapy in people with type 2 diabetes is confirmed to increase the risk of heart failure and of some fractures, mainly in women. Although the data are inconclusive about any possible effect on myocardial infarction, rosiglitazone does not increase the risk of overall cardiovascular morbidity or mortality compared with standard glucose-lowering drugs. FUNDING: GlaxoSmithKline plc, UK.

This study evaluated the impact of an Internet-based telematic system on the economic and clinical management of patients with type 1 diabetes mellitus.

10.1155/2012/872305 Objective. To evaluate the association between diabetes mellitus and health-related quality of life (HRQOL) controlled for several sociodemographic and anthropometric variables, in a representative sample of the Spanish population. Methods. A population-based, cross-sectional, and cluster sampling study, with the entire Spanish population as the target population. Five thousand and forty-seven participants (2162/2885 men/women) answered the HRQOL short form 12-questionnaire (SF-12). The physical (PCS-12) and the mental component summary (MCS-12) scores were assessed. Subjects were divided into four groups according to carbohydrate metabolism status: normal, prediabetes, unknown diabetes (UNKDM), and known diabetes (KDM). Logistic regression analyses were conducted. Results. Mean PCS-12/MCS-12 values were /, respectively. Men had higher scores than women in both PCS-12 ( versus ; ) and MCS-12 ( versus ; ). Increasing age and obesity were associated with a poorer PCS-12 score. In women lower PCS-12 and MCS-12 scores were associated with a higher level of glucose metabolism abnormality (prediabetes and diabetes), ( for trend), but only the PCS-12 score was associated with altered glucose levels in men ( for trend). The Odds Ratio adjusted for age, body mass index (BMI) and educational level, for a PCS-12 score below the median was 1.62 (CI 95%: 1.2–2.19; ) for men with KDM and 1.75 for women with KDM (CI 95%: 1.26–2.43; ), respectively. Conclusion. Current study indicates that increasing levels of altered carbohydrate metabolism are accompanied by a trend towards decreasing quality of life, mainly in women, in a representative sample of Spanish population.

Udgivelsesdato: 2007-Jun AIMS: To compare glucose control over 18 months between rosiglitazone oral combination therapy and combination metformin and sulphonylurea in people with Type 2 diabetes. METHODS: RECORD, a multicentre, parallel-group study of cardiovascular outcomes, enrolled people with an HbA(1c) of 7.1-9.0% on maximum doses of metformin or sulphonylurea. If on metformin they were randomized to add-on rosiglitazone or sulphonylurea (open label) and if on sulphonylurea to rosiglitazone or metformin. HbA(1c) was managed to < or = 7.0% by dose titration. A prospectively defined analysis of glycaemic control on the first 1122 participants is reported here, with a primary outcome assessed against a non-inferiority margin for HbA(1c) of 0.4%. RESULTS: At 18 months, HbA(1c) reduction on background metformin was similar with rosiglitazone and sulphonylurea [difference 0.07 (95% CI -0.09, 0.23)%], as was the change when rosiglitazone or metformin was added to sulphonylurea [0.06 (-0.09, 0.20)%]. At 6 months, the effect on HbA(1c) was greater with add-on sulphonylurea, but was similar whether sulphonylurea was added to rosiglitazone or metformin. Differences in fasting plasma glucose were not statistically significant at 18 months [rosiglitazone vs. sulphonylurea -0.36 (-0.74, 0.02) mmol/l, rosiglitazone vs. metformin -0.34 (-0.73, 0.05) mmol/l]. Increased homeostasis model assessment insulin sensitivity and reduced C-reactive protein were greater with rosiglitazone than metformin or sulphonylurea (all P < or = 0.001). Body weight was significantly increased with rosiglitazone compared with sulphonylurea [difference 1.2 (0.4, 2.0) kg, P = 0.003] and metformin [difference 4.3 (3.6, 5.1) kg, P < 0.001]. CONCLUSIONS: In people with diabetes, rosiglitazone in combination with metformin or sulphonylurea was demonstrated to be non-inferior to the standard combination of metformin + sulphonylurea in lowering HbA(1c) over 18 months, and produces greater improvements in C-reactive protein and basal insulin sensitivity but is also associated with greater weight gain

Sulfonylureas are used to treat patients with type 2 diabetes mellitus when diet and exercise fail. Glimepiride, a new sulfonylurea, can be administered in one daily dose, thanks to its pharmacokinetic properties. We attempted to establish the optimal time of day for the administration of Glimepiride in a group of patients from the Mediterranean area by clinical trial. No relationship was found between the time of administration and fasting blood glucose values, or HbA(1c), or the frequency or severity of hypoglycemic episodes.

To evaluate the role of metabolic control at the beginning of insulin-dependent diabetes mellitus (IDDM) in the development of diabetic retinopathy (DR) a cross-sectional study was performed with a retrospective analysis of 24 patients followed for at least seven years. The following parameters were investigated: 1) At IDDM diagnosis, age, sex, metabolic control (basal serum glucose, HbA1, cholesterol, triglycerides) and endogen insulin secretion (EIS). 2) At one year in the follow-up: EIS. 3) Since IDDM diagnosis and every 3-4 months: body mass index, dose and pattern of insulin administration and metabolic control. 4) At seven years in the follow-up: direct ophthalmoscopy, fluorescein angiography, microalbuminuria and blood pressure. In the seventh year of follow-up five patients (23.8%; 95% CI: 8.2%-47.2%) developed changes in fluorescein angiography secondary to IDDM. Compared with patients with normal fluorescein angiography their metabolic control was poorer (mean HbA1--seven years--: 11.7 +/- 0.5 versus 9.8 +/- 0.3%; p = 0.01); mean basal glycemia--seven years--: 214 +/- 13.3 versus 174 +/- 7.7 mg/dl; p = 0.03) and their systolic blood pressure (SBP) higher (124 +/- 5.5 versus 111 +/- 2.8 mmHg; p = 0.04). Logistic regression revealed that mean HbA1 values for seven years was the only independent risk factor significantly associated with the development of DR (p = 0.04). The conclusion is that in patients with IDDM of short duration, the development of DR is associated with a deficient glucose control and a higher SBP.

The natural history of islet cell antibodies (ICA), using standardized Juvenile Diabetes Foundation (JDF) units, was studied for two years in 64 type 1 (insulin dependent) diabetic patients, aged 7-45 years prospectively from clinical onset. While ICA were present among 44/64 (68.8%) of the newly diagnosed patients, only 9.3% remained positive at 24 months. The only factor which showed significant predictive value for ICA survival was high initial JDF ICA titres: Maximal persistence of ICA was observed in patients with 80 JDF units at diagnosis (100% at 12 and 24 month). This persistence was lower in patients with 40 JDF units at diagnosis (77% at 12 month, 40% at 24 month) and the lowest for patients with 5 JDF at diagnosis (14% at 12 month, 0% at 15 month). 14/20 (70%) of patients negative for the ICA test at diagnosis became positive during follow-up, but always with a low titre (5-10 JDF units) and for a short period (3-6 months). It is concluded that initial titre is the most important variable in predicting the maintenance of ICA during the first two years of clinical type 1 diabetes.