MD Conference Express EASD 2012 - (Page 13)
Figure 1. Event Rates.
Exenatide Once Weekly Sustained Improvement in Glycemic Control with Weight Loss Through 4 Years
Written by Rita Buckley
Matthew C. Riddle, MD, Oregon Health & Science University, Portland, Oregon, USA, presented new ORIGIN trial subgroup data. The findings indicate that target-directed intervention early in dysglycemia can maintain baseline HbA1C levels for at least 5 years and that the glargine-based regimen is more likely to keep HbA1C <6.5% than standard care. The main independent predictors of maintaining mean HbA1C <6.5% up to 5 years were type 2 diabetes versus no type 2 diabetes, baseline HbA1C per 1%, alcohol use >2 times/week, and glargine versus standard treatment (p<0.001 for all). The data showed that <50% of diabetic patients had HbA1C levels <6.5% at baseline, but this figure rose to 60% at 5 years among those randomized to glargine and dropped to 45% among those on standard therapy. In the group without diabetes, 91% of patients had baseline HbA1C levels <6.5%. This number fell to 87% at 5 years in those randomized to glargine and to 79% at 5 years among those on standard therapy. Both titrated glargine and a standard care approach kept HbA1C levels near baseline values for at least 5 years. According to Dr. Riddle, more data and further analyses are needed to define the benefits versus the risks of the two approaches. For more information, please see the MD Conference Express review of the ORIGIN presentation in our ADA Report.
The once-weekly formulation of exenatide, a glucagonlike peptide-1 receptor agonist, is associated with clinically sustained improvement in glycemic control, continued improvements in cardiometabolic risk factors and weight loss after 4 years of treatment in type 2 diabetes mellitus (T2DM) patients. Results of the open-label extension of the Effects of Exenatide Long-Acting Release on Glucose Control and Safety in Subjects with Type 2 Diabetes Mellitus [DURATION-1; NCT00308139] clinical trial were presented by Leigh MacConell, PhD, Amylin Pharmaceuticals, San Diego, California, USA. In the DURATION-1 trial, treatment with exenatide once weekly (EQW) for 30 weeks significantly reduced HbA1C compared with twice-daily exenatide in patients with T2DM [Drucker DJ et al. Lancet 2008]. The study included patients with T2DM and HbA1C 7.1% to 11.0%, who were treated with diet and exercise and/or a stable dose of metformin, sulfonylurea, thiazolidinedione, or a combination of these therapies. Patients were randomized to receive EQW (2 mg) or exenatide BID (5 µg for 4 weeks, then 10 µg for 26 weeks). The primary endpoint (HbA1C) was assessed at 30 weeks, after which all patients received EQW (2 mg). The objectives of the current analysis were to examine the long-term safety and efficacy of EQW over 4 years in patients with T2DM. Study endpoints included change from baseline to Year 4 in HbA1C, fasting plasma glucose (FPG), weight, blood pressure (BP), and lipid profile. Sixty percent (n=176) of the intention-to-treat (ITT) population completed 4 years of EQW treatment. The efficacy results are based on the 176 study completers. Safety data are based on the ITT population (n=295). Baseline characteristics were consistent between the ITT and completer populations: mean age 56 years, 54% men, mostly white, mean HbA1C 8.2%, mean FPG 9.2 mmol/L, and duration of diabetes 7 years. Most study participants received metformin (33%) or combination therapies (39%). At 4 years, mean HbA1C (± standard error) was 6.9% (±0.1%), with 55% of patients achieving HbA1C <7.0% and 36% achieving HbA1C ≤6.5% (Figure 1). Clinically significant (p<0.05) improvements in FPG (–1.9 mmol) and weight (–2.5 kg) were observed. Improvements in β-cell
Peer-Reviewed Highlights of the 48th Annual Meeting of the European Association for the Study of Diabetes
13
Table of Contents for the Digital Edition of MD Conference Express EASD 2012
MD Conference Express EASD 2012
Contents
Understanding Incretin Hormone Action and the Treatment of Diabetes
New ADA/EASD Guidelines Focus on Patient-Centered Care
ORIGIN Trial: Insulin Glargine and n-3 Fatty Acids Fail to Reduce CV Events in Diabetic Patients
Exenatide Once Weekly Sustained Improvement in Glycemic Control with Weight Loss Through 4 Years
DiaPep277® Shows Promise as a Therapeutic Strategy for T1DM
Linagliptin Proves Safe and Effective as Add-on Therapy to Basal Insulin
12-Week Treatment with LY2409021 Significantly Lowers HbA1C and Is Well Tolerated in Patients with T2DM
Insulin Degludec Is Superior to Sitagliptin in Improving Glycemic Control in Uncontrolled Patients with Type 2 Diabetes on Oral Agents
Dapagliflozin Does Not Impact Renal Function in Patients with T2DM
Population-Based Screening for T2DM:The ADDITION-Cambridge Trial
The Challenges of Pharmaceutical Management of Painful Diabetic Peripheral Neuropathy
Enterovirus Infection
Novel Oral Agents
GLP-1
Genetics
Renal Denervation
Hypertension and Renal Function Are Risk Factors for CAD in T1DM
MD Conference Express EASD 2012
https://www.nxtbook.com/nxtbooks/md_conference_express/easd2012
https://www.nxtbookmedia.com