【drug-news】新研究：考来维仑对于接受胰岛素治疗的糖尿病人安全有效
发布于 2008-07-30 · 浏览 1690 · IP 北京北京
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July 29, 2008 — Colesevelam treatment seems safe and effective for improving glycemic and lipid control in patients with type 2 diabetes receiving insulin therapy, according to the results of a randomized controlled trial reported in the July 28 issue of the Archives of Internal Medicine.
"Poor glycemic control is a risk factor for microvascular complications in patients with type 2 diabetes mellitus," write Ronald B. Goldberg, MD, from the University of Miami in Florida, and colleagues. "Achieving glycemic control safely with insulin therapy can be challenging."
Between August 12, 2004, and December 28, 2005, this prospective, 16-week, double-blind, parallel-group study was conducted at 50 sites in the United States and at 1 site in Mexico. Inclusion criteria were type 2 diabetes mellitus inadequately controlled (glycated hemoglobin level, 7.5% - 9.5%) with insulin therapy alone or in combination with oral antidiabetic agents.
Mean age of the participants was 57 years, mean baseline glycated hemoglobin level was 8.3%, and 52% were men. Of 287 participants, 147 were randomly assigned to receive colesevelam hydrochloride 3.75 g/day, and 140 were randomly assigned to receive placebo.
Mean change in glycated hemoglobin level from baseline to week 16 with use of the least-squares method was −0.41% ± 0.07% in the colesevelam group and 0.09% ± 0.07% in the placebo group (treatment difference, −0.50% ± 0.09%; 95% confidence interval, −0.68% to −0.32%; P < .001). Colesevelam therapy was associated with consistent reductions in fasting plasma glucose and fructosamine levels, glycemic-control response rate, and lipid control measures. Compared with the placebo group, the colesevelam group had a 12.8% decrease in low-density lipoprotein cholesterol concentration (P < .001).
Both colesevelam and placebo were generally well tolerated. In the colesevelam and placebo groups, respectively, 30 and 26 participants discontinued the study prematurely, 7 and 9 participants withdrew because of protocol-specified hyperglycemia, and 10 and 4 participants withdrew because of adverse events.
"Colesevelam treatment seems to be safe and effective for improving glycemic control and lipid management in patients with type 2 diabetes mellitus receiving insulin-based therapy, and it may provide a novel treatment for improving dual cardiovascular risk factors," the study authors write. "The use of bile acid sequestrants in the treatment of both hyperglycemia and elevated LDL-C [low-density lipoprotein cholesterol] concentrations thus comprises a novel therapeutic approach for T2DM [type 2 diabetes mellitus]. In the present trial, colesevelam was weight neutral and well tolerated, and the overall results of this study suggest a favorable safety profile in subjects with T2DM who are receiving insulin therapy."
The National Institutes of Health and Daiichi Sankyo supported this study. Daiichi Sankyo employs 2 study authors and has various financial relationships with 2 additional authors, who also have disclosed various financial relationships with Eli Lilly, Takeda, Pfizer, Merck, Merck/Schering Plough, KOS, AstraZeneca, Abbott, Novo Nordisk, the American Diabetes Association, GlaxoSmith Kline, Novartis, sanofi-aventis, Minimed, and/or Viaject.
Arch Intern Med. 2008;168:1531-1540.
"Poor glycemic control is a risk factor for microvascular complications in patients with type 2 diabetes mellitus," write Ronald B. Goldberg, MD, from the University of Miami in Florida, and colleagues. "Achieving glycemic control safely with insulin therapy can be challenging."
Between August 12, 2004, and December 28, 2005, this prospective, 16-week, double-blind, parallel-group study was conducted at 50 sites in the United States and at 1 site in Mexico. Inclusion criteria were type 2 diabetes mellitus inadequately controlled (glycated hemoglobin level, 7.5% - 9.5%) with insulin therapy alone or in combination with oral antidiabetic agents.
Mean age of the participants was 57 years, mean baseline glycated hemoglobin level was 8.3%, and 52% were men. Of 287 participants, 147 were randomly assigned to receive colesevelam hydrochloride 3.75 g/day, and 140 were randomly assigned to receive placebo.
Mean change in glycated hemoglobin level from baseline to week 16 with use of the least-squares method was −0.41% ± 0.07% in the colesevelam group and 0.09% ± 0.07% in the placebo group (treatment difference, −0.50% ± 0.09%; 95% confidence interval, −0.68% to −0.32%; P < .001). Colesevelam therapy was associated with consistent reductions in fasting plasma glucose and fructosamine levels, glycemic-control response rate, and lipid control measures. Compared with the placebo group, the colesevelam group had a 12.8% decrease in low-density lipoprotein cholesterol concentration (P < .001).
Both colesevelam and placebo were generally well tolerated. In the colesevelam and placebo groups, respectively, 30 and 26 participants discontinued the study prematurely, 7 and 9 participants withdrew because of protocol-specified hyperglycemia, and 10 and 4 participants withdrew because of adverse events.
"Colesevelam treatment seems to be safe and effective for improving glycemic control and lipid management in patients with type 2 diabetes mellitus receiving insulin-based therapy, and it may provide a novel treatment for improving dual cardiovascular risk factors," the study authors write. "The use of bile acid sequestrants in the treatment of both hyperglycemia and elevated LDL-C [low-density lipoprotein cholesterol] concentrations thus comprises a novel therapeutic approach for T2DM [type 2 diabetes mellitus]. In the present trial, colesevelam was weight neutral and well tolerated, and the overall results of this study suggest a favorable safety profile in subjects with T2DM who are receiving insulin therapy."
The National Institutes of Health and Daiichi Sankyo supported this study. Daiichi Sankyo employs 2 study authors and has various financial relationships with 2 additional authors, who also have disclosed various financial relationships with Eli Lilly, Takeda, Pfizer, Merck, Merck/Schering Plough, KOS, AstraZeneca, Abbott, Novo Nordisk, the American Diabetes Association, GlaxoSmith Kline, Novartis, sanofi-aventis, Minimed, and/or Viaject.
Arch Intern Med. 2008;168:1531-1540.
最后编辑于 2009-04-22 · 浏览 1690
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