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Martin I. Freed - One of the best experts on this subject based on the ideXlab platform.
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effects of Rosiglitazone alone and in combination with atorvastatin on the metabolic abnormalities in type 2 diabetes mellitus
American Journal of Cardiology, 2002Co-Authors: Martin I. Freed, Robert E Ratner, Santica M Marcovina, Margaret M Kreider, Nandita Biswas, Beth R Cohen, John D BrunzellAbstract:This study evaluated the effects of Rosiglitazone therapy on lipids and the efficacy and safety of Rosiglitazone in combination with atorvastatin in patients with type 2 diabetes mellitus. Three-hundred thirty-two patients entered an 8-week, open-label, run-in treatment phase with Rosiglitazone 8 mg/day, and 243 were randomized to a 16-week, double-blinded period of continued Rosiglitazone plus placebo, atorvastatin 10 mg/day, or atorvastatin 20 mg/day. With Rosiglitazone alone, a modest increase in low-density lipoprotein (LDL) cholesterol (9%), a shift in LDL phenotype from dense to large buoyant subfractions (52% of patients), and an increase in total high-density lipoprotein (HDL) cholesterol levels (6%), predominantly in HDL(2) levels (13%), occurred from week 0 to week 8. When atorvastatin was added, there was a further increase in HDL(3) (5%) and expected significant reductions (p <0.0001) in LDL cholesterol (-39%), apolipoprotein B (-35%), and triglyceride levels (-27%). Glycemic control achieved with Rosiglitazone alone was not adversely affected by add-on atorvastatin. The combination was well tolerated compared with placebo. To conclude, in addition to the beneficial effects of Rosiglitazone on glycemic control, Rosiglitazone and atorvastatin in combination achieved 2 goals: the reduction of LDL cholesterol to <100 mg/dl and the removal of small dense LDL in patients with type 2 diabetes mellitus.
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The effect of ranitidine on the pharmacokinetics of Rosiglitazone in healthy adult male volunteers.
Clinical therapeutics, 2002Co-Authors: Ann K. Miller, Robert A. Dicicco, Martin I. FreedAbstract:Abstract Background: Rosiglitazone is an insulin-sensitizing oral agent in the thiazolidinedione class used to treat patients with type 2 diabetes mellitus. It binds to peroxisome proliferator-activated receptor gamma in liver, muscle, and adipose tissue. Ranitidine, a histamine 2 -receptor antagonist, may be prescribed for patients with type 2 diabetes and esophageal symptoms such as heartburn. By raising gastrointestinal pH levels, ranitidine may affect the bioavailability of coadministered drugs. Objectives: This article presents the absolute bioavailability of Rosiglitazone, as well as the effects of ranitidine on the pharmacokinetics of Rosiglitazone. Methods: Healthy men were enrolled in a randomized, open-label, 4-period, period-balanced crossover study of Rosiglitazone and ranitidine. All individuals received each of 4 regimens successively, separated by a 4-day washout period: a single IV dose of Rosiglitazone 2 mg administered alone over 1 hour; a single IV dose of Rosiglitazone 2 mg administered over 1 hour on the fourth day of treatment with oral ranitidine 150 mg given every 12 hours; a single oral dose of Rosiglitazone 4 mg alone; and a single oral dose of Rosiglitazone 4 mg on the fourth day of treatment with oral ranitidine 150 mg given every 12 hours. The primary end point was dose-normalized area under the plasma concentration—time curve from time 0 to infinity (AUC 0-∞ ). Maximum observed plasma concentration (C max ), the time at which C max occurred (T max ), plasma clearance (CL), steady-state volume of distribution (V ss ), and terminal elimination half-life (t 12 ) were also assessed. Results: Twelve individuals were enrolled. The absolute bioavailability of Rosiglitazone was 99%. For AUC 0-∞ , the point estimate and the associated 95% CI for the ratio of ranitidine + IV Rosiglitazone to IV Rosiglitazone alone was 1.02 (range, 0.88–1.20). With oral Rosiglitazone, the AUC 0-∞ point estimate (95% CI) for the ratio of ranitidine + Rosiglitazone to Rosiglitazone alone was 0.99 (range, 0.85–1.16). C max , T max , t 12 , V ss , and CL of Rosiglitazone, whether administered orally or intravenously, were unaffected by ranitidine. Oral and IV Rosiglitazone were associated with a favorable safety profile and were well tolerated with or without concurrent ranitidine treatment. Conclusions: In this study of 12 healthy adult male volunteers, the absolute bioavailability of Rosiglitazone was 99%, and the oral and IV single-dose pharmacokinetics of Rosiglitazone were unaltered by concurrent treatment with ranitidine.
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The effect of acarbose on the pharmacokinetics of Rosiglitazone
European journal of clinical pharmacology, 2001Co-Authors: Ann K. Miller, Anne Marie L. Inglis, Kathleen Thompson Culkin, Diane K. Jorkasky, Martin I. FreedAbstract:Objectives: To investigate whether treatment with acarbose alters the pharmacokinetics (PK) of coadministered Rosiglitazone. Methods: Sixteen healthy volunteers (24–59-years old) received a single 8-mg dose of Rosiglitazone on day 1, followed by 7 days of repeat dosing with acarbose [100 mg three times daily (t.i.d.) with meals]. On the last day of acarbose t.i.d. dosing (day 8), a single dose of Rosiglitazone was given with the morning dose of acarbose. PK profiles following Rosiglitazone dosing on days 1 and 8 were compared, and point estimates (PE) and associated 95% confidence intervals (CI) were calculated. Results: Rosiglitazone absorption [as measured with peak plasma concentration (Cmax) and time to peak concentration (Tmax)] was unaffected by acarbose. The area under the concentration–time curve from time zero to infinity [AUC(0– ∞ )] was on average 12% lower (95% CI –21%, –2%) during Rosiglitazone + acarbose coadministration and was accompanied by an approximate 1-h (23%) reduction in terminal elimination half-life t 1/2 (4.9 h versus 3.8 h). This small decrease in AUC(0– ∞ ) appears to be due to an alteration in systemic clearance of Rosiglitazone and not changes in absorption. These observed changes in AUC(0– ∞ ) and t 1/2 are not likely to be clinically relevant. Coadministration of Rosiglitazone and acarbose was well tolerated. Conclusion: Acarbose administered at therapeutic doses has a small, but clinically insignificant, effect on Rosiglitazone pharmacokinetics.
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Rosiglitazone short term monotherapy lowers fasting and post prandial glucose in patients with type ii diabetes
Diabetologia, 2000Co-Authors: Philip Raskin, Elizabeth B Rappaport, S T Cole, Y Yan, R Patwardhan, Martin I. FreedAbstract:Aims/hypothesis. The short-term efficacy, safety and tolerability of Rosiglitazone were compared with placebo in patients with Type II (non-insulin-dependent) diabetes mellitus in a dose-ranging study. Methods. After a 2-week placebo run-in phase, 303 patients were randomly assigned to 8 weeks of treatment with twice-daily placebo or 2, 4 or 6 mg of Rosiglitazone. Results. All Rosiglitazone doses significantly reduced fasting plasma glucose compared with baseline. All Rosiglitazone treatment groups showed significantly reduced peak postprandial glucose concentrations compared with baseline (p < 0.001) and with placebo (p < 0.0001) and reduced postprandial glucose excursion, without an increase in the area under the postprandial insulin concentration-time curve. Rosiglitazone at 4 and 6 mg twice daily prevented the increase in HbA 1c observed in the placebo group. C peptide and serum insulin concentrations were significantly reduced from baseline in all Rosiglitazone treatment groups. In all Rosiglitazone treatment groups, nonesterified fatty acids decreased significantly (p < 0.0001) and triglycerides did not change. Although total LDL and HDL cholesterol increased significantly in the Rosiglitazone treatment groups, total cholesterol/HDL ratios did not change significantly. The proportion of patients with one or more adverse event was similar in all four treatment groups. No patient showed evidence of hepatotoxicity. Conclusion/interpretation. Rosiglitazone given twice daily significantly reduced fasting and postprandial glucose concentrations, C peptide, insulin and nonesterified fatty acids in Type II diabetic patients. The glucose-lowering effect of the 4-mg twice-daily dose of Rosiglitazone was similar to that of 6-mg twice daily, suggesting that 4 mg twice daily should be the maximum clinical dose. [Diabetologia (2000) 43: 278‐284]
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Rosiglitazone does not alter the pharmacokinetics of metformin.
Journal of clinical pharmacology, 2000Co-Authors: Robert A. Di Cicco, Diane K. Jorkasky, Ann Allen, Alison M Carr, Susan Fowles, Martin I. FreedAbstract:Rosiglitazone is a potent oral antidiabetic agent of the thiazolidinedione class that works through activation of the peroxisome proliferator-activated nuclear receptor. It improves insulin sensitivity in peripheral tissues and effectively lowers blood glucose in patients with type 2 diabetes. Metformin is a dimethyl- biguanide, also used in type 2 diabetes, that lowers fasting blood glucose primarily by decreasing hepatic glucose output. Rosiglitazone and metformin reduce plasma glucose concentrations via different mechanisms and thus could potentially be used in combination to optimize glycemic control. This study evaluated the effects of the coadministration of these two agents on the pharmacokinetics of both Rosiglitazone and metformin. Sixteen male volunteers (22-55 years old) received oral metformin (500 mg every 12 hours), Rosiglitazone (2 mg every 12 hours), or the combination each for 4 days. Plasma collected on day 4 of each regimen was assayed for Rosiglitazone and metformin concentrations. Oral doses of Rosiglitazone and metformin were safe and well tolerated when administered alone or in combination. There were no clinically significant episodes of hypoglycemia or increased blood lactic acid levels following treatment with any regimen. Coadministration of Rosiglitazone and metformin had no significant effects on the steady-state pharmacokinetics (AUC (0-12h) , C max , t max , or t 1/2 ) of either drug. The authors conclude that Rosiglitazone can be safely administered with metformin and, due to the different mechanisms of action of these agents, may offer a therapeutic advantage in patients with type 2 diabetes mellitus.
Julio Rosenstock - One of the best experts on this subject based on the ideXlab platform.
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long term 2 year safety and efficacy of vildagliptin compared with Rosiglitazone in drug naive patients with type 2 diabetes mellitus
Diabetes Obesity and Metabolism, 2009Co-Authors: Julio Rosenstock, M Niggli, M MaldonadolutomirskyAbstract:AIMS: To assess the long-term safety and the sustained glycaemic control of vildagliptin compared with Rosiglitazone over 2-year treatment in drug-naive type 2 diabetes mellitus patients. METHODS: This was an additional 80-week, multicentre, double-blind and active-controlled extension to a 24-week core study comparing the treatments of vildagliptin (50 mg b.i.d., n = 396) to Rosiglitazone (8 mg q.d., n = 202). The primary efficacy variable was the mean change in haemoglobin A1c (HbA1c) from the core study baseline (day 1) to the end of 104 weeks (the extension endpoint). RESULTS: Vildagliptin and Rosiglitazone showed statistically significant and sustained HbA1c reductions from a core mean baseline of 8.6 and 8.7% to 7.8 and 7.3% respectively (both significant, p < 0.001). However, Rosiglitazone-treated patients showed significantly greater mean HbA1c reductions (mean difference 0.62%, s.e. 0.13, p < 0.001) compared with vildagliptin. The overall lipid profile significantly improved with vildagliptin compared to Rosiglitazone treatment. Body weight remained unchanged in vildagliptin-treated patients despite improvements in glycaemic control but significantly increased (mean change from core study baseline 4.67 kg) in Rosiglitazone-treated patients (p < 0.001). Notably, a lower incidence of peripheral oedema was seen with vildagliptin (4.6%) compared with Rosiglitazone treatment (11.1%). More serious adverse events (SAEs) occurred in vildagliptin- than Rosiglitazone-treated patients (12.5 and 9.1% respectively), but only one SAE each in both treatment group was suspected to be related to study drug. Three non-study drug-related deaths (vildagliptin: 2 and Rosiglitazone: 1) were reported. Four mild hypoglycaemic events were observed with vildagliptin. CONCLUSIONS: This study showed that the similar short-term HbA1c reductions seen with both vildagliptin and Rosiglitazone treatments were more durable after 104 weeks of treatment with Rosiglitazone than vildagliptin. However, this greater durability with Rosiglitazone was at the expense of weight gain (almost 5 kg), higher incidences of peripheral oedema and a less favourable plasma lipid profile compared with vildagliptin.
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comparison of vildagliptin and Rosiglitazone monotherapy in patients with type 2 diabetes a 24 week double blind randomized trial
Diabetes Care, 2007Co-Authors: Julio Rosenstock, Michelle A Baron, Sylvie Dejager, Anja SchweizerAbstract:OBJECTIVE —To compare the efficacy and tolerability of vildagliptin and Rosiglitazone during a 24-week treatment in drug-naive patients with type 2 diabetes. RESEARCH DESIGN AND METHODS —This was a double-blind, randomized, active-controlled, parallel-group, multicenter study of 24-week treatment with vildagliptin (100 mg daily, given as equally divided doses; n = 519) or Rosiglitazone (8 mg daily, given as a once-daily dose; n = 267). RESULTS —Monotherapy with vildagliptin and Rosiglitazone decreased A1C (baseline = 8.7%) to a similar extent during the 24-week treatment, with most of the A1C reduction achieved by weeks 12 and 16, respectively. At end point, vildagliptin was as effective as Rosiglitazone, improving A1C by −1.1 ± 0.1% ( P < 0.001) and −1.3 ± 0.1% ( P < 0.001), respectively, meeting the statistical criterion for noninferiority (upper-limit 95% CI for between-treatment difference ≤0.4%). Fasting plasma glucose decreased more with Rosiglitazone (−2.3 mmol/l) than with vildagliptin (−1.3 mmol/l). Body weight did not change in vildagliptin-treated patients (−0.3 ± 0.2 kg) but increased in Rosiglitazone-treated patients (+1.6 ± 0.3 kg, P < 0.001 vs. vildagliptin). Relative to Rosiglitazone, vildagliptin significantly decreased triglycerides, total cholesterol, and LDL, non-HDL, and total-to-HDL cholesterol (−9 to −16%, all P ≤ 0.01) but produced a smaller increase in HDL cholesterol (+4 vs. +9%, P = 0.003). The proportion of patients experiencing an adverse event was 61.4 vs. 64.0% in patients receiving vildagliptin and Rosiglitazone, respectively. Only one mild hypoglycemic episode was experienced by one patient in each treatment group, while the incidence of edema was greater with Rosiglitazone (4.1%) than vildagliptin (2.1%). CONCLUSIONS —Vildagliptin is an effective and well-tolerated treatment option in patients with type 2 diabetes, demonstrating similar glycemic reductions as Rosiglitazone but without weight gain.
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comparison of vildagliptin and Rosiglitazone monotherapy in patients with type 2 diabetes a 24 week double blind randomized trial
Diabetes Care, 2007Co-Authors: Julio Rosenstock, Michelle A Baron, Sylvie Dejager, David Mills, Anja SchweizerAbstract:OBJECTIVE —To compare the efficacy and tolerability of vildagliptin and Rosiglitazone during a 24-week treatment in drug-naive patients with type 2 diabetes. RESEARCH DESIGN AND METHODS —This was a double-blind, randomized, active-controlled, parallel-group, multicenter study of 24-week treatment with vildagliptin (100 mg daily, given as equally divided doses; n = 519) or Rosiglitazone (8 mg daily, given as a once-daily dose; n = 267). RESULTS —Monotherapy with vildagliptin and Rosiglitazone decreased A1C (baseline = 8.7%) to a similar extent during the 24-week treatment, with most of the A1C reduction achieved by weeks 12 and 16, respectively. At end point, vildagliptin was as effective as Rosiglitazone, improving A1C by −1.1 ± 0.1% ( P < 0.001) and −1.3 ± 0.1% ( P < 0.001), respectively, meeting the statistical criterion for noninferiority (upper-limit 95% CI for between-treatment difference ≤0.4%). Fasting plasma glucose decreased more with Rosiglitazone (−2.3 mmol/l) than with vildagliptin (−1.3 mmol/l). Body weight did not change in vildagliptin-treated patients (−0.3 ± 0.2 kg) but increased in Rosiglitazone-treated patients (+1.6 ± 0.3 kg, P < 0.001 vs. vildagliptin). Relative to Rosiglitazone, vildagliptin significantly decreased triglycerides, total cholesterol, and LDL, non-HDL, and total-to-HDL cholesterol (−9 to −16%, all P ≤ 0.01) but produced a smaller increase in HDL cholesterol (+4 vs. +9%, P = 0.003). The proportion of patients experiencing an adverse event was 61.4 vs. 64.0% in patients receiving vildagliptin and Rosiglitazone, respectively. Only one mild hypoglycemic episode was experienced by one patient in each treatment group, while the incidence of edema was greater with Rosiglitazone (4.1%) than vildagliptin (2.1%). CONCLUSIONS —Vildagliptin is an effective and well-tolerated treatment option in patients with type 2 diabetes, demonstrating similar glycemic reductions as Rosiglitazone but without weight gain.
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triple therapy in type 2 diabetes insulin glargine or Rosiglitazone added to combination therapy of sulfonylurea plus metformin in insulin naive patients
Diabetes Care, 2006Co-Authors: Julio Rosenstock, Danny Sugimoto, Poul Strange, John Stewart, Erika Soltesrak, George DaileyAbstract:OBJECTIVE —To evaluate the efficacy and safety of add-on insulin glargine versus Rosiglitazone in insulin-naive patients with type 2 diabetes inadequately controlled on dual oral therapy with sulfonylurea plus metformin. RESEARCH DESIGN AND METHODS —In this 24-week multicenter, randomized, open-label, parallel trial, 217 patients (HbA 1c [A1C] 7.5–11%, BMI >25 kg/m 2 ) on ≥50% of maximal-dose sulfonylurea and metformin received add-on insulin glargine 10 units/day or Rosiglitazone 4 mg/day. Insulin glargine was forced-titrated to target fasting plasma glucose (FPG) ≤5.5–6.7 mmol/l (≤100–120 mg/dl), and Rosiglitazone was increased to 8 mg/day any time after 6 weeks if FPG was >5.5 mmol/l. RESULTS —A1C improvements from baseline were similar in both groups (−1.7 vs. −1.5% for insulin glargine vs. Rosiglitazone, respectively); however, when baseline A1C was >9.5%, the reduction of A1C with insulin glargine was greater than with Rosiglitazone ( P P = 0.001). Insulin glargine final dose per day was 38 ± 26 IU vs. 7.1 ± 2 mg for Rosiglitazone. Confirmed hypoglycemic events at plasma glucose n = 57) than for the Rosiglitazone group ( n = 47) ( P = 0.0528). The calculated average rate per patient-year of a confirmed hypoglycemic event ( P = 0.0073). More patients in the insulin glargine group had confirmed nocturnal hypoglycemia of P = 0.02) and P P P P = 0.02), fewer adverse events (7 vs. 29%; P = 0.0001), and no peripheral edema (0 vs. 12.5%). Insulin glargine saved $235/patient over 24 weeks compared with Rosiglitazone. CONCLUSIONS —Low-dose insulin glargine combined with a sulfonylurea and metformin resulted in similar A1C improvements except for greater reductions in A1C when baseline was ≥9.5% compared with add-on maximum-dose Rosiglitazone. Further, insulin glargine was associated with more hypoglycemia but less weight gain, no edema, and salutary lipid changes at a lower cost of therapy.
M Maldonadolutomirsky - One of the best experts on this subject based on the ideXlab platform.
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long term 2 year safety and efficacy of vildagliptin compared with Rosiglitazone in drug naive patients with type 2 diabetes mellitus
Diabetes Obesity and Metabolism, 2009Co-Authors: Julio Rosenstock, M Niggli, M MaldonadolutomirskyAbstract:AIMS: To assess the long-term safety and the sustained glycaemic control of vildagliptin compared with Rosiglitazone over 2-year treatment in drug-naive type 2 diabetes mellitus patients. METHODS: This was an additional 80-week, multicentre, double-blind and active-controlled extension to a 24-week core study comparing the treatments of vildagliptin (50 mg b.i.d., n = 396) to Rosiglitazone (8 mg q.d., n = 202). The primary efficacy variable was the mean change in haemoglobin A1c (HbA1c) from the core study baseline (day 1) to the end of 104 weeks (the extension endpoint). RESULTS: Vildagliptin and Rosiglitazone showed statistically significant and sustained HbA1c reductions from a core mean baseline of 8.6 and 8.7% to 7.8 and 7.3% respectively (both significant, p < 0.001). However, Rosiglitazone-treated patients showed significantly greater mean HbA1c reductions (mean difference 0.62%, s.e. 0.13, p < 0.001) compared with vildagliptin. The overall lipid profile significantly improved with vildagliptin compared to Rosiglitazone treatment. Body weight remained unchanged in vildagliptin-treated patients despite improvements in glycaemic control but significantly increased (mean change from core study baseline 4.67 kg) in Rosiglitazone-treated patients (p < 0.001). Notably, a lower incidence of peripheral oedema was seen with vildagliptin (4.6%) compared with Rosiglitazone treatment (11.1%). More serious adverse events (SAEs) occurred in vildagliptin- than Rosiglitazone-treated patients (12.5 and 9.1% respectively), but only one SAE each in both treatment group was suspected to be related to study drug. Three non-study drug-related deaths (vildagliptin: 2 and Rosiglitazone: 1) were reported. Four mild hypoglycaemic events were observed with vildagliptin. CONCLUSIONS: This study showed that the similar short-term HbA1c reductions seen with both vildagliptin and Rosiglitazone treatments were more durable after 104 weeks of treatment with Rosiglitazone than vildagliptin. However, this greater durability with Rosiglitazone was at the expense of weight gain (almost 5 kg), higher incidences of peripheral oedema and a less favourable plasma lipid profile compared with vildagliptin.
John D Brunzell - One of the best experts on this subject based on the ideXlab platform.
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effects of Rosiglitazone alone and in combination with atorvastatin on the metabolic abnormalities in type 2 diabetes mellitus
American Journal of Cardiology, 2002Co-Authors: Martin I. Freed, Robert E Ratner, Santica M Marcovina, Margaret M Kreider, Nandita Biswas, Beth R Cohen, John D BrunzellAbstract:This study evaluated the effects of Rosiglitazone therapy on lipids and the efficacy and safety of Rosiglitazone in combination with atorvastatin in patients with type 2 diabetes mellitus. Three-hundred thirty-two patients entered an 8-week, open-label, run-in treatment phase with Rosiglitazone 8 mg/day, and 243 were randomized to a 16-week, double-blinded period of continued Rosiglitazone plus placebo, atorvastatin 10 mg/day, or atorvastatin 20 mg/day. With Rosiglitazone alone, a modest increase in low-density lipoprotein (LDL) cholesterol (9%), a shift in LDL phenotype from dense to large buoyant subfractions (52% of patients), and an increase in total high-density lipoprotein (HDL) cholesterol levels (6%), predominantly in HDL(2) levels (13%), occurred from week 0 to week 8. When atorvastatin was added, there was a further increase in HDL(3) (5%) and expected significant reductions (p <0.0001) in LDL cholesterol (-39%), apolipoprotein B (-35%), and triglyceride levels (-27%). Glycemic control achieved with Rosiglitazone alone was not adversely affected by add-on atorvastatin. The combination was well tolerated compared with placebo. To conclude, in addition to the beneficial effects of Rosiglitazone on glycemic control, Rosiglitazone and atorvastatin in combination achieved 2 goals: the reduction of LDL cholesterol to <100 mg/dl and the removal of small dense LDL in patients with type 2 diabetes mellitus.
Anja Schweizer - One of the best experts on this subject based on the ideXlab platform.
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comparison of vildagliptin and Rosiglitazone monotherapy in patients with type 2 diabetes a 24 week double blind randomized trial
Diabetes Care, 2007Co-Authors: Julio Rosenstock, Michelle A Baron, Sylvie Dejager, Anja SchweizerAbstract:OBJECTIVE —To compare the efficacy and tolerability of vildagliptin and Rosiglitazone during a 24-week treatment in drug-naive patients with type 2 diabetes. RESEARCH DESIGN AND METHODS —This was a double-blind, randomized, active-controlled, parallel-group, multicenter study of 24-week treatment with vildagliptin (100 mg daily, given as equally divided doses; n = 519) or Rosiglitazone (8 mg daily, given as a once-daily dose; n = 267). RESULTS —Monotherapy with vildagliptin and Rosiglitazone decreased A1C (baseline = 8.7%) to a similar extent during the 24-week treatment, with most of the A1C reduction achieved by weeks 12 and 16, respectively. At end point, vildagliptin was as effective as Rosiglitazone, improving A1C by −1.1 ± 0.1% ( P < 0.001) and −1.3 ± 0.1% ( P < 0.001), respectively, meeting the statistical criterion for noninferiority (upper-limit 95% CI for between-treatment difference ≤0.4%). Fasting plasma glucose decreased more with Rosiglitazone (−2.3 mmol/l) than with vildagliptin (−1.3 mmol/l). Body weight did not change in vildagliptin-treated patients (−0.3 ± 0.2 kg) but increased in Rosiglitazone-treated patients (+1.6 ± 0.3 kg, P < 0.001 vs. vildagliptin). Relative to Rosiglitazone, vildagliptin significantly decreased triglycerides, total cholesterol, and LDL, non-HDL, and total-to-HDL cholesterol (−9 to −16%, all P ≤ 0.01) but produced a smaller increase in HDL cholesterol (+4 vs. +9%, P = 0.003). The proportion of patients experiencing an adverse event was 61.4 vs. 64.0% in patients receiving vildagliptin and Rosiglitazone, respectively. Only one mild hypoglycemic episode was experienced by one patient in each treatment group, while the incidence of edema was greater with Rosiglitazone (4.1%) than vildagliptin (2.1%). CONCLUSIONS —Vildagliptin is an effective and well-tolerated treatment option in patients with type 2 diabetes, demonstrating similar glycemic reductions as Rosiglitazone but without weight gain.
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comparison of vildagliptin and Rosiglitazone monotherapy in patients with type 2 diabetes a 24 week double blind randomized trial
Diabetes Care, 2007Co-Authors: Julio Rosenstock, Michelle A Baron, Sylvie Dejager, David Mills, Anja SchweizerAbstract:OBJECTIVE —To compare the efficacy and tolerability of vildagliptin and Rosiglitazone during a 24-week treatment in drug-naive patients with type 2 diabetes. RESEARCH DESIGN AND METHODS —This was a double-blind, randomized, active-controlled, parallel-group, multicenter study of 24-week treatment with vildagliptin (100 mg daily, given as equally divided doses; n = 519) or Rosiglitazone (8 mg daily, given as a once-daily dose; n = 267). RESULTS —Monotherapy with vildagliptin and Rosiglitazone decreased A1C (baseline = 8.7%) to a similar extent during the 24-week treatment, with most of the A1C reduction achieved by weeks 12 and 16, respectively. At end point, vildagliptin was as effective as Rosiglitazone, improving A1C by −1.1 ± 0.1% ( P < 0.001) and −1.3 ± 0.1% ( P < 0.001), respectively, meeting the statistical criterion for noninferiority (upper-limit 95% CI for between-treatment difference ≤0.4%). Fasting plasma glucose decreased more with Rosiglitazone (−2.3 mmol/l) than with vildagliptin (−1.3 mmol/l). Body weight did not change in vildagliptin-treated patients (−0.3 ± 0.2 kg) but increased in Rosiglitazone-treated patients (+1.6 ± 0.3 kg, P < 0.001 vs. vildagliptin). Relative to Rosiglitazone, vildagliptin significantly decreased triglycerides, total cholesterol, and LDL, non-HDL, and total-to-HDL cholesterol (−9 to −16%, all P ≤ 0.01) but produced a smaller increase in HDL cholesterol (+4 vs. +9%, P = 0.003). The proportion of patients experiencing an adverse event was 61.4 vs. 64.0% in patients receiving vildagliptin and Rosiglitazone, respectively. Only one mild hypoglycemic episode was experienced by one patient in each treatment group, while the incidence of edema was greater with Rosiglitazone (4.1%) than vildagliptin (2.1%). CONCLUSIONS —Vildagliptin is an effective and well-tolerated treatment option in patients with type 2 diabetes, demonstrating similar glycemic reductions as Rosiglitazone but without weight gain.
