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| |  Adding Liraglutide to Existing Therapy Improves Glycaemic Control in Patients With Type 2 Diabetes: Presented at IDF By Brian Hoyle MONTREAL -- October 22, 2009 -- Liraglutide can produce greater control of blood glucose when added to patients’ existing therapy for type 2 diabetes, according to a meta-analysis presented here October 21 at the 20th World Diabetes Congress of the International Diabetes Federation (IDF). Richard Pratley, MD, University of Vermont, Burlington, Vermont, and colleagues conducted a meta-analysis of 6 large, phase 3, randomised trials as part of the Liraglutide Effect and Action in Diabetes (LEAD) study, which sought to clarify the influence of liraglutide used alone or in combination with a number of therapies. The researchers utilised a logistic regression of an intention-to-treat subset of 1,683 patients whose treatment regimen with oral antidiabetic drugs remained the same before and during the trials and 2,284 patients who altered their pre-trial therapy to the standard background therapy. The existing therapy was diet plus exercise in 1 trial, metformin or sulphonylurea (SU) insulin secretion stimulants in 2 trials, metformin plus SU in 2 trials, and metformin plus thiazolidinediones in the last trial. The effect of the treatment options on glycosylated haemoglobin (Hb A1C), fasting blood glucose, body weight, and systolic blood pressure was assessed for 2 liraglutide doses (1.2 and 1.8 mg) and placebo. Analysis of the effects of therapy before and after the incorporation of liraglutide revealed statistically significant mean reductions in Hb A1C from baseline (1.3% and 1.5% for 1.2 and 1.8 mg liraglutide, respectively; P < .0001 for both). The decline from baseline for placebo was 0.3%. As an add-on therapy, compared with placebo, 1.2 and 1.8 mg liraglutide reduced Hb A1C by 1.0% and 1.2%, respectively (P < .0001 for both). As an add-on therapy, 1.2 mg and 1.8 mg liraglutide reduced Hb A1C to 7.1% and 7.0%, respectively. The reduction when placebo was the add-on therapy was 8.0%. The proportion of patients who attained the target Hb A1C of <7% for 1.2 mg liraglutide, 1.8 mg liraglutide, and placebo were 59%, 71%, and 18%. Odds ratio of reaching the target Hb A1C for 1.8 mg versus 1.2 mg liraglutide was 1.7 (P = .0202). Both doses of liraglutide reduced fasting plasma glucose after the 26 weeks of add-on treatment. Over the same period an increase of 0.15 mmol/L was evident for placebo (P < .0001 vs baseline). Liraglutide reduced body weight significantly from baseline at 26 weeks (1.2 mg, P = .0378 vs baseline; for 1.8 mg, P < .0001 vs baseline). The decreased body weight for placebo was -0.50. Systolic blood pressure decreased significantly after the 26-week treatment with 1.2 and 1.8 mg liraglutide (both P < .0001). Placebo did not reduce systolic blood pressure significantly from baseline. “These data demonstrate the liraglutide added to diet and exercise or existing mono- or dual oral anti-diabetic therapy, improves glycaemic control,” concluded Dr. Pratley. Funding for this study was provided by Novo Nordisk. [Presentation title: Adding Liraglutide to Existing Therapy Improves Glycaemic Control: Evidence From a Meta-Analysis of Six Large Randomised Clinical Trials. Abstract P-1401]
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