This article is part of Endocrinology Advisor’s coverage of the American Diabetes Association’s 77th Scientific Sessions (ADA 2017), taking place in San Diego, CA. Our staff will report on medical research and technological advances in diabetes and diabetes education, conducted by experts in the field. Check back regularly for more news from ADA 2017.
Data from the GOAL-RCT trial (Randomized Trial Comparing Colesevelam vs Ezetimibe; ClinicalTrials.gov identifier: NCT02682680) showed that when added to statin therapy, colesevelam was noninferior to ezetimibe in the rate of patients who achieved glycated hemoglobin A1c (HbA1c) ≤7% and low-density lipoprotein cholesterol (LDL-C) ≤77.2 mg/dL at 3 months.
The 3-month data also demonstrated that ezetimibe produced greater reductions in LDL-C when compared with colesevelam, whereas colesevelam produced greater reductions in HbA1c.
“Additionally, both colesevelam and ezetimibe are quite well tolerated overall, with a small number of trial subjects discontinuing their study medication due to adverse effects,” study investigator Harpreet S. Bajaj, MD, MPH, of LMC Diabetes and Endocrinology in Brampton, Ontario, Canada, told Endocrinology Advisor.
The results were presented at the American Diabetes Association (ADA) 77th Scientific Sessions, June 9-13, in San Diego, California.
Dr Bajaj said the aim of the GOAL-RCT trial was to fill a current knowledge gap and answer a clinical question regarding the metabolic effects of adding cholesterol lowering therapies to statins in patients with type 2 diabetes who are unable to reach target levels of LDL-C and HbA1c.
“This study is relevant in diabetic dyslipidemia because clinicians often encounter this question of which add-on oral therapy to [use] when LDL targets are not being met with statin monotherapy,” Dr Bajaj said.
The trial included 200 patients with similar baseline characteristics. Overall, mean patient age was 59±10 years, mean HbA1c was 8%, mean LDL-C was 97.2 mg/dL, and 97% of participants were taking statin drugs.
The rate of patients achieving HbA1c ≤7% and LDL-C ≤77.2 mg/dL was the primary end point measure.
At 3 months, data were available for 85 patients in the colesevelam group and 98 patients in the ezetimibe group.
The researchers reported that colesevelam was noninferior to ezetimibe in the primary end point rate (colesevelam, 14% vs ezetimibe, 9.2%).
Furthermore, significantly greater reductions were observed in LDL-C with ezetimibe (–25.2 vs –10.8 mg/dL; P <.01) and in HbA1c with colesevelam (–0.4% vs 0%; P <.01).
A total of 15 patients in the colesevelam group discontinued study treatment vs 6 patients in the ezetimibe group; 7 patients in the colesevelam arm and 5 patients in the ezetimibe arm discontinued because of adverse effects.
According to Dr Bajaj, GOAL-RCT was the first randomized controlled trial to compare colesevelam vs ezetimibe for metabolic efficacy, and that these results can guide endocrinologists and other clinicians on the appropriate choice of second-line options (ie, add-on therapies to statin treatment) in patients with diabetic dyslipidemia.
“The clinical implication of this trial is that this therapy choice should be individualized to the patient, depending on the degree of elevation in LDL and/or [Hb]A1c levels [with regard to] the desired targets for these metabolic parameters.”
Dr Bajaj added that the last study visits for all patients were completed in May, and the researchers hope to submit the final 6-month results for GOAL-RCT to the American Heart Association Scientific Sessions in November.
Disclosures: The researchers report numerous financial disclosures with pharmaceutical manufacturers.
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