Initial Combination Therapy With Metformin and Colesevelam Safely Achieves Glycemic and Lipid Goals in Early Type 2 Diabetes.
Summary of "Initial Combination Therapy With Metformin and Colesevelam Safely Achieves Glycemic and Lipid Goals in Early Type 2 Diabetes."
Objective: Metformin is recommended as initial therapy for type 2 diabetes, however many patients are unable to achieve glycemic control with metformin monotherapy. This study evaluated the efficacy and safety of initial combination therapy with metformin plus colesevelam in patients with early type 2 diabetes.Methods: In this 16-week, randomized, double-blind, placebo-controlled study, adults with type 2 diabetes (glycosylated hemoglobin [A1C], 6.5%-10.0%) and hypercholesterolemia (low-density lipoprotein cholesterol [LDL-C]>/=100mg/dL) were randomized 1:1 to colesevelam 3.75g/day or placebo in combination with open-label metformin (850mg/day; uptitrated at Week 2 to 1700mg/day). The primary efficacy evaluation was change in A1C from baseline to study end (Week 16 with last observation carried forward).Results: In total, 286 patients were randomized: metformin/colesevelam (n=145) or metformin/placebo (n=141). Mean A1C was reduced by 1.1% with metformin/colesevelam (7.8% [baseline]/6.6% [study end]) and by 0.8% with metformin/placebo (7.5%/6.7%), resulting in a treatment difference of -0.30% at study end (P=0.0035). Metformin/colesevelam significantly reduced LDL-C (-16.3%), total cholesterol (-6.1%), non-high-density lipoprotein cholesterol (-8.3%), apolipoprotein (apo) B (-8.0%), and high-sensitivity C-reactive protein (-17%) and increased apoA-I (+4.4%) and triglycerides (+18.6%) versus metformin/placebo (P>0.01 for all). The proportion of patients who achieved recommended goals with metformin/colesevelam versus metformin/placebo, respectively, were: A1C>7.0% (67% vs 56% [P=0.0092]), LDL-C>100mg/dL (48% vs 18% [P>0.0001]), and composite A1C>7.0%/LDL-C>100mg/dL (40% vs 12% [P>0.0001]). Safety and tolerability was similar between the treatment groups.Conclusion: Metformin plus colesevelam may be a valid option for initial therapy to safely achieve glycemic and lipid goals in early type 2 diabetes.
Affiliation
Dallas Diabetes and Endocrine Center at Medical City, Dallas, TX.
Journal Details
This article was published in the following journal.
Name: Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrin
ISSN: 1934-2403
Pages: 1-30
Links
- PubMed Source: http://www.ncbi.nlm.nih.gov/pubmed/20634175
- DOI: http://dx.doi.org/10.4158/EP10130.OR
Medical and Biotech [MESH] Definitions
Drug Therapy, Combination
Therapy with two or more separate preparations given for a combined effect.
Salvage Therapy
A therapeutic approach, involving chemotherapy, radiation therapy, or surgery, after initial regimens have failed to lead to improvement in a patient's condition. Salvage therapy is most often used for neoplastic diseases.
Metformin
A biguanide hypoglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus not responding to dietary modification. Metformin improves glycemic control by improving insulin sensitivity and decreasing intestinal absorption of glucose. (From Martindale, The Extra Pharmacopoeia, 30th ed, p289)
Retreatment
The therapy of the same disease in a patient, with the same agent or procedure repeated after initial treatment, or with an additional or alternate measure or follow-up. It does not include therapy which requires more than one administration of a therapeutic agent or regimen. Retreatment is often used with reference to a different modality when the original one was inadequate, harmful, or unsuccessful.
Neoadjuvant Therapy
Preliminary cancer therapy (chemotherapy, radiation therapy, hormone/endocrine therapy, immunotherapy, hyperthermia, etc.) that precedes a necessary second modality of treatment.
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