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Guntram Schernthaner - One of the best experts on this subject based on the ideXlab platform.
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long term therapy with addition of Pioglitazone to Metformin compared with the addition of gliclazide to Metformin in patients with type 2 diabetes a randomized comparative study
Diabetes-metabolism Research and Reviews, 2005Co-Authors: D R Matthews, Bh Charbonnel, M Hanefeld, P Brunetti, Guntram SchernthanerAbstract:Background This 52-week, randomized, double-blind study compared the efficacy and safety of Metformin Plus Pioglitazone with the established combination of Metformin Plus gliclazide in type 2 diabetes mellitus. Methods Patients with poorly controlled type 2 diabetes (HbA1c ≥ 7.5% to ≤11.0%) received either Pioglitazone 15 mg o.d. (titrated up to 45 mg; n = 317) or gliclazide 80 mg o.d. (titrated up to 320 mg; n = 313) and Metformin at the pre-study dose. HbA1c, fasting plasma glucose (FPG), insulin, lipids and the urinary albumin/creatinine ratio were measured. Results There were no significant differences in HbA1c (1% decrease in both groups) and FPG between groups. There was a decrease in fasting insulin in the Pioglitazone group compared to an increase in the gliclazide group (p < 0.001). There were significantly greater improvements in triglycerides and HDL-cholesterol in the Metformin Plus Pioglitazone group compared to the Metformin Plus gliclazide group (p < 0.001). Mean LDL-cholesterol decreased with Metformin Plus gliclazide and increased with Metformin Plus Pioglitazone (p < 0.001); however, this increase was considerably less marked than that in HDL-cholesterol. The mean urinary albumin/creatinine ratio was reduced by 10% in the Metformin Plus Pioglitazone group compared to an increase of 6% in the Metformin Plus gliclazide group (p = 0.027). The incidence of adverse events was comparable between groups and both combinations were well tolerated. Conclusions Compared to the established combination of Metformin Plus gliclazide, this study indicates potential benefits of addition of Pioglitazone to Metformin in terms of improvements in microalbuminuria and specific abnormalities associated with diabetic dyslipidemia. Copyright © 2004 John Wiley & Sons, Ltd.
Gravina A. - One of the best experts on this subject based on the ideXlab platform.
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Blood pressure control and inflammatory markers in type 2 diabetic patients treated with Pioglitazone or rosiglitazone and Metformin.
2007Co-Authors: Derosa G., Fogari E., Cicero A., D'angelo A., Ciccarelli L., Piccinni M.n., Pricolo F., Salvadeo S.a., Gravina A.Abstract:The aim of the study was to assess the effects of the combination of Metformin Plus Pioglitazone or rosiglitazone on glucose and blood pressure in type 2 diabetic patients with metabolic syndrome, as well as its tolerability in those patients. In this 12-month, multicentric, double-blind, randomized, controlled, parallel-group trial, all patients began with Metformin. Patients were randomized for self-administration of either Pioglitazone or rosiglitazone for 12 months. We assessed body mass index (BMI), glycemic control (glycosylated hemoglobin [HbA(1c)], fasting and postprandial plasma glucose and insulin levels [FPG, PPG, FPI and PPI, respectively] and homeostasis model assessment [HOMA] index) and systolic and diastolic blood pressure (SBP and DBP, respectively), at baseline and at 3, 6, 9 and 12 months of treatment, as well as high-sensitivity C-reactive protein (hs-CRP), nitrites/nitrates and adiponectin (ADN) at baseline and at 12 months of treatment. Significant HbA(1c) decreases were obtained after 9 (p
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Metformin-Pioglitazone and Metformin-rosiglitazone effects on non-conventional cardiovascular risk factors plasma level in type 2 diabetic patients with metabolic syndrome.
2006Co-Authors: Derosa G., D'angelo A., Ciccarelli L., Piccinni M.n., Pricolo F., Salvadeo S.a., Ragonesi P.d., Montagna L., Gravina A.Abstract:BACKGROUND AND OBJECTIVE: Metformin is considered the gold standard for type 2 diabetes treatment as monotherapy and in combination with sulphonylureas and insulin. The combination of Metformin with thiazolidinediones is less well studied. The aim of the present study was to assess the differential effect, and tolerability, of Metformin combined with Pioglitazone or rosiglitazone on glucose, coagulation and fibrinolysis parameters in patients with type 2 diabetes mellitus and metabolic syndrome. METHODS: This 12-month, multicentre, double-blind, randomized, controlled, parallel-group trial was conducted at three study sites in Italy. We assessed patients with type 2 diabetes mellitus (duration >or=6 months) and with metabolic syndrome. All patients were required to have poor glycaemic control with diet, or experienced adverse effects with diet and Metformin, administered up to the maximum tolerated dose. Patients were randomized to receive either Pioglitazone or rosiglitazone self-administered for 12 months. We assessed body mass index (BMI), glycaemic control [glycosylated haemoglobin (HbA(1c)), fasting and postprandial plasma glucose and insulin levels (FPG, PPG, FPI, and PPI respectively), homeostasis model assessment (HOMA) index], lipid profile [total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C) and triglycerides (TG)], lipoprotein (a) [Lp(a)] and homocysteine (HCT) at baseline and at 3, 6, 9 and 12 months of treatment. RESULTS AND DISCUSSION: No BMI change was observed at 3, 6, 9 and 12 months in either group. Significant HbA(1c) decreases were observed at 9 and 12 months in both groups. After 9 and 12 months, mean FPG and PPG levels decreased in both groups. Decreases in FPI and PPI were observed at 9 and 12 months compared with the baseline in both groups. Furthermore, in both groups, the HOMA index improved but only at 12 months. Significant TC, LDL-C, HDL-C, TG improvement was present in the Pioglitazone group at 12 months compared with the baseline values, and these variations were significantly different between groups. No TC, LDL-C, TG improvement was present in the rosiglitazone group after 12 months. Significant Lp(a) and HCT improvement was present in the Pioglitazone group at 12 months compared with the baseline values, and Lp(a) change was significant compared with the rosiglitazone group. Significant HCT decrease was observed in the rosiglitazone group at the end of the study. In our type 2 diabetic patients, both drugs were safe and effective for glycaemic control and improving HCT plasma levels. However, long-term treatment with Metformin Plus Pioglitazone significantly reduced Lp(a) plasma levels, whereas Metformin + rosiglitazone did not. CONCLUSION: For patients with type 2 diabetes mellitus and metabolic syndrome, combined treatment with Metformin and rosiglitazone or Pioglitazone is safe and effective, However, the Pioglitazone combination also reduced the plasma Lp(a) levels whereas the rosiglitazone combination did not
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Metformin-Pioglitazone and Metformin-rosiglitazone effects on non-conventional cardiovascular risk factors plasma level in type 2 diabetic patients with metabolic syndrome
2006Co-Authors: Derosa G., D'angelo A., Ciccarelli L., Pricolo F., Montagna L., Salvadeo Sat, Gravina A.Abstract:Metformin is considered the gold standard for type 2 diabetes treatment as monotherapy and in combination with sulphonylureas and insulin. The combination of Metformin with thiazolidinediones is less well studied. The aim of the present study was to assess the differential effect, and tolerability, of Metformin combined with Pioglitazone or rosiglitazone on glucose, coagulation and fibrinolysis parameters in patients with type 2 diabetes mellitus and metabolic syndrome.This 12-month, multicentre, double-blind, randomized, controlled, parallel-group trial was conducted at three study sites in Italy. We assessed patients with type 2 diabetes mellitus (duration >or=6 months) and with metabolic syndrome. All patients were required to have poor glycaemic control with diet, or experienced adverse effects with diet and Metformin, administered up to the maximum tolerated dose. Patients were randomized to receive either Pioglitazone or rosiglitazone self-administered for 12 months. We assessed body mass index (BMI), glycaemic control [glycosylated haemoglobin (HbA(1c)), fasting and postprandial plasma glucose and insulin levels (FPG, PPG, FPI, and PPI respectively), homeostasis model assessment (HOMA) index], lipid profile [total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C) and triglycerides (TG)], lipoprotein (a) [Lp(a)] and homocysteine (HCT) at baseline and at 3, 6, 9 and 12 months of treatment.No BMI change was observed at 3, 6, 9 and 12 months in either group. Significant HbA(1c) decreases were observed at 9 and 12 months in both groups. After 9 and 12 months, mean FPG and PPG levels decreased in both groups. Decreases in FPI and PPI were observed at 9 and 12 months compared with the baseline in both groups. Furthermore, in both groups, the HOMA index improved but only at 12 months. Significant TC, LDL-C, HDL-C, TG improvement was present in the Pioglitazone group at 12 months compared with the baseline values, and these variations were significantly different between groups. No TC, LDL-C, TG improvement was present in the rosiglitazone group after 12 months. Significant Lp(a) and HCT improvement was present in the Pioglitazone group at 12 months compared with the baseline values, and Lp(a) change was significant compared with the rosiglitazone group. Significant HCT decrease was observed in the rosiglitazone group at the end of the study. In our type 2 diabetic patients, both drugs were safe and effective for glycaemic control and improving HCT plasma levels. However, long-term treatment with Metformin Plus Pioglitazone significantly reduced Lp(a) plasma levels, whereas Metformin + rosiglitazone did not.For patients with type 2 diabetes mellitus and metabolic syndrome, combined treatment with Metformin and rosiglitazone or Pioglitazone is safe and effective, However, the Pioglitazone combination also reduced the plasma Lp(a) levels whereas the rosiglitazone combination did not
D R Matthews - One of the best experts on this subject based on the ideXlab platform.
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long term therapy with addition of Pioglitazone to Metformin compared with the addition of gliclazide to Metformin in patients with type 2 diabetes a randomized comparative study
Diabetes-metabolism Research and Reviews, 2005Co-Authors: D R Matthews, Bh Charbonnel, M Hanefeld, P Brunetti, Guntram SchernthanerAbstract:Background This 52-week, randomized, double-blind study compared the efficacy and safety of Metformin Plus Pioglitazone with the established combination of Metformin Plus gliclazide in type 2 diabetes mellitus. Methods Patients with poorly controlled type 2 diabetes (HbA1c ≥ 7.5% to ≤11.0%) received either Pioglitazone 15 mg o.d. (titrated up to 45 mg; n = 317) or gliclazide 80 mg o.d. (titrated up to 320 mg; n = 313) and Metformin at the pre-study dose. HbA1c, fasting plasma glucose (FPG), insulin, lipids and the urinary albumin/creatinine ratio were measured. Results There were no significant differences in HbA1c (1% decrease in both groups) and FPG between groups. There was a decrease in fasting insulin in the Pioglitazone group compared to an increase in the gliclazide group (p < 0.001). There were significantly greater improvements in triglycerides and HDL-cholesterol in the Metformin Plus Pioglitazone group compared to the Metformin Plus gliclazide group (p < 0.001). Mean LDL-cholesterol decreased with Metformin Plus gliclazide and increased with Metformin Plus Pioglitazone (p < 0.001); however, this increase was considerably less marked than that in HDL-cholesterol. The mean urinary albumin/creatinine ratio was reduced by 10% in the Metformin Plus Pioglitazone group compared to an increase of 6% in the Metformin Plus gliclazide group (p = 0.027). The incidence of adverse events was comparable between groups and both combinations were well tolerated. Conclusions Compared to the established combination of Metformin Plus gliclazide, this study indicates potential benefits of addition of Pioglitazone to Metformin in terms of improvements in microalbuminuria and specific abnormalities associated with diabetic dyslipidemia. Copyright © 2004 John Wiley & Sons, Ltd.
Derosa G. - One of the best experts on this subject based on the ideXlab platform.
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Blood pressure control and inflammatory markers in type 2 diabetic patients treated with Pioglitazone or rosiglitazone and Metformin.
2007Co-Authors: Derosa G., Fogari E., Cicero A., D'angelo A., Ciccarelli L., Piccinni M.n., Pricolo F., Salvadeo S.a., Gravina A.Abstract:The aim of the study was to assess the effects of the combination of Metformin Plus Pioglitazone or rosiglitazone on glucose and blood pressure in type 2 diabetic patients with metabolic syndrome, as well as its tolerability in those patients. In this 12-month, multicentric, double-blind, randomized, controlled, parallel-group trial, all patients began with Metformin. Patients were randomized for self-administration of either Pioglitazone or rosiglitazone for 12 months. We assessed body mass index (BMI), glycemic control (glycosylated hemoglobin [HbA(1c)], fasting and postprandial plasma glucose and insulin levels [FPG, PPG, FPI and PPI, respectively] and homeostasis model assessment [HOMA] index) and systolic and diastolic blood pressure (SBP and DBP, respectively), at baseline and at 3, 6, 9 and 12 months of treatment, as well as high-sensitivity C-reactive protein (hs-CRP), nitrites/nitrates and adiponectin (ADN) at baseline and at 12 months of treatment. Significant HbA(1c) decreases were obtained after 9 (p
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Metformin-Pioglitazone and Metformin-rosiglitazone effects on non-conventional cardiovascular risk factors plasma level in type 2 diabetic patients with metabolic syndrome.
2006Co-Authors: Derosa G., D'angelo A., Ciccarelli L., Piccinni M.n., Pricolo F., Salvadeo S.a., Ragonesi P.d., Montagna L., Gravina A.Abstract:BACKGROUND AND OBJECTIVE: Metformin is considered the gold standard for type 2 diabetes treatment as monotherapy and in combination with sulphonylureas and insulin. The combination of Metformin with thiazolidinediones is less well studied. The aim of the present study was to assess the differential effect, and tolerability, of Metformin combined with Pioglitazone or rosiglitazone on glucose, coagulation and fibrinolysis parameters in patients with type 2 diabetes mellitus and metabolic syndrome. METHODS: This 12-month, multicentre, double-blind, randomized, controlled, parallel-group trial was conducted at three study sites in Italy. We assessed patients with type 2 diabetes mellitus (duration >or=6 months) and with metabolic syndrome. All patients were required to have poor glycaemic control with diet, or experienced adverse effects with diet and Metformin, administered up to the maximum tolerated dose. Patients were randomized to receive either Pioglitazone or rosiglitazone self-administered for 12 months. We assessed body mass index (BMI), glycaemic control [glycosylated haemoglobin (HbA(1c)), fasting and postprandial plasma glucose and insulin levels (FPG, PPG, FPI, and PPI respectively), homeostasis model assessment (HOMA) index], lipid profile [total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C) and triglycerides (TG)], lipoprotein (a) [Lp(a)] and homocysteine (HCT) at baseline and at 3, 6, 9 and 12 months of treatment. RESULTS AND DISCUSSION: No BMI change was observed at 3, 6, 9 and 12 months in either group. Significant HbA(1c) decreases were observed at 9 and 12 months in both groups. After 9 and 12 months, mean FPG and PPG levels decreased in both groups. Decreases in FPI and PPI were observed at 9 and 12 months compared with the baseline in both groups. Furthermore, in both groups, the HOMA index improved but only at 12 months. Significant TC, LDL-C, HDL-C, TG improvement was present in the Pioglitazone group at 12 months compared with the baseline values, and these variations were significantly different between groups. No TC, LDL-C, TG improvement was present in the rosiglitazone group after 12 months. Significant Lp(a) and HCT improvement was present in the Pioglitazone group at 12 months compared with the baseline values, and Lp(a) change was significant compared with the rosiglitazone group. Significant HCT decrease was observed in the rosiglitazone group at the end of the study. In our type 2 diabetic patients, both drugs were safe and effective for glycaemic control and improving HCT plasma levels. However, long-term treatment with Metformin Plus Pioglitazone significantly reduced Lp(a) plasma levels, whereas Metformin + rosiglitazone did not. CONCLUSION: For patients with type 2 diabetes mellitus and metabolic syndrome, combined treatment with Metformin and rosiglitazone or Pioglitazone is safe and effective, However, the Pioglitazone combination also reduced the plasma Lp(a) levels whereas the rosiglitazone combination did not
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Metformin-Pioglitazone and Metformin-rosiglitazone effects on non-conventional cardiovascular risk factors plasma level in type 2 diabetic patients with metabolic syndrome
2006Co-Authors: Derosa G., D'angelo A., Ciccarelli L., Pricolo F., Montagna L., Salvadeo Sat, Gravina A.Abstract:Metformin is considered the gold standard for type 2 diabetes treatment as monotherapy and in combination with sulphonylureas and insulin. The combination of Metformin with thiazolidinediones is less well studied. The aim of the present study was to assess the differential effect, and tolerability, of Metformin combined with Pioglitazone or rosiglitazone on glucose, coagulation and fibrinolysis parameters in patients with type 2 diabetes mellitus and metabolic syndrome.This 12-month, multicentre, double-blind, randomized, controlled, parallel-group trial was conducted at three study sites in Italy. We assessed patients with type 2 diabetes mellitus (duration >or=6 months) and with metabolic syndrome. All patients were required to have poor glycaemic control with diet, or experienced adverse effects with diet and Metformin, administered up to the maximum tolerated dose. Patients were randomized to receive either Pioglitazone or rosiglitazone self-administered for 12 months. We assessed body mass index (BMI), glycaemic control [glycosylated haemoglobin (HbA(1c)), fasting and postprandial plasma glucose and insulin levels (FPG, PPG, FPI, and PPI respectively), homeostasis model assessment (HOMA) index], lipid profile [total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C) and triglycerides (TG)], lipoprotein (a) [Lp(a)] and homocysteine (HCT) at baseline and at 3, 6, 9 and 12 months of treatment.No BMI change was observed at 3, 6, 9 and 12 months in either group. Significant HbA(1c) decreases were observed at 9 and 12 months in both groups. After 9 and 12 months, mean FPG and PPG levels decreased in both groups. Decreases in FPI and PPI were observed at 9 and 12 months compared with the baseline in both groups. Furthermore, in both groups, the HOMA index improved but only at 12 months. Significant TC, LDL-C, HDL-C, TG improvement was present in the Pioglitazone group at 12 months compared with the baseline values, and these variations were significantly different between groups. No TC, LDL-C, TG improvement was present in the rosiglitazone group after 12 months. Significant Lp(a) and HCT improvement was present in the Pioglitazone group at 12 months compared with the baseline values, and Lp(a) change was significant compared with the rosiglitazone group. Significant HCT decrease was observed in the rosiglitazone group at the end of the study. In our type 2 diabetic patients, both drugs were safe and effective for glycaemic control and improving HCT plasma levels. However, long-term treatment with Metformin Plus Pioglitazone significantly reduced Lp(a) plasma levels, whereas Metformin + rosiglitazone did not.For patients with type 2 diabetes mellitus and metabolic syndrome, combined treatment with Metformin and rosiglitazone or Pioglitazone is safe and effective, However, the Pioglitazone combination also reduced the plasma Lp(a) levels whereas the rosiglitazone combination did not
Bh Charbonnel - One of the best experts on this subject based on the ideXlab platform.
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long term therapy with addition of Pioglitazone to Metformin compared with the addition of gliclazide to Metformin in patients with type 2 diabetes a randomized comparative study
Diabetes-metabolism Research and Reviews, 2005Co-Authors: D R Matthews, Bh Charbonnel, M Hanefeld, P Brunetti, Guntram SchernthanerAbstract:Background This 52-week, randomized, double-blind study compared the efficacy and safety of Metformin Plus Pioglitazone with the established combination of Metformin Plus gliclazide in type 2 diabetes mellitus. Methods Patients with poorly controlled type 2 diabetes (HbA1c ≥ 7.5% to ≤11.0%) received either Pioglitazone 15 mg o.d. (titrated up to 45 mg; n = 317) or gliclazide 80 mg o.d. (titrated up to 320 mg; n = 313) and Metformin at the pre-study dose. HbA1c, fasting plasma glucose (FPG), insulin, lipids and the urinary albumin/creatinine ratio were measured. Results There were no significant differences in HbA1c (1% decrease in both groups) and FPG between groups. There was a decrease in fasting insulin in the Pioglitazone group compared to an increase in the gliclazide group (p < 0.001). There were significantly greater improvements in triglycerides and HDL-cholesterol in the Metformin Plus Pioglitazone group compared to the Metformin Plus gliclazide group (p < 0.001). Mean LDL-cholesterol decreased with Metformin Plus gliclazide and increased with Metformin Plus Pioglitazone (p < 0.001); however, this increase was considerably less marked than that in HDL-cholesterol. The mean urinary albumin/creatinine ratio was reduced by 10% in the Metformin Plus Pioglitazone group compared to an increase of 6% in the Metformin Plus gliclazide group (p = 0.027). The incidence of adverse events was comparable between groups and both combinations were well tolerated. Conclusions Compared to the established combination of Metformin Plus gliclazide, this study indicates potential benefits of addition of Pioglitazone to Metformin in terms of improvements in microalbuminuria and specific abnormalities associated with diabetic dyslipidemia. Copyright © 2004 John Wiley & Sons, Ltd.
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Long-term therapy with addition of Pioglitazone to Metformin compared with the addition of gliclazide to Metformin in patients with type 2 diabetes: a randomized, comparative study.
'Wiley', 2005Co-Authors: Matthews Dr, Bh Charbonnel, Hanefeld M, Brunetti P, Schernthaner GAbstract:BACKGROUND: This 52-week, randomized, double-blind study compared the efficacy and safety of Metformin Plus Pioglitazone with the established combination of Metformin Plus gliclazide in type 2 diabetes mellitus. METHODS: Patients with poorly controlled type 2 diabetes (HbA1c > or = 7.5% to < or =11.0%) received either Pioglitazone 15 mg o.d. (titrated up to 45 mg; n = 317) or gliclazide 80 mg o.d. (titrated up to 320 mg; n = 313) and Metformin at the pre-study dose. HbA1c, fasting plasma glucose (FPG), insulin, lipids and the urinary albumin/creatinine ratio were measured. RESULTS: There were no significant differences in HbA1c (1% decrease in both groups) and FPG between groups. There was a decrease in fasting insulin in the Pioglitazone group compared to an increase in the gliclazide group (p < 0.001). There were significantly greater improvements in triglycerides and HDL-cholesterol in the Metformin Plus Pioglitazone group compared to the Metformin Plus gliclazide group (p < 0.001). Mean LDL-cholesterol decreased with Metformin Plus gliclazide and increased with Metformin Plus Pioglitazone (p < 0.001); however, this increase was considerably less marked than that in HDL-cholesterol. The mean urinary albumin/creatinine ratio was reduced by 10% in the Metformin Plus Pioglitazone group compared to an increase of 6% in the Metformin Plus gliclazide group (p = 0.027). The incidence of adverse events was comparable between groups and both combinations were well tolerated. CONCLUSIONS: Compared to the established combination of Metformin Plus gliclazide, this study indicates potential benefits of addition of Pioglitazone to Metformin in terms of improvements in microalbuminuria and specific abnormalities associated with diabetic dyslipidemia